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


ABSTRACT: Objective: To examine responder rates and vasomotor symptom-free days with oral 17?-estradiol/progesterone (E2/P4; TX-001HR) versus placebo in the REPLENISH trial.

Methods: REPLENISH (NCT01942668) was a phase 3, randomized, double-blind, placebo-controlled, multicenter trial, evaluating single, oral, softgel E2/P4 capsules in postmenopausal women (40-65 y) with a uterus and vasomotor symptoms (VMS). Women with moderate to severe 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. Proportions of women with ?50% or ?75% reductions in moderate to severe VMS (responders), and those with no severe VMS as well as the weekly number of days without moderate to severe VMS with TX-001HR versus placebo were determined. Mixed model repeated measures was used to analyze data and Fisher exact test was employed to compare E2/P4 versus placebo.

Results: Seven hundred twenty-six women were eligible for the VMS efficacy analysis (E2/P4?1/100 [n?=?141], 0.5/100 [n?=?149], 0.5/50 [n?=?147], 0.25/50 [n?=?154], or placebo [n?=?135]). Significantly more women treated with all E2/P4 doses versus placebo were ?50% responders and ?75% responders at weeks 4 and 12 (P?
Conclusions: Women treated with E2/P4 had a greater response to treatment with more VMS-free days than with placebo. The E2/P4?1/100 dose (Bijuva [E2 and P4] capsules) represents an oral treatment option for postmenopausal women with moderate to severe VMS and a uterus.

SUBMITTER: Kaunitz AM 

PROVIDER: S-EPMC7709918 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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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.

Kaunitz Andrew M AM   Bitner Diana D   Constantine Ginger D GD   Bernick Brian B   Graham Shelli S   Mirkin Sebastian S  

Menopause (New York, N.Y.) 20201201 12


<h4>Objective</h4>To examine responder rates and vasomotor symptom-free days with oral 17β-estradiol/progesterone (E2/P4; TX-001HR) versus placebo in the REPLENISH trial.<h4>Methods</h4>REPLENISH (NCT01942668) was a phase 3, randomized, double-blind, placebo-controlled, multicenter trial, evaluating single, oral, softgel E2/P4 capsules in postmenopausal women (40-65 y) with a uterus and vasomotor symptoms (VMS). Women with moderate to severe hot flushes (≥7/d or ≥50/wk) were randomized (VMS subs  ...[more]

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