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 mg estradiol tablet plus placebo gel (n1/4102), vaginal moisturizer plus placebo tablet (n1/4100), or dual placebo (n1/4100). 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; P1/40.01). 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; P1/40.005), 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; P1/40.38) 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.
Bibliographical noteFunding Information:
This study was funded by the National Institutes of Health/National Institute on Aging: R01 AG048209
Funding/Support: This study was funded by the National Institutes of Health/National Institute on Aging: R01 AG048209. The sponsor had no input in or control over the analysis of data, writing of manuscript, or decision to publish. All of the opinions and conclusions reported herein are the authors’ own, and do not reflect the official position of the National Institute of Aging. Clinical trial registration: Clinical trials.gov: NCT02516202. Address correspondence to: Susan J. Diem, MD, MPH, One Veterans Dr, General Internal Medicine (111-0), Minneapolis, MN 55417. E-mail: firstname.lastname@example.org
©2018 The North American Menopause Society.
- Clinical trials network
- Depressive symptoms
- Postmenopausal vulvovaginal symptoms
- Quality of life
- Vaginal estrogen
- Vaginal moisturizer