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news.BioSante Pharmaceuticals has reported positive safety data review of Phase III cardiovascular and breast cancer safety study to test the efficacy of LibiGel, by Data Monitoring Committee (DMC).
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DMC has recommended that the LibiGel safety study should continue as per the FDA-agreed protocol.
LibiGel is a testosterone gel used to treat female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD) in menopausal women.
The Phase III LibiGel randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study has enrolled 3,656 women.