Oestradiol-releasing vaginal ring versus oestriol vaginal pessaries in the treatment of bothersome lower urinary tract symptoms. Comparison of usefulness of estradiol vaginal tablets and estriol vagitories for treatment of vaginal atrophy. Comparative study: Replens versus local estrogen in menopausal women. The effect of estradiol vaginal tablet and conjugated estrogen cream on urogenital symptoms in postmenopausal women: a comparative study. Replens versus dienoestrol cream in the symptomatic treatment of vaginal atrophy in postmenopausal women. Local treatment of urogenital atrophy with an estradiol-releasing vaginal ring: a comparative and a placebo-controlled multicenter study. Vaginal Ring Study Group. Continuous low dose estradiol released from a vaginal ring versus estriol vaginal cream for urogenital atrophy. Efficacy of low-dose intravaginal estriol on urogenital aging in postmenopausal women. Local estrogen treatment in patients with urogenital symptoms. Efficacy of sustained-release vaginal oestriol in alleviating urogenital and systemic climacteric complaints. A comparative study of safety and efficacy of continuous low dose oestradiol released from a vaginal ring compared with conjugated equine oestrogen vaginal cream in the treatment of postmenopausal urogenital atrophy.
To assess the efficacy of an oestradiol-releasing vaginal ring and oestriol pessaries in the alleviation of lower urinary tract symptoms occurring after the menopause.
                Randomised, parallel group, controlled trial.
                Twenty-six clinics of practising gynaecologists and one outpatient clinic at a department of obstetrics and gynaecology.
                Two hundred and fifty-one postmenopausal women, with a mean age of 66 years, reporting at least one bothersome lower urinary tract symptom.
                One hundred and thirty-four women were treated with the oestradiol-releasing ring for 24 weeks; 117 women were treated with oestriol pessaries 0.5 mg every second day for 24 weeks.
                Subjective scores of urgency, frequency, nocturia, dysuria, stress incontinence and urge incontinence.
                The two treatments were equally efficacious in alleviating urinary urgency (51% vs 56%), urge incontinence (58% vs 58%), stress incontinence (53% vs 59%) and nocturia (51% vs 54%). Dysuria was alleviated in 76% vs 67%, equivalence was not demonstrated. No statistically significant difference was found for any primary efficacy endpoint. Sixty percent of the participants rated the form of administration via the vaginal ring as excellent, compared with 14% for the pessaries (P < 0.0001).
                Low dose vaginally administered oestradiol and oestriol are equally efficacious in alleviating lower urinary tract symptoms which appear after the menopause. The form of administration of the vaginal ring, seems to be more acceptable than oestriol pessaries. Atrophic vaginitis is a common condition. This study compared the usefulness of estradiol vaginal tablets (EVT) and estriol vagitories (EV) in treatment of atrophic vaginitis.
                Ninety-six postmenopausal women with symptoms of atrophic vaginitis were treated for 24 weeks with either EVT or with EV. Patients used the medication daily for the first 2 weeks of the study, and twice-weekly thereafter.
                Both EVT and EV were effective in treating vaginal atrophy and patients in both treatment groups experienced a significant improvement in vaginal symptoms such as itching, irritation, dryness, and dyspareunia. At the end of the study three (6%) EVT treated women reported leakage and none needed to use sanitary towels. Among the EV treated women 31 (65%) reported leakage and 14 (29%) required sanitary protection. Furthermore, 90% in the EVT group perceived the medication as hygienic compared to 79% in the EV group, and 49% in the EVT group indicated that the product was easy to use compared to 28% in the EV group. Endometrial thickness was increased (1.1 mm with EVT and 0.5 mm on EV) in both treatment groups during the first 2 weeks of the study, but returned to baseline levels when the frequency of drug application was reduced to twice-weekly.
                Estradiol vaginal tablets provides an effective alternative to traditional forms of local estrogen therapy. This was an open-label study comparing effects of a nonhormonal drug-free bioadhesive vaginal moisturizer to a local estrogen therapy in the treatment of vaginal dryness symptoms. There were 15 women evaluated in each treatment group during a 12-week period. Results indicated that the bioadhesive vaginal moisturizer was a safe and effective alternative to estrogen vaginal cream, with both therapies exhibiting statistically significant increases in vaginal moisture, vaginal fluid volume, and vaginal elasticity with a return of the premenopausal pH state. To compare the effects of estradiol vaginal tablet with conjugated estrogen cream on urogenital symptoms, vaginal health index, vaginal cytology, endometrial thickness, and plasma estradiol level in postmenopausal women.
                Fifty-three women with urogenital symptoms were randomized to local vaginal treatment of 25 microg estradiol tablet or 1 g of conjugated estrogen cream for 12 weeks. They were assessed for urogenital symptoms, vaginal health index, vaginal cytology, endometrial thickness and estradiol level.
                Forty-eight women completed the treatment. Both groups showed improvement of urogenital symptoms, vaginal health index, and vaginal cytology after the first 4 weeks of treatment. Conjugated estrogen cream showed superior efficacy in alleviating vaginal dryness and dyspareunia. Two cases of endometrial proliferation were noted.
                Estradiol vaginal tablet and conjugated estrogen cream were effective in treating urogenital symptoms, the restoration of normal vaginal epithelium and reduction of vaginal pH in postmenopausal women. However, 2 cases of endometrial proliferation were noted. This study was designed to evaluate the efficacy of Replens, a non-hormonal moisturizing vaginal gel, on symptoms of vaginal atrophy in postmenopausal women, in comparison with Dienoestrol (Cilag), an oestrogenic vaginal cream.
                Thirty-nine patients were randomly allocated to either of the two treatments. Replens was given three times a week during the 12 weeks of the study, while Dienoestrol was administered daily during the first 2 weeks and thereafter three times a week. Vaginal dryness index, itching, irritation, dyspareunia, pH and safety were evaluated every week the first month and every month thereafter.
                Both treatments had a significant increase on vaginal dryness index as soon as the first week of treatment, and the hormonal compound was significantly better than the non-hormonal one. All symptoms such as itching, irritation and dyspareunia significantly decreased or disappeared without any difference between the two treatments. For pH, no significant difference was seen either in each group or between the two groups. No adverse events related with the two drugs were found.
                This study shows that Replens applied vaginally three times a week, is a full therapy for all symptoms of vaginal atrophy as well as local estrogen. No serious adverse event was related. Replens is an alternative treatment to local estrogen and perhaps a good complement of systemic HRT in patient suffering from vaginal dryness. Local estrogen substitution has been shown to be more appropriate than any systemic application for the treatment of urogenital symptoms of hormone deficiency. The efficacy, safety and acceptability of a new low-dose drug delivery system consisting of an estradiol-releasing silicone vaginal ring was studied in two multicenter trials. In an open-label comparative trial a total of 219 postmenopausal women were randomized to the estradiol-releasing vaginal ring or to estriol suppositories. In terms of efficacy both treatment arms were shown to be equivalent; however, significantly higher rates of acceptability were found for the vaginal ring. In a double-blinded placebo-controlled study a total of 84 patients were randomized to either treatment arm for a period of 24 weeks. The statistically significant improvement of the vaginal epithelial pH and maturation values demonstrated the efficacy of the estradiol-releasing vaginal ring compared to the placebo ring. To determine if the efficacy of continuous low dose estradiol released from a vaginal ring is equivalent to estriol vaginal cream regarding improvement of the patient's subjective feeling of vaginal dryness and to determine if there is a preference for either of the two study treatments.
                Open-label randomized parallel group trial with active control with a blind evaluation of vaginal cytology and with a cross-over (change-over) phase for preference comparison. One hundred and sixty five postmenopausal women with symptoms of vaginal dryness and signs of vaginal atrophy were randomized to an estradiol ring (Estring) or estriol cream (Synapause). The duration of each treatment period was 12 weeks.
                Both study treatments were equally effective regarding the ability to alleviate the symptom feeling of vaginal dryness and the signs of vaginal atrophy. Both treatments were efficient in restoring the vaginal mucosa, recorded as higher maturation values and as decreased vaginal pH. Estring was superior to estriol cream regarding preference of treatment. Both treatments were equivalent for the occurrence of adverse events, including bleeding.
                data from this change-over study confirm efficacy and safety of both the vaginal ring and cream in the treatment of postmenopausal women with urogenital atrophy symptoms and signs. The patients had a strong preference for the vaginal ring. To assess the efficacy and safety of intravaginal estriol administration on urinary incontinence, urogenital atrophy, and recurrent urinary tract infections in postmenopausal women.
                Eighty-eight postmenopausal women with urogenital aging symptoms were enrolled in this prospective, randomized, placebo-controlled study. Participants were randomly divided into two groups, with each group consisting of 44 women. Women in the treatment group received intravaginal estriol ovules: 1 ovule (1 mg) once daily for 2 weeks and then 2 ovules once weekly for a total of 6 months as maintenance therapy. Women in the control group received inert placebo vaginal suppositories in a similar regimen. We evaluated urogenital symptomatology, urine cultures, colposcopic findings, urethral cytologic findings, urethral pressure profiles, and urethrocystometry before as well as after 6 months of treatment.
                After therapy, the symptoms and signs of urogenital atrophy significantly improved in the treatment group in comparison with the control group. Thirty (68%) of the treated participants, and only seven (16%) of the control participants registered a subjective improvement of their incontinence. In the treated participants, we observed significant improvements of colposcopic findings, and there were statistically significant increases in mean maximum urethral pressure, in mean urethral closure pressure as well as in the abdominal pressure transmission ratio to the proximal urethra. Urethrocystometry showed positive but not statistically significant modifications.
                Our results show that intravaginal administration of estriol may represent a satisfactory therapeutic choice for those postmenopausal women with urogenital tract disturbances who have contraindications or refuse to undergo standard hormone therapy. Determination of the efficacy and safety of vaginally administered low dose (25 microg) micronized 17beta-estradiol in the management of patients with urogenital symptoms.
                A total of 1612 patients with urogenital complaints were randomized to receive 25 microg of micronized 17beta-estradiol (n=828) or placebo (n=784) in a multicenter double-blind placebo-controlled study running for 12 months. Female patients were treated once a day over a period of 2 weeks, and then twice a week for the remaining of the 12 months with an active or placebo tablet. The assessment included full history-questionnaire, micturition diary, gynecologic and cystometric examination, transvaginal ultrasound, and serum 17beta-estradiol level determination. It was carried out at the beginning, and after 4 and 12 months of treatment.
                The overall success rate of micronized 17beta-estradiol and placebo on subjective and objective symptoms of postmenopausal women with vaginal atrophy was 85.5%, and 41.4%, respectively. A significant improvement of urinary atrophy symptoms was determined in vaginal ERT group as compared with the beginning of the study (51.9% vs. 15.5%, P=0.001). The maximal cystometric capacity (290 ml vs. 200 ml, P=0.023), the volume of the urinary bladder at which patients first felt urgency (180 vs. 140, P=0.048), and strong desire to void (170 ml vs. 130 ml, P=0.045) were significantly increased subsequent to the micronized 17beta-estradiol treatment. The number of patients with uninhibited bladder contractions significantly decreased following micronized 17beta-estradiol as compared with pretreatment values (17/30, P=0.013). Side effects were observed in 61 (7.8%) patients treated with low dose micronized 17beta-estradiol. Therapy with 25 microg of micronized 17beta-estradiol did not raise serum estrogen level nor stimulated endometrial growth.
                Local administration of 25 microg of micronized 17beta-estradiol is an effective and a safe treatment option in the management of women with urogenital complaints. In a double-blind, placebo-controlled study, 109 patients suffering from local and vasomotor postmenopausal complaints were randomly assigned to treatment with either depot vaginal suppositories containing 3.5 mg oestriol (E3) or a placebo. The treatment schedule comprised one vaginal suppository twice weekly for 3 weeks initially, followed by maintenance therapy with one vaginal suppository weekly for the 6-month study period. The effectiveness of the therapy was assessed on the basis of questionnaires (Kupperman index for vasomotor complaints and an original urogenital index for local complaints) and gynaecological examinations which included assessments of vaginal cytology, vaginal pH and Döderlein bacilli. To rule out induced endometrial proliferation, endometrial biopsies were performed in 50 women before and after the study. The vaginal depot (E3) formulation showed highly significant superiority over the placebo with respect to therapeutic effect on local urogenital complaints and alleviation of vasomotor complaints, including hot flushes. Analysis of the endometrial biopsies indicated that the monotherapy used caused no endometrial stimulation. Taking into account the minimal rate of adverse effects, the 3.5 mg E3 depot formulation studied represents a useful variant in the range of preparations available for the treatment of post-menopausal complaints. To compare the safety, efficacy and acceptability of a continuous low dose oestradiol releasing vaginal ring with conjugated equine oestrogen vaginal cream in the treatment of postmenopausal urogenital atrophy.
                An open, parallel, comparative multicentre trial.
                Sydney and Melbourne, Australia.
                One hundred and ninety-four postmenopausal women with symptoms and signs of urogenital atrophy were randomised on a 2:1 basis to 12 weeks of treatment with an oestrogen vaginal ring versus an oestrogen cream.
                Equivalence (95% CI) was demonstrated between the two treatments for relief of vaginal dryness and dyspareunia, resolution of atrophic signs, improvement in vaginal mucosal maturation indices and reduction in vaginal pH. No significant difference was demonstrated in endometrial response to a progestogen challenge test and equivalence was demonstrated in the incidence of intercurrent bleeding episodes. The vaginal ring was significantly more acceptable than the cream P < 0.0001), and was preferred to the cream (P < 0.001).
                With equivalent efficacy and safety and superior acceptability to vaginal cream, the low dose oestradiol vaginal ring is an advance in vaginal delivery systems for the treatment of urogenital atrophy.
Creams, pessaries, tablets and the oestradiol vaginal ring appeared to be equally effective for the symptoms of vaginal atrophy. One trial found significant side effects following cream (conjugated equine oestrogen) administration when compared to tablets causing uterine bleeding, breast pain and perineal pain. Another trial found significant endometrial overstimulation following use of the cream (conjugated equine oestrogen) when compared to the ring. As a treatment choice women appeared to favour the oestradiol-releasing vaginal ring for ease of use, comfort of product and overall satisfaction.