SAN DIEGO, June 26, 2014 (GLOBE NEWSWIRE) -- Evofem announced the completion of the largest Phase III contraceptive clinical trial to date 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."
Evofem LLC is a privately held biotechnology company that brings advanced prescription and consumer products to global markets. Through its subsidiaries, Evofem Inc. and Cosmederm Bioscience, Evofem discovers, develops and commercializes prescription and over-the-counter products, in the areas of dermatology, pain management, feminine care, contraception, and the prevention of sexually transmitted infections. In February 2013, Evofem entered into a strategic alliance with Woman Care Global, a nonprofit organization whose mission is to provide access to quality, affordable, women's healthcare products through a sustainable value chain in over 100 countries, with a particular focus on under-served markets in Africa, Asia, and Latin America. Through this alliance, Woman Care Global provides sales, marketing and global distribution support to Evofem's products.
Source: WomanCare Global