TherapeuticsMD, Inc. Phase 1 Pilot Study Shows TX-12-004-HR Estradiol VagiCap Improves Conditions of Vulvar and Vaginal Atrophy (VVA)

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BOCA RATON, Fla.--(BUSINESS WIRE)--TherapeuticsMD, Inc. (NYSE MKT: TXMD), a women’s healthcare company (“TherapeuticsMD” or the “Company”), announced today that its investigational drug, TX 12-004-HR estradiol VagiCap™, improved objective measures of VVA in a phase 1 clinical study. The study evaluated the efficacy and safety of a 10µg dose of TX 12-004-HR vs. placebo over a two-week period in 48 postmenopausal women with symptoms of VVA. Statistically significant differences were found between the treatment and placebo groups, with the treatment group showing changes in Maturation index (cell composition) and pH more closely resembling that found in premenopausal women with healthy, non-atrophied vaginal tissue.

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