Acceptability of the Woman's Condom in a phase III multicenter open-label study.

ABSTRACT:

Objective

This study aimed to evaluate the acceptability of the Woman's Condom (WC) over 6 months (183 days) and ≥6 menstrual cycles in a US-based multicenter open-label phase III contraceptive efficacy trial.

Study design

We assessed acceptability via written questionnaire at visit 2 (after the third cycle) and visit 3 (after the sixth cycle or >183 days, or upon early discontinuation). Key domains included ease of use, comfort/lubrication, sexual satisfaction, male partner satisfaction and confidence in pregnancy and sexually transmitted infection (STI) prevention. We analyzed quantitative data using descriptive statistics. We conducted a content analysis to identify major themes from four open-ended questions.

Results

Most women [327/405 (81%)] had limited or no pr

SUBMITTER: Chen BA 

PROVIDER: S-EPMC7363037 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature