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17β-estradiol/progesterone in a single, oral, softgel capsule (TX-001HR) significantly increased the number of vasomotor symptom-free days in the REPLENISH trial

Menopause Dec 11, 2020

Kaunitz AM, Bitner D, Constantine GD, et al. - Researchers sought to investigate responder rates and vasomotor symptom-free days with oral 17β-estradiol/progesterone (E2/P4; TX-001HR) vs placebo in the REPLENISH trial. This trial assessing single, oral, softgel E2/P4 capsules in postmenopausal women (40-65 y) with a uterus and vasomotor symptoms (VMS). Women with mild to extreme hot flushes (≥ 7/d or ≥ 50/wk) were randomized (VMS substudy) to daily E2/P4 (mg/mg) of 1/100, 0.5/100, 0.5/50, 0.25/50, or placebo. For the VMS efficacy analysis, 726 women were eligible. Data reported that the proportion of women without severe hot flushes at week 12 was 43% to 56% for all E2/P4 doses vs 26% for placebo. The authors discovered that women treated with E2/P4 had a higher response to treatment with more VMS-free days than placebo. The oral treatment choice for postmenopausal women with moderate to severe VMS and uterus is the E2/P4 1/100 dose (Bijuva [E2 and P4] capsules).

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