TherapeuticsMD, Inc. announced 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. Secondary amenorrhea is 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. Hormone therapy is the administration of hormones to supplement a lack of naturally occurring hormones. HT options include natural, bioidentical, and non-bioidentical (conjugated) hormones.