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.

Magnetic resonance imaging (MRI) of hormone-induced breast changes in young premenopausal women.

Objectives: We conducted a pilot study to identify whether MRI parameters are sensitive to hormone-induced changes in the breast during the natural menstrual cycle and whether changes could also be observed during an oral contraceptive (OC) cycle.

Materials And Methods: The New York University Langone Medical Center Institutional Review Board approved this HIPAA-compliant prospective study. All participants provided written informed consent.

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.

Contraceptive efficacy of a novel spermicidal microbicide used with a diaphragm: a randomized controlled trial.

Objective: Women need products that protect against both pregnancy and sexually transmitted infections, including human immunodeficiency virus (HIV). The acid buffering gel is a nondetergent spermicide that may provide this dual protection by reinforcing normal vaginal acidity to inactivate both sperm and acid-sensitive sexually transmitted pathogens. The objective of this study was to assess the gel's contraceptive effects, safety, and acceptability.

Determining the feasibility of utilizing the microbicide applicator compliance assay for use in clinical trials.

Introduction: Participant's adherence to use of study product is a major concern in microbicide clinical trials, which can impact on proving product efficacy. In a previously described assay, single-use microbicide applicators exposed to the vagina were tested by spraying the applicator with trypan blue dye, resulting in vaginal mucus staining on inserted applicators. As subjects in our Phase 3 trials return applicators only at quarterly visits, often mixing inserted and not-inserted applicators together in the same bag, cross-contamination could confound results.

Progesterone receptor modulator for emergency contraception: a randomized controlled trial.

Objective: Compare the efficacy and adverse effects of CDB-2914, a new progesterone receptor modulator, to levonorgestrel for emergency contraception.

Methods: We performed a randomized, double-blinded noninferiority trial, enrolling healthy women seeking emergency contraception within 72 hours of unprotected intercourse. Participants were randomly assigned to receive a single dose of 50 mg of CDB-2914, plus a placebo 12 hours later or two doses of 0.

Acceptability of five nonoxynol-9 spermicides.

Objective: To examine the acceptability of five nonoxynol-9 (N-9) spermicides.

Methods: We analyzed data from a randomized trial of five products, including three gels containing different amounts of N-9 per dose, a film and a suppository. In the trial, 1536 participants were asked to use the assigned spermicide for 7 months and to complete questionnaires 4 weeks after admission and at discontinuation.

Participant characteristics associated with withdrawal from a large randomized trial of spermicide effectiveness.

Background: In most recent large efficacy trials of barrier contraceptive methods, a high proportion of participants withdrew before the intended end of follow-up. The objective of this analysis was to explore characteristics of participants who failed to complete seven months of planned participation in a trial of spermicide efficacy.

Methods: Trial participants were expected to use the assigned spermicide for contraception for 7 months or until pregnancy occurred.

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.

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.

Abnormal uterine bleeding during progestin-only contraception may result from free radical-induced alterations in angiopoietin expression.

Abnormal uterine bleeding is the leading indication for discontinuation of long-term progestin-only contraceptives (LTPOCs). Histological sections of endometria from LTPOC-treated patients display abnormally enlarged blood vessels at bleeding sites. Paradoxically, a trend toward reduced endometrial perfusion in LTPOC users has been reported in these patients.