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Introduction

In the phase 3 REPLENISH trial, TX-001HR (TherapeuticsMD, Boca Raton, FL), an oral capsule combining bioidentical 17β-estradiol with bioidentical progesterone (E2/P4; 1 mg E2/100 mg P4 dose FDA approved as BIJUVATM), reduced the frequency and severity of moderate to severe hot flushes and improved quality of life outcomes in menopausal women with a uterus.

Objective

To determine the effects of the E2/P4 capsules versus placebo on vaginal dryness (secondary analysis) in postmenopausal women (younger or older than 55 years) experiencing hot flushes.

Methods

Four doses of the oral E2/P4 capsules were evaluated in the phase 3, multicenter, randomized placebo-controlled REPLENISH trial (NCT01942668), in postmenopausal women (40-65 years) with vasomotor symptoms (VMS) and an intact uterus. Women with moderate to severe hot flushes (≥7/day or ≥50/week) were randomized 1:1:1:1:1 to daily E2/P4 (mg/mg) of 1/100, 0.5/100, 0.5/50, 0.25/50, or placebo (VMS substudy); all other women were randomized 1:1:1:1 to active E2/P4 doses. This secondary analysis focused on the symptom: vaginal dryness during intercourse in the overall efficacy (MITT) population and analyzed by age (<55 and 55+) using the menopause-specific quality of life (MENQOL) questionnaire, which was administered at baseline, week 12 and months 6 and 12. The 29 items (symptoms) of the questionnaire, which if experienced were rated using a 7-item Likert scale ranging from “Not at all bothered” (analysis score of 2) to “Extremely bothered” (analysis score of 8), if the symptom was not experienced, the score for the analysis was set to 1. Baseline changes to week 12, and months 6 and 12 are reported here.

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