Comparison of self-reported female condom failure and biomarker-confirmed semen exposure.

OBJECTIVE: To investigate whether rates of self-reported Woman's Condom (WC) clinical failure and semen exposure from a functionality study are comparable to results from a contraceptive efficacy substudy. STUDY DESIGN: We structured our comparative analysis to assess whether functionality studies might credibly supplant contraceptive efficacy studies when evaluating new female condom products. Couples not at risk of pregnancy in the functionality (breakage/slippage/invagination/penile misdirection) study and women in the contraceptive efficacy study completed condom self-reports and collected precoital and postcoital vaginal samples for up to four uses of the WC. Both studies used nearly identical self-report questions and the same self-sampling procedures and laboratory for prostatic specific antigen (PSA), a well-studied semen biomarker. We compared condom failure and semen exposure proportions using generalized estimating equations methods accounting for within-couple correlation. RESULTS: Ninety-five (95) efficacy substudy participants used 334 WC and 408 functionality participants used 1572 WC. Based on self-report, 19.2% WC (64 condoms) clinically failed in the efficacy substudy compared to 12.3% WC (194 condoms) in the functionality study (p=.03). Of the 207 WC efficacy uses with evaluable postcoital PSA levels, 14.5% (30 uses) resulted in semen exposure compared to 14.2% (184 uses) of the 1293 evaluable WC functionality study uses. CONCLUSIONS: When evaluating the ability of an experimental condom to prevent semen exposure, the rate of clinical condom failure reported by participants risking pregnancy in an efficacy substudy was significantly higher than the rate reported by participants not risking pregnancy in a functionality study. The rate of semen exposure, assessed by an objective biomarker was nearly identical for the two studies. IMPLICATIONS: Our results suggest that an objective marker of semen exposure in functionality studies could provide a reasonable alternative to contraceptive efficacy studies in evaluating risk of unintended pregnancy and inferring protection from sexually transmitted infection than condom failure rates based on self-report.

Contraceptive efficacy, acceptability, and safety of C31G and nonoxynol-9 spermicidal gels: a randomized controlled trial.

OBJECTIVE: To estimate whether a gel containing the spermicide C31G was noninferior to a commercially available product containing nonoxynol-9. METHODS: Participants were healthy, sexually active women aged 18-40 years. Measured outcomes included pregnancy rates, continuation rates, adverse events, and acceptability. The primary study outcome was contraceptive efficacy. Sample size was calculated at a 2.5% significance level using a one-sided test based on assumed 6-month pregnancy probability of 15% in the nonoxynol-9 group. Sample size was sufficient to reject, with 80% power, the null hypothesis that pregnancy probability in the C31G arm would be more than 5% higher. RESULTS: Nine hundred thirty-two women were randomized in the C31G group and 633 in the nonoxynol-9 group. For randomized patients with at least one episode of coitus (modified intent-to-treat group), 6-month pregnancy probabilities were 12.0% (95% confidence interval [CI] 9.3-14.7%) and 12.0% (95% CI 8.7-15.3%) for C31G and nonoxynol-9,respectively. Twelve-month pregnancy probabilities were 13.8% (95% CI 7.6-20%) for C31G and 19.8% (95% CI 10.9-28.7%) for nonoxynol-9. Two serious adverse events were deemed possibly related to study product and neither occurred in the C31G group. Three fourths of users in either group reported that they liked their assigned study product. Approximately 40% of patients discontinued prematurely for reasons other than pregnancy with 11% lost to follow-up. CONCLUSION: C31G demonstrated noninferior contraceptive efficacy compared with nonoxynol-9. C31G may provide another marketable option for women seeking spermicidal contraception. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.ClinicalTrials.gov, NCT00274261.

The levonorgestrel two-rod implant for long-acting contraception: 10 years of clinical experience.

OBJECTIVE: To estimate the effectiveness, side effects, and retention rate of the levonorgestrel two-rod implant used as a long-acting contraceptive. METHODS: Voluntary participants, ages 18-40 years and desiring long-acting contraception, were enrolled in the study. The original design was to observe the participants for 5 years. Later, the follow-up period was extended to 6 years. RESULTS: A total of 249 women underwent two-rod implant insertion and were observed for a total of 823 woman-years. There were two pregnancies observed during the study, yielding a pregnancy rate of 0.24 per 100 woman-years. One pregnancy occurred in the first month, and the other occurred after 6 years of use. The major side effect was menstrual irregularity. No serious side effects were observed during the study. Insertion of the device was easy and took less than 2 minutes; removal time averaged 4.5 minutes. CONCLUSION: The levonorgestrel two-rod implant system is an effective, convenient, long-acting, and well-tolerated method of contraception.

Factors influencing the detection of uterine cancer by suction curettage and endometrial brushing.

OBJECTIVE: To analyze the factors that influence the detection of uterine cancers by Pipelle and Tao Brush endometrial sampling devices. STUDY DESIGN: Seventy-nine Pipelle currettages were followed by Tao Brush sampling. The curettage specimens were fixed in formalin for histology and reported by surgical pathology, whereas the Tao Brush specimens were fixed in CytoRich Red for histology and cytology and reported by cytopathology. Uterine size and features of residual tumors were obtained from hysterectomy reports. Follow-up for clinically benign cases ranged from 16 to 52 months (mean, 33.7; median, 34). RESULTS: There were 10 uterine cancers and 9 hysterectomies. Five cases of centrally located adenocarcinoma, ranging from 0.4 to 3 cm, were detected by both samplers. Additionally, a Tao Brush sampled an adenocarcinoma located near the cornu. An endometrial stromal sarcoma found with a Tao Brush was reported as necrotic tissue by Pipelle. Both samplers missed a microscopic focus of adenocarcinoma, an in situ adenocarcinoma in a polyp and a large leiomyosarcoma. CONCLUSION: The size and type of tumor and its location within the uterine cavity, the mechanism of sampling and preparation method influence the detection of uterine cancer by the Pipelle and Tao Brush.