TX-002HR (Oral Progesterone)
TherapeuticsMD temporarily stopped trial.*
WHAT IT IS:
TX-002HR is an investigational progesterone product under consideration for the treatment of secondary amenorrhea. This natural progesterone formulation does not contain the potentially allergenic component of peanut oil, which is contained in currently available FDA-approved oral progesterone formulations. The product is chemically identical to the hormone that naturally occurs in a woman’s body.
TX-002HR has completed a pivotal PK study, and we are reevaluating the phase 3 clinical development program.
DEVELOPMENT PHASE: PHASE 3 UNDER CONSIDERATION
In July 2014, we temporarily suspended enrollment in the Spry Trial, and in October 2014, we temporarily stopped it in order to update the phase 3 protocol based on discussions with the FDA. We intend to update the phase 3 protocol to, among other things, target only those women with secondary amenorrhea due to polycystic ovarian syndrome and to amend the primary endpoint of the trial.
Amenorrhea is the absence of a menstrual period in a woman of reproductive age. Secondary amenorrhea (menstruation cycles ceasing) is often caused by hormonal disturbances from the hypothalamus and the pituitary gland, from polycystic ovarian syndrome (PCOS), or from premature menopause or intrauterine scar formation. It is defined as the absence of menses for three months in a woman with previously normal menstruation.