Phase III Rejoice trial of TX 004HR (oestradiol) meets endpoints in dyspareunia- TherapeuticsMD

TherapeuticsMD Inc. has presented detailed results from the pivotal phase III Rejoice Trial for its TX 004HR (oestradiol) product candidate in two late-breaking posters at the Endocrine Society’s 98th Annual Meeting and Expo. Detailed results from the Rejoice Trial, a randomized, double-blind, placebo-controlled, multicenter, phase III study of TX-004HR at 25 mcg, 10 mcg and 4 mcg doses in postmenopausal women with a moderate-to-severe dyspareunia, showed that at week 12, all TX-004HR doses compared with placebo significantly improved the four co-primary endpoints, including vaginal superficial cells, vaginal parabasal cells, vaginal pH, and the severity of dyspareunia. Moreover, the changes in cytology, pH, and dyspareunia were significant at all intermediate time points (weeks 2, 6, and 8).

The Rejoice Trial secondary endpoint result for vaginal dryness was also statistically significant for all three doses evaluated, as moderate-to-severe vaginal dryness was reported by 93% of patients at baseline, and was significantly improved for all doses at weeks 2, 6, 8, and 12 (except the 4 mcg dose at week 2). A post-study patient questionnaire showed TX-004HR had high patient acceptability and satisfaction. TX-004HR was well tolerated; the most frequently reported treatment-emergent adverse events (AEs) were headache, vaginal discharge, nasopharyngitis and vulvovaginal pruritus. Vaginal discharge and vulvovaginal pruritus were numerically higher in the placebo group. No clinically significant differences in AEs between treatment and placebo groups were observed.