Evofem Biosciences committed to the development and commercialization of women’s healthcare products asserted the enrollment of its first patient in Phase 2b/3 clinical trial evaluating Amphora’s ability to prevent urogenital chlamydia and gonorrhea in women. Amphora is an investigational compound being studied for the prevention of certain reproductive tract infections and as an on-demand, non-hormonal vaginal contraceptive. 850 women at up to 20 centers in the United States are expected to be enrolled for a four-month interventional period and subsequent one-month follow-up period. AMPREVENCE, a Phase 2b/3 double-blinded placebo-controlled efficacy trial of Amphora for the prevention of acquisition of urogenital Chlamydia trachomatis infection in women, is intended to demonstrate Amphora’s ability to prevent urogenital acquisition of Chlamydia trachomatis (primary endpoint) and Neisseria gonorrhea (secondary endpoint).
Kelly Culwell, MD, Chief Medical Officer for Evofem Biosciences claimed “This STI study, along with Evofem’s AMPOWER contraceptive efficacy trial, represents a significant step toward the development of a multipurpose prevention product.”