Daré Bioscience Reports Positive Interim Phase 3 Results for Ovaprene Hormone-Free Contraceptive

Daré Bioscience查看公司主页 announced positive interim safety and efficacy results from its ongoing Phase 3 clinical trial of Ovaprene查看药品详情, an investigational monthly, hormone-free intravaginal contraceptive. The trial's independent Data Safety Monitoring Board (DSMB) conducted a planned interim analysis and recommended the study continue without modification, marking the second positive review following a similar recommendation in July 2025.

The interim data revealed that approximately 9% of the 339 women treated in the study had experienced a pregnancy (搜索)搜索该疾病, a rate consistent with the company's expectations based on results from the pre-pivotal postcoital test clinical study of Ovaprene查看药品详情. These findings reinforce Ovaprene's potential as a meaningful hormone-free contraceptive alternative in a market where no FDA-approved, hormone-free, monthly intravaginal contraceptives currently exist.

Safety Profile and Tolerability

The DSMB reviewed safety data from 339 study subjects, contributing 1,789 menstrual cycles of safety data, representing a meaningful proportion of the study's 2,500-cycle target. No new types of adverse events or tolerability concerns were identified, and neither an increase in the frequency of adverse events nor the emergence of new types of adverse events was observed with prolonged Ovaprene查看药品详情 use.

Approximately 12% of participants discontinued the study due to vaginal odor, the most commonly reported product-related adverse event. This represents a 5% decrease compared to data reviewed by the DSMB in July 2025. No serious adverse events related to the study device were identified. A majority of participants who had completed the study reported they would be very likely or likely to use Ovaprene查看药品详情 if it became available.

Comparative Contraceptive Effectiveness

According to the FDA's birth control guide, the number of pregnancies expected using short-acting hormonal contraceptive methods—including oral contraceptives, the patch, and the vaginal ring—is seven per 100 women. The number of pregnancies expected using male condoms is 13 per 100 women, and 17 per 100 women using diaphragms or sponges with spermicide.

"We are encouraged by these interim results and this second positive DSMB review," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience查看公司主页. "Millions of women in the U.S. are seeking effective, hormone-free birth control, and Ovaprene查看药品详情 has the potential to address a significant unmet need and transform the contraceptive landscape."

Study Design and Timeline

The ongoing pivotal Phase 3 trial is a multicenter, single-arm, open-label study enrolling women aged 18-40 across five sites. The study protocol calls for at least 2,500 cycles of exposure and at least 250 subjects completing 13 menstrual cycles of use. Based on current enrollment trends, the company expects to achieve 2,500 cycles of exposure before 250 subjects complete 13 menstrual cycles of use.

Interim safety data reviewed by the DSMB indicate that prolonged product use was not associated with the emergence of new types of adverse events or an increase in the frequency of adverse events. The company believes this may support the sufficiency of fewer than 250 subjects completing 13 menstrual cycles of use to evaluate Ovaprene查看药品详情's safety profile, and intends to engage with FDA regarding these findings.

The company currently expects to complete enrollment sufficient to achieve at least 2,500 cycles of exposure in 2026. The primary objective of the study is to assess the typical-use pregnancy (搜索)搜索该疾病 rate over 13 menstrual cycles, expressed as the Pearl Index, a standard measure of contraceptive effectiveness. Secondary objectives include assessment of Ovaprene查看药品详情's 13-cycle cumulative pregnancy rate, safety, acceptability, product fit/ease of use, and vaginal health.