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TX-001HR (Oral Estradiol + Progesterone)


WHAT IT IS:

TX-001HR is a novel combination of 17ß-estradiol and progesterone using SYMBODA technology, under investigation for treating vasomotor symptoms (VMS) related to menopause. TX-001HR is believed to be the first and only combination drug product candidate designed to replace the 17ß-estradiol and progesterone hormones the ovary has nearly stopped producing. About VMS

DEVELOPMENT PHASE: PHASE 3 –THE REPLENISH TRIAL

The purpose of the Replenish Trial is to evaluate an investigational bio-identical medication that may help reduce the frequency and severity of VMS symptoms, particularly daily hot flashes and night sweats often experienced during menopause.

The Phase 3 Replenish Trial was fully enrolled Q3 2015. Topline data anticipated Q4 2016 – Q1 2017.

Replenish Trial Study Design Summary
 Projected number of subjects  1,750
 Projected number of US sites  ~110
 Treatment arms (n=400/arm)
    • Estradiol 1 mg/progesterone 100 mg
    • Estradiol 0.5 mg/progesterone 100 mg
    • Estradiol 0.5 mg/progesterone 50 mg
    • Estradiol 0.25 mg/progesterone 50 mg
    • Placebo
 Length of study  12-month study for endometrial safety with 12-week vasomotor substudy endpoints
 Endpoints
    • Vasomotor substudy: number and severity of hot flashes (Weeks 4 and 12)
    • Endometrial safety: incidence of endometrial hyperplasia (12 months)


ABOUT VASOMOTOR SYMPTOMS (VMS)

It is estimated that more than 90% of women experience VMS, particularly frequent hot flashes and night sweats during menopause. Most rate the severity of their hot flashes as moderate to severe.1

  1. Kingsberg S, Wysocki S, Magnus L and Krychman M. Vulvar and Vaginal Atrophy in Postmenopausal Women: Findings from the REVIVE (REal Women’s VIews of Treatment Options for Menopausal Vaginal ChangEs) Survey. J Sex Med. 2013;10:1790–1799.