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LibiGel two new Phase III efficacy trials with the same FDA-required efficacy endpoints as prior clinical trials

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BioSante announced the plans to initiate two new LibiGel Phase III efficacy trials that will include the same FDA-required efficacy endpoints as prior clinical trials. The decision to continue with two new clinical trials is based on an consultation with key opinion leaders in female sexual dysfunction, extensive analysis of previous efficacy data, testosterone therapy and placebo effects, as well as a meeting with the FDA.

LibiGel Phase III clinical trial has accumulated over 6,500 women-years of data to support the safety efficacy and is considered the largest testosterone trial of its kind.

"We continue to believe that HSDD is an important unmet medical need for women and that LibiGel can provide a meaningful treatment option," stated Stephen M. Simes, BioSante's president & CEO.

Previous two completed Phase III efficacy trials were randomized, double-blind, placebo-controlled trials which enrolled 597 and 575 surgically menopausal women, respectively, for six-months of therapy. These trials were conducted according to an FDA-agreed special protocol assessment (SPA) agreement. The co-primary endpoints of both LibiGel efficacy trials were the change in the total number of days with a satisfying sexual event from baseline, and the change in mean sexual desire from baseline. The secondary endpoint for both trials was the change in sexual distress from baseline. Subjects recorded their sexually satisfying events in a validated daily diary, during a baseline period and during the full six months of therapy.

 

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