17ß-estradiol/progesterone in a single, oral, softgel capsule (TX-001HR) significantly increased the number of vasomotor symptom-free days in the REPLENISH trial.
Menopause
; 27(12): 1382-1387, 2020 12.
Article
in English
| MEDLINE | ID: covidwho-1003826
ABSTRACT
OBJECTIVE:
To examine responder rates and vasomotor symptom-free days with oral 17ß-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/P4â(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/P4â1/100 [nâ=â141], 0.5/100 [nâ=â149], 0.5/50 [nâ=â147], 0.25/50 [nâ=â154], or placebo [nâ=â135]). Significantly more women treated with all E2/P4 doses versus placebo were ≥50% responders and ≥75% responders at weeks 4 and 12 (Pâ<â0.05) and also had significantly more days per week without moderate to severe VMS at week 12 (1.9-3.0 d for E2/P4 versus 1.3 d for placebo; Pâ<â0.05). The proportion of women without severe hot flushes at week 12 was 43% to 56% for all E2/P4 doses versus 26% for placebo (P ≤ 0.01).CONCLUSIONS:
Women treated with E2/P4 had a greater response to treatment with more VMS-free days than with placebo. The E2/P4â1/100 dose (Bijuva [E2 and P4] capsules) represents an oral treatment option for postmenopausal women with moderate to severe VMS and a uterus.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Progesterone
/
Postmenopause
Type of study:
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Limits:
Female
/
Humans
Language:
English
Journal:
Menopause
Journal subject:
Gynecology
Year:
2020
Document Type:
Article
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