TherapeuticsMD Enrols First Patient In REPLENISH Trial- Quick Facts

(RTTNews) - TherapeuticsMD, Inc. (TXMD) announced the enrollment and dosing of the first patient in the REPLENISH Trial, a Phase 3 clinical trial designed to measure the safety and effectiveness of TX 12-001-HR, the company's bioidentical combination 17ß-estradiol and progesterone drug candidate, in treating the symptoms of menopause.

Clinical endpoints of the REPLENISH Trial include measuring the reduction in frequency and severity of hot flashes over a 90-day period while ensuring endometrial protection for one year, as per FDA Guidance for Estrogen/Progestins.

Robert Finizio, Co-Founder and CEO, said, "We are pleased to enroll our first patient in the pivotal Phase 3 clinical trial of TX 12-001-HR. We believe this novel combination of 17ß-estradiol and progesterone may provide a safer and effective alternative as compared to current hormone therapies..."