San Diego, California – Evofem announced the completion of a Phase III contraceptive clinical trial examining the efficacy of its contraceptive vaginal gel Amphora™. The clinical trial compared Amphora to Conceptrol®, the brand name of Nonoxynol-9, and the only spermicidal vaginal gel currently approved by the FDA. The 3,386-subject trial tested the efficacy of Amphora in preventing pregnancy as compared to Conceptrol.
“We are excited to have reached this important milestone in the development of Amphora,” said Saundra Pelletier, CEO of Evofem Inc. “We really believe Amphora has tremendous potential to impact the lives of millions of women, globally.”
Health Decisions, a leading clinical research organization (CRO) conducted the Amphora clinical trial.
“We are pleased to announce early completion on a 3,386-subject global study of a potentially important new contraceptive alternative for women worldwide,” said Health Decisions CEO Michael Rosenberg, MD, MPH. “A combination of intensive study management based on streaming information and progressive subject-by-subject closeout enabled this important early step toward regulatory approval for a non-hormonal alternative to existing contraceptives.”
About Evofem, Inc.
Evofem, Inc. is a privately held biotechnology company that discovers, develops and commercializes prescription and over-the-counter products in the areas of feminine care, contraception, and the prevention of sexually transmitted infections. Evofem, Inc. is committed to delivering effective, woman-controlled, rapidly reversible forms of contraception to women globally.