Finalizing the Ovaprene vaginal device trial for contraception
Official title: PROTOCOL FINALIZATION, PROCUREMENT OF REGULATORY APPROVAL, AND COMPLETE START-UP ACTIVITIES FOR THE OVAPRENE VAGINAL DEVICE CLINICAL TRIAL
Funded at Health Decisions, INC. · NIH-11250967 · Data updated 2026-11-12
This study is testing a new hormone-free vaginal contraceptive called Ovaprene to see how well it works, and it's looking for about 800 women who can help by participating over the next 13 months.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Health Decisions, INC. NIH-funded |
| Lab location | 1 site (Morrisville, United States) |
| Project start | September 1, 2023 |
| Project end | March 31, 2025 |
| Funding year | 2025 |
| Award (this year) | $60,836 |
| NIH project number | 75N94019D00004-P00004-759402300003-1 |
| Project ID | NIH-11250967 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for participation are women of child-bearing age who are seeking non-hormonal contraceptive methods.
✕Less likely to help
Patients who are not of child-bearing age or those who are not interested in contraceptive options may not benefit from this research.
What this research studies
This research focuses on the Ovaprene vaginal device, a hormone-free contraceptive option designed for single-cycle use by women. The study aims to finalize the trial protocol, obtain necessary regulatory approvals, and initiate recruitment and enrollment of participants. Approximately 800 women of child-bearing age will be involved in a 13-month efficacy study to evaluate the device's effectiveness. The research is coordinated by Health Decisions, Inc., in partnership with the NICHD.
Why it matters
Potential benefit: If successful, this research could provide women with a new, safe, and effective non-hormonal contraceptive option.
How similar studies have gone: Previous research in the development of non-hormonal contraceptives has shown promise, indicating potential for success in this area.
Where this research is happening
-
Health Decisions, INC.
Morrisville, United States Active
Researchers
- Principal investigator: Dart, Clint — Health Decisions, INC.
- Study coordinator: Dart, Clint
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.