Evaluation of contraceptive efficacy and cycle control of a transdermal contraceptive patch vs an oral contraceptive: a randomized controlled trial. Contraceptive efficacy, compliance and beyond: factors related to satisfaction with once-weekly transdermal compared with oral contraception. Adherence and acceptability of the contraceptive ring compared with the pill among students: a randomized controlled trial. Efficacy and safety of a contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive: a 1-year randomized trial. Prospective randomized trial of polyglactin 910 mesh to prevent recurrence of cystoceles and rectoceles. A comparative study of two low-dose combined oral contraceptives: results from a multicenter trial. Combined contraceptive ring versus combined oral contraceptive (30-μg ethinylestradiol and 3-mg drospirenone). Comparison of a transdermal contraceptive patch vs. oral contraceptives on hemostasis variables. Laparoscopic Burch colposuspension: a randomized controlled trial comparing two transperitoneal surgical techniques. Comparison of cycle control and side effects between transdermal contraceptive patch and an oral contraceptive in women older than 35 years. 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. 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. Extended regimens of the contraceptive vaginal ring: a randomized trial. A randomised-controlled pilot study using nicotine patches with pregnant women. Adolescent and young women's experience with the vaginal ring and oral contraceptive pills. Efficacy and safety of topical application of human fibrinogen/thrombin-coated collagen patch (TachoComb) for treatment of air leakage after standard lobectomy. Contraceptive vaginal ring use for women has less adverse metabolic effects than an oral contraceptive.
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. 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 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. 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. Our aim was to evaluate the efficacy of polyglactin 910 mesh in preventing recurrent cystoceles and rectoceles.
                In a prospective, randomized, controlled trial, patients undergoing vaginal reconstructive surgery with cystoceles to the hymenal ring and beyond were randomly selected to undergo anterior and posterior colporrhaphy with or without polyglactin 910 mesh reinforcement. Results were evaluated preoperatively and at 2, 6, 12, and 52 weeks postoperatively.
                A total of 161 women were randomly selected for this study. One woman was excluded at the time of surgery, and 17 women were lost to follow-up. Eighty women received mesh, and 80 did not. Both groups were found to be equivalent with respect to age, parity, concomitant surgery, and menopausal and hormone replacement status. Preoperatively 49 women had a central cystocele to the hymenal ring and 111 women had cystoceles beyond the introitus; 91 women had a rectocele to the mid-vaginal plane, 31 to the hymenal ring, and 22 beyond the introitus. After 1 year, 30 (43%) of 70 subjects without mesh and 18 (25%) of 73 subjects with mesh had recurrent cystoceles beyond the mid-vaginal plane (P =.02). Eight women without mesh and 2 women with mesh had recurrent cystoceles to the hymenal ring (P =.04). No recurrent cystoceles beyond the hymenal ring occurred in either group. Multivariate logistic regression analysis showed concurrent slings to be associated with significantly fewer recurrent cystoceles (odds ratio, 0.32; P =.005), whereas the presence of mesh remained significantly predictive of fewer cystocele recurrences in this analysis. Thirteen recurrent rectoceles were noted 1 year postoperatively, with no differences between groups.
                Polyglactin 910 mesh was found to be useful in the prevention of recurrent cystoceles. A comparative multicenter clinical trial of two low-dose combined oral contraceptives (OCs) was conducted in Malaysia, Egypt, Thailand, and Mexico. Efficacy, safety and acceptability were investigated in women taking either a norgestrel-based (NG) OC or a norethindrone acetate-based (NA) OC. This paper includes analysis of 892 women, all of whom were at least 42 days but within 26 weeks postpartum and randomly allocated to one of the above OCs. Follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. Baseline sociodemographic characteristics were similar for both groups, as well as compliance. There were nine unintended pregnancies reported; eight of these occurring in the NA group. Adverse experiences were minor with headaches and dizziness being the most common complaints; frequency of reports was similar in both groups. The group taking the NG-based OC had significantly (p < .05) fewer menstrual-related complaints. Discontinuations due to menstrual problems were significantly more common among NA users (primarily amenorrhea). Discontinuations in the NG group were primarily for other personal reasons, e.g. unable to return to the clinic. There was also a significant difference between the two groups for the 11-month gross cumulative life table discontinuation rates due to menstrual problems (p < .01); the NA group had the higher rate. 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. 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. To compare the effectiveness of two transperitoneal laparoscopic Burch procedures.
                The sample size required was 30 subjects per group to detect a statistically significant estimated difference of 15% between two surgical procedures with an alpha = 0.05 and a power of 0.7. Sixty women affected by genuine stress incontinence (GSI) were enrolled and randomly assigned to two groups of 30 women each. All women were treated with the transperitoneal laparoscopic Burch procedure using nonabsorbable sutures (group A) or Prolene mesh (Ethicon, Somerville, NJ) fixed with tacks or staples (group B). The failure rate was defined subjectively and objectively. The subjective evaluation was performed by asking the women to rate their urine loss on a visual analog scale. The objective evaluation was a clinical evaluation using multichannel urodynamic studies.
                The subjective failure rate was not significantly different between the two groups at 3 months (0% for both groups), 6 months (3.7% versus 3.8% for groups A and B, respectively), and 12 months (7.4% versus 15.4% for groups A and B, respectively) after surgery. At 3 months (3.7% versus 3.8% for groups A and B, respectively) and 6 months (7.4% versus 15.4% for groups A and B, respectively) follow-up, the objective failure rate was not significantly different between the two groups. However, at 12 months after the surgical procedure, the objective failure rate was significantly lower in group A than in group B (11.1% versus 26.9%, respectively; P <.05).
                Transperitoneal laparoscopic Burch colposuspension performed using sutures was more effective than the mesh technique. 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 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. 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. To compare the bleeding patterns and tolerability of 3 different extended ring regimens with those of the standard 28-day cycle with 21 days of contraceptive vaginal ring use followed by 7 ring-free days.
                Following a run-in 28-day ring cycle, women were randomized to 1 of 4 regimens: monthly (28-day cycle), every other month (49-day cycle), every third month (91-day cycle), or continuous (364-day cycle). Treatment duration was 1 year. Daily bleeding diary, interval visit questionnaire, and examination data were collected.
                A total of 561 women were enrolled, 429 were subsequently randomized, and 289 (67.4%) women completed the entire year. All schedules were well tolerated and acceptable to women, but study completion rates were higher for the shorter cycles. Bleeding days were reduced with postponement of the withdrawal bleeding (ring-free) week, but spotting days increased. For example, women using the continuous or 364-day ring cycle reported a median of zero bleeding days but 10-12 days of spotting during the first 3 months of extended use. Unscheduled bleeding during ring use was the lowest with the traditional 28-day cycle. Adverse events, blood pressure, body weight, and laboratory findings were comparable over the 4 treatment groups.
                The combination vaginal contraceptive ring can be used for extended cycles to alter the bleeding schedule. Women willing to tolerate some spotting might choose the longer extensions to have fewer menstrual periods.
                I. Stopping smoking in pregnancy is a public health priority and a clinical imperative. However, many women who have not been able to 'quit' in early pregnancy find it very difficult to do so. This randomised-controlled pilot study examined feasibility issues in offering free nicotine patches with counselling to a group of 20 mid-trimester pregnant women at the Women's and Children's Hospital, Adelaide. A further 20 were offered counselling only. Smoking status at each visit was measured by self-report, carbon monoxide monitoring, and salivary cotinine. The most common pattern (eleven of the twenty women) was intermittent patch use. Only five women used patches continuously up to the 12 week maximum available. Three women in the patch group were abstinent at delivery compared with none in the control group. Notable features of the study were the low interest in participation and the high withdrawal rate. Nicotine patches may not be highly useful for pregnant women. Continuing tobacco control measures and customized support for women and their partners, often smokers, may prove more fruitful. 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. Persisting air leakage after pulmonary resection remains a significant problem. The aim of the study was to evaluate the incidence of air leakage after standard lobectomy and test the efficacy and safety of TachoComb (TC).
                A total of 189 patients undergoing lobectomy were enrolled in a multi-centre, open, randomised, and prospective study to test the efficacy and safety of TachoComb (TC) for air leakage treatment. Air leakage was assessed by water submersion test, and scored as grades 0 if no, 1 if countable, 2 if a stream of and 3 if coalescent bubbles have been observed. Any sites with grade 3 air leakage received further stapling or limited suturing until grade 0, 1 or 2 was obtained. Treatment of air leakage was done with TC or suturing according to randomisation. Air leakage was assessed by further submersion tests. Postoperative air leakage was assessed using the Pleur-Evac system.
                Overall incidence of air leakage 48+/-6 h after surgery was 34% for TC and 37% for standard treatment (P=0.76). The reduction of intra-operative air leak intensity in the subgroup with grades 1-2 was significantly higher for the TC group (P=0.015). Postoperative air leakage intensity in the subgroup with air leakage grades 1-2 was lower for TC than standard treatment (P=0.047). The mean duration of postoperative air leakage in the subgroup with grades 1-2 was shorter for the TC group than for standard treatment, i.e. 1.9+/-1.4 vs. 2.7+/-2.2 days (P=0.015).
                TC could be proven as well-tolerated and safe. In the subgroup of patients with established air leakage, TC showed superior potential in reduction of intra-operative air leakage as well as in reduction of intensity and duration of postoperative air leakage. 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.
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.