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Menopause. 2018 Oct;25(10):1086-1093. doi: 10.1097/GME.0000000000001131.

Effects of vaginal estradiol tablets and moisturizer on menopause-specific quality of life and mood in healthy postmenopausal women with vaginal symptoms: a randomized clinical trial.

Author information

1
Department of Medicine and Epidemiology and Community Health, University of Minnesota, Minneapolis, MN.
2
Department of Medicine, Minneapolis VA Health Care System, Minneapolis, MN.
3
Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.
4
Vincent Obstetrics and Gynecology, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
5
Department of Obstetrics and Gynecology, University of Washington, Seattle, WA.
6
Department of Family Medicine and Public Health, University of California at San Diego, La Jolla, CA.

Abstract

OBJECTIVE:

Compare the effects of a vaginal estradiol tablet and a vaginal moisturizer, each to placebo, on menopause-related quality of life and mood in postmenopausal women with moderate-severe vulvovaginal symptoms.

METHODS:

A total of 302 postmenopausal women enrolled in a 12-week, double-blind, placebo-controlled randomized trial were assigned to vaginal 10 μg estradiol tablet plus placebo gel (n = 102), vaginal moisturizer plus placebo tablet (n = 100), or dual placebo (n = 100). We measured change from randomization to 12 weeks in total score of the Menopause-Specific Quality of Life (MENQOL) questionnaire. We also evaluated the four MENQOL domains, depressive symptoms as measured by the Patient Health Questionnaire 8, and anxiety symptoms as measured by the Generalized Anxiety Disorder (GAD-7) questionnaire.

RESULTS:

Treatment with vaginal estradiol resulted in significantly greater improvement in total MENQOL scores compared to dual placebo (mean difference between arms -0.3 at 12 weeks (95% confidence interval [CI] -0.5, 0.0; P = 0.01). A statistically significant group mean difference favoring vaginal estradiol was observed for the MENQOL sexual function domain (-0.4 at 12 weeks; 95% CI -1.0, 0.1; P = 0.005), but not for any of the other domains. Treatment with vaginal moisturizer did not provide greater improvement compared to placebo in total MENQOL scores (mean difference 0.2 at 12 weeks; 95% CI -0.1, 0.4; P = 0.38) or in any of the MENQOL domains. Neither treatment group showed improvement compared with placebo in the Patient Health Questionnaire 8 or Generalized Anxiety Disorder Questionnaire .

CONCLUSIONS:

Treatment with low-dose vaginal estradiol, but not vaginal moisturizer, modestly improved menopause-related quality of life and sexual function domain scores in postmenopausal women with moderate-severe vulvovaginal symptoms.

PMID:
29738424
PMCID:
PMC6136971
[Available on 2019-10-01]
DOI:
10.1097/GME.0000000000001131
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