BioSante Completes Pivotal Phase III Clinical Trial for Estrogen Gel

BioSante Pharmaceuticals has completed its 12-week, pivotal Phase III clinical trial to evaluate the safety and efficacy of Bio-E-Gel for the treatment of moderate-to-severe hot flashes in menopausal women.

BioSante's multicenter, randomized, double-blind, placebo-controlled trial of Bio-E-Gel (bioidentical estradiol transdermal gel) was conducted in the U.S. and Canada. Current FDA requirements for approval of new estradiol products include one 12-week Phase III clinical trial. The study included three doses of Bio-E-Gel to maximize the safety profile by identifying the lowest effective dose.