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A double-blind, randomized, placebo-controlled trial of the effect of testosterone cream on the sexual motivation of menopausal hysterectomized women with hypoactive sexual desire disorder Testosterone therapy increases sexual desire in ageing men with low–normal testosterone levels and symptoms of androgen deficiency Testosterone dose-response relationships in hysterectomized women with or without oophorectomy: effects on sexual function, body composition, muscle performance and physical function in a randomized trial Effect of testosterone supplementation with and without a dual 5α-reductase inhibitor on fat-free mass in men with suppressed testosterone production: a randomized controlled trial. Effects of testosterone and progressive resistance training in eugonadal men with AIDS wasting. A randomized, controlled trial. Testosterone therapy for human immunodeficiency virus-positive men with and without hypogonadism. Effects of testosterone and resistance training in men with chronic obstructive pulmonary disease. Effects of transdermal testosterone on cognitive function and health perception in older men with low bioavailable testosterone levels. Testosterone Treatment of Men With Mild Cognitive Impairment and Low Testosterone Levels PERCEIVED EFFECTS OF TESTOSTERONE REPLACEMENT THERAPY IN PERIMENOPAUSAL AND POSTMENOPAUSAL WOMEN: AN INTERNET PILOT STUDY Difficulties in measuring the effect of testosterone replacement therapy on muscle function in older men. Effect of testosterone supplementation on functional mobility, cognition, and other parameters in older men: a randomized controlled trial. 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Transdermal testosterone gel improves sexual function, mood, muscle strength, and body composition parameters in hypogonadal men. The Sexual Effects of Testosterone Replacement in Depressed Men: Randomized, Placebo-Controlled Clinical Trial Effects of testosterone on mood, aggression, and sexual behavior in young men: a double-blind, placebo-controlled, cross-over study. Effects of aromatase inhibition on sexual function and well-being in postmenopausal women treated with testosterone: a randomized, placebo-controlled trial Testosterone Gel Replacement Improves Sexual Function in Depressed Men Taking Serotonergic Antidepressants: A Randomized, Placebo-Controlled Clinical Trial Identification of late-onset hypogonadism in middle-aged and elderly men. Effect of Testosterone Solution 2% on Testosterone Concentration, Sex Drive and Energy in Hypogonadal Men: Results of a Placebo Controlled Study. Does oral contraceptive-induced reduction in free testosterone adversely affect the sexuality or mood of women? The relationship between pituitary‐gonadal function and sexual behavior in healthy aging men. Relation of androgen receptor sensitivity and mood to sexual desire in hormonal contraception users. REVERSAL OF URÆMIC IMPOTENCE BY ZINC Testosterone for low libido in postmenopausal women not taking estrogen. Mechanical muscle function and lean body mass during supervised strength training and testosterone therapy in aging men with low-normal testosterone levels. Restoring testosterone levels by adding dehydroepiandrosterone to a drospirenone containing combined oral contraceptive: II. Clinical effects. Effects of hypogonadism and testosterone administration on depression indices in HIV-infected men. Effectiveness of a low dose testosterone undecanoate to improve sexual function in postmenopausal women ABSENCE OF A THERAPEUTIC EFFECT OF ZINC IN THE SEXUAL DYSFUNCTION OF HÆMODIALYSED PATIENTS Effects of physiologic testosterone therapy on quality of life, self-esteem, and mood in women with primary ovarian insufficiency Testosterone treatment improves body composition and sexual function in men with COPD, in a 6-month randomized controlled trial. Effect of estrogen and testosterone replacement therapy on cognitive fatigue Correlates of low testosterone in men with chronic spinal cord injury A comparison of anastrozole and testosterone versus placebo and testosterone for treatment of sexual dysfunction in men with epilepsy and hypogonadism Effects of testosterone administration in human immunodeficiency virus-infected women with low weight: a randomized placebo-controlled study. Testosterone supplementation of megestrol therapy does not enhance lean tissue accrual in men with human immunodeficiency virus-associated weight loss: a randomized, double-blind, placebo-controlled, multicenter trial. Effects of androgen administration on the growth hormone-insulin-like growth factor I axis in men with acquired immunodeficiency syndrome wasting. Randomized controlled trial to evaluate transdermal testosterone in female cancer survivors with decreased libido; North Central Cancer Treatment Group protocol N02C3. Androgen enhances sexual motivation in females: a prospective, crossover study of sex steroid administration in the surgical menopause. Comparative feasibility of implementing rapid diagnostic test and microscopy for parasitological diagnosis of malaria in Uganda Effect of 12 month oral testosterone on testosterone deficiency symptoms in symptomatic elderly males with low-normal gonadal status. Low free testosterone concentration as a potentially treatable cause of depressive symptoms in older men. Testosterone patch for low sexual desire in surgically menopausal women: a randomized trial. Effects of nandrolone decanoate therapy in borderline hypogonadal men with HIV-associated weight loss. Testosterone therapy prevents gain in visceral adipose tissue and loss of skeletal muscle in nonobese aging men. Testosterone replacement in hypogonadal men with angina improves ischaemic threshold and quality of life Comparing effects of low- and high-volume moderate-intensity exercise on sexual function and testosterone in obese men. Effects of muscle strength training and testosterone in frail elderly males. The effects of supraphysiological doses of testosterone on angry behavior in healthy eugonadal men--a clinical research center study. Sex hormones and sexual function in obese men losing weight. Testosterone replacement therapy for hypogonadal men with major depressive disorder: a randomized, placebo-controlled clinical trial. Correlates of low testosterone and symptomatic androgen deficiency in a population-based sample. A pilot study on the effects of testosterone in hypogonadal aging male patients with Alzheimer's disease Effect of raising endogenous testosterone levels in impotent men with secondary hypogonadism: double blind placebo-controlled trial with clomiphene citrate. Safety and efficacy of a testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women: a randomized, placebo-controlled trial. The Effects of Testosterone Supplementation on Cognitive Functioning in Older Men Efficacy of vaginally applied estrogen, testosterone, or polyacrylic acid on sexual function in postmenopausal women: a randomized controlled trial. Effects of transdermal testosterone on bone and muscle in older men with low bioavailable testosterone levels, low bone mass, and physical frailty. The effects of supraphysiologic doses of testosterone on muscle size and strength in normal men. Clinical meaningfulness of the changes in muscle performance and physical function associated with testosterone administration in older men with mobility limitation. Effects of testosterone replacement in hypogonadal men. Exogenous testosterone, aggression, and mood in eugonadal and hypogonadal men ANDROGENS AND SEXUAL BEHAVIOUR IN WOMEN USING ORAL CONTRACEPTIVES Low serum testosterone and mortality in older men. Therapeutic Effects of Nandrolone and Testosterone in Adult Male HIV Patients With AIDS Wasting Syndrome (AWS): A Randomized, Double-Blind, Placebo-Controlled Trial Efficacy and safety of a testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women: a randomized, placebo-controlled trial Diet and sex hormone-binding globulin. Testosterone gel monotherapy improves sexual function of hypogonadal men mainly through restoring erection: evaluation by IIEF score. Longitudinal relation between endogenous testosterone and cardiovascular disease risk factors in middle-aged men. A 13-year follow-up of former Multiple Risk Factor Intervention Trial participants. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. The use of dehydroepiandrosterone in the treatment of hypoactive sexual desire disorder: A report of gender differences Adverse events associated with testosterone administration. Single and combined effects of growth hormone and testosterone administration on measures of body composition, physical performance, mood, sexual function, bone turnover, and muscle gene expression in healthy older men. Effects of transdermal testosterone on bone and muscle in older men with low bioavailable testosterone levels. No effect of oral testosterone treatment on sexual dysfunction in alcoholic cirrhotic men. Effects of testosterone on muscle strength, physical function, body composition, and quality of life in intermediate-frail and frail elderly men: a randomized, double-blind, placebo-controlled study. Effects of Androgen Administration in Men with the AIDS Wasting Syndrome Testosterone therapy increased muscle mass and lipid oxidation in aging men Testosterone replacement and resistance exercise in HIV-infected men with weight loss and low testosterone levels. Effects of testosterone on cognition and mood in male patients with mild Alzheimer disease and healthy elderly men. Oral testosterone supplementation increases muscle and decreases fat mass in healthy elderly males with low-normal gonadal status. Characterization of verbal and spatial memory changes from moderate to supraphysiological increases in serum testosterone in healthy older men Female sexual dysfunction and hormonal status in spinal cord injured (SCI) patients. Long-term testosterone gel (AndroGel) treatment maintains beneficial effects on sexual function and mood, lean and fat mass, and bone mineral density in hypogonadal men. Prospective longitudinal study of testosterone and incident depression in older men: The Health In Men Study Treatment with percutanous testosterone gel in postmenopausal women with decreased libido--effects on sexuality and psychological general well-being. Double-blind placebo-controlled study of testosterone patch therapy on bone turnover in men with borderline hypogonadism. Effects of testosterone on skeletal muscle architecture in intermediate-frail and frail elderly men. Effects of testosterone replacement with a nongenital, transdermal system, Androderm, in human immunodeficiency virus-infected men with low testosterone levels. Decreased testosterone levels in men with rheumatoid arthritis: effect of low dose prednisone therapy. Low serum testosterone and mortality in male veterans. Testosterone Versus Fluoxetine for Depression and Fatigue in HIV/AIDS: A Placebo-Controlled Trial Prevalence of symptomatic androgen deficiency in men. Osteopenia in eugonadal men with acquired immune deficiency syndrome wasting syndrome. Effects of Oral Testosterone Treatment on Myocardial Perfusion and Vascular Function in Men With Low Plasma Testosterone and Coronary Heart Disease Dronabinol and marijuana in HIV+ marijuana smokers: acute effects on caloric intake and mood Long-term benefits of testosterone replacement therapy on angina threshold and atheroma in men. Carnitine versus androgen administration in the treatment of sexual dysfunction, depressed mood, and fatigue associated with male aging. Testosterone patch increases sexual activity and desire in surgically menopausal women with hypoactive sexual desire disorder. Serum testosterone levels and clinical outcomes in male hemodialysis patients. Testosterone replacement for fatigue in hypogonadal ambulatory males with advanced cancer: a preliminary double-blind placebo-controlled trial Cortisol, Testosterone, and Coronary Heart Disease: Prospective Evidence From the Caerphilly Study Testosterone enhances estradiol's effects on postmenopausal bone density and sexuality. Testosterone enhances estradiol's effects on postmenopausal bone density and sexuality. Cognitive decline in women in relation to non-protein-bound oestradiol concentrations Acute haemodynamic effects of testosterone in men with chronic heart failure. Chronic testosterone cypionate therapy in men with secondary impotence. Endogenous Testosterone and Mortality Due to All Causes, Cardiovascular Disease, and Cancer in Men: European Prospective Investigation Into Cancer in Norfolk (EPIC-Norfolk) Prospective Population Study Addition of testosterone to estrogen replacement therapy in oophorectomized women: effects on sexuality and well-being Randomized controlled trial of testosterone in myotonic dystrophy Cost-Effectiveness Analysis of Test-Based versus Presumptive Treatment of Uncomplicated Malaria in Children under Five Years in an Area of High Transmission in Central Ghana Low testosterone is associated with decreased function and increased mortality risk: a preliminary study of men in a geriatric rehabilitation unit. A comparative study of the effects of local estrogen with or without local testosterone on vulvovaginal and sexual dysfunction in postmenopausal women.
INTRODUCTION Endocrine disorders may adversely affect men 's sexual function . AIM To provide recommendations based on best evidence for diagnosis and treatment of endocrine-related male sexual dysfunctions .  METHODS The Endocrine Aspects of Male Sexual Dysfunctions Committee , including 11 members from eight countries and four continents , collaborated with the Endocrine subcommittee of the St and ards Committee of the International Society for Sexual Medicine . Medical literature was review ed in detail , followed by extensive internal committee discussion over 2 years , then public presentation and discussion with the other experts before finalizing the report . MAIN OUTCOME MEASURE Recommendations based on grading of evidence -base medical literature and interactive discussion . RESULTS From animal studies , it is derived that testosterone modulates mechanisms involved in erectile machinery , including expression of enzymes that both initiate and terminate erection . In addition , testosterone is essential for sexual motivation . Whether these findings could be extrapolated to human erections is unclear . Testosterone plays a broad role in men 's overall health . Recent studies have established strong associations between low testosterone and metabolic and cardiovascular imbalances . In some studies , low testosterone decreased longevity ; however , longitudinal studies do not support the predictive value of low testosterone for further cardiovascular events . The article proposes a st and ardized process for diagnosis and treatment of endocrine-related male sexual dysfunctions , updating the knowledge on testosterone and prostate safety . There is no compelling evidence that testosterone treatment causes prostate cancer or its progression in men without severe testosterone deficiency ( TD ) . The possible roles of prolactin and thyroid hormones are also examined . CONCLUSIONS Men with erectile dysfunction , hypoactive sexual desire and retarded ejaculation  , as well as those with visceral obesity and metabolic diseases , should be screened for TD and treated . Prospect i ve interventional studies are required before screening for TD in more conditions , including cardiovascular diseases , and considering correction as preventive medicine as much data suggests BACKGROUND The goal was to evaluate the efficacy of testosterone in alleviation of hypogonadal symptoms ( diminished libido , depressed mood , low energy , and depleted muscle mass ) in men with symptomatic human immunodeficiency virus illness . METHODS Seventy-four patients were enrolled in a double-blind , placebo-controlled 6-week trial with bi-weekly testosterone injections , followed by 12 weeks of open-label maintenance treatment . Major outcome measures were Clinical Global Impressions Scale ratings for libido , mood , energy , and erectile function ; Hamilton Depression Rating Scale scores , and Chalder Fatigue Scale scores . Body composition changes were assessed with bioelectric impedance analysis . RESULTS Seventy men completed the 6-week trial . Response rates , defined as much or very much improved libido , were 74 % ( 28/38 ) for patients r and omized to testosterone , and 19 % ( 6/32 ) for placebo-treated patients ( P<.001 ) . Of the 62 completers with fatigue at baseline , 59 % ( 20/34 ) receiving testosterone and 25 % ( 7/28 ) receiving placebo reported improved energy ( P<.01 ) . Among the 26 completers with an Axis I depressive disorder at baseline , 58 % of the testosterone-treated patients reported improved mood compared with 14 % of placebo-treated patients ( Fisher exact test = .08 ) . With testosterone treatment , average increase in muscle mass over 12 weeks was 1.6 kg for the whole group , and 2.2 kg for the 14 men with wasting at baseline . Improvement on all parameters was maintained during subsequent open-label treatment for up to 18 weeks . CONCLUSION Testosterone is well tolerated and effective in the short-term treatment of symptoms of clinical hypogonadism in men with symptomatic human immunodeficiency virus illness , restoring libido and energy , alleviating depressed mood , and increasing muscle mass Despite the widespread use of and rogen in the treatment of hypogonadal men , its efficacy in restoring sexual behavior to hypogonadal patients has not been established in appropriately controlled behavioral studies . Accordingly , testosterone enanthate or vehicle was injected once every 4 weeks i m in a double blind experiment . The subjects were six adult males , aged 32 - 65 yr , two with gonadal failure and four with secondary hypogonadism . Two doses of testosterone ( 100 and 400 mg ) were administered for approximately 5 months , with the treatments varied at r and om within and among subjects . Details of sexual activity and experience were followed by the use of daily logs . Frequencies of erections , including nocturnal erections and coitus , showed significant dose-related responses to and rogen treatment which closely followed the fluctuations in the circulating testosterone level . As indicated by the Profile of Mood States test , behavioral responses did not appear to be mediated by changes in mood . We concluded that the stimulatory effects of testosterone on sexual activity are rapid , reliable , and not due to a placebo effect . To maintain plasma testosterone and adequate sexual function within normal levels , even high doses of testosterone enanthate should be given no less frequency than once every 3 weeks Testosterone increases fat-free mass ( FFM ) in men infected with human immunodeficiency virus ( HIV ) , but its effects on muscle performance , physical function , mood , and quality of life are poorly understood . Sixty-one HIV-infected men with weight loss were r and omized to receive weekly intramuscular injections of 300 mg of testosterone enanthate or placebo for 16 wk . The primary outcome of interest was physical function ( walking speed , stair-climbing power , and load-carrying ability ) . Secondary outcome measures included body weight and composition , muscle performance , sexual function , mood , and quality of life . Serum nadir free and total testosterone levels increased ( + 188.0 + /- 29.6 and + 720 + /- 86 ng/dl ) in the testosterone , but not placebo , group . Testosterone administration was associated with increased FFM ( 2.8 + /- 0.5 kg ) , which was significantly greater than in the placebo group ( P < 0.0001 ) . Leg press strength increased significantly in testosterone-treated ( P = 0.027 ) , but not placebo-treated , men ; the difference between groups was not significant . Other measures of muscle performance and physical function did not change significantly in either group . Men receiving testosterone demonstrated significantly greater improvements in mental health and quality -of-life scores than those receiving placebo and improvements in fatigue/energy and mood scores that were not significantly different from those receiving placebo .  Sexual function scores did not change in either group . In HIV-infected men with weight loss , a supraphysiological dose of testosterone significantly increased FFM but did not improve self-reported or performance-based measures of physical function . Improvements in mood , fatigue , and quality -of-life measures in the testosterone group , although clinical ly important , need further confirmation Testosterone increases muscle mass and strength and regulates other physiological processes , but we do not know whether testosterone effects are dose dependent and whether dose requirements for maintaining various and rogen-dependent processes are similar . To determine the effects of grade d doses of testosterone on body composition , muscle size , strength , power , sexual and cognitive functions , prostate-specific antigen ( PSA ) , plasma lipids , hemoglobin , and insulin-like growth factor I ( IGF-I ) levels , 61 eugonadal men , 18 - 35 yr , were r and omized to one of five groups to receive monthly injections of a long-acting gonadotropin-releasing hormone ( GnRH ) agonist , to suppress endogenous testosterone secretion , and weekly injections of 25 , 50 , 125 , 300 , or 600 mg of testosterone enanthate for 20 wk . Energy and protein intakes were st and ardized . The administration of the GnRH agonist plus grade d doses of testosterone result ed in mean nadir testosterone concentrations of 253 , 306 , 542 , 1,345 , and 2,370 ng/dl at the 25- , 50- , 125- , 300- , and 600-mg doses , respectively . Fat-free mass increased dose dependently in men receiving 125 , 300 , or 600 mg of testosterone weekly ( change + 3.4 , 5.2 , and 7.9 kg , respectively ) . The changes in fat-free mass were highly dependent on testosterone dose ( P = 0.0001 ) and correlated with log testosterone concentrations ( r = 0.73 , P = 0.0001 ) . Changes in leg press strength , leg power , thigh and quadriceps muscle volumes , hemoglobin , and IGF-I were positively correlated with testosterone concentrations , whereas changes in fat mass and plasma high-density lipoprotein ( HDL ) cholesterol were negatively correlated . Sexual function , visual-spatial cognition and mood , and PSA levels did not change significantly at any dose . We conclude that changes in circulating testosterone concentrations , induced by GnRH agonist and testosterone administration , are associated with testosterone dose- and concentration-dependent changes in fat-free mass , muscle size , strength and power , fat mass , hemoglobin , HDL cholesterol , and IGF-I levels , in conformity with a single linear dose-response relationship . However , different and rogen-dependent processes have different testosterone dose-response relationships Abstract Background : Testosterone decline becomes more prevalent as men age and symptomatic testosterone deficiency is associated with potentially serious comorbidities . Despite limitations , registries can provide an opportunity to accumulate data regarding disease management in a typical patient population , including diagnosis , treatment , and outcomes . Material s and Methods : The Testim Registry in the United States ( TRiUS ) was a prospect i ve , 12-month , observational cohort registry of men prescribed Testim ® ( 1 % testosterone gel ; Auxilium Pharmaceuticals , Inc. ) for the first time ; patients previously on other forms of testosterone replacement therapy ( TRT )  were eligible to participate in the study as well . The registry recorded total testosterone ( TT ) and free testosterone ( FT ) levels , prostate-specific antigen ( PSA ) , sexual function , mood/depression , and cardiometabolic and anthropometric criteria before and after TRT . Changes over time were analyzed by analysis of variance , and linear regression and Pearson product-moment correlation coefficients were used to examine relationships between variables . Results : At baseline , 849 patients from 72 sites were enrolled , with 743 of 849 started on 5 g gel/day ( 50 mg testosterone/day ) and 106 of 849 started on 10 g gel/day ( 100 mg testosterone/day ) . Mean TT and FT levels increased significantly after 3 months of TRT ( TT level , 16.8 ± 9.87 nmol/L [ 485 ± 284 ng/dL ] , P < 0.001 ; FT level , 286.3 ± 224.9 pmol/L [ 82.5 ± 64.8 pg/mL ] , P < 0.001 ) and were maintained at eugonadal levels . Mean PSA levels increased significantly ( P = 0.004 ) from 1.12 ± 1.11 μg/L ( 1.12 + 1.11 ng/mL ) at baseline to 1.26 ± 1.22 μg/L ( 1.26 ± 1.22 ng/mL ) after 12 months of TRT , although changes were well within guidelines ( < 1.4 μg/L/year increase ) . Significant improvements were seen in sexual function and mood/depression at 3 months and in metabolic parameters at 12 months . Conclusion : Testosterone deficiency symptoms improved with TRT use in men ; sexual function and mood/depression improvements were seen before metabolic improvements . Prostate-specific antigen levels increased , although increases were within guideline -determined safety limits OBJECTIVES The effects of supplemental testosterone on cognition , mood and wellbeing in ageing men are unclear . This study aim ed to assess the effect of 12-months of oral testosterone supplementation on cognitive function , mood and quality of life in elderly men with low-normal gonadal status , not specifically selected for cognitive or mood defects . METHODS A st and ard oral dose ( 80 mg twice daily ) of testosterone undecanoate ( TU ) or placebo was administered for one year to 76 healthy men 60 years or older . All men had a free testosterone index ( FTI ) of 0.3 - 0.5 , which represents a value below the normal lower limit for young men ( 19 - 30 years ) , but remains within the overall normal male range . A neuropsychological assessment including the trail making test ( part B ) , visuospatial ( VSP ) block design test , mini mental state exam ( MMSE ) , Geriatric Depression Scale ( GDS ) , a 5-point Likert and a 10-point visual analogue quality of life ( QoL ) scale , along with serum hormone measurements were obtained at baseline , 6 , and 12 months . RESULTS Although calculated bioavailable testosterone ( cBT ) and FTI were higher , and muscle mass increased after 12 months , there was no difference in scores on the trail making or VSP block tests , the MMSE , GDS or either of the QoL scales between the testosterone and placebo group . There was no relationship between baseline cBT or FTI and treatment effect for any of the outcome measures . CONCLUSIONS 12-month supplementation with oral TU does not affect scores on visuospatial tests or mood and quality of life scales in older men with low-normal gonadal status Objective Circulating testosterone in women declines during the late reproductive years such that otherwise healthy women in their 40s have approximately half the testosterone level as women in their 20s . Despite this , research showing the benefits of and rogen replacement has been limited to the postmenopausal years . In view of the known premenopausal physiological decline in testosterone , we have evaluated the efficacy of transdermal testosterone therapy on mood , well-being , and sexual function in eugonadal , premenopausal women presenting with low libido . Design Premenopausal women with low libido participated in a r and omized , placebo-controlled , crossover , efficacy study of testosterone cream ( 10 mg/day ) with two double-blind , 12-week , treatment periods separated by a single-blind , 4-week , washout period . Results Thirty-four women completed the study per protocol , with 31 women ( mean age 39.7 ± 4.2 years ; serum testosterone 1.07 + 0.50 nmol/L ) providing complete data  . Testosterone therapy result ed in statistically significant improvements in the composite scores of the Psychological General Well-Being Index [ + 12.9 ( 95 % CI , + 4.6 to + 21.2 ) , P = 0.003 ] and the Sabbatsberg Sexual Self-Rating Scale [ + 15.7 ( 95 % CI , + 6.5 to + 25.0 ) , P = 0.001 ] compared with placebo . A mean decrease in the Beck Depression Inventory score approached significance [ −2.8 ( 95 % CI , −5.7 to + 0.1 ) , P = 0.06 ] . Mean total testosterone levels during treatment were at the high end of the normal range , and estradiol was unchanged . No adverse effects were reported . Conclusions Testosterone therapy  improves well-being , mood , and sexual function in premenopausal women with low libido and low testosterone . As a substantial number of women experience diminished sexual interest and well-being during their late reproductive years , further research is warranted to evaluate the benefits and safety of longer-term intervention Testosterone plays a role in the organization of behavior during development . The authors examined whether testosterone could play a maintenance role in behavior as well . In a double-blind manner , verbal and visual memory , spatial cognition , motor speed , cognitive flexibility , and mood in a group of healthy older men who were supplemented for 3 months with testosterone  were assessed . The increase in testosterone levels to 150 % of baseline levels result ed in a significant enhancement of spatial cognition , but no change in any other cognitive domain was found . Testosterone supplementation influenced the endogenous production of estradiol , and estradiol was found to have an inverse relationship to spatial cognitive performance . These results suggest that testosterone supplementation can modify spatial cognition in older men ; however , it is likely that this occurs through testosterone 's influence on estrogen The effects of supraphysiological levels of testosterone , used for male contraception , on sexual behavior and mood were studied in a single-blind , placebo-controlled manner in a group of 31 normal men . After 4 weeks of baseline observations , the men were r and omized into two groups : one group received 200 mg testosterone enanthate ( TE ) weekly by i m injection for 8 weeks ( Testosterone Only group ) , the other received placebo injections once weekly for the first 4 weeks followed by TE 200 mg weekly for the following 4 weeks ( Placebo/Testosterone group ) . The testosterone administration increased trough plasma testosterone levels by 80 % , compatible with peak testosterone levels 400 - 500 % above baseline . Various aspects of sexuality were assessed using sexuality experience scales ( SES ) question naires at the end of each 4-week period while sexual activity and mood states were recorded by daily dairies and self-rating scales . In both groups there was a significant increase in scores in the Psychosexual Stimulation Scale of the SES ( i.e. SES 2 ) following testosterone administration , but not with placebo . There were no changes in SES 3 , which measures aspects of sexual interaction with the partner . In both groups there were no changes in frequency of sexual intercourse , masturbation , or penile erection on waking nor in any of the moods reported . The Placebo/Testosterone group showed an increase in self-reported interest in sex during testosterone treatment but not with placebo . The SES 2 results suggest that sexual awareness and arousability can be increased by supraphysiological levels of testosterone . However , these changes are not reflected in modifications of overt sexual behavior , which in eugonadal men may be more determined by sexual relationship factors . This contrasts with hypogonadal men , in whom testosterone replacement clearly stimulates sexual behavior . There was no evidence to suggest an alteration in any of the mood states studied , in particular those associated with increased aggression . We conclude that supraphysiological levels of testosterone maintained for up to 2 months can promote some aspects of sexual arousability without stimulating sexual activity in eugonadal men within stable heterosexual relationships . Raising testosterone does not increase self-reported ratings of aggressive feelings This double-blind placebo controlled , cross-over study was carried out to assess the effect of testosterone administration on sexual behavior mood , and psychological symptoms in healthy men with erectile dysfunction . Biweekly injections of 200 mg of testosterone enanthate were given over a period of 6 weeks separated by a washout period of 4 weeks . Blood sample s for hormonal assessment , behavioral and psychological ratings were obtained prior to each injection . Luteinizing hormone remained significantly depressed but circulating testosterone had returned to baseline levels by 2 weeks following each hormonal injection . The ejaculatory frequency during the testosterone phase was statistically higher than during the placebo phase . There were marked , although statistically nonsignificant , increases in median frequency of reported sexual desire , masturbation , sexual experiences with partner , and sleep erections during the testosterone period . Testosterone did not have demonstrable effects on ratings of penile rigidity and sexual satisfaction . Mood variables and psychological symptoms did not change following hormonal administration . Results suggest that and rogen administration to eugonadal men with erectile dysfunction may activate their sexual behavior without enhancing erectile capacity and without effects on mood and psychological symptoms IMPORTANCE Testosterone use in older men is increasing , but its long-term effects on progression of atherosclerosis are unknown . OBJECTIVE To determine the effect of testosterone administration on sub clinical atherosclerosis progression in older men with low or low-normal testosterone levels . DESIGN , SETTING , AND PARTICIPANTS Testosterone 's Effects on Atherosclerosis Progression in Aging Men ( TEAAM ) was a placebo-controlled , double-blind , parallel-group r and omized trial involving 308 men 60 years or older with low or low-normal testosterone levels ( 100 - 400 ng/dL ; free testosterone < 50 pg/mL ) , recruited at 3 US centers . Recruitment took place between September 2004 and February 2009 ; the last participant completed the study in May 2012 . INTERVENTIONS One hundred fifty-six participants were r and omized to receive 7.5 g of 1 % testosterone and 152 were r and omized  to receive placebo gel packets daily for 3 years . The dose was adjusted to achieve testosterone levels between 500 and 900 ng/dL. MAIN OUTCOMES AND MEASURES Co primary outcomes included common carotid artery intima-media thickness and coronary artery calcium ; secondary outcomes included sexual function and health-related quality of life . RESULTS Baseline characteristics were similar between groups : patients were a mean age of 67.6 years ; 42 % had hypertension ; 15 % , diabetes ; 15 % , cardiovascular disease ; and 27 % , obesity . The rate of change in intima-media thickness was 0.010 mm/year in the placebo group and 0.012 mm/year in the testosterone group ( mean difference adjusted for age and trial site , 0.0002 mm/year ; 95 % CI , -0.003 to 0.003 , P = .89 ) . The rate of change in the coronary artery calcium score was 41.4 Agatston units/year in the placebo group and 31.4 Agatston units/year in the testosterone group ( adjusted mean difference , -10.8 Agatston units/year ; 95 % CI , -45.7 to 24.2 ; P = .54 ) . Changes in intima-media thickness or calcium scores were not associated with change in testosterone levels among individuals assigned to receive testosterone . Sexual desire , erectile function , overall sexual function scores , partner intimacy , and health-related quality of life did not differ significantly between groups . Hematocrit and prostate-specific antigen levels increased more in testosterone group . CONCLUSIONS AND RELEVANCE Among older men with low or low-normal testosterone levels , testosterone administration for 3 years vs placebo did not result in a significant difference in the rates of change in either common carotid artery intima-media thickness or coronary artery calcium nor did it improve overall sexual function or health-related quality of life . Because this trial was only powered to evaluate atherosclerosis progression , these findings should not be interpreted as establishing cardiovascular safety of testosterone use in older men . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00287586 AIM Symptomatic late-onset hypogonadism is associated not only with a decline in serum testosterone , but also with a rise in serum estradiol . These endocrine changes negatively affect libido , sexual function , mood , behavior , lean body mass , and bone density . Currently , the most common treatment is exogenous testosterone therapy . This treatment can be associated with skin irritation , gynecomastia , nipple tenderness , testicular atrophy , and decline in sperm counts . In this study we investigated the efficacy of clomiphene citrate in the treatment of hypogonadism with the objectives of raising endogenous serum testosterone ( T ) and improving the testosterone/estrogen ( T/E ) ratio . METHODS Our cohort consisted of 36 Caucasian men with hypogonadism defined as serum testosterone level less than 300 ng/dL. Each patient was treated with a daily dose of 25 mg clomiphene citrate and followed prospect ively . Analysis of baseline and follow-up serum levels of testosterone and estradiol levels were performed . RESULTS The mean age was 39 years , and the mean pretreatment testosterone and estrogen levels were 247.6 + /- 39.8 ng/dL and 32.3 + /- 10.9 , respectively . By the first follow-up visit ( 4 - 6 weeks ) , the mean testosterone level rose to 610.0 + /- 178.6 ng/dL ( P < 0.00001 ) . Moreover , the T/E ratio improved from 8.7 to 14.2 ( P < 0.001 ) . There were no side effects reported by the patients . CONCLUSIONS Low dose clomiphene citrate is effective in elevating serum testosterone levels and improving the testosterone/estradiol ratio in men with hypogonadism . This therapy represents an alternative to testosterone therapy by stimulating the endogenous and rogen production pathway Objectives To assess the safety and efficacy of 10 mg topical testosterone therapy daily ( 2 cm And ro-Feme ® cream ) as a treatment for low sexual desire in postmenopausal hysterectomized women who were already on transdermal estrogen . Methods A double-blind , r and omized , placebo-controlled , cross-over study ( each period being of 3 months ' duration ) was performed in the research center of a tertiary referral women 's hospital . Thirty-six menopausal healthy women were recruited who had undergone a hysterectomy , who were not depressed , were in a stable relationship and who fulfilled diagnostic criteria for low sexual desire , as measured by the Brief Index of Sexual Function for Women ( BISF-W ) . Main outcome measures The primary outcome measure was improvement in the sexuality score as measured by a vali date d tool ( BISF-W ) ; secondary measures were sub-scores of the BISF-W , effect on mood and energy , lipids and testosterone levels .  Results Testosterone cream significantly improved sexual desire , frequency of sex , receptivity and initiation as measured by the BISF-W score . It did not change mood , energy , lipids , blood pressure or weight over the study period . Conclusions Testosterone cream significantly improved sexual scores in menopausal women with low sexual desire . It was effective , easy to use and had no side-effects over the 3-month period of active treatment . It offers a novel and acceptable method of administering testosterone to menopausal women Although decline in sexual function is a common reason for ageing men to seek advice regarding testosterone therapy , placebo-controlled trial data have been unable to show a consistent , beneficial role for testosterone . The objective of this study was to determine the effect of testosterone therapy on sexual function in non-obese ageing men with symptoms of and rogen deficiency and low – normal serum testosterone levels . A total of 60 men aged 55 years or older in good general health with total testosterone ( TT ) levels < 15 nM , and with symptoms suggestive of and rogen deficiency , were r and omized in a double-blinded protocol to transdermal testosterone patches or placebo for 12 months  . Sexual function was assessed using the International Index of Erectile Function at weeks 0 , 26 and 52 . In men receiving testosterone TT levels increased by 30 % ( P=0.01 ) and luteinizing hormone decreased by 50 % ( P<0.001 ) . Relative to placebo , testosterone therapy improved sexual desire ( P=0.04 ) ; however other parameters of sexual function including erectile function were unaffected by the treatment . Ageing men in good general health and with symptoms of and rogen deficiency and low – normal serum testosterone levels receiving 12 months of transdermal testosterone therapy experienced , relative to placebo , improved sexual desire but no effect on other parameters of sexual function Objective This study aims to determine the dose-dependent effects of testosterone on sexual function , body composition , muscle performance , and physical function in hysterectomized women with or without oophorectomy . Methods Seventy-one postmenopausal women who previously underwent hysterectomy with or without oophorectomy and had total testosterone levels less than 31 ng/dL or free testosterone levels less than 3.5 pg/mL received a st and ardized transdermal estradiol regimen during the 12-week run-in period and were r and omized to receive weekly intramuscular injections of placebo or 3 , 6.25 , 12.5 , or 25 mg of testosterone enanthate for 24 weeks .  Total and free testosterone levels were measured by liquid chromatography – t and em mass spectrometry and equilibrium dialysis , respectively . The primary outcome was change in sexual function measured by the Brief Index of Sexual Functioning for Women . Secondary outcomes included changes in sexual activity , sexual distress , Derogatis Interview for Sexual Functioning , lean body mass , fat mass , muscle strength and power , and physical function .  Results Seventy-one women were r and omized ; five groups were similar at baseline . Sixty-two women with analyzable data for the primary outcome were included in the final analysis . The mean on-treatment total testosterone concentrations were 19 , 78 , 102 , 128 , and 210 ng/dL in the placebo , 3-mg , 6.25-mg , 12.5-mg , and 25-mg groups , respectively . Changes in composite Brief Index of Sexual Functioning for Women scores , thoughts/desire , arousal , frequency of sexual activity , lean body mass , chest-press power , and loaded stair-climb power were significantly related to increases in free testosterone concentrations ; compared with placebo , changes were significantly greater in women assigned to the 25-mg group , but not in women in the lower-dose groups . Sexual activity increased by 2.7 encounters per week in the 25-mg group . The frequency of and rogenic adverse events was low . Conclusions Testosterone administration in hysterectomized women with or without oophorectomy for 24 weeks was associated with dose and concentration-dependent gains in several domains of sexual function , lean body mass , chest-press power , and loaded stair-climb power . Long-term trials are needed to weigh improvements in these outcomes against potential long-term adverse effects CONTEXT Steroid 5α-reductase inhibitors are used to treat benign prostatic hyperplasia and and rogenic alopecia , but the role of 5α-dihydrotestosterone ( DHT ) in mediating testosterone 's effects on muscle , sexual function , erythropoiesis , and other and rogen-dependent processes remains poorly understood . OBJECTIVE To determine whether testosterone 's effects on muscle mass , strength , sexual function , hematocrit level , prostate volume , sebum production , and lipid levels are attenuated when its conversion to DHT is blocked by dutasteride ( an inhibitor of 5α-reductase type 1 and 2 ) . DESIGN , SETTING , AND PATIENTS The 5α-Reductase Trial was a r and omized controlled trial of healthy men aged 18 to 50 years comparing placebo plus testosterone enthanate with dutasteride plus testosterone enanthate from May 2005 through June 2010 . INTERVENTIONS Eight treatment groups received 50 , 125 , 300 , or 600 mg/wk of testosterone enanthate for 20 weeks plus placebo ( 4 groups ) or 2.5 mg/d of dutasteride ( 4 groups ) . MAIN OUTCOME MEASURES The primary outcome was change in fat-free mass ; secondary outcomes : changes in fat mass , muscle strength , sexual function , prostate volume , sebum production , and hematocrit and lipid levels . RESULTS A total of 139 men were r and omized ; 102 completed the 20-week intervention . Men assigned to dutasteride were similar at baseline to those assigned to placebo . The mean fat-free mass gained by the dutasteride groups was 0.6 kg ( 95 % CI , -0.1 to 1.2 kg ) when receiving 50 mg/wk of testosterone enanthate , 2.6 kg ( 95 % CI , 0.9 to 4.3 kg ) for 125 mg/wk , 5.8 kg ( 95 % CI , 4.8 to 6.9 kg ) for 300 mg/wk , and 7.1 kg ( 95 % CI , 6.0 to 8.2 kg ) for 600 mg/wk . The mean fat-free mass gained by the placebo groups was 0.8 kg ( 95 % CI , -0.1 to 1.7 kg ) when receiving 50 mg/wk of testosterone enanthate , 3.5 kg ( 95 % CI , 2.1 to 4.8 kg ) for 125 mg/wk , 5.7 kg ( 95 % CI , 4.8 to 6.5 kg ) for 300 mg/wk , and 8.1 kg ( 95 % CI , 6.7 to 9.5 kg ) for 600 mg/wk . The dose-adjusted differences between the dutasteride and placebo groups for fat-free mass were not significant ( P = .18 ) . Changes in fat mass , muscle strength , sexual function , prostate volume , sebum production , and hematocrit and lipid levels did not differ between groups . CONCLUSION Changes in fat-free mass in response to grade d testosterone doses did not differ in men in whom DHT was suppressed by dutasteride from those treated with placebo , indicating that conversion of testosterone to DHT is not essential for mediating its anabolic effects on muscle . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00493987 BACKGROUND Substantial loss of muscle mass occurs among men with AIDS wasting . OBJECTIVE To investigate the independent effects of testosterone therapy and progressive resistance training in eugonadal men with AIDS wasting . DESIGN R and omized , controlled trial . SETTING University hospital . PATIENTS 54 eugonadal men with AIDS wasting ( weight < 90 % ideal body weight or weight loss > 10 % ) . INTERVENTION In a 2 x 2 factorial design , patients were assigned to receive testosterone enanthate ( 200 mg/wk ) or placebo injections and progressive resistance training ( three times weekly ) or no training for 12 weeks . MEASUREMENTS Cross-sectional muscle area and other indices of muscle mass . RESULTS Cross-sectional muscle area increased in response to training compared with nontraining ( change in arm muscle mass , 499 + /- 349 mm2 vs. 206 + /- 264 mm2 [ P = 0.004 ] ; change in leg muscle mass , 1106 + /- 854 mm2 vs. 523 + /- 872 mm2 [ P = 0.045 ] ) and in response to testosterone therapy compared with placebo ( change in arm muscle mass , 512 + /- 371 mm2 vs. 194 + /- 215 mm2 [ P < 0.001 ] ; change in leg muscle mass , 1,236 + /- 881 mm2 vs. 399 + /- 729 mm2 [ P = 0.002 ] ) . Levels of high-density lipoprotein cholesterol decreased in response to testosterone therapy compared with placebo ( -0.03 + /- 0.13 mmol/L vs. 0.05 + /- 0.13 mmol/L [ -1 + /- 5 mg/dL vs. 2 + /- 5 mg/dL ] ; P= 0.011 ) and increased in response to training compared with nontraining ( 0.05 + /- 0.13 mmol/L vs. 0.00 + /- 0.16 mmol/L [ 2 + /- 5 mg/dL vs. 0 + /- 6 mg/dL ] ; P = 0.052 ) . CONCLUSIONS In contrast to anabolic therapies that may have adverse effects on metabolic variables , supervised exercise effectively increases muscle mass and is associated with significant positive health benefits in eugonadal men with AIDS wasting This study was design ed to evaluate the safety and effectiveness of testosterone therapy for clinical symptoms of hypogonadism ( low libido , low mood , low energy , loss of appetite/weight ) in human immunodeficiency virus-positive men with CD4 cell counts less than 400 cells/mm3 and deficient or low normal serum testosterone levels . The trial consisted of 8 weeks of open treatment with 400 mg of intramuscular testosterone cypionate biweekly . Responders were maintained at this dosage for another 4 weeks and then were r and omized in a double-blind , placebo-controlled , 6-week discontinuation trial . Of the 112 men who completed at least 8 weeks of treatment , 102 ( 91 % ) were rated as responders on a global assessment of sexual desire/function .  Of the 34 study completers with major depressive disorder and /or dysthymia , 79 % reported significant improvement in mood at week 8 . Average weight change was a gain of 3.7 pounds , with 45 % gaining more than 5 pounds . Eighty-four men entered and 77 completed the double-blind phase ; of these , 78 % of completers r and omized to testosterone and 13 % r and omized to placebo maintained their response . No significant medical or immunologic adverse effects were identified . Testosterone therapy was well tolerated and effective in ameliorating symptoms of clinical hypogonadism , and equally so for men with and without testosterone deficiency . For patients with major depression and /or dysthymia , improvement was equal to that achieved with st and ard antidepressants Dysfunction of the muscles of ambulation contributes to exercise intolerance in chronic obstructive pulmonary disease ( COPD ) . Men with COPD have high prevalence of low testosterone levels , which may contribute to muscle weakness . We determined effects of testosterone supplementation ( 100 mg of testosterone enanthate injected weekly ) with or without resistance training ( 45 minutes three times weekly ) on body composition and muscle function in 47 men with COPD ( mean FEV(1 ) = 40 % predicted ) and low testosterone levels ( mean = 320 ng/dl ) . Subjects were r and omized to 10 weeks of placebo injections + no training , testosterone injections + no training , placebo injections + resistance training , or testosterone injections + resistance training . Testosterone injections yielded a mean increase of 271 ng/dl in the nadir serum testosterone concentration ( to the middle of the normal range for young men ) . The lean body mass ( by dual-energy X-ray absorptiometry ) increase averaged 2.3 kg with testosterone alone and 3.3 kg with combined testosterone and resistance training ( p < 0.001 ) . Increase in one-repetition maximum leg press strength averaged 17.2 % with testosterone alone , 17.4 % with resistance training alone , and 26.8 % with testosterone + resistance training ( p < 0.001 ) . Interventions were well tolerated with no abnormalities in safety measures . Further studies are required to determine long-term benefits of adding testosterone supplementation and resistance training to rehabilitative programs for carefully screened men with COPD and low testosterone levels BACKGROUND Many men older than 50 years have bioavailable testosterone levels below the reference range for young adult men . The impact of the decreased and rogen levels on cognition and health perception has received little attention . METHODS Sixty-seven men ( mean age 76 + /- 4 years , range 65 - 87 ) with bioavailable testosterone levels below 128 ng/dl ( lower limit for adult normal range ) were r and omized to receive transdermal testosterone ( 2 - 2.5 mg patches/d ) or placebo patches for 1 year . All men received 500 mg supplemental calcium and 400 IU vitamin D. Outcome measures included sex hormones [ testosterone , bioavailable testosterone , sex hormone binding globulin ( SHBG ) , estradiol , and estrone ] , cognitive tests ( Digit Symbol , Digit Span , Trailmaking A and B ) , health perception ( Medical Outcome Survey Short-form 36 or SF-36 ) , lower extremity muscle strength and power , and calcium intake . RESULTS Twenty-three men ( 34 % ) withdrew from the study ; 44 men completed the trial .  Bioavailable testosterone levels increased from 93 + /- 34 ( SD ) to 162 + /- 100 ng/dl ( p < .002 ) at 12 months in the testosterone group ( n = 24 ) while no change occurred in the control group ( n = 20 ) . While there was no change in estradiol levels in either group , estrone levels increased in the testosterone group ( 28 + /- 7 to 32 + /- 9 pg/dl , p = .017 ) . Scores on the Digit Symbol test improved in both the testosterone and placebo groups . Scores on Trailmaking B improved in men treated with testosterone ( p < .005 ) , although the changes were not statistically different from the changes seen in the placebo group . Twelve-month scores on Trailmaking B for the entire group were correlated with 12-month testosterone levels ( p = .016 ) . Scores for health perception measured by SF-36 did not change significantly , though scores of mental and general health declined in both groups during the 12-month intervention . Twelve-month bioavailable testosterone scores were directly correlated with scores for physical role ( p = .022 ) , vitality ( p = .036 ) , and the physical composite score ( p = .010 ) . CONCLUSIONS Transdermal testosterone treatment in men with low bioavailable testosterone levels does not impair and may improve cognitive function . Treatment did not improve health perception but this may have been due to the side effects of skin irritation suggested by similar reactions in both the testosterone and placebo groups Introduction : This study investigated the effects of testosterone ( T ) treatment on cognition , mood , and quality of life in men with mild cognitive impairment ( MCI ) and low serum T levels . Methods : A total of 351 community-dwelling men were screened , and 37 men evidence d both MCI and low T of whom 27 agreed for further screening . Twenty-two met all the study inclusion /exclusion criteria and enrolled in a 6-month r and omized , double-blind , placebo-controlled study . Results : Total T levels significantly increased in the T treatment group . No significant changes were observed in measures of cognition , mood , or quality of life other than improvement in 1 objective measure of verbal memory ( P < .05 ) and decreased depression symptoms ( P < .02 ) in the treatment group . Conclusions : Testosterone treatment may modestly improve verbal memory and depression symptoms in men with both MCI and low Women experience somatic , mood , energy , and libido changes during menopause .  Testosterone replacement therapy is being prescribed in conjunction with estrogen replacement therapy ( ERT ) for these symptoms . Little is known about women ’s perceptions of the benefits and risks of testosterone , so an Internet survey was conducted to elicit women ’s perceptions of the effects on mood , energy , sexuality , and somatic symptoms .  A sample of 61 women primarily from the United States and Canada participated in the survey ; one woman from Germany and one from Sweden also took part in the survey . Participants reported significantly improved sexuality and improved mood and vigor , with a decline in fatigue . Of the 7 somatic complaints assessed , improvements were noted in 5 ( sleep disturbances , hot flashes , night sweats , vaginal dryness , and appetite ) . A prospect i ve clinical trial is needed to confirm these results Muscle wasting in older men may be related to and rogen deficiency . We have assessed the effect of testosterone replacement therapy on muscle function in the upper and lower limbs of older ( age > 60 years ) men with blood testosterone levels < 14 nmol/L. Subjects ( n = 7 per group ) received testosterone enanthate 200 mg i.m . or placebo every 2 weeks in a double blind study over a 12-week period and underwent muscle testing every 4 weeks . A significant increase in blood levels of testosterone and a reduction in levels of sex hormone binding globulin occurred in the treatment group . Total body mass , haemoglobin and packed cell volume also increased significantly ( p < 0.05 ) . No improvements in h and grip strength , isometric strength of knee flexors and extensors or leg extensor power were seen in either group . Wide variability in all measures of muscle function were observed in these elderly men suggesting that very large study groups would be required to determine potential treatment benefits on muscle function CONTEXT Serum testosterone levels decline significantly with aging . Testosterone supplementation to older men might beneficially affect the aging processes . OBJECTIVE To investigate the effect of testosterone supplementation on functional mobility , cognitive function , bone mineral density , body composition , plasma lipids , quality of life , and safety parameters in older men with low normal testosterone levels . DESIGN , SETTING , AND PARTICIPANTS Double-blind , r and omized , placebo-controlled trial of 237 healthy men between the ages of 60 and 80 years with a testosterone level lower than 13.7 nmol/L conducted from January 2004 to April 2005 at a university medical center in the Netherl and s. INTERVENTION Participants were r and omly assigned to receive 80 mg of testosterone undecenoate or a matching placebo twice daily for 6 months . MAIN OUTCOME MEASURES Functional mobility ( Stanford Health Assessment Question naire , timed get up and go test , isometric h and grip strength , isometric leg extensor strength ) , cognitive function ( 8 different cognitive instruments ) , bone mineral density of the hip and lumbar spine ( dual-energy x-ray absorptiometry scanning ) , body composition ( total body dual-energy x-ray absorptiometry and abdominal ultrasound of fat mass ) , metabolic risk factors ( fasting plasma lipids , glucose , and insulin ) , quality of life ( Short-Form Health 36 Survey and the Questions on Life Satisfaction Modules ) , and safety parameters ( serum prostate-specific antigen level , ultrasonographic prostate volume , International Prostate Symptom score , serum levels of creatinine , aspartate aminotransferase , alanine aminotransferase , gamma-glutamyltransferase , hemoglobin , and hematocrit ) . RESULTS A total of 207 men completed the study . During the study , lean body mass increased and fat mass decreased in the testosterone group compared with the placebo group but these factors were not accompanied by an increase of functional mobility or muscle strength . Cognitive function and bone mineral density did not change . Insulin sensitivity improved but high-density lipoprotein cholesterol decreased ; by the end of the study , 47.8 % in the testosterone group vs 35.5 % in the placebo group had the metabolic syndrome ( P = .07 ) . Quality -of-life measures were no different except for one hormone-related quality -of-life measure that improved . No negative effects on prostate safety were detected . CONCLUSION Testosterone supplementation during 6 months to older men with a low normal testosterone concentration did not affect functional status or cognition but increased lean body mass and had mixed metabolic effects . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N23688581 BACKGROUND Erectile dysfunction and low testosterone levels frequently occur together . OBJECTIVE To determine whether addition of testosterone to sildenafil therapy improves erectile response in men with erectile dysfunction and low testosterone levels . DESIGN R and omized , double-blind , parallel , placebo-controlled trial . ( Clinical Trials.gov registration number : NCT00512707 ) SETTING Outpatient academic research center . PARTICIPANTS Men aged 40 to 70 years with scores of 25 or less for the erectile function domain ( EFD ) of the International Index of Erectile Function , total testosterone levels less than 11.45 nmol/L ( < 330 ng/dL ) , or free testosterone levels less than 173.35 pmol/L ( < 50 pg/mL ) . INTERVENTION Sildenafil dose was optimized , and 140 participants were then r and omly assigned to 14 weeks of daily transdermal gel that contained 10-g testosterone for 70 participants and placebo for the remaining 70 participants . All participants were included in the primary analysis , although 10 in the testosterone group and 12 in the placebo group did not complete the study . RESULTS At baseline , the 2 groups had similar EFD scores . Administration of sildenafil alone was associated with a substantial increase in EFD score ( mean , 7.7 [ 95 % CI , 6.5 to 8.8 ] ) , but change in EFD score after r and omization did not differ between the groups ( difference , 2.2 [ CI , -0.8 to 5.1 ] ; P = 0.150 ) . The findings were similar for other domains of sexual function in younger men , more obese men , and men with lower baseline testosterone levels or an inadequate response to sildenafil alone . Frequency of adverse events was similar for testosterone and placebo groups . LIMITATION Whether testosterone could improve erectile function without sildenafil was not studied . CONCLUSION Sildenafil plus testosterone was not superior to sildenafil plus placebo in improving  erectile function in men with erectile dysfunction and low testosterone levels . PRIMARY FUNDING SOURCE National Institute of Child Health and Human Development Purpose To determine the dose-dependent effects of testosterone administration on cognition in women with low testosterone levels . Methods 71 hysterectomized women with or without oophorectomy with total testosterone < 31 ng/dl and /or free testosterone < 3.5 pg/ml received a st and ardized transdermal estradiol regimen during the 12-week run-in period and were then r and omized to receive weekly intramuscular injections of placebo , 3 , 6.25 , 12.5 , or 25 mg testosterone enanthate for 24 weeks .  Total testosterone  was measured in serum by LC – MS/MS , and free testosterone levels were measured by equilibrium dialysis .  Cognitive function was evaluated using a comprehensive battery of st and ardized neuropsychological tests at baseline and 24 weeks . Results 46 women who had baseline and end-of-treatment cognitive function data constituted the analytic sample . The five groups were similar at baseline . Mean on-treatment nadir total testosterone concentrations were 15 , 89 , 98 , 134 , and 234 ng/dl in the placebo , 3 , 6.25 , 12.5 , and 25 mg groups , respectively . No significant changes in spatial ability , verbal fluency , verbal memory , or executive function were observed in any treatment arm compared to placebo even after adjustment for baseline cognitive function , age , and education . Multiple regression analysis did not show any significant relation between changes in testosterone concentrations and change in cognitive function scores . ConclusionS hort-term testosterone administration over a wide range of doses for 24 weeks in women with low testosterone levels was neither associated with improvements nor worsening of cognitive function Serum testosterone levels decline significantly with aging and this has been associated with reduced sexual function . We have conducted a double-blind , r and omized , placebo-controlled trial to investigate the effect of testosterone supplementation on sexual function in 237 elderly men with a testosterone level < 13.7 nmol l−1 . Participants were r and omly assigned to receive oral testosterone undecanoate or a placebo for 6 months . A total of 207 men completed the study . After treatment , there were no differences in scores on sexual function between the groups . Sub analysis showed that although a baseline testosterone level in the lowest tertile was associated with significantly lower scores for sexual fantasies , desire of sexual contact and frequency of sexual contact , supplementation of testosterone did not result in improvement on any of these items in this group . In conclusion , the findings do not support the view that testosterone undecanoate supplementation for 6 months to elderly men with low-normal testosterone concentrations favorably affects sexual function BACKGROUND The role of sex hormones in the prevention of cognitive decline is uncertain . Animal studies suggest mechanisms for sex hormones including testosterone to maintain optimal cognitive function . But , there are studies to suggest that endogenous testosterone levels are associated with aggression in men with cognitive impairment . METHODS In this pilot study , 11 men ( mean age 80 + /- 5 years , range 73 - 87 years ) with early cognitive decline and bioavailable testosterone levels below 128 ng/dl ( lower limit for adult normal range ) were r and omized to receive intramuscular testosterone ( 200 mg every 3 weeks ) or placebo for 12 weeks . Outcome measures included sex hormones ( testosterone , bioavailable testosterone , sex hormone binding globulin , estradiol , and estrone ) , Behave AD Question naire , Katz Activities of Daily Living , Geriatric Depression Scale , Digit Span , Clock Face Drawing , Clock Face Perception , Verbal Fluency , Trail-Making B , and International Prostate Symptom Score at baseline , 4 weeks , and 10 weeks . RESULTS All men completed the study . Total and bioavailable testosterone , estrone , and estradiol levels increased in men receiving testosterone , but no changes were detected in men receiving placebo . No significant changes were found in behavior following testosterone supplementation , nor was there evidence of change in depression or activities of daily living . No discernable changes were found in any of the cognitive tests . Symptoms of prostate hyperplasia remained unchanged in the testosterone ( 6.6 + 5.8 to 5.2 + 3.6 ; p = .39 ) and placebo ( 8.8 + 6.4 to 6.4 + 3.8 ; p = .15 ) groups , and prostate-specific antigen levels did not change significantly . CONCLUSION No significant changes in behavior , function , depression , or cognitive performance occurred following 12 weeks of testosterone replacement in men with low testosterone levels and early-to-moderate cognitive impairment . This pilot work suggests that testosterone can be given to men with early cognitive impairment without significant concern about worsening aggressive or unwanted behaviors BACKGROUND The ovaries provide approximately half the circulating testosterone in premenopausal women . After bilateral oophorectomy , many women report impaired sexual functioning despite estrogen replacement . We evaluated the effects of transdermal testosterone in women who had impaired sexual function after surgically induced menopause . METHODS Seventy-five women , 31 to 56 years old , who had undergone oophorectomy and hysterectomy received conjugated equine estrogens ( at least 0.625 mg per day orally ) and , in r and om order , placebo , 150 microg of testosterone , and 300 microg of testosterone per day transdermally for 12 weeks each . Outcome measures included scores on the Brief Index of Sexual Functioning for Women , the Psychological General Well-Being Index , and a sexual-function diary completed over the telephone . RESULTS The mean ( + /-SD ) serum free testosterone concentration increased from 1.2+/-0.8 pg per milliliter ( 4.2+/-2.8 pmol per liter ) during placebo treatment to 3.9+/-2.4 pg per milliliter ( 13.5+/-8.3 pmol per liter ) and 5.9+/-4.8 pg per milliliter ( 20.5+/-16.6 pmol per liter ) during treatment with 150 and 300 microg of testosterone per day , respectively ( normal range , 1.3 to 6.8 pg per milliliter [ 4.5 to 23.6 pmol per liter ] ) . Despite an appreciable placebo response , the higher testosterone dose result ed in further increases in scores for frequency of sexual activity and pleasure-orgasm in the Brief index of Sexual Functioning for Women ( P=0.03 for both comparisons with placebo ) . At the higher dose the percentages of women who had sexual fantasies , masturbated , or engaged in sexual intercourse at least once a week increased two to three times from base line . The positive-well-being , depressed-mood , and composite scores of the Psychological General Well-Being Index also improved at the higher dose ( P=0.04 , P=0.03 , and P=0.04 , respectively , for the comparison with placebo ) , but the scores on the telephone-based diary did not increase significantly . CONCLUSIONS In women who have undergone oophorectomy and hysterectomy , transdermal testosterone improves sexual function and psychological well-being Loss of lean body and muscle mass characterizes the acquired immunodeficiency syndrome ( AIDS ) wasting syndrome ( AWS ) .  Testosterone and exercise increase muscle mass in men with AWS , with unclear effects on muscle composition . We examined muscle composition in 54 eugonadal men with AWS who were r and omized to 1 ) testosterone ( 200 mg i m weekly ) or placebo and simultaneously to 2 ) resistance training or no training in a 2 x 2 factorial design . At baseline and after 12 wk , we performed assessment s of whole body composition by dual-energy X-ray absorptiometry and single-slice computed tomography for midthigh cross-sectional area and muscle composition . Leaner muscle has greater attenuation . Baseline muscle attenuation correlated inversely with whole body fat mass ( r = -0.52 , P = 0.0001 ) . This relationship persisted in a model including age , body mass index , testosterone level , viral load , lean body mass , and thigh muscle cross-sectional area ( P = 0.02 ) . Testosterone ( P = 0.03 ) and training ( P = 0.03 ) increased muscle attenuation . These data demonstrate that thigh muscle attenuation by computed tomography varies inversely with whole body fat and increases with testosterone and training . Anabolic therapy in these patients increases muscle leanness BACKGROUND Hypogonadism and anemia are common comorbid conditions in dialysis patients .  Testosterone replacement may improve such clinical parameters as anemia , sarcopenia , and low libido . Additionally , by increasing hemoglobin levels , testosterone replacement may allow for a dose reduction in recombinant human erythropoietin ( rHuEPO ) , thereby reducing cost . METHODS This phase IV , single-center , placebo-controlled , double-blind study assessed the effect of transdermal testosterone on serum testosterone levels , rHuEPO dose required to maintain hemoglobin level , bone mineral content , lean body mass and fat content , cholesterol level , sexual function , and mood . Forty hypogonadal male hemodialysis patients who were administered rHuEPO were r and omly assigned to 100 mg of topical 1 % testosterone gel ( Testim ; Auxilium Pharmaceuticals , Norristown , PA ) or placebo , applied daily for 6 months . RESULTS Forty men with a mean age of 56 years and baseline serum testosterone level less than 300 ng/dL ( < 10.4 nmol/L ) participated in this trial . In men assigned to administration of transdermal testosterone , there was an increase beyond that in the placebo group in mean serum testosterone ( 77.1 ng/dL [ 2.7 nmol/L ] ) , dihydrotestosterone ( DHT ; 0.8 nmol/L ) , and estradiol levels ( 6.3 pg/mL [ 23.0 pmol/L ] ) and a decrease in mean serum luteinizing hormone levels ( -3.1 IU/L ) . Compared with subjects administered placebo , participants on testosterone replacement therapy did not show an appreciable change in  rHuEPO dose ( mean difference adjusted for baseline values , 12.6 U/kg/wk ; P = 0.73 ) , bone mineral density , lean body mass or fat content , cholesterol level , sexual function , or mood . CONCLUSION Daily administration of 100 mg of topical 1 % testosterone gel for 6 months failed to significantly increase serum testosterone or DHT levels in hypogonadal men with end-stage renal disease . Treatment with transdermal testosterone did not impact on rHuEPO requirement or clinical parameters in this small placebo-controlled study . Greater serum testosterone levels may be required to show clinical benefit in men with end-stage renal disease Objective : To determine the relationship between exogenous testosterone administration and cognitive abilities in a population of healthy older men . Background : Serum levels of total and bioavailable testosterone gradually decrease with age in men and are associated with reductions in muscle mass , osteoporosis , decreased sexual activity , and changes in cognition . Methods : Twenty-five healthy , community-dwelling volunteers , aged 50 to 80 years , completed a r and omized , double-blind , placebo-controlled study . Participants received weekly intramuscular injections of either 100 mg testosterone enanthate or placebo ( saline ) for 6 weeks . Cognitive evaluations were conducted at baseline , week 3 , and week 6 of treatment by use of a battery of neuropsychologic tests . Results : Circulating total testosterone was raised an average of 130 % from baseline at week 3 and 116 % at week 6 in the treatment group . Because of aromatization of testosterone , estradiol increased an average of 77 % at week 3 and 73 % at week 6 in the treatment group . Significant improvements in cognition were observed for spatial memory ( recall of a walking route ) , spatial ability ( block construction ) , and verbal memory ( recall of a short story ) in older men treated with testosterone compared with baseline and the placebo group , although improvements were not evident for all measures . Conclusions : The results suggest that short-term testosterone administration enhances cognitive function in healthy older men . However , it remains unclear whether these improvements in cognition are attributable to increased testosterone or estradiol levels , or both . The potential role of testosterone vs its metabolites on cognition requires further research Recent studies have shown that testosterone is involved in the pathogenesis of cardiovascular diseases . Moreover , in observational studies blood testosterone concentrations , result ed consistently lower , not only among men with cardiovascular disease but also in men with uremia . In order to correlate the blood level of testosterone with the degree of erectile dysfunction ( ED ) and chronic renal failure ( CRF ) ( stage I-V ) we selected a group of patients with renal failure on conservative treatment , who attended our nephrology out patients clinic . All the patients had stage II and III renal failure , respectively with a creatinine clearance between 59 - 30 and 29 - 15 ml/m ' . The sexual evaluation was done using a 15-item question naire , i.e. the International Index of Erectile Function ( IIEF ) . Mean score of patients with ED were significantly lower than mean scores for healthy controls for all 15 questions ( all p values < 0.01 ) . Preliminary results show a direct correlation between -IIEF and glomerular filtration rate ( GFR ) ( R2 0.08 ) ; an inverse correlation between testosterone and cholesterol ( R2 0.045 ) ; a higher number of diabetic patients with lower levels of testosterone , at level 3 of CRF ; low levels of testosterone for smokers especially in stage II ( GFR ) . These data confirm the direct correlation between ED and renal failure , and the role of diabetes and smoking in hypotestosteronemia , in patients with different degrees of renal insufficiency . Further prospect i ve studies are needed in order to correlate cardiovascular morbidity and mortality in patients with CRF and blood levels of testosterone Testosterone ( T ) therapy for hypogonadal men should correct the clinical abnormalities of T deficiency , including improvement of sexual function , increase in muscle mass and strength , and decrease in fat mass , with minimal adverse effects . We have shown that administration of a new transdermal T gel formulation to hypogonadal men provided dose proportional increases in serum T levels to the normal adult male range . We now report the effects of 180 days of treatment with this 1 % T gel preparation ( 50 or 100 mg/day , contained in 5 or 10 g gel , respectively ) compared to those of a permeation-enhanced T patch ( 5 mg/day ) on defined efficacy parameters in 227 hypogonadal men . In the T gel groups , the T dose was adjusted up or down to 75 mg/day ( contained in 7.5 g gel ) on day 90 if serum T concentrations were below or above the normal male range . No dose adjustment was made with the T patch group . Sexual function and mood changes were monitored by question naire , body composition was determined by dual energy x-ray absorptiometry , and muscle strength was measured by the one repetitive maximum technique on bench and leg press exercises . Sexual function and mood improved maximally on day 30 of treatment , without differences across groups , and showed no further improvement with continuation of treatment . Mean muscle strength in the leg press exercise increased by 11 to 13 kg in all treatment groups by 90 days and did not improve further at 180 days of treatment . Moderate increases were also observed in arm/chest muscle strength . At 90 days of treatment , lean body mass increased more in the 100 mg/day T gel group ( 2.74 + /- 0.28 kg ; P = 0.0002 ) than in the 50 mg/day T gel ( 1.28 + /- 0.32 kg ) and T patch groups ( 1.20 + /- 0.26 kg ) . Fat mass and percent fat were not significantly decreased in the T patch group , but showed decreases in the T gel groups ( 50 mg/day , -0.90 + /- 0.32 kg ; 100 mg/day , - 1.05 + /- 0.22 kg ) . The increase in lean mass and the decrease in fat mass were correlated with the changes in average serum T levels attained after transdermal T replacement . These beneficial effects of T replacement were accompanied by the anticipated increases in hematocrit and hemoglobin but without significant changes in the lipid profile . The increase in mean serum prostate-specific antigen levels ( within the normal range ) was correlated with serum levels of T. The greatest increases were noted in the 100 mg/day T gel group . Skin irritation was reported in 5.5 % of subjects treated with T gel and in 66 % of subjects in the permeation-enhanced T patch group . We conclude that T gel replacement improved sexual function and mood , increased lean mass and muscle strength ( principally in the legs ) , and decreased fat mass in hypogonadal men with less skin irritation and discontinuation compared with the recommended dose of the permeation-enhanced T patch Symptoms of male hypogonadism such as low libido and erectile dysfunction ( ED ) respond to testosterone ( T ) replacement . In hypogonadal men with major depressive disorder ( MDD ) , the extent to which T replacement alleviates sexual symptoms of hypogonadism is not known . We conducted 6 week double-blind placebo-controlled clinical trial in men with low and low-normal T levels ( i.e. , total T ≤ 350 ng/dl ) and MDD . Men were r and omized to receive weekly intramuscular injections of either T enanthate 200 mg or sesame-seed oil ( placebo ) . The primary outcome measure was self-reported sexual functioning . We r and omized 30 patients . The mean age was 52(SD ± 8) years , mean T level 262.5(SD ± 8) ng/dl , and mean baseline Hamilton Rating Scale for Depression ( HAM-D ) score 21(SD ± 8) . At baseline , sexual function was low , with the majority reporting having had normal erectile and orgasmic functioning 0–1 time in the preceding month . All patients who received T achieved normalization of their T levels . The HAM-D scores decreased significantly in both T and placebo groups , and there were no significant between-group differences : reduction in mean HAM-D score from baseline to endpoint was 10.1 in patients who received T and 10.5 in those who received  placebo . Self-reported sexual functioning improved slightly in both groups ; a between-group difference was not detected . Both T replacement and placebo were associated with improvement in sexual function and mood , but differences between T and placebo were not distinguishable The prospect s of wider application of testosterone ( T ) in novel indications such as male contraception have prompted renewed interest in the investigation of nonreproductive actions and safety of and rogens . This study investigated potential changes in mood and behavior in response to elevations in circulating T concentrations produced by the new long-acting preparation , T undecanoate ( TU ) .  Twenty-eight eugonadal men were r and omized into one of two treatment groups : A1 ) active , receiving 1000 mg TU i.m . followed by A2 ) washout , followed by A3 ) placebo , receiving 4 ml castor oil i.m . ; B1 ) placebo , 4 ml castor oil i.m . ; B2 ) washout followed by B3 ) active , receiving 1000 mg TU i.m .. Mood , self- and partner-reported physical and verbal aggression , anger , hostility , irritability , assertiveness , self-esteem , and sexual function were assessed . A single injection of 1000 mg TU i.m . increased plasma T concentrations from 20.7 + /- 1.5 to 37.5 + /- 2.2 nmol/liter at wk 1 and 31.6 + /- 1.5 nmol/liter at wk 2 , and estradiol from 74.0 + /- 4.9 to 120.4 + /- 10.7 pmol/liter at wk 1 , and 100.0 + /- 6.3 pmol/liter at wk 2 . The T increment was associated with detectable but minor mood changes . Increased circulating T was associated with significant increases in anger-hostility from baseline ( mean score = 7.48 ) to wk 2 ( mean score = 10.71 ) accompanied by an overall reduction in fatigue-inertia ( treatment = 6.21 vs. placebo = 7.84 ) . TU treatment did not increase aggressive behavior or induce any changes in nonaggressive or sexual behavior . Changes in estradiol were not associated with any behavioral alterations . Our results suggest that exogenous TU-induced elevation of circulating T , to the range likely to be used in hormonal male contraception , has limited psychological effects . Future research should investigate the implication s of these minor mood changes Objective : The extent to which aromatization of testosterone ( T ) to estradiol is required for the observed effects of testosterone therapy on sexual function and well-being are not known . Therefore , the authors investigated the effects of aromatase enzyme inhibition on sexual function , well-being , and mood in estrogen- and T-replete postmenopausal women in a double-blind , r and omized , placebo-controlled study . Design : Postmenopausal women using transdermal estrogen therapy for at least 8 weeks and reporting low sexual satisfaction ( score < 42 for the Sabbatsberg Sexual Self-rating Scale [ SSS ] ) with a total T value of less than 1.2 nmol/L were treated with 400 μL of a 0.5 % T gel ( total dose 2 mg ) and were r and omly assigned to receive treatment with either 2.5 mg/day of letrozole or an identical placebo tablet . Women were assessed at baseline ( week −2 ) and at 0 , 4 , 8 , and 16 weeks . Sexual function was assessed with the SSS , well-being was assessed with the Psychological General Well-being Index , and mood was assessed with the Beck Depression Inventory at 0 and 16 weeks . Eighty-one women were screened , 76 were r and omly assigned to a treatment group , and 30 in each group completed the study . Because this was a mechanistic study , only the 60 women who completed the study per protocol were included in the final analysis . Results : Total T and calculated free T increased from baseline in both groups , with no difference between groups . At 16 weeks , estradiol , sex hormone-binding globulin , fasting lipids , lipoprotein(a ) , and C-reactive protein did not differ from baseline or between groups . Significant increases in total Sabbatsberg Sexual Self-rating Scale scores , total Psychological General Well-being Index scores , and a reduction in Beck Depression Inventory scores from baseline to 16 weeks was seen for both treatment groups , with no effect of treatment allocation . No adverse treatment effects were reported . Conclusions : Increases in total and free T in the physiologic range in postmenopausal women were associated with improved sexual satisfaction , well-being , and mood . In this study , aromatase inhibition did not influence any of these outcomes . Short-term transdermal T therapy did not modify fasting lipids , lipoprotein(a ) , or C-reactive protein Testosterone replacement is the most effective treatment for  sexual dysfunction in hypogonadal men . Comorbid depression and antidepressant side effects may reduce its influence . The authors conducted a 6-week , double-blind , placebo-controlled clinical trial of testosterone gel versus placebo gel in men with major depressive disorder who were currently taking a serotonergic antidepressant and exhibited low or low-normal testosterone level . A total of 100 men were enrolled at 2 study sites ( Boston , Massachusetts , USA , and Tel Aviv , Israel ) . The effects of testosterone augmentation on sexual functioning were determined using domain scores on the International Index of Erectile Function ( IIEF ) . Complete pre- and posttrial IIEF data were available for 63 subjects . Men r and omized to testosterone ( n = 31 ) and placebo ( n = 32 ) were similar in age , baseline testosterone levels , and baseline IIEF scores . At study termination , men r and omized to placebo showed virtually no change from baseline in mean ( 95 % CI ) IIEF score ( −0.7 [ −6.5 , 5.2 ] ) , whereas those receiving testosterone exhibited a substantial increase ( 15.8 [ 8.5 , 23.1 ] ) . The estimated mean difference between groups was 16.8 [ 7.5 , 26.1 ] ; p = .001 by linear regression with adjustment for age and study site . There were also significant between-group differences in each of the 5 IIEF subscales , as well as on the single question involving ejaculatory ability ( p ≤ .03 in all cases ) . Effect sizes in these comparisons remained little changed , and generally remained statistically significant , when we further adjusted for change in depression scores on the Montgomery Asberg Depression Rating Scale . It is notable that the subgroup of men with the highest baseline testosterone levels showed virtually the same improvement as those with lower levels , suggesting that the observed improvement was unlikely to be due simply to correction of hypogonadism alone . In depressed men with low or low-normal testosterone levels who continued to take serotonergic antidepressants , treatment with exogenous testosterone was associated with a significant improvement in sexual function , particularly including ejaculatory ability BACKGROUND The association between aging-related testosterone deficiency and late-onset hypogonadism in men remains a controversial concept . We sought evidence -based criteria for identifying late-onset hypogonadism in the general population on the basis of an association between symptoms and a low testosterone level . METHODS We surveyed a r and om population sample of 3369 men between the ages of 40 and 79 years at eight European centers . Using question naires , we collected data with regard to the subjects ' general , sexual , physical , and psychological health . Levels of total testosterone  were measured in morning blood sample s by mass spectrometry , and  free testosterone levels  were calculated with the use of Vermeulen 's formula . Data were r and omly split into separate training and validation sets for confirmatory analyses . RESULTS In the training set , symptoms of poor morning erection , low sexual desire , erectile dysfunction , inability to perform vigorous activity , depression , and fatigue were significantly related to the testosterone level . Increased probabilities of the three sexual symptoms and limited physical vigor were discernible with decreased testosterone levels ( ranges , 8.0 to 13.0 nmol per liter [ 2.3 to 3.7 ng per milliliter ] for total testosterone and 160 to 280 pmol per liter [ 46 to 81 pg per milliliter ] for free testosterone ) . However , only the three sexual symptoms had a syndromic association with decreased testosterone levels . An inverse relationship between an increasing number of sexual symptoms and a decreasing testosterone level was observed . These relationships were independently confirmed in the validation set , in which the strengths of the association between symptoms and low testosterone levels determined the minimum criteria necessary to identify late-onset hypogonadism . CONCLUSIONS Late-onset hypogonadism can be defined by the presence of at least three sexual symptoms associated with a total testosterone level of less than 11 nmol per liter ( 3.2 ng per milliliter ) and a free testosterone level of less than 220 pmol per liter ( 64 pg per milliliter ) PURPOSE We determined the effect of testosterone solution 2 % on total testosterone level and the 2 symptoms of hypogonadism , sex drive and energy level . MATERIAL S AND METHODS This was a r and omized , multicenter , double-blind , placebo controlled , 16-week study to compare the effect of testosterone and placebo on the proportion of men with a testosterone level within the normal range ( 300 to 1,050 ng/dl ) upon treatment completion . We also assessed the impact of testosterone on sex drive and energy level measured using SAID ( Sexual Arousal , Interest and Drive scale ) and HED ( Hypogonadism Energy Diary ) , respectively . A total of 715 males 18 years old or older with total testosterone less than 300 ng/dl and at least 1 symptom of testosterone deficiency ( decreased energy and /or decreased sexual drive ) were r and omized to 60 mg topical testosterone solution 2 % or placebo once daily . RESULTS Of study completers 73 % in the testosterone vs 15 % in the placebo group had a testosterone level within the normal range at study end point ( p < 0.001 ) . Participants assigned to testosterone showed greater baseline to end point improvement in SAID scores ( low sex drive subset p < 0.001 vs placebo ) and HED scores ( low energy subset p = 0.02 vs placebo , not significant at prespecified p < 0.01 ) . No major adverse cardiovascular or venous thrombotic events were reported in the testosterone group . The incidence of increased hematocrit was higher with testosterone vs placebo ( p = 0.04 ) . CONCLUSIONS Once daily testosterone solution 2 % for 12 weeks was efficacious in restoring normal testosterone levels and improving sexual drive  in hypogonadal men . Improvement was also seen in energy levels on HED though not at the prespecified p < 0.01 . No new safety signals were identified The aim of this study was to examine whether changes in plasma and rogen levels ( total testosterone ( T ) , free testosterone ( FT ) , and dehydro-epi and rosterone-sulfate ( DHEA-S ) ) induced by oral contraceptive ( OC ) use were related to changes in sexual interest or response or in mood . Sixty-one women provided blood sample s and were assessed , using interviews and st and ardized question naires , prior to starting , and after 3 months on OCs ( Ortho-Tricyclen , Ortho-Tricyclen-Lo , or Ortho-Cyclen , all containing the same progestagen , norgestimate ) . Significant decreases in T , FT , and DHEA-S were found after 3 months , although the extent of reduction was variable across women . There was some support for a relationship between the degree of reduction in total T and FT and the frequency of sexual thoughts after 3 months on OCs . However , some women had no loss of sexual interest in spite of substantial reduction in FT , and there was overall no evidence that reduction in FT affected enjoyment of sexual activity with a partner . The findings are consistent with the idea that some women may be more sensitive to changes in T than others . No relationship was found between negative mood , as assessed by the Beck Depression Inventory , and changes in T , FT , or & NA ; Few studies have assessed the role of pituitary and gonadal hormones on age‐related changes in sexual behavior in healthy men . We conducted a retrospective and prospect i ve evaluation of sexual function and behavior in 77 healthy married men aged 45 to 74 years . The subjects were studied in the sleep laboratory for four nights with the last night devoted to sequential blood sampling every 20 minutes . Significant age‐related decreases in sexual desire , sexual arousal and activity , and increases in erectile problems were noted . Aging was negatively correlated with bioavailable testosterone ( bT ) , was positively correlated with luteinizing hormone ( LH ) , and was not related to total testosterone , estradiol , and prolactin . Bioavailable testosterone , and the ratio of bT over LH showed a close association with several sexual behavior dimensions while total testosterone , estradiol , and prolactin demonstrated few or no behavioral relationships . The age‐related effect of bT was , however , a more important determinant of the reported behavioral differences than were the effect of bT independent of age . There was no evidence that changes in circulating hormones contribute to erectile disorders in healthy aging men BACKGROUND Since very little research in this field is available , this study aims to assess the role of psychosexual , relationship , hormonal and genetic measures in the sexual desire of users of three hormonal contraceptive products [ low-dose combined oral contraceptive ( 20 mcg ethinylestradiol/150 mcg desogestrel ) , progestin-only pill ( 75 mcg desogestrel ) and vaginal ring ( daily dose of 15 mcg ethinylestradiol/120 mcg etonogestrel ) ]  . STUDY DESIGN Fifty-five couples were r and omized over three groups in which the women consecutively used each product during 3 months . Both partners repeatedly filled out question naires on solitary and dyadic sexual desire ( desire to behave sexually by oneself or towards a partner ) .  Total and free testosterone , sex hormone binding globulin and a genetic marker of and rogen receptor sensitivity [ cytosine-adenine-guanine ( CAG ) repeat length ] were assessed on blood sample s of the female partners . RESULTS Sexual desire was higher in women with either short or long CAG repeats ( solitary , p=.004 ; dyadic , p=.008 ) . Desire levels were higher during vaginal ring use ( solitary , p=.018 ; dyadic , p=.007 ) . The woman 's mood was found to impact her dyadic sexual desire ( p<.001 ) ; this scale was also strongly associated with the male partner 's dyadic sexual desire ( p<.001 ) . CONCLUSIONS The current study found evidence for a role of and rogen receptor sensitivity and mood in the sexual desire of hormonal contraceptive users In eight impotent haemodialysed men with low plasma-zinc levels  sexual function , including potency , frequency of intercourse , libido , and plasma testosterone , follicle-stimulating hormone , and luteinising hormone levels , was determined before and after therapy with zinc ( four patients ) or placebo ( four patients ) . Dialytic administration of zinc strikingly improved potency in all patients and raised the plasma-testosterone to normal in the two with low pretreatment plasma-testosterone levels . Placebo did not improve sexual function in any patient . Zinc deficiency is a reversible cause of gonadal dysfunction in uraemia BACKGROUND The efficacy and safety of testosterone treatment for hypoactive sexual desire disorder in postmenopausal women not receiving estrogen therapy  are unknown . METHODS We conducted a double-blind , placebo-controlled , 52-week trial in which 814 women with hypoactive sexual desire disorder were r and omly assigned to receive a patch delivering 150 or 300 microg of testosterone per day or placebo .  Efficacy was measured to week 24 ; safety was evaluated over a period of 52 weeks , with a subgroup of participants followed for an additional year . The primary end point was the change from baseline to week 24 in the 4-week frequency of satisfying sexual episodes . RESULTS At 24 weeks , the increase in the 4-week frequency of satisfying sexual episodes was significantly greater in the group receiving 300 microg of testosterone per day than in the placebo group ( an increase of 2.1 episodes vs. 0.7 , P<0.001 ) but not in the group receiving 150 microg per day ( 1.2 episodes , P=0.11 ) . As compared with placebo , both doses of testosterone were associated with significant increases in desire ( 300 microg per day , P<0.001 ; 150 microg per day , P=0.04 ) and decreases in distress ( 300 microg per day , P<0.001 ; 150 microg per day , P=0.04 ) . The rate of and rogenic adverse events - primarily unwanted hair growth - was higher in the group receiving 300 microg of testosterone per day than in the placebo group ( 30.0 % vs. 23.1 % ) . Breast cancer was diagnosed in four women who received testosterone ( as compared with none who received placebo ) ; one of the four received the diagnosis in the first 4 months of the study period , and one , in retrospect , had symptoms before undergoing r and omization . CONCLUSIONS In postmenopausal women not receiving estrogen therapy  , treatment with a patch delivering 300 microg of testosterone per day result ed in a modest but meaningful improvement in sexual function . The long-term effects of testosterone , including effects on the breast , remain uncertain . ( Clinical Trials.gov number , NCT00131495 . OBJECTIVES To examine the effect of strength training and testosterone therapy on mechanical muscle function and lean body mass ( LBM ) in aging men with low-normal testosterone levels in a r and omized , double-blind , placebo-controlled 24-week study . DESIGN R and omized , double-blind , placebo-controlled . SETTING Odense , Denmark . PARTICIPANTS Men aged 60 to 78 , with bioavailable testosterone levels of less than 7.3 nmol/L and a waist circumference greater than 94 cm were r and omized to testosterone  ( 50 - 100 mg/d , n = 22 ) placebo ( n = 23 ) or strength training  ( n = 23 ) for 24 weeks . The strength training group was r and omized to addition of testosterone or placebo after 12 weeks . Subjects performed supervised strength training ( 2 - 3 sets with 6- to 10-repetition maximum loads , 3 times per week ) . MEASUREMENTS Testosterone levels , maximal voluntary contraction and rate of force development , and LBM were obtained at 0 and at Weeks 12 and 24 of the intervention . RESULTS No changes in any variables were recorded with placebo . In the strength training group , maximal voluntary contraction increased 8 % after 12 weeks ( P = .005 ) . During the following 12 weeks of strength training rate of force development increased by 10 % ( P = .04 ) and maximal voluntary contraction further increased ( P < .001 ) . Mechanical muscle function was unchanged in men receiving only testosterone for 24 weeks . LBM increased only in men receiving testosterone ( P = .004 ) . CONCLUSION Strength training in aging men with low-normal testosterone levels may improve mechanical muscle function , but this effect occurs without a significant increase in LBM . Clinical ly , only the combination of testosterone therapy and strength training result ed in an increase in mechanical muscle function and LBM OBJECTIVES Combined oral contraceptives ( COCs ) decrease and rogen levels , including testosterone ( T ) , which may be associated with sexual dysfunction and mood complaints in some women . We have shown that ' co-administration ' of dehydroepi and rosterone ( DHEA ) to a drospirenone (DRSP)-containing COC restored total T levels to baseline and free T levels by 47 % . Here we describe the effects on sexual function , mood and quality of life of such an intervention . STUDY DESIGN This was a r and omized , double-blind , placebo-controlled study in 99 healthy COC starters . A COC containing 30 mcg ethinylestradiol ( EE ) and 3 mg DRSP was used for three cycles , followed by six cycles of the same COC combined with 50 mg/day DHEA or placebo . Subjects completed the Moos Menstrual Distress Question naire ( MDQ ) , the McCoy Female Sexuality Question naire and the short form of the Quality of Life Enjoyment and Satisfaction Question naire ( Q-LES-Q ) . Safety and tolerability , including effects on skin , were evaluated . RESULTS The addition of DHEA induced small but significant improvements compared to placebo in the MDQ score for autonomic reactions during the menstrual ( -2.0 vs. 0.71 ; p=0.05 ) and the premenstrual phase ( -3.1 vs. 2.9 ; p=0.01 ) and for behavior during the intermenstrual phase ( -1.4 vs. 3.6 ; p=0.02 ) . A significant difference was found in the MDQ score for arousal during the premenstrual phase in favor of placebo ( -5.0 vs. 1.0 ; p=0.01 ) . There were no statistically significant differences between groups for the MSFQ and Q-LES-Q scores .  DHEA ' co-administration ' result ed in an acceptable safety profile . DHEA negated the beneficial effect of the COC on acne according to the subjects ' self- assessment . CONCLUSIONS ' Co-administration ' with DHEA did not result in consistent improvements in sexual function , mood and quality of life indicators in women taking EE/DRSP . Retrospectively , the 50 mg dose of DHEA may be too low for this COC . IMPLICATION S A well-balanced judgment of the clinical consequences of normalizing and rogens during COC use may require complete normalization of free Hypogonadism is prevalent among human immunodeficiency virus-infected men , in whom significantly reduced quality of life and mood disturbances have been reported . Previous studies have not investigated the relationship between depression score and gonadal function among such patients . We first compared depression scores in  hypogonadal ( n = 52 ) and eugonadal ( n = 10 ) patients with acquired immunodeficiency syndrome ( AIDS ) wasting , matched for weight and disease status , and then investigated the effects of testosterone administration on depression score in a r and omized , double-blind , placebo-controlled study among the group of hypogonadal men with AIDS wasting . The primary end point in all comparisons was the Beck Depression Inventory .  Hypogonadal patients demonstrated significantly increased scores on the Beck inventory compared with eugonadal- , age- , weight- , and disease status-matched subjects ( 15.5+/-1.1 vs. 10.6+/-1.4 mean + /- SEM , P = 0.02 ) . Among the combined hypogonadal and eugonadal subjects , a significant inverse correlation was seen between the Beck score and both free ( r = 0.41 , P<0.01 ) and total serum testosterone levels ( r = -0.43 , P<0.001 ) . The relationship between the Beck score and testosterone levels remained highly significant , controlling for weight , viral load , CD4 count , and antidepressant use ( P<0.01 for free testosterone , P<0.001 for total testosterone ) . Furthermore , when subjects were divided into two groups , based on a Beck score greater than 18 or less than or equal to 18 , serum total and free testosterone levels were significantly lower in the subjects with a Beck score greater than 18 , whereas there were no differences in weight , viral load , CD4 count , or Karnofsky status . End of study data were available in 39 patients who completed the r and omized , placebo-controlled study . Beck score decreased significantly only in the subjects receiving testosterone ( -5.8+/-1.3 , P < 0.001 ) , but not in subjects r and omized to placebo ( -2.7+/-1.3 , P > 0.05 ) . In a regression analysis , the change in Beck score was related significantly to change in weight ( P<0.01 ) . These data demonstrate increased depression score in association with hypogonadism in men with AIDS wasting , independent of weight , virologic status , and other disease factors . In such patients , administration of testosterone results in a significant improvement in depression inventory score . This effect may be a direct effect of testosterone or related to positive effects of testosterone on weight and /or other anthropometric indices . Additional studies are needed to assess the effects of testosterone on clinical depression indices in human immunodeficiency virus-infected patients Background Adding testosterone to hormonal therapy could improve sexual function and general well-being among women during climacteric . We evaluated the effectiveness of testosterone undecanoate on sexual function in postmenopausal women utilizing the st and ardized question naire FSFI score . Methods Postmenopausal women with sexual complaints and Female Sexual Function Index ( FSFI ) ≤ 26.5 were enrolled in to this r and omized , double-blinded , placebo-controlled trial . Participants were r and omly assigned to 8-week treatment with either oral testosterone undecanoate 40 mg or placebo twice weekly with daily oral estrogen .  The FSFI scores before and after treatment were compared to assess any improvement of sexual function . Results Seventy women were recruited of which each group had 35 participants . The baseline characteristics and baseline FSFI scores were comparable between both groups . After 8 weeks of treatment , the FSFI scores significantly improved in both groups when compared to the baseline but the FSFI scores from the testosterone group were significantly higher than in the placebo group post-treatment ( 28.6 ± 3.6 , 25.3 ± 6.7 , respectively , p = 0.04 ) . There was no difference in adverse effect between the two groups Conclusions The twice weekly addition of testosterone undecanoate to daily oral estrogen was associated with a significant improvement in sexual function  among postmenopausal women than the use of the estrogen alone . Trial registration Clinical Trials.gov Identifier NCT01724658 ( February 17 , 2012 ) The effect of zinc therapy and placebo on sexual function and endocrine status was investigated in a double-blind study of 14 male patients with chronic renal failure on regular haemodialysis .  Zinc chloride was added to the dialysate of 7 patients for 6 weeks , raising the serum zinc concentration by 17 % and placebo was added to the dialysate of the other patients . At the start of the trial 9 patients said they had decreased sexual function . Records of penile erectile activity during sleep confirmed the organic nature of the sexual dysfunction . Plasma testosterone concentrations were low or in the low normal range , basal serum luteinising-hormone levels were raised , and the early luteinising-hormone response to luteinising-hormone-releasing hormone was exaggerated , suggesting primary testicular failure . Zinc administration had no significant effect on any aspect of sexual function assessed by question naire or nocturnal penile tumescence monitoring . Plasma testosterone and basal and stimulated gonadotrophin levels were also unaltered by zinc administration Objective Women with primary ovarian insufficiency ( POI ) display low and rogen levels , which could contribute to mood and behavioral symptoms observed in this condition . We examined the effects of physiologic testosterone therapy added to st and ard estrogen/progestin therapy on quality of life , self-esteem , and mood in women with POI . Methods One hundred twenty-eight women with 46,XX spontaneous POI participated in a 12-month r and omized , placebo-controlled , parallel- design investigation of the efficacy of testosterone augmentation of estrogen/progestin therapy .  Quality of life , self-esteem , and mood symptoms were evaluated with st and ardized rating scales and a structured clinical interview . Differences in outcome measures between the testosterone and placebo treatments were analyzed by Wilcoxon rank sum tests . Results No differences in baseline characteristics , including serum hormone levels ( P > 0.05 ) , were found . Baseline mean ( SD ) Center for Epidemiologic Studies Depression Scale scores were 10.7 ( 8.6 ) and 9.2 ( 7.8 ) for testosterone and placebo , respectively ( P = 0.35 ) . After 12 months of treatment , measures of quality of life , self-esteem , and mood symptoms did not differ between treatment groups . Serum testosterone levels achieved physiologic levels in the testosterone group and were significantly higher compared with placebo ( P < 0.001 ) . Baseline testosterone levels were not associated with either adverse or beneficial clinical effects . Conclusions A 150-&mgr;g testosterone patch achieves physiologic hormone levels in women with POI . Our findings suggest that augmentation of st and ard estrogen/progestin therapy with physiologic testosterone therapy in young women with POI neither aggravates nor improves baseline reports of quality of life or self-esteem and had minimal effects on mood . Other mechanisms might play a role in the altered mood accompanying this disorder The aim of this study was to assess the effect of a low-dose testosterone on body composition and pulmonary function , as well as on quality of life , sexuality , and psychological symptoms in patients with chronic obstructive pulmonary disease ( COPD ) . Twenty-nine men with moderate to severe COPD were allocated to receive either 250 mg of testosterone or placebo intra-muscularly , every fourth week , during the 26 weeks study period . Fat-free mass increased in the treatment group ( P<0.05 ) , and a significant difference between the treatment and the control group was seen after 26 weeks ( P<0.05 ) . Fat mass decreased in the treatment group ( P<0.05 ) , and there was a significant difference between the treatment and the control group after 12 weeks ( P<0.01 ) . A significantly better erectile function was reported in the treatment group at the final visit ( P<0.05 ) , and the overall sexual quality of life was significantly better in the treatment group after 12 weeks ( P<0.05 ) . No improvement in pulmonary function was found . In conclusion , administration of a low-dose testosterone  to men with COPD for 26 weeks was associated with improvement of body composition , better erectile function and sexual quality of life . Furthermore , there were no clinical or biochemical side effects Both estrogen and testosterone insufficiency has been associated with reduced psychological well-being including fatigue . However , hormonal replacement studies on fatigue are rare . Therefore , we wanted to study the effect of testosterone and estrogen replacement therapy on cognitive fatigue and the relation between sex hormone levels and cognitive fatigue in oophorectomized women . Fifty women with surgically induced menopause ( mean age : 54.0 ± 2.9 years ) were r and omly assigned to treatment with estradiol valerate in combination with testosterone undecanoate or placebo for 24 weeks in a double-blind cross-over study . Neuropsychological tests and question naires were used to assess cognitive fatigue and psychological well-being . Cognitive fatigue was significantly associated to poor self-rated health and higher body mass index but not to general psychological well-being or sex hormone levels . Treatment with testosterone + estrogen had no significant effect on cognitive fatigue but the results indicated a curvilinear relation for hormonal levels . The estrogen/testosterone ratio was more related to functions rather than high or low hormone levels per se . We found that cognitive fatigue is frequent in oophorectomized women and negatively associated to self-perceived health and positively associated to BMI . A well-balanced ratio between estrogen and testosterone levels may be important for cognitive fatigue Although high rates of serum testosterone deficiency have been reported in men with spinal cord injury ( SCI ) , its determinants and attributes are not yet established . The aim of this study was to recognize , among putative determinants and attributes of and rogen deficiency , those significantly associated to low testosterone after adjustment for confounders recognizable in men with chronic SCI . A biochemical and rogen deficiency ( total testosterone < 300 ng/dL ) was exhibited by 18 of 51 patients ( 35.3 % ) . Significant correlates of testosterone levels were as follows : weekly leisure time physical activity ( LTPA )  explored by the LTPA Question naire for people with SCI , body mass index ( BMI ) , homeostatic model assessment of insulin resistance ( HOMA‐IR ) , triglycerides and sexual symptoms , explored by the aging males ' symptom ( AMS ) question naire . At the multiple linear regression analysis , among putative determinants of low testosterone , only weekly LTPA and BMI exhibited a significant association with testosterone levels , explaining 54.2 and 9.0 % of testosterone variability respectively . At the linear regression models , among various putative attributes of and rogen deficiency , only lower sexual desire and , at a lesser extent , higher HOMA‐IR , exhibited significant associations with lower testosterone levels , after adjustment for BMI , age , comorbidities and weekly LTPA . In conclusion , poor LTPA , high BMI and low sexual desire are independent predictors of low testosterone in men with chronic SCI . This is relevant to clinical practice , as all these features are routinely assessed in rehabilitation setting s for SCI . As poor LTPA and high BMI are modifiable life‐style related risk factors , prospect i ve studies could clarify whether life‐style modification could increase the level of testosterone and improve the low sexual desire , relevant clinical attribute of low testosterone in men with SCI Hyposexuality is commonly associated with low bioavailable testosterone ( BAT ) and relative estradiol elevation in men with epilepsy . This prospect i ve , r and omized , double-blind trial compared the effects of depotestosterone+the aromatase inhibitor anastrozole ( T-A ) versus depotestosterone+placebo ( T-P ) on sexual function , hormone levels , mood , and seizure frequency in men with epilepsy . Forty men with focal epilepsy , hyposexuality , and hypogonadism were r and omized 1:1 to two groups ( T-A or T-P ) for a 3-month treatment trial of depotestosterone+either anastrozole or matching placebo . Outcomes included both efficacy and safety measures . Normalization of sexual function ( S-score ) occurred with greater frequency in the T-A ( 72.2 % ) than in the T-P ( 47.4 % ) group , but the difference was not statistically significant . T-A result ed in significantly lower estradiol levels and S-scores correlated inversely with estradiol levels at baseline and during treatment . Beck Depression Inventory II ( BDI-II ) scores improved significantly in both groups and changes in S-score correlated inversely with changes in BDI-II score . Changes in seizure frequency correlated with changes in BDI-II score . Seizure frequency decreased with both treatments and showed significant correlations with estradiol levels . Triglyceride levels increased with T-P and decreased with T-A. The difference in triglyceride changes between the two treatments was significant and correlated with changes in estradiol levels . Significant correlations between estradiol levels and S-scores , as well as seizure outcomes and triglyceride levels , suggest further study regarding a potential role for anastrozole in the treatment of men with epilepsy who have hyposexuality and hypogonadism BACKGROUND The prevalence of human immunodeficiency virus ( HIV ) disease is increasing among women , many of whom remain symptomatic with low weight and poor functional status . Although and rogen levels may often be reduced in such patients , the safety , tolerability , and efficacy of testosterone administration in this population remains unknown . METHODS A total of 57 HIV-infected women with free testosterone levels less than the median of the reference range and weight less than 90 % of ideal body weight or weight loss greater than 10 % were r and omly assigned to receive transdermal testosterone ( 4 mg/patch ) twice weekly or placebo for 6 months . Muscle mass was assessed by urinary creatinine excretion . Muscle function was assessed by the Tufts Quantitative Muscle Function Test . Treatment effect at 6 months was determined by analysis of covariance . Results are mean + /- SEM unless otherwise specified . RESULTS At baseline , subjects were low weight ( body mass index [ calculated as weight in kilograms divided by the square of height in meters ] 20.6 + /- 0.4 ) , with significant weight loss from pre-illness maximum weight ( 18.7 % + /- 1.2 % ) , and demonstrated reduced muscle function ( upper and lower extremity muscle strength , 83 % and 67 % , respectively , of predicted range ) . Testosterone treatment result ed in significant increases in testosterone levels vs placebo ( total testosterone : 37 + /- 5 vs -2 + /- 2 ng/dL [ 1.3 + /- 0.2 vs -0.1 + /- 0.1 nmol/L ] [ P<.001 ] ; free testosterone : 3.7 + /- 0.5 vs -0.4 + /- 0.3 pg/mL [ 12.8 + /- 1.7 vs -1.4 vs 1.0 pmol/L ] [ P<.001 ] ) and was well tolerated , without adverse effects on immune function , lipid and glucose levels , liver function , or body composition or the adverse effect of hirsutism . Muscle mass tended to increase ( 1.4 + /- 0.6 vs 0.3 + /- 0.8 kg ; P = .08 ) , and shoulder flexion ( 0.4 + /- 0.3 vs -0.5 + /- 0.3 kg ; P = .02 ) , elbow flexion ( 0.3 + /- 0.4 vs -0.7 + /- 0.4 kg ; P = .04 ) , knee extension ( 0.2 + /- 1.0 vs -1.7 + /- 1.3 kg ; P = .02 ) , and knee flexion ( 0.7 + /- 0.5 vs 0.3 + /- 0.7 kg ; P = .04 ) increased in the testosterone-treated compared with the placebo-treated subjects . CONCLUSIONS Testosterone administration is well-tolerated and increases muscle strength in low-weight HIV-infected women .  Testosterone administration may be a useful adjunctive therapy to maintain muscle function in symptomatic HIV-infected women CONTEXT Reduced energy intake is a primary factor in HIV-associated wasting .  Megestrol acetate ( MA ) stimulates appetite and weight gain . However , much of the weight gained is fat , possibly as a result of MA-induced hypogonadism . OBJECTIVE The objective of the study was to determine whether coadministration of testosterone with MA could enhance lean body mass ( LBM ) accrual and evaluate the effects of MA , alone or combined with testosterone , on sexual functioning and the hypothalamic-pituitary-adrenal axis . DESIGN This was a r and omized , double-blind , placebo-controlled , multicenter trial . SETTING Fourteen AIDS Clinical Trials Units in the United States participated in the study . SUBJECTS Seventy-nine HIV-positive men with 5 % or more weight loss or body mass index less than 20 kg/m2 took part in the study . INTERVENTION Subjects were r and omized to receive MA ( 800 mg daily ) plus testosterone enanthate ( 200 mg ; MA/TE ; n = 41 ) or placebo ( MA/PL ; n = 38 ) biweekly for 12 wk . MAIN OUTCOME MEASURES Weight , body composition ( bioelectric impedance analysis ) , adrenal and gonadal hormones , and sexual functioning ( question naire ) were measured . RESULTS Both groups experienced robust increases in weight ( median 5.3 and 7.3 kg in MA/TE and MA/PL , respectively ) , LBM ( 3.3 and 3.3 kg ) , and fat ( 3.0 and 3.8 kg ) . There were no significant differences between groups in the magnitude or composition of weight gain ( P = 0.44 , 0.90 , and 0.11 for weight , LBM , and fat , respectively ) . Trough testosterone concentrations decreased to a greater extent in MA/PL ( -12.3 vs. -6.1 nmol/liter in MA/TE ; P = 0.04 ) . Cortisol levels became nearly undetectable in subjects with plasma MA levels greater than 150 ng/ml . Sexual functioning was preserved with MA/TE but worsened in MA/PL . CONCLUSIONS MA produced robust weight gain . Coadministration of testosterone preserved sexual functioning but did not enhance LBM accrual It is unknown whether hypogonadism contributes to decreased insulin-like growth factor I ( IGF-I ) production and /or how testosterone administration may effect the GH-IGF-I axis in human immunodeficiency virus (HIV)-infected men with the acquired immunodeficiency syndrome ( AIDS ) wasting syndrome ( AWS ) . In this study , we investigate the GH-IGF-I axis in men with the AWS and determine the effects of testosterone on GH secretory dynamics , pulse characteristics determined from overnight frequent sampling , arginine stimulation , and total and free IGF-I levels . Baseline GH-IGF-I parameters in hypogonadal men with AWS ( n=51 ) were compared before testosterone administration ( 300 mg , i m , every 3 weeks vs. placebo for 6 months ) with cross-sectional data obtained in two age-matched control groups : eugonadal men with AIDS wasting ( n=10 ) and healthy age-matched normal men ( n=15 ) . The changes in GH-IGF-I parameters were then compared prospect ively in testosterone- and placebo-treated patients . Mean overnight GH levels [ 1.8+/-0.3 and 2.4+/-0.3 vs. 0.90+/-0.1 microg/L ( P=0.04 and P=0.003 vs. healthy controls ) ] and pulse frequency [ 0.35+/-0.06 and 0.37+/-0.02 vs. 0.22+/-0.03 pulses/h ( P=0.06 and P=0.002 vs. healthy controls ) ] were comparably elevated in the eugonadal and hypogonadal HIV-positive groups , respectively , compared to those in the healthy control group . No significant differences in pulse amplitude , interpulse interval , or maximal GH stimulation to arginine administration ( 0.5 g/kg , i.v . ) were seen between either the eugonadal and hypogonadal HIV-positive or healthy control patients . In contrast , IGF-I levels were comparably decreased in both HIV-positive groups compared to the healthy control group [ 143+/-16 and 165+/-14 vs. 216+/-14 microg/L ( P=0.004 and P=0.02 vs. healthy controls ) ] . At baseline , before treatment with testosterone , overnight GH levels were inversely correlated with IGF-I ( r=-0.42 ; P=0.003 ) , percent ideal body weight ( r=-0.36 ; P=0.012 ) , albumin ( r=-0.37 ; P=0.012 ) , and fat mass ( r=-0.52 ; P=0.0002 ) , whereas IGF-I levels correlated with free testosterone ( r=0.35 ; P=0.011 ) and caloric intake ( r=0.32 ; P= 0.023 ) in the hypogonadal HIV-positive men . In a stepwise regression model , albumin ( P=0.003 ) and testosterone ( P=0.011 ) were the only significant predictors of GH [ mean GH (microg/L)=-1.82 x albumin ( g/dL ) + 0.003 x total testosterone ( microg/L ) + 6.5 ] , accounting for 49 % of the variation in GH . Mean overnight GH levels decreased significantly in the testosterone-treated patients compared to those in the placebo-treated  hypogonadal patients ( 0.9+/-0.3 vs. 0.2+/-0.4 microg/L ; P=0.020 ) . In contrast , no differences in IGF-I or free IGF-I were observed in response to testosterone administration . The decrement in mean overnight GH in response to testosterone treatment was inversely associated with increased fat-free mass ( r=-0.49 ; P= 0.024 ) , which was the only significant variable in a stepwise regression model for change in GH [ change in mean GH (microg/L)=-0.197 x kg fat-free mass - 0.53 ] and accounted for 27 % of the variation in the change in GH . In this study , we demonstrate increased basal GH secretion and pulse frequency in association with reduced IGF-I concentrations , consistent with GH resistance , among both hypogonadal and eugonadal men with AIDS wasting .  Testosterone administration decreases GH  in hypogonadal men with AIDS wasting . The change in GH is best predicted by and is inversely related to the magnitude of the change in lean body mass in response to testosterone administration . These data demonstrate that among hypogonadal men with the AWS , testosterone administration has a significant effect on the GH axis BACKGROUND Decreased libido is one of several changes in sexual function that are often experienced by female cancer patients .  Transdermal testosterone therapy has been associated with increased libido among estrogen-replete women who report low libido . METHODS In a phase III r and omized , placebo-controlled crossover clinical trial , we evaluated whether transdermal testosterone would increase sexual desire in female cancer survivors . Postmenopausal women with a history of cancer and no current evidence of disease were eligible if they reported a decrease in sexual desire and had a sexual partner . Eligible women were r and omly assigned to receive 2 % testosterone in Vanicream for a testosterone dose of 10 mg daily or placebo Vanicream for 4 weeks and were then crossed over to the opposite treatment for an additional 4 weeks . The primary endpoint was sexual desire or libido , as measured using the desire subscales of the Changes in Sexual Functioning Question naire , as assessed at baseline and at the end of 4 and 8 weeks of treatment . Serum levels of bioavailable testosterone were measured at the same times . All statistical tests were two-sided . RESULTS We enrolled 150 women . Women who were on active testosterone cream had higher serum levels of bioavailable testosterone than women on placebo ( mean change from baseline , testosterone versus placebo , week 4 , 11.57 % versus 0 % , difference = 11.57 % , 95 % confidence interval [ CI ] = 8.49 % to 14.65 % ; week 8 , 10.21 % versus 0.28 % , difference = 9.92 % , 95 % CI = 5.42 % to 14.42 % ; P<.001 for all ) . However , the average intrapatient libido change from baseline to weeks 4 and 8 was similar on both arms . CONCLUSION Increased testosterone level did not translate into improved libido , possibly because women on this study were estrogen depleted & NA ; Various parameters of sexual functioning were assessed in a prospect i ve , crossover investigation of 53 surgically menopausal women . Patients r and omly received either an estrogen‐ and rogen combined preparation , an estrogen‐alone drug , an and rogen‐alone drug , or a placebo .  Also included were a group of women who had undergone hysterectomy and whose ovaries had been left intact . Two treatment phases , each of 3 months ' duration , were separated by an intervening placebo month . Additionally , plasma levels of total estrogens and testosterone were assayed four times during the study concurrent with monitoring of sexual behaviors . It was clear that exogenous and rogen enhanced the intensity of sexual desire and arousal and the frequency of sexual fantasies in hysterectomized and oophorectomized women . However , there was no evidence that testosterone affected physiologic response or interpersonal aspects of sexual behavior . These findings suggest that the major impact of and rogen in women is on sexual motivation and not on sexual activity per se Background In Ug and a , parasite-based diagnosis is recommended for every patient suspected to have malaria before prescribing anti-malarials . However , the majority of patients are still treated presumptively especially in low-level health units . The feasibility of implementing parasite-based diagnosis for uncomplicated malaria in rural health centres ( HCs ) was investigated with a view to recommending measures for scaling up the policy . Methods Thirty HCs were r and omized to implement  parasite-based diagnosis based on rapid diagnostic tests [ RDTs ] ( n = 10 ) , blood microscopy ( n = 10 ) and presumptive diagnosis ( control arm ) ( n = 10 ) . Feasibility was assessed by comparing the proportion of patients who received parasite-based diagnosis ; with a positive malaria parasite-based diagnosis who received artemether-lumefantrine ( AL ) ; with a negative malaria parasite-based diagnosis who received AL ; and patient waiting time . Clinical trials.gov : NCT00565071 . Results 102 , 087 out patients were enrolled . Patients were more likely to be  tested in the RDT 44 , 565 ( 96.6 % ) than in microscopy arm 19 , 545 ( 60.9 % ) [ RR : 1.59 ] . RDTs reduced patient waiting time compared to microscopy and were more convenient to health workers and patients . Majority 23 , 804 ( 99.7 % ) in presumptive arm were prescribed AL . All ( 100 % ) of patients who tested positive for malaria in RDT and microscopy arms were prescribed anti-malarials . Parasitological-based diagnosis significantly reduced AL prescription in RDT arm [ RR : 0.62 ] and microscopy arm [ RR : 0.72 ] compared to presumptive treatment . Among patients not tested in the two intervention arms , 12 , 044 ( 96.1 % ) in microscopy and 965 ( 61.6 % ) in RDT arm were treated with AL [ RR : 1.56 ] . Overall 10 , 558 ( 29.4 % ) with negative results [ 5 , 110 ( 23.4 % ) in RDT and 5 , 448 ( 39.0 % ) in microscopy arms ] were prescribed AL . Conclusion It was more feasible to implement parasite-based diagnosis for malaria using RDT than with microscopy . A high proportion of patients with negative malaria results are still prescribed anti-malarials . There is need to increase access to parasite-based diagnosis where microscopy is used . In order to fully harness the benefits of parasitological confirmation of malaria , it is necessary to reduce the prescription of anti-malarials in negative patients BACKGROUND Relative and rogen deficiency in ageing males is assumed to have adverse health effects . This study assessed the effect of 12 months ' st and ard dose , oral testosterone , on symptoms attributed to testosterone deficiency in older men with plasma testosterone levels in the low-normal range for young men . METHODS Testosterone undecanoate ( TU , 80 mg bid ) or placebo was administered for one year to 76 healthy men , 60 years or older , with a free testosterone index ( FTI ) of 0.3 - 0.5 and significant symptoms on a question naire design ed to evaluate and rogen deficiency ( ADAM ) . The ADAM was completed at baseline , 6 and 12 months . Hormone and safety data were collected at baseline , 1 , 3 , 6 and 12 months . RESULTS After 12 months , plasma total testosterone was unchanged in both groups and sex hormone binding globulin decreased in the testosterone group ( P = 0.01 ) . FTI and calculated bioavailable testosterone ( cBT ) were greater in the testosterone group as compared with the placebo group ( P = 0.021 and 0.025 , respectively ) . There was no significant difference in total symptom score between testosterone and placebo groups after 12 months of oral TU . However , there were trends toward improvements in sadness/grumpiness ( P = 0.063 ) , reduced erection strength ( P = 0.059 ) and decreased work performance symptoms ( P = 0.077 ) , particularly in men with baseline cBT levels below 3.1 nmol/l . CONCLUSIONS This study concludes that 80 mg bid oral TU does not improve overall ADAM question naire scores  in older men with low-normal gonadal status . Oral TU may preserve mood and erectile function , as assessed by this question naire , particularly in men with the lowest testosterone levels CONTEXT Serum concentrations of gonadal hormones have been associated with various measures of well-being , but it is unclear whether their association with mood is confounded by concurrent physical morbidity . OBJECTIVE To determine whether the association between serum testosterone concentration and mood in older men is independent of physical comorbidity . DESIGN Cross-sectional study . SETTING Community of Perth , Western Australia . PARTICIPANTS A community sample of men aged 71 to 89 years . MAIN OUTCOME MEASURES We used the 15-item Geriatric Depression Scale ( GDS-15 ) to assess depressed mood . Clinical ly significant depression was defined a priori as a GDS-15 score of 7 or greater . Physical health was assessed using the weighted Charlson index and the Physical Component Summary score of the 36-Item Short Form Health Survey . RESULTS Of 3987 men included in the study , 203 ( 5.1 % ; 95 % confidence interval [ CI ] , 4.4%-5.8 % ) had depression . Participants with depression had significantly lower total and free testosterone concentrations than nondepressed men ( P < .001 for both ) . However , they were also more likely to smoke and to have low educational attainment , a body mass index categorized as obese , a Mini-Mental State Examination score less than 24 , a history of antidepressant drug treatment , and greater concurrent physical morbidity . After adjusting for these factors and for age , men with depression were 1.55 ( 95 % CI , 0.91 - 2.63 ) and 2.71 ( 95 % CI , 1.49 - 4.93 ) times more likely to have total and free testosterone concentrations , respectively , in the lowest quintile . CONCLUSIONS A free testosterone concentration in the lowest quintile is associated with a higher prevalence of depression , and this association can not be adequately explained by physical comorbidity . A r and omized controlled trial is required to determine whether the link between low free testosterone level and depression is causal because older men with depression may benefit from systematic screening of free testosterone concentration and testosterone supplementation OBJECTIVE To assess the efficacy and safety of a 300 mug/d testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women on concomitant estrogen therapy . METHODS Five hundred thirty-three women with hypoactive sexual desire disorder who had undergone previous hysterectomy and bilateral oophorectomy were enrolled in a 24-week , multicenter , double-blind , placebo-controlled trial . Patients were r and omly assigned to receive placebo or the testosterone patch twice weekly . The primary efficacy endpoint was change from baseline at week 24 in the frequency of total satisfying sexual activity , measured by the Sexual Activity Log . Secondary measures included sexual desire using the Profile of Female Sexual Function and personal distress as measured by the Personal Distress Scale . Hormone levels , adverse events , and clinical laboratory measures were review ed . RESULTS Total satisfying sexual activity significantly improved in the testosterone patch group compared with placebo after 24 weeks ( mean change from baseline , 1.56 compared with 0.73 episodes per 4 weeks , P = .001 ) . Treatment with the testosterone patch also significantly improved sexual desire ( mean change , 10.57 compared with 4.29 , P < .001 ) and decreased personal distress ( P = .009 ) . Serum free , total , and bioavailable testosterone concentrations increased from baseline . Overall , adverse events were similar in both groups ( P > .05 ) . The incidence of and rogenic adverse events was higher in the testosterone group ; most and rogenic adverse events were mild . CONCLUSION In surgically menopausal women with hypoactive sexual desire disorder , a 300 mug/d testosterone patch significantly increased satisfying sexual activity and sexual desire , while decreasing personal distress , and was well tolerated through up to 24 weeks of use Serum testosterone concentrations are frequently in the low-normal range ( lowest quartile , < 500 ng/dl ) in men with AIDS-wasting syndrome ( AWS ) and in other chronic wasting disorders . The response of patients in this group to and rogen treatment has not been determined , however . Eighteen men with AWS ( mean + /- st and ard error [ SE ] : 87 % + /- 1 % usual body weight ; CD4 count 90 + /- 24 ) and borderline low serum testosterone concentrations ( 382 + /- 33 ng/dl ) completed a 21-day placebo-controlled inpatient metabolic ward study comparing intramuscular ( i.m . ) placebo ( n = 7 ) with low-dose ( 65 mg/week ; n = 4 ) and high-dose ( 200 mg/week ; n = 7 ) n and rolone decanoate , a testosterone analogue .  Nitrogen balance , stable isotope-mass spectrometric measurement of de novo lipogenesis ( DNL ) , resting energy expenditure , and gonadal hormone levels were measured . Both low-dose and high-dose n and rolone result ed in significant nitrogen retention ( 33 - 52 g nitrogen/14 days , representing gains of 0.5 to 0.9 kg lean tissue/week ) compared with placebo ( loss of 11 g nitrogen/week ) . This was reflected biochemically in a borderline significant reduction of high DNL ( p < .06 ) . Serum testosterone and gonadotropins were suppressed whereas resting energy expenditure was unchanged by n and rolone treatment . In 10 study subjects completing a 12-week open-label follow-up phase , body weight increased by 4.9 + /- 1.2 kg , including 3.1 + /- 0.5 kg lean body mass , and treadmill exercise performance also improved . In summary , n and rolone decanoate therapy in the absence of an exercise program in borderline hypogonadal men with AWS caused substantial nitrogen retention compared with placebo , similar in extent to the nitrogen retention previously achieved with recombinant growth hormone . It is reasonable to exp and the criteria for and rogen treatment in AWS to include at least patients in the lowest quartile of serum testosterone BACKGROUND Trials of testosterone therapy in aging men have demonstrated increases in fat-free mass ( FFM ) and skeletal muscle and decreases in fat mass ( FM ) but have not reported the impact of baseline body composition . OBJECTIVE The objective of the study was to determine the effect , in nonobese aging men with symptoms of and rogen deficiency and low-normal serum testosterone levels , of testosterone therapy on total and regional body composition and hormonal and metabolic indices . METHODS Sixty healthy but symptomatic , nonobese men aged 55 yr or older with total testosterone ( TT ) levels less than 15 nm were r and omized to transdermal testosterone patches or placebo for 52 wk . Body composition , by dual-energy x-ray absorptiometry ( FM , FFM , skeletal muscle ) and magnetic resonance imaging ( abdominal sc and visceral adipose tissue , thigh skeletal muscle , and intermuscular fat ) and hormonal and metabolic parameters were measured at wk 0 and 52 . RESULTS Serum TT increased by 30 % ( P = 0.01 ) , and LH decreased by 50 % ( P < 0.001 ) . Relative to placebo , total body FFM ( P = 0.03 ) and skeletal muscle ( P = 0.008 ) were increased and thigh skeletal muscle loss was prevented ( P = 0.045 ) with testosterone therapy and visceral fat accumulation decreased ( P = 0.001 ) without change in total body or abdominal sc FM ; change in visceral fat was correlated with change in TT levels ( r2 = 0.36 ; P = 0.014 ) . There was a trend to increasing total and low-density lipoprotein cholesterol with placebo . CONCLUSION Testosterone therapy , relative to placebo , selectively lessened visceral fat accumulation without change in total body FM and increased total body FFM and total body and thigh skeletal muscle mass . Further studies are needed to determine the impact of these body compositional changes on markers of metabolic and cardiovascular risk Background : Low serum testosterone is associated with several cardiovascular risk factors including dyslipidaemia , adverse clotting profiles , obesity , and insulin resistance . Testosterone has been reported to improve symptoms of angina and delay time to ischaemic threshold in unselected men with coronary disease . Objective : This r and omised single blind placebo controlled crossover study compared testosterone replacement therapy ( Sustanon 100 ) with placebo in 10 men with ischaemic heart disease and hypogonadism . Results : Baseline total testosterone and bioavailable testosterone were respectively 4.2 ( 0.5 ) nmol/l and 1.7 ( 0.4 ) nmol/l . After a month of testosterone , delta value analysis between testosterone and placebo phase showed that mean ( SD ) trough testosterone concentrations increased significantly by 4.8 ( 6.6 ) nmol/l ( total testosterone ) ( p = 0.05 ) and 3.8 ( 4.5 ) nmol/l ( bioavailable testosterone ) ( p = 0.025 ) , time to 1 mm ST segment depression assessed by Bruce protocol exercise treadmill testing increased by 74 ( 54 ) seconds ( p = 0.002 ) , and mood scores assessed with vali date d question naires all improved . Compared with placebo , testosterone therapy was also associated with a significant reduction of total cholesterol and serum tumour necrosis factor α with delta values of −0.41 ( 0.54 ) mmol/l ( p = 0.04 ) and −1.8 ( 2.4 ) pg/ml ( p = 0.05 ) respectively . Conclusion : Testosterone replacement therapy  in hypogonadal men delays time to ischaemia , improves mood , and is associated with potentially beneficial reductions of total cholesterol and serum tumour necrosis factor α INTRODUCTION Obesity and inactivity are associated with erectile dysfunction and hypogonadism . AIM To compare the effects of low volume ( LV ) and high volume ( HV ) of moderate-intensity exercise  on sexual function , testosterone , lower urinary tract symptoms ( LUTS ) , endothelial function , and quality of life ( QoL ) in obese men . MAIN OUTCOME MEASURES Weight , waist circumference ( WC ) , body composition , International Index of Erectile Function 5-item ( IIEF-5 ) , International Prostate Symptom Scale ( IPSS ) ( for LUTS ) , and 36-item Short Form Survey version 2 Instrument ( SF-36 ) ( for QoL ) scores , plasma testosterone , sex-hormone binding globulin , glucose , insulin and lipids , and endothelial function ( by Reactive Hyperaemia Index [ RHI ] using finger plethysmography ) were measured at baseline and 24 weeks . METHODS Ninety abdominally obese ( body mass index > 27.5 kg/m(2 ) , WC > 90 cm ) , sedentary ( exercise ≈ 80 minutes/week ) Asian men ( mean age 43.6 years , range 30 - 60 ) were prescribed a diet to reduce daily intake by ≈ 400 kcal below calculated requirement and r and omized to perform moderate-intensity exercise of LV ( < 150 minutes/week ) or HV ( 200 - 300 minutes/week ) ( n = 45 each ) for 24 weeks . Seventy-five men ( 83.3 % ) completed the study .  RESULTS Weekly exercise volume was significantly greater in the HV ( 236 ± 9 minutes ) than the LV ( 105 ± 9 minutes ) group . The HV group had significantly greater increases in IIEF-5 score ( 2.6 ± 0.5 points ) and testosterone ( 2.06 ± 0.46 nmol/L ) and reductions in weight ( -5.9 ± 0.7 kg , -6.2 % ) , WC ( -4.9 ± 0.8 cm , -4.9 % ) , and fat mass ( -4.7 ± 1.0 kg , -14.5 % ) than the LV group ( -2.9 ± 0.7 kg , -3.0 % ; -2.7 ± 0.7 cm , -2.5 % ; -1.1 ± 0.8 kg , -3.2 % ; 0.79 ± 0.46 nmol/L ; and 1.8 ± 0.5 points ) . Improvements in IPSS and SF-36 scores , and RHI , were similar . CONCLUSIONS Moderate-intensity HV aerobic exercise > 200 minutes/week produces greater improvements in sexual function , testosterone , weight , WC , and fat mass than smaller exercise volume PURPOSE Determine the independent and combined effects of progressive resistance muscle strength training ( PRMST ) and testosterone on strength , muscle mass , and function in hypogonadal elderly male recuperative care patients . METHODS Between 1999 and 2004 , 71 subjects ( mean age 78.2 + /- 6.4 yr , 86 % white ) were enrolled . After baseline one-repetition maximum ( 1RM ) strength testing and then r and omization to one of four treatment groups ( low-resistance ( 20 % of the 1RM ) exercises and weekly injections of either 100 mg of testosterone enanthate or placebo or high-intensity PRMST ( > or = 80 % 1RM ) and weekly injections ) , each subject received training and injections for 12 wk . RESULTS Ten subjects withdrew from the study before its completion . Based on intent-to-treat analyses , strength improved in all groups , but was greater with high-intensity PRMST compared with low-resistance exercise ( e.g. , leg press , ( mean + /- SE ) , 28 + /- 4 vs 13 + /- 4 % , P = 0.009 ) . Although testosterone led to significantly greater increases in midthigh cross-sectional muscle area compared with placebo ( 7.9 + /- 1.3 vs 2.4 + /- 1.4 % , P = 0.005 ) , it produced only a nonsignificant trend toward greater strength gains ( e.g. , leg press 25 + /- 4 vs 16 + /- 4 % , P = 0.144 ) . Change in aggregate functional performance score ( the sum of 4 functional performance test scores ) did not differ between the four intervention groups nor with high-intensity PRMST compared with low-resistance exercise ( 7 + /- 5 vs 15 + /- 5 % , P = 0.263 ) . There was not a significant interaction between exercise and testosterone for any outcome . CONCLUSION High-intensity PRMST is as safe and well tolerated as a similarly structured low-resistance exercise regimen for very frail elderly patients , but produces greater muscle strength improvements . The addition of testosterone leads to greater muscle size and a trend toward greater strength but did not produce a synergistic interaction with exercise . Neither intervention had a significant effect on functional performance UNLABELLED Anecdotal reports of " roid rage " and violent crimes by and rogenic steroid users have brought attention to the relationship between anabolic steroid use and angry outbursts . However , testosterone effects on human aggression remain controversial . Previous studies have been criticized because of the low and rogen doses , lack of placebo control or blinding , and inclusion of competitive athletes and those with preexisting psychopathology . To overcome these pitfalls , we used a double-blind , placebo-controlled design , excluded competitive athletes and those with psychiatric disorders , and used 600 mg testosterone enanthate (TE)/week . Forty-three eugonadal men , 19 - 40 yr , were r and omized to 1 of 4 groups : Group I , placebo , no exercise ; Group II , TE , no exercise ; Group III , placebo , exercise ; Group IV , TE plus exercise . Exercise consisted of thrice weekly strength training sessions . The Multi-Dimensional Anger Inventory ( MAI ) , which includes 5 different dimensions of anger ( inward anger , outward anger , anger arousal , hostile outlook , and anger eliciting situations ) , and a Mood Inventory ( MI ) , which includes items related to mood and behavior , were administered to subjects before , during , and after the 10 week intervention . The subject 's significant other ( spouse , live-in partner , or parent ) also answered the same questions about the subject 's mood and behavior ( Observer Mood Inventory , OMI ) . No differences were observed between exercising and nonexercising and between placebo and TE treated subjects for any of the 5 subdomains of MAI . Overall there were no significant changes in MI or OMI during the treatment period in any group . CONCLUSION Supraphysiological doses of testosterone , when administered to normal men in a controlled setting , do not increase angry behavior . These data do not exclude the possibility that still higher doses of multiple steroids might provoke angry behavior in men with preexisting psychopathology OBJECTIVE To study the impact of a weight-loss program on sex hormones and sexual function among 38 middle-aged obese men ( BMI > or=35 kg/m(2 ) ) . RESEARCH METHODS AND PROCEDURES A r and omized controlled clinical trial was conducted . The treatment group ( n = 19 ) participated in a 4-month weight-loss program including 10 weeks on a very-low-energy diet ( VLED ) and 17 behavior modification visits . There was no intervention in the control  group ( n = 19 ) . Both groups were followed for 8 months , i.e. , 22 weeks after the active weight loss in the treatment group . The outcome measures ( weight , sex hormones , sexual function , leptin , and metabolic variables ) were obtained at baseline and at three time-points during follow-up . RESULTS The mean weight loss in the treatment group was 21 kg at the end of the 10-week VLED . At the end of follow-up , the maintained weight loss was 17 kg of baseline weight . The control group was weight stable throughout the study . In the treatment group , increases in sex hormone-binding globulin , testosterone , and high-density lipoprotein-cholesterol , as well as decreases in insulin and leptin , were maintained until the end of follow-up , although with VLED , the level of several hormones and metabolic variables improved transiently during the rapid weight loss . There were no significant changes in the question naire scores on sexual function in either group . DISCUSSION We conclude that obese men lose weight and increase their serum testosterone level on a weight-loss program with VLED and behavior modification . However , they do not change their sexual function scores BACKGROUND Symptoms of male hypogonadism include low libido , fatigue , and dysphoria and are alleviated with testosterone replacement . The prevalence of major depressive disorder ( MDD ) in hypogonadal men is not known , nor is the antidepressant efficacy of testosterone replacement in depressed , hypogonadal men . METHOD A 6-week double-blind , placebo-controlled clinical trial was conducted in 32 men with DSM-IV MDD and a low testosterone level , defined as total serum testosterone < or = 350 ng/dL. Patients were r and omly assigned to receive weekly 1-mL intramuscular injections of either testosterone enanthate , 200 mg , or sesame seed oil ( placebo ) . The primary outcome measure was the 24-item Hamilton Rating Scale for Depression ( HAM-D ) . RESULTS Thirty patients were r and omly assigned to an intervention ; 13 received testosterone , and 17 received placebo .  Mean + /- SD age was 52+/-10 years , mean testosterone level was 266.1+/-50.6 ng/dL , and mean baseline HAM-D score was 21+/-8 . All patients who received testosterone achieved normalization of their testosterone levels . The HAM-D scores decreased in both testosterone and placebo groups , and there were no significant between-group differences : reduction in group mean HAM-D score from baseline to endpoint was 10.1 in patients who received testosterone and 10.5 in those who received placebo .  Response rate , defined as a 50 % or greater reduction in HAM-D score , was 38.5 % ( 5/13 ) for patients who received testosterone and 41.2 % ( 7/17 ) for patients who received placebo . Patients receiving testosterone had a marginal but statistically significant improvement in sexual function ( p = .02 ) . CONCLUSION In this clinical trial with depressed , hypogonadal men , antidepressant effects of testosterone replacement could not be differentiated from those of placebo CONTEXT Risk factors for low testosterone and symptomatic and rogen deficiency ( AD ) may be modifiable . OBJECTIVE Our objective was to examine demographic , anthropometric , and medical correlates of low testosterone and symptomatic AD . DESIGN Data were used from the Boston Area Community Health Survey , an epidemiological study conducted from 2002 - 2005 . SETTING Data were obtained from a community-based r and om sample of racially and ethnically diverse men . PATIENTS OR OTHER PARTICIPANTS Data were available for 1822 men . MAIN OUTCOME MEASURES Multivariate logistic regression  was used to estimate odds ratios ( OR ) and 95 % confidence intervals ( CI ) for associations of covariates with 1 ) low testosterone and 2 ) symptomatic AD . The operational definition of low testosterone was serum total testosterone less than 300 ng/dl and free testosterone less than 5 ng/dl ; symptomatic AD was defined as the additional presence of symptoms : any of low libido , erectile dysfunction , or osteoporosis or two or more of sleep disturbance , depressed mood , lethargy , or diminished physical performance . RESULTS Factors associated with low testosterone included age ( OR = 1.36 ; 95 % CI= 1.11 - 1.66 , per decade ) , low per-capita income ( $ 6000 or less per household member vs. more than $ 30,000 ; OR = 2.86 ; 95 % CI = 1.39 - 5.87 ) , and waist circumference ( per 10-cm increase ; OR = 1.75 ; 95 % CI = 1.45 - 2.12 ) . Only age ( OR = 1.36 ; 95 % CI = 1.04 - 1.77 ) , waist circumference ( OR = 1.88 ; 95 % CI = 1.44 - 2.47 ) , and health status ( OR = 0.21 ; 95 % CI = 0.05 - 0.92 , excellent vs. fair/poor ) were associated with our construct of symptomatic AD . Of all variables , waist circumference was the most important contributor in both models . CONCLUSIONS Waist circumference is a potentially modifiable risk factor for low testosterone and symptomatic AD . Manifestation of symptoms may be a consequence of generally poor health status The male aging process brings about declines in hormonal function including a gradual decline in bioavailable testosterone levels . Animal studies suggest that testosterone modulates cognitive function through enhancing acetylcholine release and up-modulation of nicotinic receptors . Tau protein deposition is also affected by and rogen supplementation in animals . We hypothesize that testosterone replacement in elderly hypogonadal males may improve cognition , in particular the visual-spatial domain . Thirty-six male patients with a new diagnosis of Alzheimer 's disease had their total and bioavailable testosterone levels measured . None of the patients had been on acetylcholinesterase inhibitors .  Ten of the 36 patients ( 28 % ) were deemed biochemically hypogonadal ( total testosterone < 240 ng/dl or 7 nmol/l ) . Five of the hypogonadal patients were r and omized to testosterone and five to placebo . Initial Alzheimer 's Disease Assessment Scale cognitive subscale ( ADAScog ) and Mini Mental Status Examination ( MMSE ) ranged from 31 to 19 and from 17 to 22 , respectively . The  clock drawing test ( CDT ) and the pentagon-tracing portion of the MMSE were used as measures of visual-spatial abilities . Normal prostate-specific antigen ( PSA ) levels were essential before treatment with intramuscular testosterone , 200 mg every 2 weeks . Measurement of testosterone , complete blood count , lipids , PSA and neuropsychological cognitive tests were repeated at 3 , 6 , 9 and 12 months of treatment . In the testosterone-treated group , levels of total testosterone increased from a mean of 126.4 ng/dl to 341 ng/dl or 3.6 nmol/l to 9.7 nmol/l ( p = 0.11 ) . Bioavailable testosterone also increased from a mean of 48.7 ng/dl to 142 ng/dl or 1.39 nmol/l to 4.05 nmol/l ( p = 0.10 ) . PSA levels were also elevated from a mean of 0.98 to 1.37 ng/ml ( p = 0.07 ) . ADAScog improved from a mean of 25 to 16.3 ( p = 0.02 ) ; MMSE improved from a mean of 19.4 to 23.2 ( p = 0.02 ) , CDT also improved from 2.2 to 3.2 ( p = 0.07 ) . One patient stopped treatment because of hypersexual behavior . The placebo-treated group deteriorated gradually . This small pilot study performed in aging male patients suggests that testosterone could indeed improve cognition , including visual-spatial skills in mild to moderate Alzheimer 's disease Secondary hypogonadism is not an infrequent abnormality in older patients presenting with the primary complaint of erectile dysfunction . Because of the role of testosterone in mediating sexual desire and erectile function in men , these patients are usually treated with exogenous testosterone , which , while elevating the circulating and rogens , suppresses gonadotropins from the hypothalamic-pituitary axis . The response of this form of therapy , although extolled in the lay literature , has usually not been effective in restoring or even improving sexual function . This failure of response could be the result of suppression of gonadotropins or the lack of a cause and effect relationship between sexual function and circulating and rogens in this group of patients . Further , because exogenous testosterone can potentially increase the risk of prostate disease , it is important to be sure of the benefit sought , i.e. an increase in sexual function . In an attempt to answer this question , we measured the hormone levels and studied the sexual function in 17 patients with erectile dysfunction who were found to have secondary hypogonadism . This double blind , placebo-controlled , cross-over study consisted of treatment with clomiphene citrate and a placebo for 2 months each . Similar to our previous observations , LH , FSH , and total and free testosterone levels showed a significant elevation in response to clomiphene citrate over the response to placebo . However , sexual function , as monitored by question naires and nocturnal penile tumescence and rigidity testing , did not improve except for some limited parameters in younger and healthier men . The results confirmed that there can be a functional secondary hypogonadism in men on an out-patient basis , but correlation of the hormonal status does not universally reverse the associated erectile dysfunction to normal , thus requiring closer scrutiny of cl aims of cause and effect relationships between hypogonadism and erectile dysfunction BACKGROUND Oophorectomy reduces serum testosterone levels . We studied the efficacy and safety of transdermal testosterone in treating hypoactive sexual desire disorder in surgically menopausal women . METHODS A 24-week , r and omized , double-blind , placebo-controlled , parallel-group , multicenter trial was conducted in women ( aged 24 - 70 years ) who developed distressful low sexual desire after bilateral salpingo-oophorectomy and hysterectomy and who were receiving oral estrogen therapy .  Women were r and omized to receive placebo ( n = 119 ) or testosterone patches in dosages of 150 microg/d ( n = 107 ) , 300 microg/d ( n = 110 ) , or 450 microg/d ( n = 111 ) twice weekly for 24 weeks . Sexual desire and frequency of satisfying sexual activity were primary efficacy outcome measures . RESULTS Of the 447 women r and omized , 318 ( 71 % ) completed the trial . Compared with placebo , women receiving the 300-microg/d testosterone patch had significantly greater increases from baseline in sexual desire ( 67 % vs 48 % ; P = .05 ) and in frequency of satisfying sexual activity ( 79 % vs 43 % ; P = .049 ) . The 150-microg/d group showed no evidence of a treatment effect . The 450-microg/d group also was not statistically different from the 300-microg/d or placebo groups . Marginally significant linear dose-response trends were observed for total satisfying sexual activity and sexual desire at 24 weeks ( P = .06 and .06 , respectively ) . Adverse events occurred with similar frequency in both groups ; no serious safety concerns were observed . CONCLUSIONS The 300-microg/d testosterone patch increased sexual desire and frequency of satisfying sexual activity and was well tolerated in women who developed hypoactive sexual desire disorder after surgical menopause Reduction in testosterone levels in men during aging is associated with cognitive decline and risk of dementia . Animal studies have shown benefits for testosterone supplementation in improving cognition and reducing Alzheimer ’s disease pathology . In a r and omized , placebo-controlled , crossover study of men with subjective memory complaint and low testosterone levels , we investigated whether testosterone treatment significantly improved performance on various measures of cognitive functioning . Forty-four men were administered a battery of neuropsychological tests to establish the baseline prior to being r and omly divided into two groups . The first group ( Group A ) received 24 weeks of testosterone treatment ( T treatment ) followed by 4 weeks washout , and then 24 weeks of placebo ( P ) ; the second group ( Group B ) received the same treatments , in reverse order ( Placebo , washout , and then T treatment ) . In group A ( TèP ) , compared to baseline , there was a modest ( 1 point ) but significant improvement in general cognitive functioning as measured by the Mini Mental State Examination ( MMSE ) following testosterone treatment . This improvement from baseline was sustained following the washout period and crossover to placebo treatment . Similar Mini Mental State Examination ( MMSE ) scores were observed when comparing testosterone treatment with placebo . In group B ( PèT ) a significant increase was observed from baseline following testosterone treatment and a trend towards an increase when compared to placebo treatment . Improvements in baseline depression scores ( assessed by Geriatric Depression Scale ) were observed following testosterone/placebo treatment in both groups , and no difference was observed when comparing testosterone with placebo treatment . Our findings indicate a modest improvement on global cognition with testosterone treatment . Larger clinical trials with a longer follow- up and with the inclusion of blood and brain imaging markers are now needed to conclusively determine the significance of testosterone treatment INTRODUCTION Female libido is multifactorial and complex . Declining estrogen levels in postmenopausal women affects vaginal function . AIM The aim of this study was to evaluate female sexual function after using topical estrogen , testosterone , or polyacrylic acid as vaginal lubricants with K-Y jelly as a placebo lubricant . METHODS This was a r and omized controlled clinical trial on 80 postmenopausal women between 40 and 70 years of age with follow-up at the Menopause Clinic of the CAISM Unicamp . The women were r and omized to treatment with topical vaginal estrogen , testosterone , polyacrylic acid , or oil lubricant alone , three times a week for a period of 12 weeks from November 2011 to January 2013 . MAIN OUTCOME MEASURE We used the Female Sexual Function Index ( FSFI ) to assess changes in sexual response at baseline , and after 6 and 12 weeks . RESULTS After 12 weeks of treatment , polyacrylic acid and topical testosterone produced improvements in the FSFI domains of sexual desire , lubrication , satisfaction , reduced pain during intercourse , and total score compared with lubricant alone . Treatment with topical estrogen in comparison with lubricant alone showed an improvement in the FSFI field of desire . The intragroup analysis over the time of the treatment showed improvements in the fields of desire , lubrication , and reduced pain for polyacrylic acid , testosterone , and estrogen . Furthermore , women who used testosterone showed improvements over time in the fields of arousal , orgasm , and satisfaction . CONCLUSIONS Treatment of postmenopausal women with symptoms of vaginal atrophy with polyacrylic acid , testosterone , and estrogen for 12 weeks produced improvements in self-reported female sexual function when compared with a placebo lubricant OBJECTIVES To investigate the effects of testosterone supplementation on bone , body composition , muscle , physical function , and safety in older men . DESIGN Double-blind , r and omized , placebo-controlled trial . SETTING A major medical institution . PARTICIPANTS One hundred thirty-one men ( mean age 77.1 + /- 7.6 ) with low testosterone , history of fracture , or bone mineral density ( BMD ) T-score less than -2.0 and frailty . INTERVENTION Participants received 5 mg/d of testosterone or placebo for 12 to 24 months ; all received calcium ( 1500 mg/d diet and supplement ) and cholecalciferol ( 1,000 IU/d ) . MEASUREMENTS BMD of hip , lumbar spine , and mid-radius ; body composition ; sex hormones , calcium-regulating hormones ; bone turnover markers ; strength ; physical performance ; and safety parameters . RESULTS Ninety-nine men ( 75.6 % ) completed 12 months , and 62 ( 47.3 % ) completed end therapy ( mean 23 months ; range 16 - 24 months for 62 who completed therapy ) . Study adherence was 54 % , with 40 % of subjects maintaining 70 % or greater adherence . Testosterone and bioavailable testosterone levels at 12 months were 583 ng/dL and 157 ng/dL , respectively , in the treatment group . BMD on testosterone  increased 1.4 % at the femoral neck and 3.2 % at the lumbar spine ( P=.005 ) and decreased 1.3 % at the mid-radius ( P<.001 ) . There was an increase in lean mass and a decrease in fat mass in the testosterone group but no differences in strength or physical performance . There were no differences in safety parameters . CONCLUSION Older , frail men receiving  testosterone replacement increased testosterone levels and had favorable changes in body composition , modest changes in axial BMD , and no substantial changes in physical function BACKGROUND Athletes often take and rogenic steroids in an attempt to increase their strength . The efficacy of these substances for this purpose is unsubstantiated , however . METHODS We r and omly assigned 43 normal men to one of four groups : placebo with no exercise ; testosterone with no exercise ; placebo plus exercise ; and testosterone plus exercise . The men received injections of 600 mg of testosterone enanthate or placebo weekly for 10 weeks . The men in the exercise groups performed st and ardized weight-lifting exercises three times weekly . Before and after the treatment period , fat-free mass was determined by underwater weighing , muscle size was measured by magnetic resonance imaging , and the strength of the arms and legs was assessed by bench-press and squatting exercises , respectively . RESULTS Among the men in the no-exercise groups , those given testosterone had greater increases than those given placebo in muscle size in their arms ( mean [ + /-SE ] change in triceps area , 424 + /- 104 vs. -81 + /- 109 square millimeters ; P < 0.05 ) and legs ( change in quadriceps area , 607 + /- 123 vs. -131 + /- 111 square millimeters ; P < 0.05 ) and greater increases in strength in the bench-press ( 9 + /- 4 vs. -1 + /- 1 kg , P < 0.05 ) and squatting exercises ( 16 + /- 4 vs. 3 + /- 1 kg , P < 0.05 ) . The men assigned to testosterone and exercise had greater increases in fat-free mass ( 6.1 + /- 0.6 kg ) and muscle size ( triceps area , 501 + /- 104 square millimeters ; quadriceps area , 1174 + /- 91 square millimeters ) than those assigned to either no-exercise group , and greater increases in muscle strength ( bench-press strength , 22 + /- 2 kg ; squatting-exercise capacity , 38 + /- 4 kg ) than either no-exercise group . Neither mood nor behavior was altered in any group . CONCLUSIONS Supraphysiologic doses of testosterone , especially when combined with strength training , increase fat-free mass and muscle size and strength in normal men CONTEXT Testosterone in Older Men with Mobility Limitations Trial determined the effects of testosterone on muscle performance and physical function in older men with mobility limitation . Trial 's Data and Safety Monitoring Board recommended enrollment cessation due to increased frequency of adverse events in testosterone arm . The changes in muscle performance and physical function were evaluated in relation to participant 's perception of change . METHODS Men aged 65 years and older , with mobility limitation , total testosterone 100 - 350 ng/dL , or free testosterone less than 50 pg/mL , were r and omized to placebo or 10 g testosterone gel daily for 6 months . Primary outcome was leg-press strength . Secondary outcomes included chest-press strength , stair-climb , 40-m walk , muscle mass , physical activity , self-reported function , and fatigue . Proportions of participants exceeding minimally important difference in study arms were compared . RESULTS Of 209 r and omized participants , 165 had follow-up efficacy measures . Mean ( SD ) age was 74 ( 5.4 ) years and short physical performance battery score 7.7 ( 1.4 ) .  Testosterone arm exhibited greater improvements in leg-press strength , chest-press strength and power , and loaded stair-climb than placebo . Compared with placebo , significantly greater proportion of men receiving testosterone improved their leg-press and chest-press strengths ( 43 % vs 18 % , p = .01 ) and stair-climbing power ( 28 % vs 10 % , p = .03 ) more than minimally important difference . Increases in leg-press strength and stair-climbing power were associated with changes in testosterone levels and muscle mass . Physical activity , walking speed , self-reported function , and fatigue did not change . CONCLUSIONS Testosterone administration in older men with mobility limitation was associated with patient-important improvements in muscle strength and stair-climbing power . Improvements in muscle strength and only some physical function measures should be weighed against the risk of adverse events in this population Treatment of hypogonadal men with testosterone  has been shown to ameliorate the effects of testosterone deficiency on bone , muscle , erythropoiesis , and the prostate . Most previous studies , however , have employed somewhat pharmacological doses of testosterone esters , which could result in exaggerated effects , and /or have been of relatively short duration or employed previously treated men , which could result in dampened effects . The goal of this study was to determine the magnitude and time course of the effects of physiological testosterone replacement for 3 yr on bone density , muscle mass and strength , erythropoiesis , prostate volume , energy , sexual function , and lipids in previously untreated hypogonadal men . We selected 18 men who were hypogonadal ( mean serum testosterone + /- SD , 78 + /- 77 ng/dL ; 2.7 + /- 2.7 nmol/L ) due to organic disease and had never previously been treated for hypogonadism . We treated them with testosterone transdermally for 3 yr . Sixteen men completed 12 months of the protocol , and 14 men completed 36 months . The mean serum testosterone concentration reached the normal range by 3 months of treatment and remained there for the duration of treatment . Bone mineral density of the lumbar spine ( L2-L4 ) increased by 7.7 + /- 7.6 % ( P < 0.001 ) , and that of the femoral trochanter increased by 4.0 + /- 5.4 % ( P = 0.02 ) ; both reached maximum values by 24 months . Fat-free mass increased 3.1 kg ( P = 0.004 ) , and fat-free mass of the arms and legs individually increased , principally within the first 6 months . The decrease in fat mass was not statistically significant . Strength of knee flexion and extension did not change . Hematocrit increased dramatically , from mildly anemic ( 38.0 + /- 3.0 % ) to midnormal ( 43.1 + /- 4.0 % ; P = 0.002 ) within 3 months , and remained at that level for the duration of treatment . Prostate volume also increased dramatically , from subnormal ( 12.0 + /- 6.0 mL ) before treatment to normal ( 22.4 + /- 8.4 mL ; P = 0.004 ) , principally during the first 6 months . Self-reported sense of energy ( 49 + /- 19 % to 66 + /- 24 % ; P = 0.01 ) and sexual function ( 24 + /- 20 % to 66 + /- 24 % ; P < 0.001 ) also increased , principally within the first 3 months . Lipids did not change . We conclude from this study that replacing testosterone in hypogonadal men increases bone mineral density of the spine and hip , fat-free mass , prostate volume , erythropoiesis , energy , and sexual function . The full effect of testosterone on bone mineral density took 24 months , but the full effects on the other tissues took only 3 - 6 months . These results provide the basis for monitoring the magnitude and the time course of the effects of testosterone replacement in hypogonadal men To investigate ( 1 ) the effects of exogenous testosterone ( T ) on  self- and partner-reported aggression and mood  and ( 2 ) the role of trait impulsivity in the T-aggression relationship .  Thirty eugonadal men with partners were r and omized into two treatment groups to receive : ( 1 ) 200 mg i m T enanthate weekly for 8 weeks or ( 2 ) 200 mg i m sodium chloride weekly for 8 weeks . Eight hypogonadal men received 200 mg i m T enanthate biweekly for 8 weeks . All groups completed a battery of behavior measures at baseline ( Week 0 ) and at Weeks 4 and 8 . Cognitive and motor impulsivity were the only predictors of self-reported total aggression ( over and above age and T levels ) at Weeks 0 , 4 , and 8 . No significant changes in aggression or mood levels were found in the eugonadal-treated group . Significant reductions in negative mood ( tension , anger , and fatigue ) followed by an increase in vigor were found in response to T treatment in the hypogonadal group . These results demonstrate that inability to control one 's behavior when such control is required by a particular situation ( impulsivity ) was found to significantly predict levels of aggression over and above age and T level . These data do not support the hypothesis that supraphysiological levels of T ( within this range ) lead to an increase in self- and partner-reported aggression or mood disturbances . Instead , for the first time , this study has identified the high level of negative affect experienced by hypogonadal patients . These findings have implication s for T replacement therapy and male contraception Twenty women using oral contraceptives and complaining of impaired sexual function were compared with twenty women without sexual problems , matched for age and oral contraceptive . Whilst the sexual behaviour differed in the two groups , the plasma testosterone , and rostenedione , oestradiol and SHBG concentrations were very similar . The total and rogen levels were low in both groups . Plasma testosterone and oestradiol concentrations were correlated with measures of sexual interest in the no‐problem group , but not in the problem group . Administration of exogenous and rostenedione to women in the problem group , using a double blind cross‐over comparison with a placebo , failed to improve their sexual function except in one case . The majority of women showed a rise in and rogen and oestradiol between day 24 of one pill cycle and day 4 of the next . The possible behavioural indications of this pattern are discussed CONTEXT Declining testosterone levels in elderly men are thought to underlie many of the symptoms and diseases of aging ; however , studies demonstrating associations of low testosterone with clinical outcomes are few . OBJECTIVE The objective of the study was to examine the association of endogenous testosterone levels with mortality in older community-dwelling men . DESIGN , SETTING , AND PARTICIPANTS This was a prospect i ve , population -based study of 794 men , aged 50 - 91 ( median 73.6 ) yr who had serum testosterone measurements at baseline ( 1984 - 1987 ) and were followed for mortality through July 2004 . MAIN OUTCOME MEASURE All-cause mortality by serum testosterone level  was measured . RESULTS During an average 11.8-yr follow-up , 538 deaths occurred . Men whose total testosterone levels were in the lowest quartile ( < 241 ng/dl ) were 40 % [ hazards ratio ( HR ) 1.40 ; 95 % confidence interval ( CI ) 1.14 - 1.71 ] more likely to die than those with higher levels , independent of age , adiposity , and lifestyle . Additional adjustment for health status markers , lipids , lipoproteins , blood pressure , glycemia , adipocytokines , and estradiol levels had minimal effect on results . The low testosterone-mortality association was also independent of the metabolic syndrome , diabetes , and prevalent cardiovascular disease but was attenuated by adjustment for IL-6 and C-reactive protein . In cause-specific analyses , low testosterone predicted increased risk of cardiovascular ( HR 1.38 ; 95 % CI 1.02 - 1.85 ) and respiratory disease ( HR 2.29 ; 95 % CI 1.25 - 4.20 ) mortality but was not significantly related to cancer death ( HR 1.34 ; 95 % CI 0.89 - 2.00 ) . Results were similar for bioavailable testosterone . CONCLUSIONS Testosterone insufficiency in older men is associated with increased risk of death over the following 20 yr , independent of multiple risk factors and several preexisting health conditions Abstract Purpose : We aim ed to compare therapeutic effects of intramuscular ( IM ) n and rolone decanoate and IM testosterone enanthate in male HIV patients with AIDS wasting syndrome ( AWS ) with placebo control . Methods : In this r and omized , double-blind , placebo-controlled , 12-week trial , 104 patients with AWS who satisfied our inclusion criteria were r and omly allotted in a 2:2:1 ratio to the 3 intervention groups : n and rolone , testosterone , and placebo . We administered 150 mg n and rolone and 250 mg testosterone ( both IM , biweekly ) . The primary outcome measure was a comparison of absolute change in weight at 12 weeks between the n and rolone decanoate , testosterone , and placebo groups . Results : Intent-to-treat analysis was done . The n and rolone group recorded maximum mean increase in weight ( 3.20 kg ; post hoc P < .01 compared to placebo ) . Body mass index ( BMI ) of subjects in the n and rolone group had a significantly greater increase ( mean = 1.28 ) compared to both testosterone ( post hoc P < .05 ) and placebo ( post hoc P < .01 ) . Waist circumference and triceps skinfold thickness of patients on n and rolone showed similar results . N and rolone also ensured a better quality of life . Patients with low testosterone level ( <3 ng/mL ) benefited immensely from n and rolone therapy , which increased their weight and BMI significantly compared to placebo ( P < .05 ) . Conclusion : Our trial demonstrates the superior therapeutic effects of n and rolone in male AWS patients , including the and rogen deficient Objective : Evaluation of the use of testosterone therapy for hypoactive sexual desire disorder ( HSDD ) after oophorectomy has mostly involved women treated with oral estrogen preparations . We investigated the efficacy and safety of a testosterone patch in surgically menopausal women receiving concurrent transdermal estrogen . Design : Women with HSDD after oophorectomy , for whom this was a concern , who were using transdermal estrogen , were recruited to a 24-week , r and omized , double-blind , placebo-controlled  trial in Europe and Australia . Patients were r and omly allocated to placebo ( n = 40 ) or testosterone 300 & mgr;g/day ( n = 37 ) treatment . Primary endpoints were changes in sexual desire measured by the sexual desire domain of the Profile of Female Sexual Function and the frequency of satisfying sexual activity at 24 weeks . Results : Sixty-one women ( 79 % ) completed the trial . All subjects who received at least one application of study medication were included in analysis . The testosterone-treated group experienced a significantly greater change from baseline in the domain sexual desire score compared with placebo ( change from baseline , 16.43 versus 5.98 ; P = 0.02 ) . The domain scores for arousal , orgasm , decreased sexual concerns , responsiveness , and self-image as well as decreased distress were also significantly greater with testosterone therapy than placebo . The frequency of satisfactory sexual events increased but was not statistically different between treatment groups ( P = 0.06 ) Adverse events occurred with similar frequency in both groups , and no serious risks of therapy were observed Conclusions : In this study , transdermal testosterone therapy via a skin patch improved sexual desire and other sexual function domains . It was well tolerated in these oophorectomized women with HSDD receiving concomitant transdermal estrogen The serum concentration of sex hormone-binding globulin ( SHBG ) is inversely related to weight and in animal studies is inversely related to protein intake . As SHBG can affect the biological activity of testosterone and estradiol , we wished to determine the role of protein intake on SHBG levels in men . Using data from the Massachusetts Male Aging Study we examined cross-sectional relationships between dietary components and SHBG levels in 1552 men ( aged 40 - 70 yr ) for whom these factors were known . Analyzed by multiple regression , controlling for testosterone and estradiol levels , age ( P<0.001 ) and fiber intake ( P = 0.02 ) were positively correlated to SHBG concentration , whereas body mass index ( P<0.001 ) and protein intake ( P<0.03 ) were negatively correlated to SHBG concentration . The intakes of calories , fat ( animal or vegetable ) , and carbohydrate were not related to SHBG concentration . We conclude that age and body mass index are major determinants of SHBG concentrations in older men , and fiber and protein intake are also significant contributors to SHBG levels , but total caloric intake and the intake of carbohydrate or fat are not significant . Thus , diets low in protein in elderly men may lead to elevated SHBG levels and decreased testosterone bioactivity . The decrease in bioavailable testosterone can then result in declines in sexual function and muscle and red cell mass , and contribute to the loss of bone density OBJECTIVES To use the International Index of Erectile Function ( IIEF ) to evaluate the improvement of erectile function and other sexual functions after testosterone monotherapy . Testosterone replacement therapy alone was reported to be effective for the improvement in sexual function in hypogonadal males . However , it is still unclear that which kind of the sexual function is most beneficial and to what extent the sexual function could be improved . METHODS A double-blind , r and omized , placebo-controlled study was conducted with a treatment group ( n = 20 ) and control group ( n = 20 ) . Using a critical review of the different sexual functional domain scores of the IIEF-15 and the scores of the IIEF-5 , we evaluated the sexual function of men in hypogonadal status before and after 3 months of testosterone gel treatment . Effect size was used to compare the drug effects for each sexual functional domain , and the results were confirmed by multivariate analysis . RESULTS A total of 30 men remained at the end of the study . After 3 months of testosterone gel therapy for the hypogonadal men , the most beneficial effect on sexual function was erectile function , with sexual desire and orgasmic satisfaction insignificantly affected . CONCLUSIONS The results of our study have shown that transdermal testosterone gel treatment for hypogonadal patients can improve their sexual dysfunction mainly through restoring erectile function The present study examined lifestyle and behavioral correlates of the change in total testosterone over 13 years in 66 men aged 41 - 61 years who were former participants of the Multiple Risk Factor Intervention Trial ( MRFIT ) at the Pittsburgh , Pennsylvania , center . The authors also determined in these men if changes in total testosterone are related to changes in cardiovascular disease risk factors . The mean total testosterone level was 751 ( st and ard deviation , 248 ) ng/dl at baseline and decreased by 41 ( st and ard deviation , 314 ) ng/dl during follow-up . The correlation between measures was r = 0.44 ( p < 0.001 ) . In multivariate analysis , higher type A coronary-prone behavior score , greater pack-years of cigarette smoking , and the MRFIT special intervention group were associated with larger decreases in total testosterone . Age , body weight , weight change , leisure time activity level , and alcohol intake were not related to the change in total testosterone . The decrease in endogenous testosterone was associated with an increase in triglycerides and a decrease in high density lipoprotein cholesterol in multivariate analysis controlling for obesity and other lifestyle covariates . There was little relation between change in testosterone and change in total and low density lipoprotein cholesterol or blood pressure . This longitudinal study confirms a gradual decline in total testosterone levels with advancing age in older men and provides evidence that lifestyle and psychosocial factors are related to this decline . Decreases in endogenous testosterone levels with age in men are associated with potentially unfavorable changes in triglycerides and high density lipoprotein cholesterol IMPORTANCE Rates of testosterone therapy are increasing and the effects of testosterone therapy on cardiovascular outcomes and mortality are unknown . A recent r and omized clinical trial of testosterone therapy in men with a high prevalence of cardiovascular diseases was stopped prematurely due to adverse cardiovascular events raising concerns about testosterone therapy safety . OBJECTIVES To assess the association between testosterone therapy and all-cause mortality , myocardial infa rct ion ( MI ) , or stroke among male veterans and to determine whether this association is modified by underlying coronary artery disease . DESIGN , SETTING , AND PATIENTS A retrospective national cohort study of men with low testosterone levels ( < 300 ng/dL ) who underwent coronary angiography in the Veterans Affairs ( VA ) system between 2005 and 2011 . MAIN OUTCOMES AND MEASURES Primary outcome was a composite of all-cause mortality , MI , and ischemic stroke . RESULTS Of the 8709 men with a total testosterone level lower than 300 ng/dL , 1223 patients started testosterone therapy after a median of 531 days following coronary angiography . Of the 1710 outcome events , 748 men died , 443 had MIs , and 519 had strokes . Of 7486 patients not receiving testosterone therapy  , 681 died , 420 had MIs , and 486 had strokes . Among 1223 patients receiving testosterone therapy , 67 died , 23 had MIs , and 33 had strokes . At 3 years after coronary angiography , the Kaplan-Meier estimated cumulative percentages with events were 19.9%in the no testosterone therapy group vs 25.7%in the testosterone therapy group , with an absolute risk difference of 5.8%(95%CI , -1.4%to 13.1 % ) [corrected].The Kaplan-Meier estimated cumulative percentages with events among the no testosterone therapy group vs testosterone therapy group at 1 year after coronary angiography were 10.1 % vs 11.3 % ; at 2 years , 15.4 % vs 18.5 % ; and at 3 years , 19.9 % vs 25.7 [corrected].There was no significant difference in the effect size of testosterone therapy among those with and without coronary artery disease ( test for interaction , P = .41 ) . CONCLUSIONS AND RELEVANCE Among a cohort of men in the VA health care system who underwent coronary angiography and had a low serum testosterone level , the use of testosterone therapy was associated with increased risk of adverse outcomes . These findings may inform the discussion about the potential risks of testosterone therapy Data regarding the efficacy of dehydroepi and rosterone ( DHEA ) in the treatment of hypoactive sexual desire disorder ( HSDD ) are scarce and inconsistent . We aim ed to determine possible gender differences in the efficacy of DHEA as a treatment for HDSS . Postmenopausal women ( n=27 ) , and men ( n=21 ) with HSDD , were r and omized to receive either DHEA 100 mg daily or placebo for 6 weeks in a controlled , double blind study . Primary outcome measures were sexual function question naires . Hormone serum levels of DHEAS , total and bioavailable testosterone , estradiol , and urine levels of DHEA and and rosterone were also measured . Participants on active treatment showed a significant increase in circulating serum levels of DHEAS , while bioavailable testosterone levels increased in women only . In women only , significant interaction effects were observed for sexual arousal ( p<0.05 ) , satisfaction ( p<0.05 ) , and cognition ( trend ; p=0.06 ) . For arousal , a significant improvement was observed for the DHEA treated group at 6 weeks ( p=0.001 ) . Significant correlations were observed between bioavailable T and sexual cognitions , arousal and orgasm , while DHEAS was correlated with satisfaction . In the men , significant correlations were observed between testosterone and arousal ( r=.45 ) , sexual drive ( r=.50 ) and orgasm ( r=.55 ) . In women with HSDD , DHEA treatment had a significant beneficial effect on arousal , whereas no efficacy was demonstrated in men , indicating a possible gender difference . This improvement seems to be mediated via DHEA 's metabolism to testosterone . Our positive results suggest that the neurosteroid DHEA may be effective as a treatment for women with HSDD if administered at a dose of at least 100 mg per day BACKGROUND Testosterone supplementation has been shown to increase muscle mass and strength in healthy older men . The safety and efficacy of testosterone treatment in older men who have limitations in mobility have not been studied . METHODS Community-dwelling men , 65 years of age or older , with limitations in mobility and a total serum testosterone level of 100 to 350 ng per deciliter ( 3.5 to 12.1 nmol per liter ) or a free serum testosterone level of less than 50 pg per milliliter ( 173 pmol per liter ) were r and omly assigned to receive placebo gel or testosterone gel , to be applied daily for 6 months . Adverse events were categorized with the use of the Medical Dictionary for Regulatory Activities classification . The data and safety monitoring board recommended that the trial be discontinued early because there was a significantly higher rate of adverse cardiovascular events in the testosterone group than in the placebo group . RESULTS A total of 209 men ( mean age , 74 years ) were enrolled at the time the trial was terminated . At baseline , there was a high prevalence of hypertension , diabetes , hyperlipidemia , and obesity among the participants . During the course of the study , the testosterone group had higher rates of cardiac , respiratory , and dermatologic events than did the placebo group . A total of 23 subjects in the testosterone group , as compared with 5 in the placebo group , had cardiovascular-related adverse events . The relative risk of a cardiovascular-related adverse event remained constant throughout the 6-month treatment period . As compared with the placebo group , the testosterone group had significantly greater improvements in leg-press and chest-press strength and in stair climbing while carrying a load . CONCLUSIONS In this population of older men with limitations in mobility and a high prevalence of chronic disease , the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events . The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy . ( Clinical Trials.gov number , NCT00240981 . We examined the effects of GH and /or testosterone ( T ) administration on body composition , performance , mood , sexual function , bone turnover , and muscle-gene expression in healthy older men . Ten men [ mean ( SEM ) age , 68 ( 2.5 ) yr ; height , 171.5 ( 2.4 ) cm ; and weight , 80 ( 3.0 ) kg ] completed each of the following 1-month , double-blind interventions after a baseline ( B ) study in r and omized order with an intervening 3-month washout : transdermal T patch ( 5.0 mg/daily ) ; recombinant human GH ( 6.25 micro g/kg sc daily ) ; and combined hormones ( GHT ) . ANOVA with repeated measures was used to evaluate interventional effects . Integrated serum GH concentrations [ mean ( SEM ) ] were elevated comparably by GH and GHT : [ B = 363 ( 55 ) , GH = 1107 ( 120 ) , T = 459 ( 131 ) , and GHT = 1189 ( 46 ) micro g/liter.min ; P < 0.0001 ] . Serum IGF-I concentrations also increased commensurately after GH and GHT : [ B = 168 ( 14 ) , GH = 285 ( 16 ) , T = 192 ( 25 ) , and GHT = 294 ( 25 ) micro g/liter ; P < 0.0001 ] . GHT administration increased total estradiol : [ B = 110 ( 20 ) , GH = 106 ( 13 ) , T = 129 ( 13 ) , and GHT = 153 ( 17 ) pmol/liter ; P < 0.02 ] , and both T and GHT elevated free T : [ B = 12 ( 2.1 ) , GH = 11 ( 1.5 ) , T = 22 ( 2.8 ) , and GHT = 24 ( 2.5 ) pg/ml ; P < 0.0001 ] . No significant changes occurred in strength , flexibility , percentage body fat , or sexual function and mood . However , fat-free mass increased under combined GHT exposure : [ B = 55 ( 1.3 ) , GH = 56 ( 1.1 ) , T = 55 ( 1.5 ) , GHT = 57 ( 1.7 ) kg ; P < 0.03 ] . Balance improved in response to GH intervention ( P < 0.05 ) , as did 30-m walk time during T and GHT interventions [ B = 6.6 ( 0.3 ) , GH = 6.2 ( 0.7 ) , T = 5.9 ( 0.3 ) , GHT = 5.5 ( 0.3 ) sec ; P = 0.04 ] and stair climb time for all three interventions [ B = 32.2 ( 1.4 ) , GH = 29.8 ( 1.2 ) , T = 30.5 ( 1.4 ) , and GHT = 29.9 ( 1.2 ) sec ( P = 0.0034 ) , wherein the effects of GH , T , and GHT were different from that of B ] . Muscle IGF-I gene expression increased by 1.9-fold during GH administration and by 2.3-fold during GHT administration ( P < 0.05 , compared with B ) . Myostatin and and rogen receptor gene expression were not affected . Serum osteocalcin increased in response to the GH and GHT interventions : [ B = 4.8 ( 0.52 ) , GH = 5.7 ( 0.54 ) , T = 4.7 ( 0.33 ) , and GHT = 5.5 ( 0.39 ) ; P < 0.009 ] . There were no significant adverse events during 30 patient-months of intervention . We conclude that 1 month of GH and /or T administration improves certain measures of balance and physical performance in older men and increases muscle IGF-I gene expression BACKGROUND A large proportion of men over 65 years of age have bioavailable testosterone levels below the reference range of young adult men . The impact of this on musculoskeletal health and the potential for improvement in function in this group with testosterone supplementation require investigation . METHODS Sixty-seven men ( mean age 76 + /- 4 years , range 65 - -87 ) with bioavailable testosterone levels below 4.44 nmol/l ( lower limit for adult normal range ) were r and omized to receive transdermal testosterone  ( two 2.5-mg patches per day ) or placebo patches for 1 year . All men received 500 mg supplemental calcium and 400 IU vitamin D. Outcome measures included sex hormones ( testosterone , bioavailable testosterone , sex-hormone binding globulin [ SHBG ] , estradiol , and estrone ) , bone mineral density ( BMD ; femoral neck , Ward 's triangle , trochanter , lumbar spine , and total body ) , bone turnover markers , lower extremity muscle strength , percent body fat , lean body mass , hemoglobin , hematocrit , prostate symptoms , and prostate specific antigen ( PSA ) levels . RESULTS Twenty-three men ( 34 % ) withdrew from the study ; 44 men completed the trial . In these men , bioavailable testosterone levels increased from 3.2 + /- 1.2 nmol/l ( SD ) to 5.6 + /- 3.5 nmol/l ( p < .002 ) at 12 months in the testosterone group , whereas no change occurred in the control group . Although there was no change in estradiol levels in either group , estrone levels increased in the testosterone group ( 103 + /- 26 pmol/l to 117 + /- 33 pmol/l ; p < .017 ) . The testosterone group had a 0.3 % gain in femoral neck BMD , whereas the control group lost 1.6 % over 12 months ( p = .015 ) . No significant changes were seen in markers of bone turnover in either group . Improvements in muscle strength were seen in both groups at 12 months compared with baseline scores . Strength increased 38 % ( p = .017 ) in the testosterone group and 27 % in the control group ( p = .06 ) , with no statistical difference between the groups . In the testosterone group , body fat decreased from 26.3 + /- 5.8 % to 24.6 + /- 6.5 % ( p = .001 ) , and lean body mass increased from 56.2 + /- 5.3 kg to 57.2 + /- 5.1 kg ( p = .001 ) , whereas body mass did not change . Men receiving testosterone had an increase in PSA from 2.0 + /- 1.4 microg/l to 2.6 + /- 1.8 microg/l ( p = .04 ) , whereas men receiving placebo had an increase in PSA from 1.9 + /- 1.0 microg/l to 2.2 + /- 1.5 microg/l ( p = .09 ) . No significant differences between groups were seen in hemoglobin , hematocrit , symptoms or signs of benign prostate hyperplasia , or PSA levels . CONCLUSIONS Transdermal testosterone ( 5 mg/d ) prevented bone loss at the femoral neck , decreased body fat , and increased lean body mass in a group of healthy men over age 65 with low bioavailable testosterone levels . In addition , both testosterone and placebo groups demonstrated gains in lower extremity muscle strength , possibly due to the beneficial effects of vitamin D. Testosterone did result in a modest increase in PSA levels but result ed in no change in signs or symptoms of prostate hyperplasia The prevalence and course of sexual dysfunction was evaluated in 221 alcoholic cirrhotic men participating in a double-blind , placebo-controlled study on the effect of oral testosterone treatment on liver disease . At entry , 67 % ( 95 % confidence limits , 61%-74 % ) complained of sexual dysfunction .  Sexual dysfunction was significantly ( p less than 0.05 ) associated with lower serum concentrations of testosterone , non-protein-bound testosterone , and non-sex hormone-binding globulin-bound testosterone . The significant associations between sexual dysfunction and non-protein-bound and non-sex hormone-binding globulin-bound testosterone concentrations disappeared , however , when age , ethanol consumption , and severity of liver disease were included as covariates in the analysis . During follow-up ( median 30 mo , range 1 - 48 mo ) sexual dysfunction improved significantly ( p less than 0.05 ) at 6 , 12 , and 24 mo . Furthermore , the reported libido and erectile and ejaculatory function improved significantly at the end of the follow-up period ( p less than 0.01 ) . However , the testosterone-treated patients did not differ significantly from the placebo-treated patients regarding any of the changes in sexual function . In conclusion , oral testosterone treatment does not significantly influence the type or course of sexual dysfunction in alcoholic cirrhotic men . However , sexual function improved after reduction of ethanol consumption in these patients CONTEXT Physical frailty is associated with reduced muscle strength , impaired physical function , and quality of life .  Testosterone ( T ) increases muscle mass and strength in hypogonadal patients . It is unclear whether T has similar effects in intermediate-frail and frail elderly men with low to borderline-low T. OBJECTIVE Our objective was to determine the effects of 6 months T treatment in intermediate-frail and frail elderly men , on muscle mass and strength , physical function , and quality of life . DESIGN AND SETTING We conducted a r and omized , double-blind , placebo-controlled , parallel-group , single-center study . PARTICIPANTS PARTICIPANTS were community-dwelling intermediate-frail and frail elderly men at least 65 yr of age with a total T at or below 12 nmol/liter or free T at or below 250 pmol/liter . METHODS Two hundred seventy-four participants were r and omized to transdermal T ( 50 mg/d ) or placebo gel for 6 months . Outcome measures included muscle strength , lean and fat mass , physical function , and self-reported quality of life . RESULTS Isometric knee extension peak torque improved in the T group ( vs. placebo at 6 months ) , adjusted difference was 8.6 ( 95 % confidence interval , 1.3 - 16.0 ; P = 0.02 ) Newton-meters . Lean body mass increased and fat mass decreased significantly in the T group by 1.08 + /- 1.8 and 0.9 + /- 1.6 kg , respectively . Physical function improved among older and frailer men . Somatic and sexual symptom scores decreased with T treatment ; adjusted difference was -1.2 ( -2.4 to -0.04 ) and -1.3 ( -2.5 to -0.2 ) , respectively . CONCLUSIONS T treatment in intermediate-frail and frail elderly men with low to borderline-low T for 6 months may prevent age-associated loss of lower limb muscle strength and improve body composition , quality of life , and physical function . Further investigations are warranted to extend these results The AIDS wasting syndrome is characterized by loss of lean body mass out of proportion to weight [ 1 , 2 ] . The few effective treatments that have been identified are short-term pharmacologic agonists . Because loss of lean body mass is associated with decreased survival in men with the AIDS wasting syndrome [ 3 ] , development of therapeutic strategies to increase lean body mass is of critical importance . Half of all men with AIDS are hypogonadal [ 4 ] , and serum and rogen levels correlate with lean body mass among hypogonadal men with the AIDS wasting syndrome [ 5 ] . Previous studies in non-HIV-infected hypogonadal men show that and rogen administration has a significant anabolic effect on body composition [ 6 - 10 ] . We hypothesized that loss of the potent anabolic hormone testosterone in men with the AIDS wasting syndrome may contribute to the critical loss of lean body mass . Therefore , we investigated the effects of physiologic testosterone administration in men with the AIDS wasting syndrome . Methods Patients In 1995 and 1996 , 51 HIV-positive men ( 42 8 years of age ) were recruited from the multidisciplinary HIV practice at the Massachusetts General Hospital and from newspaper , television , and radio advertisements .  Weight , testosterone levels , and medication history were determined at a screening assessment . To be included in the study , patients had to have decreased free testosterone levels  , defined as less than 42 pmol/L at screening ( normal range for men 18 to 49 years of age , 42 to 121 pmol/L [ 12.0 to 35.0 pg/mL ] ) , and wasting , defined as weight less than 90 % of ideal body weight or involuntary weight loss greater than 10 % of baseline weight [ 11 ] . The CD4 count was not an inclusion criterion . We excluded patients with severe diarrhea ( > 6 stools/d ) ; hemoglobin value less than 5.0 mmol/L ( < 8 g/dL ) ; platelet count less than 50 000 cells/mm3 ; creatinine concentration greater than 177 mol/L ( > 2 mg/dL ) ; new opportunistic infection within 6 weeks of screening ; use of testosterone  , anabolic steroids , growth hormone , ketoconazole  , or  systemic steroid therapy within 3 months before screening ; or history of prostate cancer . In addition , patients receiving antiretroviral agents , including protease inhibitors , were required to be receiving a stable regimen for at least 6 weeks before study entry . Ten patients were receiving long-term , stable therapy with megestrol acetate for at least 8 weeks before study entry and were equally distributed between the two treatment groups ( 5 in the testosterone group and 5 in the placebo group ) . All patients gave written consent , and the study was approved by the Human Studies Committee of the Massachusetts General Hospital . Protocol Patients were r and omly assigned to receive testosterone enanthate , 300 mg ( Bio-Technology General Corp. , Iselin , New Jersey ) , or placebo intramuscularly every 3 weeks by self-injection . Participants were stratified for weight less than or greater than 90 % of ideal body weight and megestrol acetate use before r and omization . R and omization was performed by the Massachusetts General Hospital Pharmacy by using a permuted block algorithm . The correspondence between patient code number and drug was generated by the study statistician ; this list was available to the hospital pharmacist but not to the investigators or patients . The placebo contained sesame oil with chlorobutanol as a preservative and matched testosterone enanthate in color and consistency . The study drug was bottled by the Massachusetts General Hospital Pharmacy in containers labeled with the study name , expiration date , and patient code . Before the first injection , participants returned within approximately 2 weeks of the screening visit for a 3-day baseline inpatient visit to the General Clinical Research Center at the Massachusetts General Hospital for hormonal , nutritional , immune function , and body composition analysis , which included assessment by dual-energy x-ray absorptiometry , bioimpedance analysis , potassium-4040 K ) isotope analysis , and measurement of urinary creatinine excretion . No patient experienced the onset of a new opportunistic infection , other complication , or substantial weight change between the screening and baseline visits . Patients were instructed on the proper technique for intramuscular injection ; those who were unable to self-administer the study drug received injections every 3 weeks from the nursing staff of the General Clinical Research Center . Patients returned for an outpatient visit at 3 months for assessment of weight and determination of total-body potassium content and for a 3-day inpatient visit at 6 months ; this visit was identical to the baseline evaluation . Patients also reported on response to therapy at the 6-month visit . Baseline data from 26 patients have been reported elsewhere [ 5 ] . Subsequent study visits were timed to correspond to the midpoint between study drug injections . Study drug compliance was confirmed by history , medication diaries , outpatient injection records , empty vial counts , and serum testosterone levels . History of medication use was assessed at each visit . The change in fat-free mass assessed by dual-energy x-ray absorptiometry was the primary clinical end point ; changes in weight , muscle mass , total body potassium content , and quality of life were secondary end points . Body Composition Analysis Body composition was determined by four methods : 1 ) dual-energy x-ray absorptiometry to assess fat and fat-free mass ( Hologic-2000 densitometer , Hologic , Inc. , Waltham , Massachusetts ; precision error , 3 % for fat and 1.5 % for fat-free mass [ 12 ] , 2 ) 40 K isotope analysis to assess  total-body potassium content in a whole-body counter with sodium iodide detectors fixed above and below the patient at the xiphoid level ( Canberra Nuclear , Meriden , Connecticut ; precision error < 2.5 % on the basis of repeated calibration with a known potassium chloride source [ Appendix ] ) , 3 ) urinary creatinine excretion averaged over 3 days ( during which the patient received a meat-free diet ) multiplied by a constant of 18 kg of muscle per gram of urinary creatinine and indexed for height to determine the percentage of predicted muscle mass [ 13 , 14 ] , and 4 ) bioimpedance analysis to determine total-body water content ( Bioelectrical Impedance Analyzer Model BIA-101 , RJL Systems , Clinton Turnpike , Michigan ; correlation with deuterium oxide equivalent to R = 0.99 [ 15 ] ) . Lean body mass was derived from total-body potassium content by using the Equation of Forbes and Lewis of 68.1 mEq of potassium per kg of lean body mass [ 16 ] . Nutritional Assessment Weight was measured on the first day of each visit after an overnight fast . The percentage of ideal body weight was calculated on the basis of st and ard height and weight tables [ 17 ] . Patients were instructed on completion of a 4-day food record , which was analyzed for total calorie , fat , protein , and carbohydrate content ( Minnesota Nutrition Data Systems , version 8A/2.6 , Minneapolis , Minnesota ) by the Clinical Research Center dietitian . Patients received an isocaloric , meat-free , protein-substituted diet 3 days before and during the inpatient assessment s at baseline and at 6 months , during which creatinine excretion and nitrogen balance were measured . Total urinary nitrogen excretion was measured by the Kjeldal technique from consecutive 24-hour collection s averaged over 3 days . Nonurinary nitrogen losses were assumed to be constant at 4 g/d [ 13 , 18 , 19 ] . Nitrogen intake was derived from total protein intake divided by a constant of 6.25 g of protein per g of nitrogen [ 19 ] . Calorie and  protein  intake were monitored on a daily basis and were modified to match the reports in the outpatient food records immediately before these visits . Resting energy expenditure was measured by indirect calorimetry with a metabolic cart . Energy requirements were calculated by using the Harris-Benedict equation [ 20 ] . Patient Reports of Response to Therapy Each patient 's perceived well-being was assessed at the end of the study by using nine linear analogue-scale questions on the overall treatment effect , change in quality of life , personal appearance , weight , and appetite ( Table 1 ) [ 21 ] . A Karnofsky score was also determined at each visit . Table 1 . Assessment of Patient Response to Therapy * Exercise Functional Testing Exercise history was assessed by a st and ardized question naire adapted from the study by Kohl and coworkers [ 22 ] . Exercise functional status was determined at the baseline and final visits by the physical therapy department of the Massachusetts General Hospital by using the 6-minute walk test , the timed sit-to-st and test , and the timed get-up- and -go test [ 23 - 25 ] . The distance covered in 6 minutes , the number of times the patient was able to move from a sitting to st and ing position in 10 seconds , and the time to cover a distance of 3 meters after st and ing from a seated position was recorded for each patient . Biochemical and Immunologic Assays Hematocrit and serum levels of follicle-stimulating hormone , luteinizing hormone , sex hormone-binding globulin , and prolactin were measured at the baseline and final visits by using published methods [ 26 ] . Serum levels of total and free testosterone were measured by radioimmunoassay kit ( Diagnostics Products Corp. , Los Angeles , California ) with intra-assay coefficients of variation of 5 % to 12 % for total testosterone and 3.2 % to 4.3 % for free testosterone . CD4 cell counts were measured by flow cytometry ( Becton Dickinson Immunocytochemistry Systems , San Jose , California ) . Viral burden was determined by using the Amplicor HIV-1 monitor test ( Roche Molecular Systems , Branchburg , New Jersey ) . Statistical Analysis Sample size was based on the change in lean body mass in response to testosterone administration among adult men with acquired hypogonadism [ 8 ] . A change of 3.2 % 4.0 % was expected over 6 months . With 20 patients in each group , the study had an 80 % chance of seeing an effect of testosterone at a The indication for testosterone therapy in aging hypogonadal men without hypothalamic , pituitary , or testicular disease remains to be eluci date d. The aim of this study was to investigate the effect of testosterone therapy on insulin sensitivity , substrate metabolism , body composition , and lipids in aging men with low normal bioavailable testosterone levels using a predefined cutoff level for bioavailable testosterone . A r and omized , double-blinded , placebo-controlled study of testosterone treatment ( gel ) was done on 38 men , aged 60–78 years , with bioavailable testosterone < 7.3 nmol/l and a waist circumference > 94 cm .  Insulin-stimulated glucose disposal ( Rd ) and substrate oxidation were assessed by euglycemic hyperinsulinemic clamps combined with indirect calorimetry . Lean body mass ( LBM ) and total fat mass ( TFM ) were measured by dual x-ray absorptiometry , and serum total testosterone was measured by t and em mass spectrometry . Bioavailable testosterone was calculated . Coefficients ( b ) represent the placebo-controlled mean effect of intervention . LBM ( b = 1.9 kg , p = 0.003 ) increased while HDL – cholesterol ( b = −0.12 mmol/l , p = 0.043 ) and TFM decreased ( b = −1.2 kg , p = 0.038 ) in the testosterone group compared to placebo . Basal lipid oxidation ( b = 5.65 mg/min/m2 , p = 0.045 ) increased and basal glucose oxidation ( b = −9.71 mg/min/m2 , p = 0.046 ) decreased in response to testosterone therapy even when corrected for changes in LBM . No significant changes in insulin-stimulated Rd was observed ( b = −0.01mg/min/m2 , p = 0.92 ) . Testosterone therapy increased muscle mass and lipid oxidation in aging men with low normal bioavailable testosterone levels ; however , our data did not support an effect of testosterone on whole-body insulin sensitivity using the euglycemic hyperinsulinemic clamp technique CONTEXT Previous studies of testosterone supplementation in HIV-infected men failed to demonstrate improvement in muscle strength . The effects of resistance exercise combined with testosterone supplementation in HIV-infected men are unknown . OBJECTIVE To determine the effects of testosterone replacement with and without resistance exercise on muscle strength and body composition in HIV-infected men with low testosterone levels and weight loss . DESIGN AND SETTING Placebo-controlled , double-blind , r and omized clinical trial conducted from September 1995 to July 1998 at a general clinical research center . PARTICIPANTS Sixty-one HIV-infected men aged 18 to 50 years with serum testosterone levels of less than 12.1 nmol/L ( 349 ng/dL ) and weight loss of 5 % or more in the previous 6 months , 49 of whom completed the study . INTERVENTIONS Participants were r and omly assigned to 1 of 4 groups : placebo , no exercise ( n = 14 ) ; testosterone enanthate ( 100 mg/wk intramuscularly ) , no exercise ( n = 17 ) ; placebo and exercise ( n = 15 ) ; or testosterone and exercise ( n = 15 ) . Treatment duration was 16 weeks . MAIN OUTCOME MEASURES Changes in muscle strength , body weight , thigh muscle volume , and lean body mass compared among the 4 treatment groups . RESULTS Body weight increased significantly by 2.6 kg ( P<.001 ) in men receiving testosterone alone and by 2.2 kg ( P = .02 ) in men who exercised alone but did not change in men receiving placebo alone ( -0.5 kg ; P = .55 ) or testosterone and exercise ( 0.7 kg ; P = .08 ) . Men treated with testosterone alone , exercise alone , or both experienced significant increases in maximum voluntary muscle strength in leg press ( range , 22%-30 % ) , leg curls ( range , 18%-36 % ) , bench press ( range , 19%-33 % ) , and latissimus pulls ( range , 17%-33 % ) . Gains in strength in all exercise categories were greater in men assigned to the testosterone-exercise group or to the exercise-alone group than in those assigned to the placebo-alone group . There was a greater increase in thigh muscle volume in men receiving testosterone alone ( mean change , 40 cm3 ; P<.001 vs zero change ) or exercise alone ( 62 cm3 ; P = .003 ) than in men receiving placebo alone ( 5 cm3 ; P = .70 ) . Average lean body mass increased by 2.3 kg ( P = .004 ) and 2.6 kg ( P<.001 ) , respectively , in men who received testosterone alone or testosterone and exercise but did not change in men receiving placebo alone ( 0.9 kg ; P = .21 ) . Hemoglobin levels increased in men receiving testosterone but not in those receiving placebo . CONCLUSION Our data suggest that testosterone and resistance exercise promote gains in body weight , muscle mass , muscle strength , and lean body mass in HIV-infected men with weight loss and low testosterone levels . Testosterone and exercise together did not produce greater gains than either intervention alone CONTEXT There is a compelling need for therapies that prevent , defer the onset , slow the progression , or improve the symptoms of Alzheimer disease ( AD ) . OBJECTIVE To evaluate the effects of testosterone therapy on cognition , neuropsychiatric symptoms , and quality of life in male patients with mild AD and healthy elderly men . DESIGN Twenty-four-week , r and omized , double-blind , placebo-controlled , parallel-group study . SETTING Memory disorders clinics as well as general neurology and medicine clinics from University of California medical centers at Los Angeles , San Francisco , and Irvine . PATIENTS OR OTHER PARTICIPANTS Sixteen male patients with AD and 22 healthy male control subjects . Healthy elderly control men were recruited from the community through advertisements as well as through the university-based clinics . INTERVENTION Testosterone and placebo , in the form of hydroalcoholic gel ( 75 mg ) , were applied daily to the skin of the participants . MAIN OUTCOME MEASURES Instruments assessing cognitive functioning ( Alzheimer 's Disease Assessment Scale-Cognitive Subscale , California Verbal Learning Test , Block Design Subtest , Judgment of Line Orientation , Developmental Test of Visual-Motor Integration ) , neuropsychiatric symptoms ( Neuropsychiatric Inventory ) , global functioning ( Clinician 's Interview-Based Impression of Change ) , and quality of life ( Quality of Life-Alzheimer Disease Scale ) . RESULTS For the patients with AD , the testosterone-treated group had significantly greater improvements in the scores on the caregiver version of the quality -of-life scale ( P = .01 ) . No significant treatment group differences were detected in the cognitive scores at end of study , although numerically greater improvement or less decline on measures of visuospatial functions was demonstrated with testosterone treatment compared with placebo . In the healthy control group , a nonsignificant trend toward greater improvement in self-rated quality of life was observed in the testosterone-treated group ( P = .09 ) compared with placebo treatment . No difference between the treatment groups was detected in the remaining outcome measures . Testosterone treatment was well tolerated with few adverse effects relative to placebo . CONCLUSIONS Results suggest that testosterone replacement therapy improved overall quality of life in patients with AD .  Testosterone had minimal effects on cognition BACKGROUND Loss of muscle mass ( sarcopenia ) leads to frailty in older men . The decline in testosterone over the life span may contribute to this muscle loss . We studied the ability of oral testosterone to prevent muscle loss in older men over a 12-month period . METHODS A st and ard dose ( 80 mg twice daily ) of testosterone undecanoate or placebo was administered for 1 year to 76 healthy men aged 60 years or older . All men had a free testosterone index of 0.3 - 0.5 , which represents a value below the normal lower limit for young men ( 19 - 30 years ) , but remains within the overall normal male range . Measurements of body composition , muscle strength , hormones , and safety parameters were obtained at 0 , 6 , and 12 months . RESULTS Lean body mass increased ( p = .0001 ) and fat mass decreased ( p = .02 ) in the testosterone as compared with the placebo-treated group . There were no significant effects on muscle strength . There was a significant increase in hematocrit ( 0.02 % ) in the testosterone-treated group ( p = .03 ) . Plasma triglycerides , total cholesterol , and low-density lipoprotein cholesterol levels were similar in both groups , but there was a decrease in high-density lipoprotein cholesterol ( -0.1 mmol/L ) at 12 months in the testosterone group as compared to the placebo group ( p = 0.026 ) . There were no differences in prostate-specific antigen or systolic or diastolic blood pressure between the groups . CONCLUSION Oral testosterone administration to older relatively hypogonadal men results in an increase in muscle mass and a decrease in body fat BACKGROUND It has been suggested that cognitive changes in response to T supplementation may occur within an ideal range . The objective of this study was to compare the cognitive responses of older , eugonadal men in whom moderate or large increases in serum testosterone levels was induced by exogenous testosterone supplementation .  DESIGN R and omized , double-blind , placebo-controlled study with subsequent grouping of participants according to average increase in circulating T from baseline . SETTING Community dwelling participants . PARTICIPANTS Fifty-seven healthy , eugonadal , community dwelling male volunteers , mean age 67 years ( + /-11 years ) . INTERVENTIONS Participants were r and omized to receive weekly intramuscular ( i.m . ) injections of either 50 , 100 or 300 mg T enanthate or placebo ( saline ) injection for 6 weeks . Cognitive evaluations using a battery of neuropsychological tests were conducted at baseline , weeks 3 and 6 of treatment and after 6 weeks of wash-out . MAIN OUTCOME MEASURES Performance on cognitive tests of verbal and spatial memory . RESULTS Men with moderate increases in serum T and /or its metabolites demonstrated significant improvements in verbal and spatial memory . In contrast , men with large or low increases in circulating T levels , failed to demonstrate significant changes in memory . CONCLUSION These results suggest that in healthy older men , beneficial changes in cognitive function induced by T supplementation are most evident with moderate changes in cognition from moderate to high T supplementation increases in T levels . Large or no to low increases in T levels do not appear to appreciably effect cognition To investigate a possible correlation between sexual hormonal status and the presence of female sexual dysfunction ( FSD ) using the Female Sexual Function Index ( FSFI ) in females with spinal cord injuries ( SCI ) , we selected 39 SCI fertile-aged women . At visit 1 , we assessed the presence of FSD using the FSFI , and all individuals were su bmi tted to a  blood hormone evaluation  on the third day of their menstrual cycle . The levels of serum follicle-stimulating hormone ( FSH ) , luteinizing hormone ( LH ) , prolactin ( PRL ) , thyroid-stimulating hormone ( TSH ) , cortisol , dehydroepi and rosterone sulphate ( DHEA-S ) , and rostenedione , 17[alpha]-hydroxyprogesterone ; total and free testosterone , 17beta-estradiol , inhibin , sex hormone-binding globulin ( SHBG ) , and thyroid hormones ( fT3 and fT4 ) were checked .  Progesterone  was measured on the 20th to 21st day after the menstrual cycle . In patients with amenorrhea , we tested all the hormones using 1 r and om blood test . After a 3-month period , the tests were repeated . Overall , 23/39 ( 58.9 % ) patients continued to manifest at least one sexual dysfunction . These patients reached a median score of 19.52 . All but 6 patients ( 15.3 % ) consistently showed hormonal values within the normal range . Of the 6 patients with abnormal hormonal alterations , 5 showed at least one sexual dysfunction , 2 had low levels of total testosterone , 1 had a low level of free testosterone , 1 suffered from hypothyroidism , 1 presented with low levels of cortisol , and 1 showed hypoprogesterone . There was no significant correlation between abnormal hormonal status and the presence of a specific sexual dysfunction , as assessed with the FSFI Transdermal testosterone ( T ) delivery represents an effective alternative to injectable and rogens . We studied 163 hypogonadal men who applied 5 , 7.5 , or 10 g And roGel ( T gel ) 1 % CIII per day for up to 42 months .  Efficacy data were presented in 123 subjects considered evaluable . Continuous And roGel treatment normalized mean serum T and free T levels . Mean serum 5alpha-dihydrotestosterone concentrations and 5alpha-dihydrotestosterone/T ratio slightly increased , mean serum estradiol/T ratio doubled , and mean serum FSH and LH levels were suppressed by T replacement . Sexual function and mood parameters improved rapidly and were maintained throughout T treatment . Lean body mass increased ( P = 0.0001 ) and fat mass decreased ( P = 0.0001 ) , and these changes were maintained with treatment but were not accompanied by significant increases in muscle strength . Increases in serum bone markers suggestive of increased bone formation were followed by gradual and progressive increases in bone mineral density more in the spine ( P = 0.0001 ) than the hip ( P = 0.0004 ) . Mild local skin irritation occurred in 12 subjects , result ing in discontinuation in only one subject . Except for the anticipated increase in hematocrit and hemoglobin , there were no clinical ly significant changes in blood counts or biochemistry . In three subjects with elevated serum prostate-specific antigen , prostate biopsies showed cancer . We conclude that continued application of And roGel result ed in beneficial effects similar to those with injectables and other transdermal preparations . This study was neither placebo controlled nor powered to determine the effects of T treatment on prostate cancer risk . Thus , monitoring for prostatic disease and assessment for erythrocytosis are strongly advised to reduce the risk of adverse events with T treatment of hypogonadal men BACKGROUND Depression in older men has been associated with low circulating testosterone concentration but data from prospect i ve studies are limited . METHODS We conducted a prospect i ve longitudinal study in a community representative cohort of 3179 older men free of clinical ly significant depressive symptoms at baseline . The main objective of this study was to determine if low serum testosterone , dihydrotestosterone and estradiol concentrations are associated with the development of depressive symptoms . Incident depression was assessed with the Patient Health Question naire and via an electronic health record data base ( The West Australian Data Linkage System ) . The main exposures of interest were serum testosterone , dihydrotestosterone and estradiol measured by liquid chromatography-mass spectrometry and calculated free testosterone in baseline blood sample s ( collected between 2001 and 2004 ) . RESULTS One hundred and thirty five men ( 4.2 % ) developed depression over a median follow up time of 9.4 years ( range 8.4 - 10.9 ) . Men with incident depression were older ( median age 77.7 vs 76.1 years , z=-3.82 , p=0<0.001 ) and were more likely to have cardiovascular disease ( 43.0 % vs 32.6 % , χ(2)=6.32 , p=0.012 ) and diabetes ( 22.2 % vs 13.2 % , χ(2)=8.95 , p=0.003 ) . Low serum total testosterone ( < 6.4 nmol/L ) was associated with incident depression ( HR 2.07 , 95%CI 1.17 - 3.68 ) and this remained significant after adjustment for relevant potential confounding factors ( HR 1.86 , 95%CI 1.05 - 3.31 ) . Low serum dihydrotestosterone , estradiol and calculated free testosterone were not associated with risk of depression . CONCLUSIONS Low serum total testosterone , but not calculated free testosterone , was associated with incident depression in this sample of older men OBJECTIVES To eluci date if percutanous treatment with 10 mg testosterone per day could enhance sexuality and psychological well-being in postmenopausal women presenting problems with low libido . Secondary to study the influence on blood lipids , hemoglobin and erythropoietin levels . METHODS Fifty-three postmenopausal women participated . As a complement to their already on-going HRT , 10 mg of a testosterone gel ( Testogel , Besins-Iscovesco ) or placebo was administered . Treatment continued for three plus three months in a double blind , r and omized , crossover design . RESULTS The scores concerning " frequency of sexual activity , orgasm and intercourse " , " sexual arousal , fantasies and enjoyment " , " satisfaction with orgasms " , and " interest in sex " were all significally improved for testosterone addition as compared to placebo both before and after crossover . Testosterone levels increased more than 10-fold during treatment while DHT-levels were more than doubled . Estrogen levels were not affected during the addition of testosterone . Liver enzymes , total cholesterol , triglycerides , HDL and LDL revealed no significant differences between any of the periods or groups . Endometrial thickness did not change significantly during treatment . Hemoglobin and erythropoietin remained unchanged . No significant differences in the number of experienced side effects were found . CONCLUSION Testosterone gel of 10 mg had positive effects on several aspects of sexual life such as frequency of sexual activity , orgasm , arousal , fantasies and sexual interest in postmenopausal women on HRT . Several psychological variables were positively influenced . The given dose result ed in too high serum levels . Even if no negative effects were observed , monitoring of serum levels and a decreased dose should be considered in future studies Clinical studies suggest there may be a threshold concentration of serum testosterone below which replacement will result in skeletal and psychological benefit . We evaluated the response to testosterone in men with borderline hypogonadism . A r and omized double-blind placebo-controlled trial in 39 men over age 40 years presenting with sexual dysfunction and a borderline low testosterone level ( total testosterone < 10 nmol/L or free and rogen index < 30 % ) . Patients were r and omized to Testoderm TTS body patch ( 5 mg/day , n = 20 ) or a placebo patch ( n = 19 ) for 6 months , followed by open-label testosterone replacement for a further 6 months in all patients . During the placebo-controlled phase of the study serum testosterone increased significantly on testosterone vs. placebo treatment ( p = 0.004 ) ; this was associated with a decrease in total body fat mass ( p = 0.019 ) and increase in haemoglobin level ( p = 0.036 ) . There were no significant changes in lean body mass , markers of bone turnover , and measures of bone mineral density ( BMD ) . There was evidence of difference in quality of life according to the Male Erectile Dysfunction Quality of Life question naire ( MEDQoL score , p = 0.017 ) , mainly accounted for by deterioration in the placebo arm . When the active treatment period was combined for placebo and testosterone groups , the within-patient analysis showed a significant effect of testosterone to decrease markers of bone resorption ( uNTX/Cr , p = 0.007 ; iFDPD/Cr , p = 0.0006 ) and to increase lean body mass ( p = 0.001 ) . There was little convincing evidence from this study that testosterone replacement is likely to have major benefit in men over age 40 years with borderline hypogonadism and sexual dysfunction . However , there was evidence of suppression in bone resorption and hence longer and larger studies are needed to examine its effect on BMD BACKGROUND Testosterone increases lean mass and may help to counter the changes in muscle architecture associated with sarcopenia . This study was design ed to investigate the effects of testosterone replacement therapy on skeletal muscle architecture in intermediate-frail and frail elderly men . METHODS A subgroup of 30 intermediate-frail and frail elderly men ( 65 - 89 years ) with low to borderline-low testosterone levels were enrolled from a single-center r and omized , double-blind placebo-controlled trial . Participants received either a transdermal testosterone ( 50 mg ) or placebo gel daily for 6 months . Architecture ( muscle thickness , fascicle length , and pennation angle ) of the gastrocnemius medialis muscle was assessed by ultrasound imaging at baseline and after 6 months of treatment .  RESULTS Serum testosterone  increased from 11.6 ± 3.5 to 18.0 ± 8.1 nmol/L by 10 days after r and omization in the active group ( but not the placebo group ) and was maintained throughout the treatment period . Testosterone treatment result ed in a preservation of muscle thickness at 6 months while it decreased in the placebo group ( effect size 1.4 [ 95 % confidence interval = 0.3 - 2.5 ; p = .015 ] ) . There was no significant effect of treatment on fascicle length ( effect size 1.9 mm [ 95 % confidence interval = -1.2 to 5.0 mm ; p = .22 ] ) or pennation angle ( effect size 1.2 ° [ 95 % confidence interval = -1.3 to 3.7 ° ; p = .32 ] ) . CONCLUSIONS Testosterone replacement in intermediate-frail and frail elderly men is associated with preservation of muscle thickness . The results suggest that testosterone mitigates sarcopenia by improving muscle tissue to maintain a state of normality in aging men Although weight loss associated with human immunodeficiency virus ( HIV ) infection is multifactorial in its pathogenesis , it has been speculated that hypogonadism , a common occurrence in HIV disease , contributes to depletion of lean tissue and muscle dysfunction . We , therefore , examined the effects of testosterone replacement by means of And roderm , a permeation-enhanced , nongenital transdermal system , on lean body mass , body weight , muscle strength , health-related quality of life , and HIV-disease markers . We r and omly assigned 41 HIV-infected , ambulatory men , 18 - 60 yr of age , with serum testosterone levels below 400 ng/dL , to 1 of 2 treatment groups : group I , two placebo patches ( n = 21 ) ; or group II , two testosterone patches design ed to release 5 mg testosterone over 24 h. Eighteen men in the placebo group and 14 men in the testosterone group completed the 12-week treatment . Serum total and free testosterone and dihydrotestosterone levels increased , and LH and FSH levels decreased in the testosterone-treated , but not in the placebo-treated , men . Lean body mass and fat-free mass , measured by dual energy x-ray absorptiometry , increased significantly in men receiving testosterone patches [ change in lean body mass , + 1.345 + /- 0.533 kg ( P = 0.02 compared to no change ) ; change in fat-free mass , + 1.364 + /- 0.525 kg ( P = 0.02 compared to no change ) ] , but did not change in the placebo group [ change in lean body mass , 0.189 + /- 0.470 kg ( P = NS compared to no change ) ; change in fat-free mass , 0.186 + /- 0.470 kg ( P = NS compared to no change ) ] . However , there was no significant difference between the 2 treatment groups in the change in lean body mass . The change in lean body mass during treatment was moderately correlated with the increment in serum testosterone levels ( r = 0.41 ; P = 0.02 ) . The testosterone-treated men experienced a greater decrease in fat mass than those receiving placebo patches ( P = 0.04 ) . There was no significant change in body weight in either treatment group . Changes in overall quality of life scores did not correlate with testosterone treatment ; however , in the subcategory of role limitation due to emotional problems , the men in the testosterone group improved an average of 43 points of a 0 - 100 possible score , whereas those in the placebo group did not change . Red cell count increased in the testosterone group ( change in red cell count , + 0.1 + /- 0.1 10(12)/L ) but decreased in the placebo group ( change in red cell count , -0.2 + /- 0.1 10(12)/L ) . CD4 + and CD8 + T cell counts and plasma HIV copy number did not significantly change during treatment . Serum prostate-specific antigen and plasma lipid levels did not change in either treatment group . Testosterone replacement in HIV-infected men with low testosterone levels is safe and is associated with a 1.35-kg gain in lean body mass , a significantly greater reduction in fat mass than that achieved with placebo treatment , an increased red cell count , and an improvement in role limitation due to emotional problems . Further studies are needed to assess whether testosterone supplementation can produce clinical ly meaningful changes in muscle function and disease outcome in HIV-infected men OBJECTIVE To determine whether men with rheumatoid arthritis ( RA ) have abnormal hypothalamic-pituitary-gonadal axis function and to measure the effects of low dose prednisone therapy in these patients . METHODS We measured testosterone , follicle stimulating hormone ( FSH ) , and luteinizing hormone ( LH ) in 36 men aged 38 - 75 ( mean age + /- 1 sd = 62 + /- 10 years ) who had longst and ing active RA ( mean disease duration = 17 + /- 12 years ) and in 70 healthy elderly male controls , aged 53 - 83 ( mean age 68 = + /- 6 years ) . We divided the group with RA into those taking no prednisone ( n = 12 ) and those taking 5 to 10 mg/day of prednisone ( n = 24 ) and analyzed these groups separately to determine whether low doses of prednisone affected testosterone levels . RESULTS Compared to the healthy controls , patients with RA not taking prednisone had normal testosterone levels but significantly elevated levels of FSH and LH ( p < 0.01 for both comparisons ) . In contrast , patients with RA taking prednisone had significantly lower testosterone levels ( p < 0.05 ) , but levels of FSH and LH were only slightly elevated compared to controls . Compared to patients not taking prednisone , patients taking prednisone had lower levels of testosterone , FSH , and LH . CONCLUSION Male patients with RA who are not taking prednisone have significantly elevated levels of FSH and LH with normal testosterone levels , suggesting a state of compensated partial gonadal failure . Male patients with RA taking low doses of prednisone have lower testosterone and gonadotropin levels , suggesting that prednisone may suppress the hypothalmic-pituitary-testicular axis . Since testosterone affects immune function as well as bone and muscle metabolism , and rogen deficiency in some men with RA may predispose these patients to more severe disease and to increased complications of steroid therapy such as myopathy and osteoporosis BACKGROUND Low serum testosterone is a common condition in aging associated with decreased muscle mass and insulin resistance . This study evaluated whether low testosterone levels are a risk factor for mortality in male veterans . METHODS We used a clinical data base to identify men older than 40 years with repeated testosterone levels obtained from October 1 , 1994 , to December 31 , 1999 , and without diagnosed prostate cancer . A low testosterone level was a total testosterone level of less than 250 ng/dL ( < 8.7 nmol/L ) or a free testosterone level of less than 0.75 ng/dL ( < 0.03 nmol/L ) . Men were classified as having a low testosterone level ( 166 [ 19.3 % ] ) , an equivocal testosterone level ( equal number of low and normal levels ) ( 240 [ 28.0 % ] ) , or a normal testosterone level ( 452 [ 52.7 % ] ) . The risk for all-cause mortality was estimated using Cox proportional hazards regression models , adjusting for demographic and clinical covariates over a follow-up of up to 8 years . RESULTS Mortality in men with normal testosterone levels was 20.1 % ( 95 % confidence interval [ CI ] , 16.2%-24.1 % ) vs 24.6 % ( 95 % CI , 19.2%-30.0 % ) in men with equivocal testosterone levels and 34.9 % ( 95 % CI , 28.5%-41.4 % ) in men with low testosterone levels . After adjusting for age , medical morbidity , and other clinical covariates , low testosterone levels continued to be associated with increased mortality ( hazard ratio , 1.88 ; 95 % CI , 1.34 - 2.63 ; P<.001 ) while equivocal testosterone levels were not significantly different from normal testosterone levels ( hazard ratio , 1.38 ; 95 % CI , 0.99%-1.92 % ; P=.06 ) . In a sensitivity analysis , men who died within the first year ( 50 [ 5.8 % ] ) were excluded to minimize the effect of acute illness , and low testosterone levels continued to be associated with elevated mortality . CONCLUSIONS Low testosterone levels were associated with increased mortality in male veterans . Further prospect i ve studies are needed to examine the association between low testosterone levels and mortality Background : While testosterone 's ameliorative effects on depressive disorders and fatigue in HIV-positive patients have been suggested in the literature , no placebo-controlled trial selecting for depressive disorders and including a st and ard antidepressant has been conducted . Accordingly , this double-blind trial was design ed to determine whether testosterone , as well as fluoxetine , is superior to placebo for depression , fatigue , or both . Method : One hundred twenty-three men with HIV/AIDS with a Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition depressive disorder entered the 8-week trial and were r and omized to testosterone ( up to 400 mg IM testosterone cypionate biweekly ) , fluoxetine ( up to 60 mg/d ) , or double placebo . Outcome variables were the Clinical Global Impressions Scale for mood and for fatigue , the Hamilton Rating Scale for Depression , and the Chalder Fatigue Scale . Results : Ninety men completed the trial . In intention-to-treat analyses , mood response rates were 54 % , 47 % , and 44 % for fluoxetine , testosterone , and placebo , respectively . Among completers , mood response rates were 70 % , 57 % , and 53 % , respectively ; in neither analysis were differences between treatments statistically significant . In contrast , testosterone was superior to fluoxetine and placebo for completers regarding fatigue . In intention-to-treat analysis , response rates were 39 % , 56 % , and 42 % for fluoxetine , testosterone , and placebo , respectively , and for study completers , 41 % , 63 % , and 52 % , respectively , ( P < 0.05 ) , Conclusion : While over 50 % of patients treated with testosterone reported improved mood , this rate was not statistically superior to placebo . Thus , our findings do not support prescription of testosterone as a first-line treatment for depressive disorders  in HIV-positive men . However , if vali date d in additional studies , testosterone may be a useful option for medically ill men experiencing significant fatigue as well as depression CONTEXT Despite recognition that and rogen deficiency in men should be defined according to biochemical and clinical criteria , most prevalence estimates are based on low testosterone levels alone . OBJECTIVE The objective of this study was to examine the association between symptoms of and rogen deficiency and low total and calculated free testosterone levels and estimate the prevalence of symptomatic and rogen deficiency in men . DESIGN This study was a population -based , observational survey . PARTICIPANTS A total of 1,475 Black , Hispanic , and white men , between the ages of 30 - 79 yr , with complete data on testosterone , SHBG , and symptoms of and rogen deficiency , and who are not taking medications that impact sex steroid levels were r and omly selected from the Boston Area Community Health Survey . OUTCOME Outcomes were measured as symptomatic and rogen deficiency , defined as low total ( < 300 ng/dl ) and free ( < 5 ng/dl ) testosterone plus presence of low libido , erectile dysfunction , osteoporosis or fracture , or two or more of following symptoms : sleep disturbance , depressed mood , lethargy , or diminished physical performance . RESULTS Mean age of the sample was 47.3 + /- 12.5 yr . Approximately 24 % of subjects had total testosterone less than 300 ng/dl , and 11 % of subjects had free testosterone less than 5 ng/dl . Prevalence of symptoms were as follows : low libido ( 12 % ) , erectile dysfunction ( 16 % ) , osteoporosis/fracture ( 1 % ) , and two or more of the nonspecific symptoms ( 20 % ) . Low testosterone levels were associated with symptoms , but many men with low testosterone levels were asymptomatic ( e.g. in men 50 + yr , 47.6 % ) . Crude prevalence of symptomatic and rogen deficiency was 5.6 % ( 95 % confidence interval : 3.6 % , 8.6 % ) , and was not significantly related to race and ethnic group . Prevalence was low in men less than 70 yr ( 3.1 - 7.0 % ) and increased markedly with age to 18.4 % among 70 yr olds . Projection of these estimates to the year 2025 suggests that there will be as many as 6.5 million American men ages 30 - 79 yr with symptomatic and rogen deficiency , an increase of 38 % from 2000 population estimates . CONCLUSIONS Prevalence of symptomatic and rogen deficiency in men 30 and 79 yr of age is 5.6 % and increases substantially with age . The aging of the U.S. male population will cause a large increase in the burden of symptomatic and rogen deficiency . Future work should address the clinical significance of low testosterone levels in asymptomatic men Multiple endocrine and metabolic consequences of human immunodeficiency virus ( HIV ) infection exist that may contribute to  bone loss in men with the acquired immune deficiency syndrome ( AIDS ) wasting syndrome . Recent studies suggest that anabolic strategies can increase lean body mass in men with AIDS wasting . Prior studies have not examined the effects of anabolic agents on bone mineral density ( BMD ) or bone turnover in these men . To determine the effects of testosterone and progressive resistance training on BMD and bone turnover in eugonadal men with AIDS wasting , we r and omly assigned 54 eugonadal men with AIDS wasting ( weight < 90 % IBW or weight loss > 10 % from preillness baseline ) to receive either testosterone enanthate ( 200 mg/week , i m ) or placebo and to progressive resistance training ( 3 times/week ) or no training in a 2 x 2 factorial study design for 3 months . The BMD of the lumbar spine , proximal femur , and total body ; lean body mass ; and fat mass were measured by dual energy x-ray absorptiometry . Total body scans were repeated after 12 weeks of therapy . Baseline bone turnover and BMD were compared with those in 35 age-matched healthy non-HIV-infected control subjects . Compared with controls , lumbar spine BMD ( 1.021 + /- 0.018 vs. 1.084 + /- 0.025 g/cm(2 ) ; P = 0.04 ) and total hip BMD ( 0.951 + /- 0.017 vs. 1.070 + /- 0.019 g/cm(2 ) ; P < 0.0001 ) were reduced in men with AIDS wasting . T-scores were lower in men with AIDS wasting at the lumbar spine ( -0.62 + /- 0.17 vs. -0.07 + /- 0.23 , P = 0.05 ) and total hip ( -0.65 + /- 0.11 vs. + 0.20 + /- 0.014 , P < 0.0001 ) . Total hip T scores were less than -1.0 in 33 % of men with AIDS wasting . Neither the use of protease inhibitors nor the duration of protease inhibitors use correlated with BMD . Serum osteocalcin levels were lower ( 3.63 + /- 0.29 vs. 4.54 + /- 0.31 nmol/L ; P < 0.04 ) and urinary N-telopeptide excretion was higher ( 45.4 + /- 4.5 vs. 26.8 + /- 3.0 nmol BCE/mmol creatinine ; P = 0.004 ) in men with AIDS wasting than in controls . Lumbar spine BMD , as assessed on regional total body dual energy x-ray absorptiometry scan , increased over the 12-week treatment period in response to testosterone ( + 2.4 + /- 1.3 vs. -1.3 + /- 1.0 % , testosterone vs. placebo , respectively ; P = 0.02 ) , but not in response to training ( + 0.8 + /- 1.0 vs. + 0.4 + /- 1.3 % , training vs. no training ; P = 0.70 ) . Lumbar spine and total hip BMD are reduced in eugonadal men with AIDS wasting .  Biochemical markers of bone turnover suggest that bone formation and bone resorption are uncoupled in these men . Testosterone administration , but not resistance training , over 3 months increases lumbar spine BMD in eugonadal men with AIDS wasting Intracoronary testosterone infusions induce coronary vasodilatation and increase coronary blood flow . Longer term testosterone supplementation favorably affected signs of myocardial ischemia in men with low plasma testosterone and coronary heart disease . However , the effects on myocardial perfusion are unknown . Effects of longer term testosterone treatment on myocardial perfusion and vascular function were investigated in men with CHD and low plasma testosterone . Twenty-two men ( mean age 57 ± 9 [ SD ] years ) were r and omly assigned to oral testosterone undecanoate ( TU ; 80 mg twice daily ) or placebo in a crossover study design . After each 8-week period , subjects underwent at rest and adenosine-stress first-pass myocardial perfusion cardiovascular magnetic resonance , pulse-wave analysis , and endothelial function measurements using radial artery tonometry , blood sampling , anthropomorphic measurements , and quality -of-life assessment . Although no difference was found in global myocardial perfusion after TU compared with placebo , myocardium supplied by unobstructed coronary arteries showed increased perfusion ( 1.83 ± 0.9 vs 1.52 ± 0.65 ; p = 0.037 ) . TU decreased basal radial and aortic augmentation indexes ( p = 0.03 and p = 0.02 , respectively ) , indicating decreased arterial stiffness , but there was no effect on endothelial function . TU significantly decreased high-density lipoprotein cholesterol and increased hip circumference , but had no effect on hemostatic factors , quality of life , and angina symptoms . In conclusion , oral TU had selective and modest enhancing effects on perfusion in myocardium supplied by unobstructed coronary arteries , in line with previous intracoronary findings . The TU-related decrease in basal arterial stiffness may partly explain previously shown effects of exogenous testosterone on signs of exercise-induced myocardial ischemia Rationale No studies to date have directly compared the tolerability and efficacy of smoked marijuana and oral dronabinol in HIV+ marijuana smokers . Objectives The aim of this study was to compare dronabinol ( 0 , 10 , 20 , 30 mg p.o . ) and marijuana [ 0.0 , 1.8 , 2.8 , 3.9 % Δ9-tetrahydrocannabinol ( THC ) ] in two sample s of HIV+ marijuana smokers : those with ( n=15 ) and those without ( n=15 ) a clinical ly significant loss of muscle mass ( < 90 % body cell mass/height ) , which is one component of AIDS wasting . Methods Mood , physical symptoms , self-selected food intake , cardiovascular data , and cognitive task performance were measured before and repeatedly after dronabinol and marijuana administration in eight 7-h sessions . Marijuana and dronabinol were administered in r and omized order using a within-subject , staggered , double-dummy design . Results As compared to placebo , ( 1 ) marijuana ( 1.8 , 2.8 , 3.9 % THC ) and the lower dronabinol doses ( 10 , 20 mg ) were well tolerated ( e.g. , few physical symptoms , significant increases in ratings of “ good drug effect ” ) in both groups of participants ; the highest dose of dronabinol ( 30 mg ) was poorly tolerated in a subset of participants ; ( 2 ) marijuana and dronabinol significantly increased caloric intake in the low bioelectrical impedance analysis ( BIA ) group but not in the normal BIA group ; and ( 3 ) drug effects on cognitive performance were minor . Conclusions These data suggest that for experienced marijuana smokers with clinical ly significant muscle mass loss , both dronabinol ( at acute doses at least four to eight times the current recommendation ) and marijuana produce substantial and comparable increases in food intake without producing adverse effects INTRODUCTION In short-term studies , testosterone replacement therapy has been shown to protect male subjects from exercise-induced ischaemia and modify cardiovascular risk factors such as insulin resistance , fat mass and lipid profiles . METHODS This r and omised parallel group controlled trial was design ed to assess the treatment effect of testosterone therapy ( Nebido ) compared with placebo in terms of exercise-induced ischaemia , lipid profiles , carotid intima-media thickness ( CIMT ) and body composition during 12 months treatment in men with low testosterone levels and angina . RESULTS A total of 15 men were recruited but 13 ( n=13 ) reached adequate duration of follow-up ; seven were treated with testosterone  and six with placebo . Testosterone increased time to ischaemia ( 129+/-48 s versus 12+/-18 , P=0.02 ) and haemoglobin ( 0.4+/-0.6 g/dl versus -0.03+/-0.5 , P=0.04 ) , and reduced body mass index ( -0.3 kg/m(2 ) versus 1.3+/-1 , P=0.04 ) and triglycerides ( -0.36+/-0.4 mmol/l versus 0.3+/-1.2 , P=0.05 ) . The CIMT decreased in the testosterone group more than placebo , but full between group analyses suggested this was only a statistical trend ( -0.5+/-0.1 vs -0.09+/-0.06 , P=0.16 ) . There were no significant effects on serum prostate specific antigen , total or high-density lipoprotein cholesterol ; or on mood and symptom scores as assessed by Seattle Angina Score and EuroQol . CONCLUSION The protective effect of testosterone on myocardial ischaemia is maintained throughout treatment without decrement . Previously noted potentially beneficial effects of testosterone on body composition were confirmed and there were no adverse effects OBJECTIVES To To compare testosterone undecanoate versus propionyl-L-carnitine plus acetyl-L-carnitine and placebo in the treatment of male aging symptoms . METHODS A total of 120 patients were r and omized into three groups . The mean patient age was 66 years ( range 60 to 74 ) . Group 1 was given testosterone undecanoate 160 mg/day , the second group was given propionyl-L-carnitine 2 g/day plus acetyl-L-carnitine 2 g/day . The third group was given a placebo ( starch ) . Drugs and placebo were given for 6 months . The assessed variables were total prostate-specific antigen , prostate volume , peak systolic velocity , end-diastolic velocity , resistive index of cavernosal penile arteries , nocturnal penile tumescence , total and free testosterone , prolactin , luteinizing hormone , International Index of Erectile Function score , Depression Melancholia Scale score , fatigue scale score , and incidence of side effects . The assessment was performed at intervals before , during , and after therapy . RESULTS Testosterone and carnitines significantly improved the peak systolic velocity , end-diastolic velocity , resistive index , nocturnal penile tumescence , International Index of Erectile Function score , Depression Melancholia Scale score , and fatigue scale score . Carnitines proved significantly more active than testosterone in improving nocturnal penile tumescence and International Index of Erectile Function score . Testosterone significantly increased the prostate volume and free and total testosterone levels and significantly lowered serum luteinizing hormone ; carnitines did not . No drug significantly modified prostate-specific antigen or prolactin . Carnitines and testosterone proved effective for as long as they were administered , with suspension provoking a reversal to baseline values . Only the group 1 prostate volume proved significantly greater than baseline 6 months after testosterone suspension . Placebo administration proved ineffective . Negligible side effects emerged . CONCLUSIONS Testosterone and , especially , carnitines proved to be active drugs for the therapy of symptoms associated with male aging CONTEXT Hypoactive sexual desire disorder ( HSDD ) is one of the most common sexual problems reported by women , but few studies have been conducted to evaluate treatments for this condition . OBJECTIVE The objective of this study was to evaluate the efficacy and safety of a testosterone patch in surgically menopausal women with HSDD . DESIGN The design was a r and omized , double-blind , parallel-group , placebo-controlled , 24-wk study ( the Intimate SM 1 study ) . SETTING The study was performed at private or institutional practice s. PATIENTS The subjects studied were women , aged 26 - 70 yr , with HSDD after bilateral salpingo-oophorectomy who were receiving concomitant estrogen therapy . Placebo ( n = 279 ) or testosterone 300 microg/d ( n = 283 ) was administered . There were 19 patients who withdrew due to adverse events in the placebo group and 24 in the 300 mug/d testosterone group . INTERVENTION Testosterone ( 300 microg/d ) or placebo patches were applied twice weekly . MAIN OUTCOME MEASURE(S ) The primary end point was the change in the frequency of total satisfying sexual activity at 24 wk . Secondary end points included other sexual functioning end points and safety assessment s. RESULTS At 24 wk , there was an increase from baseline in the frequency of total satisfying sexual activity of 2.10 episodes/4 wk in the testosterone group , which was significantly greater than the change of 0.98 episodes/4 wk in the placebo group ( P = 0.0003 ) . The testosterone group also experienced statistically significant improvements in sexual desire and a decrease in distress . The overall safety profile was similar in both treatment groups . CONCLUSION In the Intimate SM 1 study , the testosterone patch improved sexual function and decreased distress in surgically menopausal women with HSDD and was well tolerated in this trial BACKGROUND Studies linking low serum testosterone concentration to adverse clinical outcomes in hemodialysis patients have been relatively small . We investigated the role of testosterone in adverse outcomes and quality of life in an incident cohort of male Canadian hemodialysis patients . STUDY DESIGN A prospect ively design ed multicenter observational study using data from the Canadian Kidney Disease Cohort Study ( CKDCS ) . SETTING & PARTICIPANTS Male patients initiating hemodialysis therapy since February 14 , 2005 , in 3 Canadian centers serving ethnically diverse population s were studied ( N = 623 ) . PREDICTOR Serum  testosterone levels using the International Society of And rology , International Society for the Study of the Aging Male , and European Association of Urology cutoffs ( low , < 231 ng/dL ; borderline , 231 - 346 ng/dL ; normal , > 346 ng/dL ) . OUTCOMES All-cause mortality , fatal and nonfatal cardiovascular ( CV ) events , and Health Utility Index (HUI)-assessed health-related quality of life . MEASUREMENTS Participants completed a structured interview on demographics and medical history and an HUI question naire ( version 3 ) . Routine laboratory test results captured into the study data base , and serum testosterone measured within 3 months after initiation of the baseline hemodialysis session . RESULTS During a median follow-up of 20 ( range , 1 - 81 ) months , 166 ( 27 % ) died and 98 ( 20 % ) had a CV event . Mean serum testosterone level was 234.1 ± 146.1 ( SD ) ng/dL. Higher serum testosterone levels were associated with significantly decreased unadjusted risk of death ( HR per 10-ng/dL increase , 0.58 ; 95 % CI , 0.37 - 0.90 ) . There was a statistically significant trend for higher all-cause mortality with low serum testosterone levels in adjusted analyses ( P < 0.001 ) . Higher levels of log-transformed testosterone were associated with significantly higher HUI scores ( P for trend < 0.001 ) , and low levels of serum testosterone were associated significantly with lower HUI scores ( P for trend < 0.001 ) . Although there was a significant trend in the unadjusted risk of CV events among participants with low serum testosterone levels ( P < 0.001 ) , the risk was no longer significant after adjustment for age . There was no significant interaction with age and serum testosterone level tested as continuous variables ( P = 0.07 ) . LIMITATIONS A short follow-up period and serum testosterone measured on a single occasion . CONCLUSIONS Low serum testosterone concentration may be a modifiable risk factor for adverse outcomes and poor quality of life in male hemodialysis patients . This hypothesis should be tested in r and omized controlled trials Background Uncontrolled studies show fatigue , anorexia , depression , and mortality are associated with low testosterone in men with cancer .  Testosterone replacement improves quality of life and diminishes fatigue in patients with non-cancer conditions . The primary objective was to evaluate the effect of testosterone replacement on fatigue in hypogonadal males with advanced cancer , by the Functional Assessment of Chronic Illness Therapy-Fatigue subscale ( FACIT-Fatigue ) at day 29 . Methods This is a r and omized , double-blinded placebo-controlled trial . Out patients with advanced cancer , bioavailable testosterone ( BT ) < 70 ng/dL and fatigue score > 3/10 on the Edmonton Symptom Assessment Scale were eligible .  Intra-muscular testosterone or sesame seed oil placebo was administered every 14 days to achieve BT levels 70–270 ng/dL. Results Sixteen placebo and 13 testosterone-treated subjects were evaluable . No statistically significant difference was found for FACIT-fatigue scores between arms ( −2 ± 12 for placebo , 4 ± 8 for testosterone , p = 0.11 ) . Sexual Desire Inventory score ( p = 0.054 ) and performance status ( p = 0.02 ) improved in the testosterone group . Fatigue subscale scores were significantly better ( p = 0.03 ) in those treated with testosterone by day 72 . Conclusions Four weeks of intramuscular testosterone replacement in hypogonadal male patients with advanced cancer did not significantly improve quality of life . Larger studies of longer duration are warranted Background —There is a popular belief that chronic stress causes heart disease through psychoneuroendocrine mechanisms . We have examined whether an elevated circulating cortisol-to-testosterone ratio increases the risk of ischemic heart disease . Methods and Results —We undertook a prospect i ve cohort study of 2512 men aged 45 to 59 years between 1979 and 1983 from Caerphilly , South Wales , with a mean follow-up of 16.5 years . Subjects underwent a clinical examination , and morning fasting blood sample s were taken for analysis of cortisol levels , testosterone levels , and other cardiovascular risk factors . The ratio of cortisol to testosterone showed weak associations with potential confounding factors but strong positive associations with components of the insulin resistance syndrome ( P<0.001 ) . A positive linear trend was seen across quintiles of cortisol : testosterone ratio for incident ischemic heart disease ( age-adjusted OR per z score change in ratio 1.22 , 95 % CI 1.07 to 1.38 , P=0.003 ) . This was markedly attenuated after adjustment for components of the insulin resistance syndrome ( age-adjusted OR per z score change in ratio 1.10 , 95 % CI 0.96 to 1.25 , P=0.18 ) . There was no association between the cortisol : testosterone ratio and other causes of death ( age-adjusted hazard ratio 0.99 , 95 % CI 0.88 to 1.11 , P=0.81 ) . Conclusions —This is the first population -based prospect i ve study that has found a specific association between cortisol : testosterone ratio and incident ischemic heart disease , apparently mediated through the insulin resistance syndrome . Whether this reflects the effects of chronic stress , behavioral factors , or genetic influences remains to be determined To investigate the role of and rogens in increasing bone density and improving low libido in postmenopausal women , we have studied the long-term effects of estradiol and testosterone implants on bone mineral density and sexuality in a prospect i ve , 2 year , single-blind r and omised trial . Thirty-four postmenopausal volunteers were r and omised to treatment with either estradiol implants 50 mg alone ( E ) or estradiol 50 mg plus testosterone 50 mg ( E&T ) , administered 3-monthly for 2 years . Cyclical oral progestins were taken by those women with an intact uterus . Thirty-two women completed the study .  BMD ( DEXA ) of total body , lumbar vertebrae ( L1-L4 ) and hip area increased significantly in both treatment groups . BMD increased more rapidly in the testosterone treated group at all sites . A substantially greater increase in BMD occurred in the E&T group for total body ( P < 0.008 ) , vertebral L1-L4 ( P < 0.001 ) and trochanteric ( P < 0.005 ) measurements . All sexual parameters ( Sabbatsberg sexual self-rating scale ) improved significantly in both groups . Addition of testosterone result ed in a significantly greater improvement compared to E for sexual activity ( P < 0.03 ) , satisfaction ( P < 0.03 ) , pleasure ( P < 0.01 ) , orgasm ( P < 0.035 ) and relevancy ( P < 0.05 ) . Total cholesterol and LDL-cholesterol fell in both groups as did total body fat . Total body fat-free mass ( DEXA , anthropometry , impedance ) increased in the E&T group only . We concluded that in postmenopausal women , treatment with combined estradiol and testosterone implants was more effective in increasing bone mineral density in the hip and lumbar spine than estradiol implants alone . Significantly greater improvement in sexuality was observed with combined therapy , verifying the therapeutic value of testosterone implants for diminished libido in postmenopausal women . The favourable estrogenic effects on lipids were preserved in women treated with T , in association with beneficial changes in body composition To investigate the role of and rogens in increasing bone density and improving low libido in postmenopausal women , we have studied the long-term effects of estradiol and testosterone implants on bone mineral density and sexuality in a prospect i ve , 2 year , single-blind r and omised trial . Thirty-four postmenopausal volunteers were r and omised to treatment with either estradiol implants 50 mg alone ( E ) or estradiol 50 mg plus testosterone 50 mg ( E&T ) , administered 3-monthly for 2 years . Cyclical oral progestins were taken by those women with an intact uterus . Thirty-two women completed the study .  BMD ( DEXA ) of total body , lumbar vertebrae ( L1-L4 ) and hip area increased significantly in both treatment groups . BMD increased more rapidly in the testosterone treated group at all sites . A substantially greater increase in BMD occurred in the E&T group for total body ( P < 0.008 ) , vertebral L1-L4 ( P < 0.001 ) and trochanteric ( P < 0.005 ) measurements . All sexual parameters ( Sabbatsberg sexual self-rating scale ) improved significantly in both groups . Addition of testosterone result ed in a significantly greater improvement compared to E for sexual activity ( P < 0.03 ) , satisfaction ( P < 0.03 ) , pleasure ( P < 0.01 ) , orgasm ( P < 0.035 ) and relevancy ( P < 0.05 ) . Total cholesterol and LDL-cholesterol fell in both groups as did total body fat . Total body fat-free mass ( DEXA , anthropometry , impedance ) increased in the E&T group only . We concluded that in postmenopausal women , treatment with combined estradiol and testosterone implants was more effective in increasing bone mineral density in the hip and lumbar spine than estradiol implants alone . Significantly greater improvement in sexuality was observed with combined therapy , verifying the therapeutic value of testosterone implants for diminished libido in postmenopausal women . The favourable estrogenic effects on lipids were preserved in women treated with T , in association with beneficial changes in body composition BACKGROUND Previous studies have found no association between serum concentrations of total oestradiol and cognitive function , but these measurements may not reflect concentrations of hormone available to the brain . We tested the hypothesis that concentrations of non-protein-bound ( free ) and loosely bound ( bioavailable ) sex hormones are associated with cognitive function  in older women . METHODS We measured cognitive performance with a  modified mini mental status examination ( mMMSE ) at baseline ( 1986 - 88 ) and 6 years later in 425 women ( 65 years or older ) . Concentrations of non-protein-bound and bioavailable oestradiol and total and non-protein-bound testosterone were measured by RIA in serum sample s taken at baseline . FINDINGS Initial cognitive scores did not differ by tertile of non-protein-bound oestradiol , bioavailable oestradiol , or testosterone . Cognitive impairment ( a decrease of 3 points or more in mMMSE score ) occurred in five ( 5 % ) of 94 women in the high tertile for non-protein-bound oestradiol and in 17 ( 16 % ) of 106 in the low tertile ( odds ratio 0.3 [ 95 % CI 0.1 - 0.8 ] ) . After adjustment for age , years of education , body-mass index , current oestrogen use , history of surgical menopause , and baseline mMMSE score , the odds ratio was 0.3 ( 0.1 - 0.9 ) . The results were similar for bioavailable oestradiol ( five [ 5 % ] vs 15 [ 15 % ] ; adjusted odds ratio 0.3 [ 0.1 - 1.0 ] ) . There was no association between risk of cognitive impairment and serum testosterone . INTERPRETATION Women with high serum concentrations of non-protein-bound and bioavailable oestradiol , but not testosterone , were less likely to develop cognitive impairment than women with low concentrations . This finding supports the hypothesis that higher concentrations of endogenous oestrogens prevent cognitive decline AIMS Anabolic therapy with testosterone may be useful in the treatment of wasting associated with chronic heart failure but little is known about its cardiovascular actions . The aim of this study was to determine the acute haemodynamic effects of testosterone administration in men with heart failure . METHODS AND RESULTS Twelve men with stable chronic heart failure were enrolled in a double-blind , r and omised , placebo-controlled , cross-over trial . Subjects were given testosterone 60 mg or placebo via the buccal route and central haemodynamics were monitored over 6h , using a pulmonary flotation catheter . Subjects received the second treatment on day 2 and haemodynamic monitoring was repeated . Treatment was well tolerated . Compared with placebo , testosterone treatment result ed in a relative increase in cardiac output ( p<0.0001 , ANCOVA ) , with maximum treatment effect after 180 min ( 10.3+/-4.6 % increase from baseline , p=0.035 ; 95 % CI 0.8 - 19.8 ) . This was accompanied by reduction in systemic vascular resistance compared with baseline ( p<0.0001 , ANCOVA ) , with maximum treatment effect also at 180 min ( -17.4+/-9.6 % from baseline , p=0.085 ; 95 % CI -37.3 to + 2.6 ) . These maximal changes coincided with the peak elevation in serum bio-available testosterone . There was no significant change in any other haemodynamic parameter measured . CONCLUSIONS Administration of testosterone increases cardiac output acutely , apparently via reduction of left ventricular afterload There have not been studies assessing the effects of chronic testosterone cypionate ( TC ) therapy on circulating levels of testosterone ( T ) , estradiol ( E2 ) , free T , bioavailable T ( BAT ) , luteinizing hormone ( LH ) , and sexual function in impotent men with low T levels . This study was a double-blind crossover using 200 mg of TC or placebo given intramuscularly every 14 days for six injections and the other medication given for six doses . Blood was drawn before each injection . Mean concentrations of T , E2 , free T , and BAT were the same on TC or on placebo , but serum LH was significantly suppressed during intramuscular TC . With TC statistically significant improvements in libido and in potency were noted . Five of the men were able to have vaginal sex while taking TC . TC injections every 14 days do not appear to maintain increased T concentrations for 2 full weeks , and other dosage/injection schedules are being evaluated , but there were improvements in libido and potency Background — The relation between endogenous testosterone concentrations and health in men is controversial . Methods and Results — We examined the prospect i ve relationship between endogenous testosterone concentrations and mortality due to all causes , cardiovascular disease , and cancer in a nested case-control study based on 11 606 men aged 40 to 79 years surveyed in 1993 to 1997 and followed up to 2003 . Among those without prevalent cancer or cardiovascular disease , 825 men who subsequently died were compared with a control group of 1489 men still alive , matched for age and date of baseline visit .  Endogenous testosterone concentrations at baseline were inversely related to mortality due to all causes ( 825 deaths ) , cardiovascular disease ( 369 deaths ) , and cancer ( 304 deaths ) . Odds ratios ( 95 % confidence intervals ) for mortality for increasing quartiles of endogenous testosterone compared with the lowest quartile were 0.75 ( 0.55 to 1.00 ) , 0.62 ( 0.45 to 0.84 ) , and 0.59 ( 0.42 to 0.85 ) , respectively ( P<0.001 for trend after adjustment for age , date of visit , body mass index , systolic blood pressure , blood cholesterol , cigarette smoking , diabetes mellitus , alcohol intake , physical activity , social class , education , dehydroepi and rosterone sulfate , and rostanediol glucuronide , and sex hormone binding globulin ) . An increase of 6 nmol/L serum testosterone ( ≈1 SD ) was associated with a 0.81 ( 95 % confidence interval 0.71 to 0.92 , P<0.01 ) multivariable-adjusted odds ratio for mortality . Inverse relationships were also observed for deaths due to cardiovascular causes and cancer and after the exclusion of deaths that occurred in the first 2 years . Conclusions — In men  , endogenous testosterone concentrations are inversely related to mortality due to cardiovascular disease and all causes . Low testosterone may be a predictive marker for those at high risk of cardiovascular disease Objective : To evaluate the effect of adding testosterone undecanoate 40 mg daily to estrogen replacement on sexual function , psychological well-being and self-esteem in surgically postmenopausal women . Methods : A letter of invitation to participate in the study was mailed to women who had undergone hysterectomy and bilateral oophorectomy for benign disorders during 1990 - 98 . Fifty women , 45 - 60 years old , were consecutively recruited and r and omly assigned to oral treatment with testosterone undecanoate 40 mg plus estradiol valerate 2 mg daily or placebo plus estradiol valerate 2 mg daily for 24 weeks . A double-blind design was chosen , with cross-over to the other regimen for another 24 weeks of treatment . Forty-four women completed the study . Outcome included scores on McCoy 's sex scale question naire , the Psychological General Well-Being index and a self-esteem question naire , at baseline and after 24 weeks of either treatment . Serum concentrations of total testosterone , sex hormone binding globulin , free testosterone , dihydrotestosterone , and rostenedione , estradiol , follicle stimulating hormone and luteinizing hormone were analyzed at baseline and after 24 weeks of both treatment regimens . Results : After 24 weeks , both treatment regimens had significantly improved some of the sexual variables . The addition of testosterone had a significantly better effect on the sex variables ' enjoyment of sex ' , ' satisfaction with frequency of sexual activity ' and ' interest in sex ' . The total McCoy score was significantly increased by both treatments , but there was a stronger effect when testosterone was also given . Although both regimens improved psychological well-being and self-esteem , we found no significant differences between testosterone-estrogen or estrogen alone at 24 weeks . Serum levels of all and rogens , with considerable individual variation , increased significantly from baseline after 24 weeks of testosterone-estrogen treatment . Supraphysiological levels were achieved in a significant proportion of the women . Increases in estradiol and sex hormone binding globulin were less marked when testosterone was also given . Both treatments reduced gonadotropin levels . Conclusions : The addition of testosterone undecanoate improved specific aspects of sexual function more than treatment with estrogen alone . Improvements in well-being and self-esteem were similar for both treatments . If testosterone undecanoate 40 mg daily should be used for clinical treatment , regular monitoring of and rogen serum levels is needed Because testosterone has an anabolic effect in myotonic dystrophy , we conducted a 12-month , r and omized , double-blind therapeutic trial of testosterone enanthate ( 3 mg/kg/wk ) in 40 men with myotonic dystrophy . We evaluated strength by manual muscle tests , quantitative myometry , pulmonary function , and quantitative functional assessment . A sustained , significant elevation of testosterone levels was produced but there was no effect on any measurement of muscle strength . Muscle mass as estimated by creatinine excretion and lean body mass ( 40 K method ) increased significantly . We conclude that testosterone does not improve strength in myotonic dystrophy despite increasing muscle mass Background The presumptive approach of confirming malaria in health facilities leads to over-diagnosis of malaria , over use of anti-malaria drugs and the risk of drug resistance development . WHO recommends parasitological confirmation before treatment with artemisinin-based combination therapy ( ACT ) in all suspected malaria patients . The use of malaria rapid diagnostic tests ( mRDTs ) would make it possible for prescribers to diagnose malaria at point-of-care and better target the use of antimalarials . Therefore , a cost-effectiveness analysis was performed on the introduction of mRDTs for management of malaria in under-five children in a high transmission area in Ghana where presumptive diagnosis was the norm in public health centres . Methods A cluster-r and omised controlled trial where thirty-two health centres were r and omised into test-based diagnosis of malaria using mRDTs ( intervention ) or clinical judgement ( control ) was used to measure the effect of mRDTs  on appropriate treatment : ‘ a child with a positive reference diagnosis prescribed a course of ACT or a child with a negative reference diagnosis not given an ACT ’ . Cost data was collected from five purposively selected health centres and used to estimate the health sector costs of performing an mRDT and treat children for malaria and other common febrile illnesses . Costs of training healthcare personnel and supervision in the study period were also collected . A sample of caregivers to children participating in the trial was interviewed about household cost incurred on transport , drugs , fees , and special food during a period of one week after the health centre visit as well as days unable to work . A decision model approach was used to calculate the incremental cost-effectiveness ratios ( ICERs ) . Univariate and multivariate sensitivity analyses were applied to assess the robustness of ICERs . Results The availability of mRDTs for malaria diagnosis result ed in fewer ACT treatments compared to the clinical judgement approach ( 73 % versus 81 % ) and more children appropriately treated ( 70 % versus 57 % ) . The introduction of mRDT-based diagnosis would cost the Ministry of Health US$ 18.6 per extra appropriately treated child under five compared to clinical judgement while the ICER from a societal perspective was lower at US$ 11.0 per appropriately treated child . ICERs were sensitive to a decrease in adherence to negative mRDTs , malaria positivity rate and specificity of the mRDT . Conclusion The introduction of mRDTs is likely to be considered cost-effective in this high transmission setting as this intervention increased the number of appropriately treated children at low cost . Trial Registration Clinical Trials.gov OBJECTIVES To evaluate whether low testosterone levels are associated with greater depression or poorer function in a geriatric rehabilitation unit . DESIGN Retrospective review . SETTING Geriatric rehabilitation unit . MEASUREMENTS Low testosterone levels were defined as total testosterone of 3.0 ng/mL or less or free testosterone of 9.0 pg/mL or less . Age , ethnicity , weight , depression , ambulation , length of rehabilitation , and 6-month rehospitalization and mortality rates were obtained . Overall illness severity was determined using the Cumulative Illness Rating Scale for Geriatrics . RESULTS  Low testosterone levels  were present in 29 of 44 ( 65.9 % ) men . There were no significant differences between men with low and normal testosterone levels in ethnicity , age , weight , depression , and overall illness severity . Lower testosterone levels were correlated with decreased ability to ambulate and transfer ( Spearman P>.34 ; P<.05 ) . There were no significant differences between men with low and normal testosterone in length of stay on the rehabilitation unit ( mean+/-st and ard deviation= 19.6+/-11.6 vs 17.7+/-17.5 days , P=.68 ) or rehospitalization rates ( 41.4 % vs 26.7 % ; P=.34 ) . Men with low testosterone had a trend toward increased 6-month mortality ( 31.0 % vs 6.7 % ; chi(2)=3.3 , P=.07 ) and shorter survival time ( log rank=3.2 ; df 1 , P=.07 ) . After entering testosterone and variables with potential prognostic significance for mortality in a stepwise manner in a Cox regression analysis , there was a significant mortality risk associated with low testosterone ( hazard ratio=27.9 , 95 % confidence interval=2.0 - 384.0 ; P=.01 ) . CONCLUSION Low testosterone levels were correlated with decreased physical function and increased risk for 6-month mortality . Prospect i ve studies with larger sample sizes and better st and ardized testosterone measures are needed to confirm these findings INTRODUCTION A significant number of postmenopausal women suffer from distressing problems because of urogenital atrophy secondary to the decline in circulating estrogen levels . Treatment with topical hormones may provide relief in such women when used judiciously . AIM To study the effects of local estrogen with or without local testosterone on urogenital and sexual health in postmenopausal women . METHODS Seventy-five postmenopausal women symptomatic for urogenital atrophy and sexual dysfunction were r and omly divided into two study groups and one control group . The women in study group 1 received local estrogen cream ; study group 2 received local estrogen and testosterone cream ; the control group received nonhormonal lubricant KY gel for 12 weeks . The urogenital and sexuality score , along with the vaginal health index and the vaginal maturation index ( VMI ) , was calculated at the beginning of therapy and 12 weeks later . MAIN OUTCOME MEASURES Changes in the urogenital and sexuality score along with vaginal health index and VMI . RESULTS After 12 weeks of therapy , there was a significant improvement in all the four study parameters , which correlated well with the improvement in symptoms of urogenital atrophy and sexual dysfunction in both the study groups as compared with the control group . Improvement in sexuality score was greatest with combined estrogen- and rogen therapy . There were no adverse effects and the therapies were well accepted without any compliance issue . CONCLUSION Local estrogen either alone or with and rogen is highly effective in relieving symptoms of urogenital atrophy and in improving sexual function in symptomatic postmenopausal women
Testosterone supplementation did not show consistent benefit for cardiovascular risk , sexual function , mood and behavior , or cognition .
Studies that examined clinical cardiovascular endpoints have not favored testosterone therapy over placebo .
Testosterone is ineffective in treating erectile dysfunction and controlled trials did not show a consistent effect on libido .
Testosterone supplementation consistently increased muscle strength but did not have beneficial effects on physical function .
Most studies on mood-related endpoints found no beneficial effect of testosterone treatment on personality , psychological well-being , or mood .
Testosterone products are recommended by some prescribers in response to a diagnosis or presumption of " low testosterone " ( low-T ) for cardiovascular health , sexual function , muscle weakness or wasting , mood and behavior , and cognition .