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17ß-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; Bitner, Diana; Constantine, Ginger D; Bernick, Brian; Graham, Shelli; Mirkin, Sebastian.
  • Kaunitz AM; University of Florida College of Medicine-Jacksonville, Jacksonville, FL.
  • Bitner D; Spectrum Health, Grand Rapids, MI.
  • Constantine GD; EndoRheum Consultants, LLC, Malvern, PA.
  • Bernick B; TherapeuticsMD, Boca Raton, FL.
  • Graham S; TherapeuticsMD, Boca Raton, FL.
  • Mirkin S; TherapeuticsMD, Boca Raton, FL.
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/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 < 0.05) 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; P < 0.05). 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/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.
Subject(s)

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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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