LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced today that it has initiated a new Phase III safety and efficacy trial of LibiGel® (transdermal testosterone gel) in the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD). This is the second of two safety and efficacy trials to be conducted under conditions set forth in a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). The double-blind, placebo-controlled Phase III trial will enroll approximately 500 surgically menopausal women for a six-month clinical trial. BioSante also is enrolling women in an ongoing Phase III safety study of LibiGel, and another Phase III safety and efficacy trial under the same SPA.
