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 FDA. The double-blind, placebo-controlled Phase III trial will enroll approximately 500 surgically menopausal women for a six-month clinical trial.
The primary endpoints in the two LibiGel safety and efficacy clinical trials are an increase in the number of satisfying sexual events and sexual desire with a secondary endpoint of a decrease in sexual distress. These SPA trials use BioSante’s validated instruments to measure these clinical endpoints.
The SPA agreement affirms that the FDA agrees that the LibiGel Phase III clinical trial design, clinical endpoints, sample size, planned conduct and statistical analyses are acceptable to support regulatory approval. Further, it provides assurance that these agreed measures will serve as the basis for regulatory review and the decision by the FDA to approve a new drug application (NDA) for LibiGel.