TherapeuticsMD, Inc. Begins Patient Enrollment in Pivotal Phase 3 Clinical Trial of TX 12-001-HR to Treat Symptoms of Menopause and Provide Endometrial Protection
Published: Sep 05, 2013
BOCA RATON, Fla.--(BUSINESS WIRE)--TherapeuticsMD, Inc. (NYSE MKT: TXMD) announced today 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 (www.ReplenishTrial.com) include measuring the reduction in frequency and severity of hot flashes over a 90-day period while ensuring endometrial protection for one year, in accordance with FDA Guidance for Estrogen/Progestins.
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