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news.BioSante Pharmaceuticals has completed patient recruitment in the first of two Phase 3 trial evaluating the safety and efficacy of LibiGel (testosterone gel).
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BioSante Pharma is developing LibiGel as a treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women.
The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement.
LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
BioSante Pharma Clinical Development vice president Joanne Zborowski said this is an important milestone for BioSante nad this achievement represents a key positive step toward completing the LibiGel Phase III clinical development program.
"To date, we have a combined enrollment in our three LibiGel Phase III clinical studies of approximately 4,000 women and we anticipate announcing completion of enrollment in the second efficacy trial very soon," Zborowski said.