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news.BioSante Pharmaceuticals has completed patient recruitment in the second of two double-blind, placebo-controlled pivotal Phase III safety and efficacy trials evaluating LibiGel (testosterone gel).
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BioSante Pharma said that LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD).
The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement.
BioSante Clinical Development vice president Joanne Zborowski said there are more than 1,000 subjects in the efficacy trials and they anticipate announcing top-line efficacy data this fall.
"In addition, we have over 3,000 subjects enrolled in our LibiGel Phase III safety study," Zborowski said.