Positive Ovaprene Interim Phase 3 Results Support Potential First-in-Class, Hormone-Free Monthly Contraceptive

July 14, 2025

DENVER, Colo., Jul 14, 2025 (247marketnews.com)- Daré Bioscience (NASDAQ:DARE) revealed encouraging interim safety and efficacy data from its ongoing Phase 3 clinical trial evaluating Ovaprene, a first-of-its-kind, hormone-free, monthly intravaginal contraceptive. If approved, Ovaprene would be the first FDA-approved contraceptive of its kind.

The independent Data Safety Monitoring Board (DSMB) conducted a scheduled interim analysis of the study’s safety data and recommended the trial continue without changes—affirming a favorable safety profile to date.

As of the interim review, approximately 9% of trial participants had experienced pregnancy, aligning with expectations from earlier pre-pivotal studies. These results continue to support Ovaprene’s potential as a meaningful, non-hormonal alternative for women seeking monthly birth control.

Sabrina Martucci Johnson, Daré Bioscience’s President and CEO, stated, “We are encouraged by these interim results, which reinforce the potential of our hormone-free contraceptive candidate to provide women with a meaningful alternative to existing hormonal and non-hormonal methods. With millions of women in the U.S. seeking effective, hormone-free birth control, Ovaprene has the potential to address a significant unmet need and transform the contraceptive landscape. We look forward to the completion of the study and the final analysis of study endpoints, including the primary endpoint of pregnancy rate calculated using the Pearl Index.”

No new safety or tolerability concerns were observed. The most frequently reported product-related adverse event was vaginal odor, leading to study discontinuation in approximately 17% of participants. However, overall tolerability remained favorable. Importantly, women who completed the study indicated they would be “very likely” or “likely” to use Ovaprene if available.

According to FDA data, typical-use pregnancy rates for short-acting hormonal methods like the pill, patch, and ring are approximately seven per 100 women annually, while male condoms, diaphragms, and sponges with spermicide result in 13–17 pregnancies per 100 women. Ovaprene’s interim results suggest it could offer a competitive, hormone-free alternative within the contraceptive landscape.

The Phase 3 trial is a multicenter, single-arm, open-label study enrolling women ages 18–40 across five U.S. sites. At interim analysis, about 115 participants had completed or were ongoing in the study, with a target enrollment of 250 completing approximately 12 months of use. The primary endpoint is the typical-use pregnancy rate over 13 menstrual cycles (Pearl Index). Secondary endpoints include cumulative pregnancy rate, safety, acceptability, ease of use, product fit, and vaginal health metrics. Additional details are available at clinicaltrials.gov (NCT06127199).

Under an agreement with Bayer, the company has the right to acquire exclusive U.S. commercialization rights to Ovaprene following the trial’s completion, contingent upon a $20 million payment. Daré could also receive up to $310 million in commercial milestones, plus double-digit tiered royalties on net sales, subject to a third-party minority interest related to a royalty purchase agreement signed in April 2024.

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