Prevention of Pregnancy
The AMPOWER Clinical Research Study (AMP002)
The AMPOWER study is our second pivotal, Phase 3 clinical trial designed to assess the effectiveness of Amphora® in preventing pregnancy and to evaluate its safety over 7 menstrual cycles of use in women who are using no other forms of birth control. Amphora® is a novel, non-hormonal birth control designed to maintain the pH of the vagina to inhibit sperm motility and to form a layer of gel over the vagina and cervix, preventing sperm from reaching an egg. The study will enroll approximately 1350 women at about 100 study centers in the US.
Chlamydia/Gonorrhea Prevention Clinical Trial (EVO-003)
EVO-003 is a Phase 2b/3 clinical trial designed to assess the ability of our antimicrobial drug product to prevent urogenital acquisition of Chlamydia trachomatis (primary endpoint) and Neisseria gonorrhea (secondary endpoint). EVO-003 is a double-blind, placebo controlled study in approximately 850 women at about 20 sites in the United States. Approximately 850 women will be enrolled for a 4-month interventional period followed by a 1-month follow-up period.
Reduction in the Recurrence of Bacterial Vaginosis (BV) Clinical Trial
This clinical trial is a Phase 2b/3 study designed to assess the ability of our antimicrobial drug product to reduce the recurrence of BV. It is a double-blind, placebo controlled study in approximately 100 women at about 4 sites in the United States. Women with BV will be treated with standard of care then randomized to active or placebo arms. The drug will be administered once-weekly for up to 16 weeks followed by at least of 12 weeks of follow-up.