Comparison of a transdermal contraceptive patch vs. oral contraceptives on hemostasis variables. Efficacy, acceptability and tolerability of the combined contraceptive ring, NuvaRing, compared with an oral contraceptive containing 30 microg of ethinyl estradiol and 3 mg of drospirenone. A comparison between the vaginal ring and oral contraceptives. Transdermal contraception: evaluation of three transdermal norelgestromin/ethinyl estradiol doses in a randomized, multicenter, dose-response study. Combined contraceptive ring versus combined oral contraceptive (30-μg ethinylestradiol and 3-mg drospirenone). Adolescent and young women's experience with the vaginal ring and oral contraceptive pills. Comparison profiles of cycle control, side effects and sexual satisfaction of three hormonal contraceptives. Contraceptive vaginal ring use for women has less adverse metabolic effects than an oral contraceptive. Bleeding patterns after immediate initiation of an oral compared with a vaginal hormonal contraceptive. Efficacy and safety of a contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive: a 1-year randomized trial. Contraceptive efficacy, compliance and beyond: factors related to satisfaction with once-weekly transdermal compared with oral contraception. Comparison of cycle control and side effects between transdermal contraceptive patch and an oral contraceptive in women older than 35 years. Comparative effects of a contraceptive vaginal ring delivering a nonandrogenic progestin and continuous ethinyl estradiol and a combined oral contraceptive containing levonorgestrel on hemostasis variables. Evaluation of contraceptive efficacy and cycle control of a transdermal contraceptive patch vs an oral contraceptive: a randomized controlled trial. Effects of two types of hormonal contraception--oral versus intravaginal--on the sexual life of women and their partners. Adherence and acceptability of the contraceptive ring compared with the pill among students: a randomized controlled trial. A comparative study on the effects of a contraceptive vaginal ring NuvaRing and an oral contraceptive on carbohydrate metabolism and adrenal and thyroid function.
The aim of this study was to compare effects of the transdermal contraceptive patch, a desogestrel/ethinyl estradiol (EE)-containing, monophasic combination oral contraceptive (COC) and a levonorgestrel/EE-containing, triphasic COC on hemostasis variables.
                This was a randomized, open-label study of 104 young women who received six cycles of treatment. Blood was collected at baseline and on treatment; changes by Day 20/Cycle 6 in baseline hemostasis markers [prothrombin fragment 1+2 (F 1+2), plasmin-plasmin inhibitor complex (PAP) and fibrin degradation products (D-dimer)] were assessed.
                All contraceptives induced similar increases in F 1+2 and D-dimer. Patch-induced PAP increases were less than with the monophasic and similar to the triphasic COC. Decreases in protein S and increases in sex hormone-binding globulin were greater with the patch than with either COC. Patch-induced increases in activated protein C resistance were greater than with the triphasic and similar to the monophasic COC.
                These contraceptives appeared to accelerate baseline procoagulation processes to a similar extent and to change coagulation potency variables differently. This randomized multicenter, open-label, trial compared efficacy, acceptability, tolerability and compliance of NuvaRing with a combined oral contraceptive (COC), containing 30 microg of ethinyl estradiol (EE) and 3 mg of drospirenone.
                In this 13-cycle study, 983 women were randomized and treated (intent-to-treat population) with NuvaRing or COC.
                One in-treatment pregnancy occurred with NuvaRing (Pearl Index=0.25) (95% confidence interval [CI]: 0.006, 1.363) and four with the COC (Pearl Index=0.99) (95% CI: 0.269, 2.530). For both groups, compliance (89.2% NuvaRing, 85.5% COC) and satisfaction (84% NuvaRing; 87% COC) were high; the vast majority of women found NuvaRing easy to insert (96%) and remove (97%). Tolerability was similar; the most frequent adverse events with NuvaRing were related to ring use, whereas estrogen-related events were more common with the COC.
                NuvaRing has comparable efficacy and tolerability to a COC containing 30 microg of EE and 3 mg drospirenone. User acceptability of both methods was high. To investigate whether contraceptive vaginal ring use results in similar estimated genital symptoms, signs, examination, and laboratory findings compared with oral contraceptive use.
                Women were randomly assigned to either contraceptive vaginal ring or a 20 microg ethinyl estradiol oral contraceptive pill use for 3 consecutive 28-day cycles, directly followed by 3 cycles of the study drug not initially assigned. Subjects scored genital symptoms on a daily diary using a 0-4 scale and underwent a baseline, cycle 2, cycle 4, and exit pelvic examination including vaginal discharge evaluation, vaginal Gram stain and white cell count, and culture for yeast and Lactobacillus, including colony count and hydrogen peroxide production.
                Of the 40 subjects assigned to each arm, 33 (82.5%) subjects in the ring-first arm and 31 (77.5%) subjects in the pill-first arm completed all study visits (P =.58). Most subjects reported few genital symptoms with either method, but 63% of subjects reported vaginal wetness during ring use compared with 43% during pill use. During ring use larger numbers of Lactobacillus colonies present were positive for hydrogen peroxide production (fold difference 2.67, 95% confidence interval 1.49, 4.78, P <.001). All other laboratory data, including yeast colony counts, Nugent Gram stain score, vaginal white blood cell count, vaginal pH, and discharge weight, were not significantly different by method.
                Some women may notice an increase in vaginal wetness during contraceptive ring use yet the method is well tolerated and appears to improve the vaginal flora. The objective of this study was to identify the dose for a contraceptive patch that provides a predetermined level of ovulation suppression and cycle control and that is well tolerated.
                In this randomized study, 610 subjects received 10-, 15-, or 20-cm(2) patch dose sizes (20-cm(2), Ortho Evra/Evra) (Janssen Pharmaceutica, NV Belgium) or Ortho-Cyclen/Cilest (Janssen Pharmaceutica, NV Belgium) for up to 4 cycles. As with Ortho-Cyclen, patch regimens included 21 dosing days (3 consecutive 7-day patches) followed by 1 dose-free week.
                The patch regimens demonstrated a dose-response for ovulation suppression and cycle control. Presumed ovulation, determined on the basis of serum progesterone concentrations > or = 3 ng/mL in cycles 1 and 3, occurred in 6.2% (Ortho Evra) and 7.2% (Ortho-Cyclen) of subjects. At cycle 3, breakthrough bleeding/spotting was reported by 10.5% and 15.0% of subjects, respectively. Compliance with each patch was superior to that with Ortho-Cyclen (all P <.001). All regimens had safety profiles typical of oral contraceptives.
                The 20-cm(2) patch (Ortho Evra) provided ovulation suppression, cycle control, and safety similar to that of Ortho-Cyclen, with significantly better compliance. To compare the adverse effects, cycle control, and metabolic effects of NuvaRing and a combined oral contraceptive (COC).
                Women seeking contraception received NuvaRing (n = 300) or a COC (n = 300) for 12 cycles in a randomized, open-label trial.
                The total number of women with adverse effects did not differ significantly between the 2 groups. Leucorrhea, vaginitis, decreased libido, and ring-related problems were more common with NuvaRing, whereas weight increase, acne, and emotional lability were more common with the COC. Breakthrough bleeding occurred in 11.3% of women receiving NuvaRing and in 14.7% of women receiving the COC; 2.1% and 2.9% of women, respectively, had no withdrawal bleeding. Differences in blood pressure, blood sugar levels, lipid profile, liver enzyme activity, and anticoagulant activity were not statistically significant, with the exception of low-density lipoprotein levels measured at 6 and 12 months, which were significantly lower in the NuvaRing group than in the COC group.
                NuvaRing is a good alternative to a COC. It is associated with a slightly reduced incidence of breakthrough bleeding and there were no clinically relevant adverse effects or changes in blood pressure, blood sugar levels, lipid profile, or anticoagulant activity when compared with the COC.
                Copyright © 2011 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. To compare acceptability of the vaginal contraceptive ring to that of oral contraceptive pills.
                Randomized, cross-over, 6-month study.
                Urban family planning clinic for young low-income patients.
                Sexually active females aged 15-21 years (n = 130).
                Participants were randomly assigned to use the vaginal ring or oral contraceptive pills for an initial study interval of three 28-day cycles, followed by three cycles of the alternate method.
                Participants completed surveys about method use, acceptability, and side effects at baseline, after three cycles, and after six cycles. We analyzed study data using ANOVA models for cross-over designs.
                We did not detect higher compliance with the ring as compared to oral contraceptive pills (P = 0.176), although overall approval of the ring was significantly higher on several items measured, including liked using method (P = 0.015), would recommend it to friends (P = 0.012), and not as hard to remember to use method correctly (P < or = 0.000). Participants were less worried about health risks while using the ring (P = 0.006), but reported that the ring was more likely to interfere with sex than the pill (P < or = 0.001) and that sex partners liked the pill (P = 0.034). Most women did not report bothersome side effects with either method.
                Adolescent and young women showed favorable acceptability of the vaginal contraceptive ring compared to oral contraceptive pills. The objective of this study was to compare cycle control, tolerability and sexual well-being with the use of three hormonal contraceptives.
                In this prospective randomized study, the effects of two combined oral contraceptives [20 microg of ethinylestradiol (EE)/100 microg of levonorgestrel and 15 microg of EE/60 microg of gestodene] were compared with those of the vaginal ring (15 microg of EE/120 microg of etonogestrel). One-year data from 280 women were obtained. We investigated the pattern of menstrual cycle and the incidence of weight gain, nausea, headache, breast tenderness, irritability, depression and vaginal dryness. Moreover, desire and sexual satisfaction were evaluated. Finally, the cumulative rate of discontinuation in the three groups was estimated.
                The analysis of adverse events revealed two crucial points for acceptability, compliance and continuation: poor cycle control and disturbance of sexual intercourse due to vaginal dryness and loss of desire. This study compared metabolic, hormonal and lipid profiles before and during use of a contraceptive vaginal ring (RING) releasing 15 mcg ethinyl estradiol (EE) and 120 mcg etonogestrel per day NuvaRing, Organon USA Inc., Roseland, NJ versus a low-dose oral contraceptive (PILL) containing 20 mcg EE and 100 mcg levonorgestrel daily (Aviane, Barr Pharmaceuticals Inc., Pomona, NY).
                Sixty-five women were randomized to either the RING or PILL treatment for five cycles. In the pretreatment cycle (Cycle Days 2-5) and during Weeks 2 and 3 of the fifth treatment cycle, a 75-g oral glucose tolerance test (OGTT) was performed. Baseline samples were used to evaluate basal hormonal, metabolic and lipid levels.
                Forty-two women completed the study. Basal insulin resistance (HOMA-IR) was slightly decreased, whereas a significant reduction in the insulin sensitivity index (IS(OGTT)) was found in women on PILL therapy compared to those in the RING group (p<.035). Pancreatic beta-cell function was not significantly altered with either treatment.
                The lower-dose, nonoral hormonal RING had a lesser impact on carbohydrate metabolism and greater reduction of free androgen and dehydroepiandrosterone sulfate levels than PILL treatment. This study compared 84-day bleeding patterns after immediate initiation of a triphasic oral contraceptive with a 25-mug daily dose of ethinyl estradiol (E2) compared with the contraceptive vaginal ring, which has a 15-mug daily dose of ethinyl E2.
                This was an open-label controlled trial. We randomly assigned 201 women to immediate start of a contraceptive pill or immediate start of the ring in a 1:1 allocation ratio. Our primary outcome was difference in mean bleeding-spotting days per woman according to treatment assignment. Secondary outcomes were differences in World Health Organization-defined menstrual indices, differences in perceived bleeding changes, and differences in bleeding according to cycle day at the start of method.
                The mean bleeding-spotting days in the 84-day reference period for all subjects was 19.2 days (17.0 days for ring users and 21.4 days for pill users, mean difference 4.4 days). Using the World Health Organization menstrual indices, the ring users experienced fewer days or episodes of bleeding-spotting and shorter intervals. Among ring users, no baseline characteristics were associated with bleeding outcomes. Older nulliparous pill users, however, reported more bleeding-spotting days. Significantly more ring users reported a decrease in duration of bleeding compared with pill users (P < .01). We found no significant differences in bleeding patterns based on analysis of cycle day at study enrollment.
                Our study shows advantageous bleeding patterns for subjects using the contraceptive vaginal ring. It also confirms our previous findings that immediate start of hormonal contraception is an acceptable alternative to waiting for menses.
                II-1. This open-label, randomized, Phase III study compared the efficacy and tolerability of and compliance with NuvaRing, a combined contraceptive vaginal ring releasing 15 microg of ethinylestradiol (EE) and 120 microg of etonogestrel daily, with those of and with a combined oral contraceptive (COC) containing 150 microg of levonorgestrel (LNG) and 30 microg of EE. Subjects received NuvaRing or a COC for 13 cycles (3 weeks of ring/pill treatment followed by a 1-week ring-/pill-free period). A total of 1030 subjects (NuvaRing, n=512; COC, n=518) was randomized and started treatment (intent-to-treat [ITT] population). The percentage of women in the ITT population who completed the trial was 70.9% for the NuvaRing group and 71.2% for the COC group. Five in-treatment pregnancies occurred in each group, giving Pearl indices of 1.23 for NuvaRing and 1.19 for the COC. Compliance with both treatments was excellent and both were well tolerated. In conclusion, NuvaRing has comparable efficacy and tolerability with a COC containing 150 microg of LNG and 30 microg of EE and does not require daily dosing. To investigate contraceptive efficacy, compliance and user's satisfaction with transdermal versus oral contraception (OC). Study design: Randomized, open-label, parallel-group trial conducted at 65 centers in Europe and South Africa. One thousand four hundred and eighty-nine women received a contraceptive patch (n = 846) or an OC (n = 643) for 6 or 13 cycles.
                Overall/method-failure Pearl Indices were 0.88/0.66 with the patch and 0.56/0.28 with the OC (p = n.s.). Compliance was higher at all age groups with the patch compared to the OC. Significantly more users were very satisfied with the contraceptive patch than with the OC. The percentage of patch users being very satisfied increased with age whereas it did not in the OC group. Likewise, improvements of premenstrual symptoms as well as emotional and physical well-being increased with age in the patch-group in contrast to the OC group. Ratings of satisfaction with the study medication correlated weakly with emotional (r = 0.33) and physical well-being (r = 0.39) as well as premenstrual symptoms (r = 0.30; p < 0.001).
                Contraceptive efficacy of the patch is comparable to OC, but compliance is consistently better at all age groups. Higher satisfaction with the patch at increasing age may be attributed to improvements in emotional and physical well-being as well as reduction of premenstrual symptoms. To compare menstrual patterns and side effects between transdermal contraceptive patch and oral contraceptive use in Thai women over 35 years old.
                Open labeled randomized control trial.
                Family Planning Clinic, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
                Ninety-six women above the age of 35 years old were randomized to receive either transdermal contraceptive patch (n = 48) or oral contraceptive (n = 48). The patch regimen was three consecutive 7-day patches (21 days) followed by 1 patch-free week per cycle; the oral contraceptive contained with ethinyl estradiol (EE) 30 microg and levonorgestrel 150 microg.
                There were no statistically significant differences between the two groups in terms of cycle length. The mean duration in the transdermal contraceptive group was longer than the COC group with statistically significant difference. More patients in the COC group experienced spotting than the transdermal contraceptive group. Neither amenorrhea nor pregnancies occurred in both groups.
                Transdermal contraceptive patch provides reliable contraceptive efficacy. It also provides good cycle control equal to COC in Thai women aged above 35 years old. However, a higher incidence of minor adverse effects such as breast tenderness and nausea were demonstrated when compared to oral contraceptive containing with ethinyl estradiol (EE) 30 microg and levonorgestrel 150 microg. This study aimed to compare the effects on hemostasis variables of a contraceptive vaginal ring with those of an oral contraceptive.
                Twenty-three and 22 healthy premenopausal women were randomized to the contraceptive vaginal ring (150 microg Nestorone and 15 microg ethinyl estradiol) or Stediril 30 during 3 cycles. Analysis of covariance was performed with baseline values as covariate.
                The contraceptive vaginal ring changed most hemostasis variables similarly but raised (95% confidence intervals of percent treatment differences) Factor VIIt (28% to 49%), extrinsic activated protein C resistance (14% to 65%), and sex hormone-binding globulin (117% to 210%) and lowered Protein S (-32% to -16%) and the global activated partial thromboplastin time-based activated protein C resistance (-12% to -2%) more than the oral contraceptive.
                The contraceptive vaginal ring affected some measured hemostasis variables and sex hormone-binding globulin differently from the oral contraceptive, most likely because of difference in androgenicity of the progestins. The results suggest that the contraindications for oral contraceptive use would also apply to the tested contraceptive vaginal ring. Oral contraceptive (OC) pills are effective, but poor compliance increases rates of pregnancy during treatment.
                To compare the contraceptive efficacy, cycle control, compliance, and safety of a transdermal contraceptive patch and an OC.
                Randomized, open-label, parallel-group trial conducted October 1997 to June 1999.
                Forty-five clinics in the United States and Canada.
                A total of 1417 healthy adult women of child-bearing potential.
                Participants were randomly assigned to receive a transdermal contraceptive patch (n = 812) vs an OC (n = 605) for 6 or 13 cycles. Patch treatment consisted of application of 3 consecutive 7-day patches followed by 1 patch-free week.
                Overall and method-failure Pearl Indexes (number of pregnancies/100 person-years of use) and life-table estimates of the probability of pregnancy were calculated. Cycle control, compliance, patch adhesion, and adverse events were also assessed.
                Overall and method-failure Pearl Indexes were numerically lower with the patch (1.24 and 0.99, respectively) vs the OC (2.18 and 1.25, respectively); this difference was not statistically significant (P =.57 and.80, respectively). The incidence of breakthrough bleeding and/or spotting was significantly higher only in the first 2 cycles in the patch group, but the incidence of breakthrough bleeding alone was comparable between treatments in all cycles. The mean proportion of participants' cycles with perfect compliance was 88.2% (811 total participants, 5141 total cycles) with the patch and 77.7% (605 total participants, 4134 total cycles) with the OC (P <.001). Only 1.8% (300/16 673) of patches completely detached. Both treatments were similarly well tolerated; however, application site reactions, breast discomfort, and dysmenorrhea were significantly more common in the patch group.
                The contraceptive patch is comparable to a combination OC in contraceptive efficacy and cycle control. Compliance was better with the weekly contraceptive patch than with the OC. Data relating to the influence of hormonal contraception on sexual life are conflicting and mostly they refer to oral contraceptives. In this randomized, controlled, prospective study we compared the effect of an intravaginal hormonal contraceptive with the effect of a combined oral contraceptive on sexual function.
                Fifty-one healthy women with a permanent partner and an active sexual life were randomly divided in two groups according to a computer-generated randomization list: 26 women (group A) used an intravaginal contraceptive releasing 120 microg/day of etonogestrel and 15 microg/day of ethinylestradiol (EE) and 25 women (group B) used an oral contraceptive containing 20 microg di EE and 150 microg of desogestrel. Twenty-five women participated in the study as control group (group C). A specific questionnaire was completed by the patients and their partners at the start of the study and after cycles 3 and 6 of contraceptive use.
                Within 3 months of contraceptive use, women from both groups A and B reported a global improvement in sexual function. A statistically significant increase in sexual fantasy was reported only by patients of group A. Whereas partners of the women in both groups A and B reported an improvement in sexual function after 3 months of contraceptive intake, only patients' partners of group A reported a significant increase in sexual interest, complicity and sexual fantasy.
                Both hormonal contraceptives tested were seen to have a positive effect on some aspects of sexual function. The intravaginal contraceptive ring seems to exert a further positive effect on the psychological aspect of both women and their partners, which is evident from an improved complicity and sexual satisfaction. To compare satisfaction with and adherence to the contraceptive vaginal ring and a daily low-dose oral contraceptive pill (OCP) among college and graduate students using a novel method of electronic data collection.
                We randomly assigned 273 women to the contraceptive vaginal ring (n=136) or OCP (n=137) for three consecutive menstrual cycles. Participants completed daily Internet-based, online diaries regarding method adherence and satisfaction during cycles of use. At 3 months, they completed an online survey regarding intention to continue their method and overall acceptability. At 6 months, we surveyed participants to see whether they continued using contraception and, if so, which method.
                Rates of loss to follow-up were similar between groups. Contraceptive vaginal ring users reported more perfect use in the first 2 months (P=.05). After the 3-month study period, 52 (43%) of 121 contraceptive vaginal ring users and 65 (52%) of 126 OCP users reported plans to continue their method (P=.16). However, at 6 months, only 31 (26%) of 117 contraceptive vaginal ring users and 36 (29%) of 123 OCP users had continued their assigned study method (P=.61). Almost 50% of both groups were using condoms or no method.
                Contraceptive vaginal ring users were more likely to report perfect use during the 3-month trial period than were OCP users. Despite randomization, participants were equally satisfied with their assigned hormonal contraceptive method. At 6 months, less than 30% of participants were still using their assigned method.
                ClinicalTrials.gov, www.clinicaltrials.gov, NCT00635570. To compare carbohydrate metabolism, adrenal and thyroid function during use of a combined contraceptive vaginal ring (NuvaRing, NV Organon, Oss, The Netherlands) with those of a combined oral contraceptive.
                Healthy women aged 18-40 years used either the vaginal ring, delivering 15 microg ethinylestradiol and 120 microg of etonogestrel per day, or a combined oral contraceptive containing 30 microg ethinylestradiol and 150 microg levonorgestrel, for six cycles. Each cycle comprised 3 weeks of use of the ring or the pill followed by 1 ring- or pill-free week. The following parameters were measured at baseline and at the end of cycles 3 and 6: carbohydrate metabolism (glucose, insulin, glycosylated hemoglobin); adrenal function (total cortisol, cortisol binding globulin, dehydroepiandrosterone sulfate); thyroid function (thyroid stimulating hormone, free thyroxine).
                Small and similar increases in insulin were seen in both groups. Concentrations of cortisol binding globulin and total cortisol rose significantly less during ring use than during combined oral contraceptive use (cycle 3, p= 0.0002; cycle 6, p < 0.0001). Levels of dehydroepiandrosterone sulfate did not change in either group. Thyroid stimulating hormone levels increased significantly more in the ring group at cycle 3 (p = 0.0016) but free thyroxine levels were unchanged in both groups.
                Both the vaginal ring and the oral contraceptive have no clinically relevant effects on carbohydrate metabolism, adrenal or thyroid function.
Effectiveness was not significantly different for the methods compared. Pregnancy data were available from half of the patch trials but two-thirds of ring trials. The patch could lead to more discontinuation than the COC. The patch group had better compliance than the COC group. Compliance data came from half of the patch studies and one-third of the ring trials. Patch users had more side effects than the COC group. Ring users generally had fewer adverse events than COC users but more vaginal irritation and discharge.
The quality of the evidence for this review was considered low for the patch and moderate for the ring. The main reasons for downgrading were lack of information on the randomization sequence generation or allocation concealment, the outcome assessment methods, high losses to follow up, and exclusions after randomization.