TX-004HR (Vaginal Estradiol)
WHAT IT IS:
TX-004HR is an investigational 17β-estradiol vaginal drug product candidate being studied for the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women. TX-004HR utilizes a unique VagiCap™ softgel capsule technology that may provide easy delivery.
DEVELOPMENT PHASE: PHASE 3 – THE REJOICE TRIAL
The purpose of the Rejoice Trial was to evaluate the safety and efficacy of three doses of TX-004HR vaginal estradiol softgel capsules for moderate to severe dyspareunia associated with postmenopausal vulvar and vaginal atrophy (VVA).
The Rejoice Trial was a randomized, double-blinded, placebo-controlled, multicenter Phase 3 clinical trial designed to evaluate the safety and efficacy of three doses of TX-004HR — 25 mcg, 10 mcg and 4 mcg — compared to placebo for the treatment of moderate to severe dyspareunia in postmenopausal women with VVA. The co-primary efficacy endpoints were change from baseline to week 12 in the percentage of vaginal superficial cells, percentage of vaginal parabasal cells, vaginal pH, and severity of moderate to severe dyspareunia as the most bothersome symptom of VVA. The trial enrolled 764 postmenopausal women (40 to 75 years old) experiencing moderate to severe dyspareunia at 89 sites across the United States and Canada. Trial participants were randomized to receive either TX-004HR at 25 mcg (n=190), 10 mcg (n=191), or 4 mcg (n=191) doses or placebo (n=192) for a total of 12 weeks, all administered once daily for two weeks and then twice weekly (approximately three to four days apart) for ten weeks. Statistically significant results were achieved for all co-primary endpoints. All doses of TX-004HR were well-tolerated with a safety profile consistent with previous studies.