Angie Wheeless

Comparative crossover study of the PATH Woman's Condom and the FC Female Condom®

BACKGROUND Only one female condom [FC1 Female Condom (FC1)] is currently marketed, but it is poorly utilized, perhaps due to difficulty with insertion, discomfort and suboptimal functional performance during intercourse. The Program for Appropriate Technology in Health (PATH) Womans Condom (WC) was developed in an effort to overcome these obstacles. STUDY DESIGN This was a randomized crossover study to evaluate the functional performance, safety and acceptability of the FC1 and WC. Seventy-five couples were assigned to one of two condom use sequences (WC/FC1 or FC1/WC) at three centers. Four condoms of the first type were used by couples in four acts of intercourse at home over a 2-4-week period. After a follow-up visit, these procedures were repeated with the second assigned condom type. In a substudy of participants (n=25), a colposcopy was performed prior and subsequent to the first condom use of each of the two condom types. Condom performance was evaluated by calculating measures of function from questionnaires completed by the couple after each condom use. Safety was evaluated by reported urogenital symptoms with a given condom during or immediately following condom use and colposcopic signs of genital irritation in the substudy. Acceptability of each given condom type was measured by questionnaire. RESULTS Total condom failure (slippage, breakage, etc., divided by the number of female condoms opened) was 31% for the WC and 42% for the FC1. Total clinical failure (slippage, breakage, etc., divided by the number of female condoms used) was 17% for the WC and 24% for the FC1. The proportion of condom failures was 10.9 percentage points less, and the proportion of clinical failure 6.7 percentage points less, when couples used the WC compared to the FC1 [90% CI: -18.5 to -3.3 and -12.6 to -0.8, respectively). Fewer women reported symptoms of urogenital irritation when using the WC vs. the FC1 either overall or when analyzing each use of the condom [woman as unit: -20 percentage points (90% CI: -30.5 to -9.3); condom use as unit: -12.3 percentage points (90% CI: -18.0 to -6.7)]. A similar result was seen for signs of urogenital irritation [woman as unit: -20 percentage points (90% CI: -42.7 to 4.8)]. Among participants with a preference, WC was preferred over the FC1 by twice as many males and by 2.6 times as many females. CONCLUSIONS While both female condoms were safe and acceptable in short-term use, the PATH Womans Condom leads to less failure, was associated with fewer adverse events, and was more acceptable than the FC1 Female Condom.

Retrospective vs. prospective coital frequency and menstrual cycle length in a contraceptive effectiveness trial.

PURPOSE To determine how well information at enrollment would predict coital frequency and menstrual segment length during a prospective contraceptive effectiveness trial. METHODS We compared retrospective reports of monthly coital frequency and menstrual segment (cycle) length with prospective information for women participating in a contraceptive trial of the Reality((R)) female condom. RESULTS Participants reported slightly higher mean monthly coital frequency and slightly longer menstrual segments prior to the study than during the study (12.6 acts vs. 12.0 acts per month and 30.8 days vs. 28.4 days). We examined the actual distribution of differences between the retrospective and prospective measures and found considerable variability. Among the 195 participants studied, parous women were less likely to predict accurately menstrual segment length (OR 0.4; 95% CI 0.3--0.9), while older women were more likely to predict accurately coital frequency (OR 1.9; 95% CI 0.9--3.3). CONCLUSIONS Coital frequency and menstrual segment length vary considerably over time. Hence, prospective data collection is essential to accurately characterize these variations and to properly interpret results from contraceptive trials and other studies concerned with fecundability and hazards of reproduction.

Safety evaluation of 1% tenofovir gel in healthy men.

This study was conducted to determine the safety of tenofovir (TFV) gel, a potential microbicide, following seven consecutive daily penile applications. Eighteen circumcised and 18 uncircumcised healthy men were randomly assigned to TFV gel versus K-Y® Jelly in a 2:1 ratio within circumcision group. TFV gel or K-Y Jelly was applied onto the penis at bedtime and washed off 6–10 hours later. Safety was assessed by reported symptoms, findings and laboratory tests. Three of 24 (13%) men in the TFV group reported mild genital symptoms compared with two of 11 (18%) men in the K-Y group. Few mild genital findings were observed and no significant systemic toxicities were reported or observed. TFV gel applied to the penis for seven days was well tolerated locally and systemically and it is unlikely that male partners exposed to small amounts of TFV gel will experience significant genital or systemic toxicity.

Performance of Sino-implant (II) in routine service delivery in Madagascar

BACKGROUND Sino-implant (II) is a low-cost subdermal contraceptive implant containing levonorgestrel that is currently labeled for 4 years of use. Widely used in China and Indonesia, it has been little studied elsewhere. We conducted a prospective study of Sino-implant (II) use by women in Madagascar. METHODS We enrolled a total of 621 women 18 or older who had Sino-implant (II) inserted on day of enrollment, some in fixed clinical sites, and some at outreach sites. Half of the women were scheduled for follow-up visits at 3 months and at 12 months postinsertion (active follow-up cohort); the other half were advised to return if they desired care for any problem, thought they were pregnant or wanted the implants removed (passive surveillance cohort). RESULTS No insertion complications were reported. A total of 384 women returned for an earlier visit, and 351 returned for a later visit, for a total of 419 woman-years of observation. No postinsertion pregnancies or serious adverse events were observed. Twenty-eight implant removals were reported by 12 months, a cumulative removal probability of 7.3 per 100 women. Acceptability of the implants was very high, as was satisfaction with clinic services. CONCLUSIONS This is the first report on the performance of Sino-implant (II) from outside China and Indonesia and among the first in the English-language literature. These initial data from Madagascar indicate a favorable level of safety, effectiveness and acceptability during the first year of use.

How well do male latex condoms work? Pregnancy outcome during one menstrual cycle of use

To evaluate the contraceptive effectiveness of male latex condoms, we assembled a cohort of 300 women relying on male latex condoms for contraception and followed them prospectively for one menstrual cycle. None of the 234 women who completed the study and reported at least one act of intercourse conceived (one cycle pregnancy rate 0%; 95% CI 0%--2%). Given the pattern of intercourse during the cycle and 3 different sets of conception probabilities for different days of the cycle, we would have expected between 32 and 36 pregnancies if no condoms had been used. Thus, the prevented fraction due to condom use (effectiveness) is 100% and the lower bounds of the 95% CI are between 89% and 90%. For this cohort, male latex condoms were an effective method of contraception. This cost-efficient approach of evaluating contraceptive effectiveness shows promise for post-marketing studies.

Influence of cycle variability and coital frequency on the risk of pregnancy

Researchers have cautioned against generalizing results from contraceptive trials because these studies rely on self-selected participants meeting strict selection criteria who may differ from typical users. Using information collected on daily diaries, we reanalyzed data from the recently completed Reality female condom clinical trial to evaluate factors that influence the probability of pregnancy. Noncompliant women, women with less variable menstrual cycles (17-43 days), and women engaging in intercourse frequently (> or = 11 acts per month) were more likely to conceive during this 6-month trial. The adjusted hazard ratios and 95% confidence intervals for these three covariates were 6.1 (2.0-18.7), 7.2 (1.0-54.3), and 2.0 (0.7-5.3), respectively. The strict selection criteria used in this study failed to recruit a homogeneous cohort with respect to factors that influence the risk of pregnancy. The overall pregnancy rate does not pertain to individual study participants, but rather represent average effects for a population with the particular mix of characteristics found in this study. In particular, we not only confirm the well known importance of compliance and the obvious role of frequency of intercourse, but also demonstrate that women with cycles outside the range of 17-43 days appear to be at a much lower risk of pregnancy.

Pelvic surgery and hospitalization among Chilean women after nonsurgical sterilization with quinacrine pellets between 1977 and 1989.

BACKGROUND Concern about quinacrine lingers because of its carcinogenic effects in rats. We describe results of long-term follow-up of women who underwent quinacrine pellet sterilization in Chile between 1977 and 1989 (N=1492). METHODS We interviewed the women or relatives in five rounds of data collection between 1991-1993 and 2006-2007, and reviewed hospital records. Median follow-up was 18.5 years; total person-time was 23,894 woman-years. This analysis focuses on pelvic and abdominal surgeries and conditions. We used survival analysis to estimate the 15-year cumulative probability of hysterectomy, other pelvic surgical procedures and relevant adverse events. RESULTS Uterine fibroids were by far the most common gynecologic condition, reported by 11% of the cohort. Surgical procedures were recorded for 15% of the cohort; hysterectomy was the most frequent procedure (10%), followed by salpingectomy (2%). The 15-year probability of any pelvic or abdominal procedure was 14.7 per 100 women (95% confidence interval 12.4-16.9). The probability of hysterectomy was 9.3 per 100 women (95% confidence interval 7.4-11.1). Number of quinacrine insertions had little impact on the probabilities. CONCLUSION During long-term follow-up of women who received quinacrine pellets for nonsurgical sterilization, the incidence of noncancer adverse outcomes was not unusually high, and no alarming patterns emerged.