Daré Bioscience Inc (NASDAQ:DARE), a clinical stage women’s biopharmaceutical company, is beginning its post-coital-test clinical trial for its lead product Ovaprene, a monthly non-hormonal contraceptive vaginal ring.
The trial is designed to analyze the safety and effectiveness in using the device to prevent mobile sperm from reaching the cervical canal during sex. The study will enroll 50 couples, with the woman to be evaluated over the course of five menstrual cycles.
Each woman’s cervical mucus will be measured at several points during the study, including a baseline measurement at the first menstrual cycle which excludes the use of any product. The second menstrual cycle will include the use of a diaphragm while the third and fourth cycle will revolve around the Ovaprene non-hormonal vaginal ring.
Sabrina Martucci Johnson, president and chief executive of Daré Bioscience, says that the ring’s selling point is that it is a hormone-free birth control option.
“We believe Ovaprene has the potential to offer women a viable, hormone-free birth control option that provides protection over several weeks and is an alternative to hormone-based contraceptive products,” she said in a statement.
Data from the study is expected to be available in the second half of next year. If the trial is successful, Daré plans to file an Investigational Device exemption with the FDA to launch a key clinical trial ahead of seeking approval for Ovaprene in the US, Europe and elsewhere.
Daré Bioscience shares were flat at US$1.07.