Daré Bioscience’s Ovaprene Trial Yields 9% Pregnancy Rate, 12% Discontinuations
DARE•Daré Bioscience’s interim Phase 3 data for Ovaprene show a 9% pregnancy rate across 1,789 menstrual cycles from 339 women, securing a second positive DSMB review. Discontinuations due to vaginal odor totaled 12%, down 5% from prior analysis, with no new adverse events observed.
1. Interim Data and DSMB Review
Daré Bioscience reported a second positive DSMB review of its ongoing pivotal Phase 3 trial for Ovaprene, the hormone-free monthly intravaginal contraceptive. The interim analysis of 339 women covering 1,789 menstrual cycles showed a 9% typical-use pregnancy rate, matching pre-pivotal expectations and supporting continued study progress.
2. Safety and Tolerability Findings
Safety data revealed no new adverse events or increased event frequency with prolonged Ovaprene use. Approximately 12% of participants discontinued due to vaginal odor, a 5% reduction from the prior interim analysis, and no serious device-related adverse events were identified.
3. Study Progress and Next Steps
The single-arm, open-label trial aims for 2,500 menstrual cycles of exposure and at least 250 subjects completing 13 cycles, with the company expecting to meet the cycle target in 2026. Daré Bioscience plans to engage the FDA on interim safety findings and advance to primary endpoint evaluation upon study completion.
