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)||
|Length of study||12-month study for endometrial safety with 12-week vasomotor substudy endpoints|
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
- 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.