Study of Ovaprene, a Non-Hormonal Intravaginal Ring, to Evaluate Contraceptive Effectiveness and Safety in Women Aged 18 to 40

What this Trial Is About

Researchers are evaluating Ovaprene, a non-hormonal intravaginal ring, to study its contraceptive effectiveness, safety, and acceptability in people assigned female at birth who are sexually active and desire contraception. This open-label, single-arm study is conducted across multiple centers to observe how well Ovaprene works in preventing pregnancy over a 12-month period. Participants will use Ovaprene as their sole method of contraception throughout the study. Before starting Ovaprene, participants must stop their current contraceptive methods except condoms and experience at least one menstrual cycle. The study includes a detailed screening and follow-up process to monitor participants health and contraceptive use. During the study, participants will attend scheduled clinic visits for assessments including pregnancy testing and health evaluations. Researchers will measure the pregnancy rate over 12 months to determine contraceptive effectiveness. Additional monitoring includes safety assessments and adherence to using Ovaprene only. The total study duration for each participant is about one year, with ongoing follow-up visits to ensure safety and collect data.

Contraceptive Efficacy Study of Ovaprene