Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 15

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 15
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, pivotal Phase 3 clinical study of Ovaprene to evaluate its effectiveness as a contraceptive along with its safety and acceptability (ClinicalTrials.gov ID: NCT06127199). The study aims to enroll sufficient participants across approximately 20 study sites in the U.S. to have approximately 250 participants complete approximately 12 months (13 menstrual cycles) of use. Based on typical dropout rates for contraceptive efficacy studies, we will seek to enroll more than double the number of subjects we target to complete 13 menstrual cycles of use. Twenty clinical research sites from within the Eunice Kennedy Shriver National Institute of Child Health and Human Development's (NICHD) Contraceptive Clinical Trials Network (CCTN) were trained on the protocol and were initiated to start screening and enrolling participants in late 2023 and early 2024. Currently, there are 15 active NICHD CCTN sites following enrolled participants in the study. Enrollment is currently proceeding at five study sites that were initiated in 2025, funded by a grant we received in 2024 from the Gates Foundation, or the Foundation, to accelerate the overall study timeline. We anticipate that approximately 125 women, which is half of our target number of participants to complete the study, will complete approximately six months of Ovaprene use by the end of the second quarter of 2025. This is a designated check point for review of interim data by the study's data safety monitoring board, or DSMB, an independent group of experts which evaluates the safety and integrity of the study. The primary objective of the study is to assess the typical use pregnancy rate over 13 menstrual cycles, or the estimated Pearl Index for Ovaprene. Secondary objectives are to assess Ovaprene's 13-cycle use cumulative pregnancy rate, safety, acceptability, product fit/ease of use, and assessments of vaginal health. If successful, we expect the study to support the submission of a premarket approval application for Ovaprene to the FDA, as well as regulatory filings in Europe and other countries worldwide, to allow for marketing approvals of Ovaprene. The Phase 3 study is being conducted, in part, under our Cooperative Research and Development Agreement, or CRADA, with the U.S. Department of Health and Human Services (HHS), as represented by the NICHD, part of the U.S. National Institutes of Health (NIH), and within the CCTN. Under the CRADA, we and NICHD each provide medical oversight