Dare Bioscience announces trial initiation for Ovaprene
Dare Bioscience announced the initiation of its post-coital test clinical trial for its lead product candidate Ovaprene, a monthly non-hormonal contraceptive vaginal ring. This clinical trial is designed to assess general safety, acceptability, and effectiveness in preventing progressively motile sperm from reaching the cervical canal following intercourse. The study is enrolling 50 couples, with the woman to be evaluated over the course of five menstrual cycles, with a target of having at least 25 women complete a total of 21 visits. Each woman's cervical mucus will be measured at several points during the study, including a baseline measurement at menstrual cycle 1 that excludes the use of any product. Subsequent cycles and visits will include the use of a diaphragm and the Ovaprene non-hormonal vaginal ring. Data from the study is expected to be available in the second half of 2019. If there is demonstration of feasibility in the PCT clinical trial, the company intends to prepare and file an Investigational Device Exemption with the FDA to commence a pivotal clinical trial to support marketing approvals of Ovaprene in the United States, Europe and other countries worldwide.