A first-of-its-kind capsule combining natural 17β-estradiol and progesterone has promise for menopause-related hot flushes, according to results of a Phase 3 multicenter trial presented at the 65th Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists in San Diego. If approved, the product may provide an option for women in the United States who are currently using unregulated, unapproved, compounded bioidentical hormone replacement therapy (HRT).
Researchers from Eastern Virginia Medical School, conducted the REPLENISH study in 1,847 women with intact uteri. A total of 767 were randomized to 1 of 4 daily doses of TX-001HR (estradiol 1.0 mg/progesterone 100 mg, 0.5 mg/100 mg, 0.5 mg/50 mg, or 02.5 mg/50 mg) or placebo for 12 months. The other 1,080 women were randomly assigned between the active treatments. Change from baseline to weeks 4 and 12 in frequency and severity of moderate to severe vasomotor symptoms was the primary efficacy endpoint. Endometrial hyperplasia at 12 months as the primary safety endpoint.
TX-001Hr 1.0 mg/100 mg and 0.5 mg/100 mg significantly improved the frequency and severity of moderate to severe hot flushes at weeks 4 (P < 0.05) and 12 (P < 0.05) versus placebo whereas 0.25 mg/50 mg significantly improved frequency but not severity of hot flushes. With all 4 doses and placebo after 12 months of therapy, incidence of endometrial hyperplasia or malignancy was 0%. All 4 TX-001HR doses were associated with a high incidence of amenorrhea.
Archer DF, Graham S, Gasper G, et al. REPLENISH trial: Combination capsule of estradiol/progesterone (TX-001HR) for treating hot flushes. Abstract 5M. Presented Monday, May 8 at the 65th Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists in San Diego, California.