Ovaprene
- User: Female
- Hormonal: Non-Hormonal
-
Delivery type:
- Multiple
- Barrier
- Vaginal Ring
-
Intended Duration:
- Short-Acting
- Development Stage: Phase III
- Developer(s)/researcher(s): Dare BioScience Inc.
Details
- API: Ferrous Gluconate, Ascorbic Acid
-
Mechanism of Action:
- Physical Barrier
- Inhibition of Sperm Motility
- Inactive Materials: Silicone
- Regimen: 1 Insertion/Month
- MPT: Not Potential MPT
- Promising Attributes: Ovaprene has a distinct product profile - non-hormonal, spermiostatic, primarily a barrier method, and effective for one month - and may fill a market gap.
Product Status
Active Clinical Development
History
2009: Phase I study results published by Poly-Med Inc, noting that their novel non-hormonal vaginal ring, Ovaprene, was well tolerated and acceptable to 20 participants and their sexual partners
2018: Dare Bioscience receives NICHD grant funding to support a Phase II trial of Ovaprene. Results are published in January 2024.
2023-2024: Dare receives additional funding to support a Phase III trial of Ovaprene, evaluating 12 month efficacy. Study initiates in 20 sites with planned completion in 2026.
2025: Dare announces positive interim results from Phase III trial, with pregnancy rates aligning with earlier pre-pivotal clinical evaluation (approx. 10% of participants becoming pregnant) and no new safety or tolerability concerns. In Dec. 2025, Dare announces that Bayer, which previously held a licensing agreement with the company for the product, had elected to terminate their agreement and return all rights for Ovaprene commercialization to Dare as part of a strategic re-alignment of their product portfolio. This shift will enable Dare to fully control product licensing and marketing.
2026: Daré announces 2026 DSMB review results, indicating that 9% of participants have experienced a pregnancy (aligned with 2025 analysis), 12% have discontinued due to vaginal odor, there has been no increase in rates of adverse events, and no serious adverse events have been identified. The Ph III trial will continue until 2027.