Evofem Biosciences completes enrollment in Phase 3 Clinical Trial for Amphora 

Evofem Biosciences aiming to meet women’s unmet healthcare needs asserted completion of enrollment in its Phase 3 Clinical Trial evaluating Amphora vaginal gel for the prevention of pregnancy. Trial data is expected in the first quarter of 2019.

Phase 3 clinical trial enrolled over 1,350 women aged 18-35 at risk of pregnancy at over 100 centers in the United States. The primary endpoint of the study is the contraceptive efficacy of Amphora over seven cycles of use.

Brandi Howard, PhD, Evofem’s VP of Global Clinical Development and Medical Affairs said  “We believe this strong demand may be attributed to the non-hormonal attributes of Amphora which underscores the need for a new birth control option. We would like to thank our investigators and patients who are participating in this clinical trial, and look forward to reporting study outcomes in the first quarter of 2019.”

Amphora is a non-hormonal, surfactant-free bioadhesive vaginal gel designed for on-demand use as needed or desired by a woman.  This investigational new drug is being developed as an on-demand, non-hormonal vaginal contraceptive and for the prevention of certain sexually transmitted infections (STIs).