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TherapeuticsMD Initiates Phase 3 Clinical Trial Of Its Progesterone Candidate (TX 12-002-HR) For Treatment Of Secondary Amenorrhea

TherapeuticsMD, Inc. (NYSE MKT:TXMD), a women’s healthcare company ("TherapeuticsMD" or the "Company"), announced today that 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 United States 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. This investigational product is chemically identical to the hormone that naturally occurs in a woman’s body.

Robert G. Finizio, Chief Executive Officer 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."

Secondary amenorrhea is defined as the absence of menses for three months in a woman with previously normal menstruation. Causes include hormonal disturbances from the hypothalamus and the pituitary gland, polycystic ovarian syndrome, premature menopause, and intrauterine scar formation.

About Hormone Therapy

Hormone therapy (HT) is the administration of hormones to supplement a lack of naturally occurring hormones. HT options include natural, bioidentical, and non-bioidentical (conjugated) hormones. HT is projected to be the largest growth segment in the overall women’s health market. In a recent study commissioned by the Company, inThought™, a Symphony Health Solutions company, estimated the current market to be over $3.7 billion per year.

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