TherapeuticsMD Initiates Phase 3 Trial Of TX 12-002-HR, Progesterone Candidate

(RTTNews) - TherapeuticsMD, Inc. (TXMD), a women's healthcare company, announced it has initiated the SPRY Trial, a randomized, placebo-controlled phase 3 clinical trial designed to evaluate the safety and efficacy of TX 12-002-HR, its oral progesterone candidate for secondary amenorrhea, a condition treated to maintain fertility in young premenopausal women. Clinical endpoints of the SPRY Trial include withdrawal bleeding and complete secretory change in three consecutive cycles. The trial is designed to enroll approximately 180 patients in the U.S. and is expected to be completed in late 2014.

TX 12-002-HR is a natural progesterone formulation without the potentially allergenic component of peanut oil, which is contained in currently available oral progesterone formulations.

Robert Finizio, CEO and Co-founder, said, "Based on its increased bioavailability, we believe that our oral progesterone candidate may provide a safe and effective treatment for secondary amenorrhea at a lower dose than oral therapies that are currently approved by the Food and Drug Administration. If approved, we believe our lower-dose bioidentical progesterone, with its non-allergenic formulation, would have a significant competitive advantage. We look forward to completing enrollment and reporting the results of the SPRY Trial after the 12-week treatment phase."