Daré Bioscience announced positive interim safety and efficacy results from its Phase 3 clinical trial of Ovaprene, a hormone-free, monthly intravaginal contraceptive. An interim analysis by the Data Safety Monitoring Board recommended the study continue as planned, with a pregnancy rate of approximately 9%, aligning with company projections. While about 17% of participants discontinued due to vaginal odor, no serious safety concerns arose, and overall tolerability was favorable, with many participants indicating they would likely use Ovaprene if available.
This news is potentially transformative for women’s health. Current hormone-free contraceptive options like condoms and diaphragms have significantly higher typical-use failure rates than hormonal methods. Ovaprene offers the possibility of a long-acting, hormone-free option, addressing a substantial unmet need for women seeking alternatives to hormonal birth control or less effective barrier methods. A successful Phase 3 trial could significantly shift the contraceptive landscape, providing a new category of choice for women.
The ongoing Phase 3 trial involves approximately 115 participants, with a target enrollment of 250 women completing roughly 12 months of use. The primary objective is to determine the typical-use pregnancy rate (Pearl Index) over 13 menstrual cycles. Secondary objectives include cumulative pregnancy rate, safety, acceptability, ease of use, and impact on vaginal health. Bayer holds the option to acquire exclusive U.S. commercialization rights for Ovaprene after the trial’s completion for a $20 million payment, with potential milestone payments up to $310 million and tiered royalties on net sales.
The positive interim results suggest Ovaprene is on track to potentially become the first FDA-approved hormone-free, monthly intravaginal contraceptive. If the final Phase 3 results confirm these interim findings, it could lead to a significant advancement in contraceptive options for women, offering a new method that addresses both efficacy and hormonal concerns. This could reshape the market and establish a new standard in non-hormonal birth control.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
