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Sexual frequency and pain in a randomized clinical trial of vaginal estradiol tablets, moisturizer, and placebo in postmenopausal women

Mitchell, Caroline M. MD, MPH1; Guthrie, Katherine A. PhD2; Larson, Joseph MS2; Diem, Susan MD3,4; LaCroix, Andrea Z. PhD5; Caan, Bette DrPH6; Shifren, Jan L. MD1; Woods, Nancy F. PhD, RN7; Heiman, Julia R. PhD8; Lindau, Stacy T. MD, MAPP9; Reed, Susan D. MD, MPH2,10

doi: 10.1097/GME.0000000000001341
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Objective: To evaluate the efficacy of two common interventions for bothersome postmenopausal vaginal symptoms on improving sexual frequency and pain.

Methods: This is a post-hoc analysis of data from a 12-week double-blind placebo-controlled trial that randomized postmenopausal women (ages 45-70 years) with moderate-severe genitourinary discomfort to vaginal 10 μg estradiol tablet plus placebo gel (n = 102), placebo tablet plus vaginal moisturizer (n = 100), or dual placebo (n = 100). Outcomes were proportion of sexually active women at 12 weeks, frequency of sexual activity, and pain severity with sexual activity (0-3 scale). Consistent with the original study design, comparisons were made between each active arm and the dual placebo arm.

Results: Most women enrolled in the trial, 294/302 (97%), had sufficient data to be included in this analysis. Mean age of participants was 61 years, most were white (88%), college educated (66%), and most reported sexual activity in the month before enrollment (81%). After 12 weeks of treatment, a similar proportion of women in the vaginal estrogen and dual placebo groups reported sexual activity in the past week (50% and 40%; P = 0.10) and the past month (78% and 84%, P = 0.52). Mean (standard deviation) pain with sexual activity scores at 12 weeks were similar between vaginal estrogen (1.0 [1.0]) and placebo (0.9 [0.9], P = 0.52] groups. The proportion sexually active at 12 weeks (35%) and mean (standard deviation) pain severity in the vaginal moisturizer group (1.1 [0.9]) did not differ from placebo (P = 0.36).

Conclusions: Compared to placebo, neither low-dose vaginal estradiol nor vaginal moisturizer treatment over 12 weeks resulted in significantly greater increases in the proportions of women reporting sexual activity or improvement in pain scores with sexual activity.

Trial registration: Clinical trials.gov: NCT02516202.

1Vincent Obstetrics and Gynecology, Massachusetts General Hospital and Harvard Medical School, Boston, MA

2Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA

3Departments of Medicine and Epidemiology and Community Health, University of Minnesota, Minneapolis, MN

4Department of Medicine, Minneapolis VA Health Care System, Minneapolis, MN

5Department of Family Medicine and Public Health, University of California at San Diego, La Jolla, CA

6Division of Research, Kaiser Permanente, Oakland of Northern California, CA

7University of Washington School of Nursing, Seattle, WA

8Kinsey Institute for Research in Sex, Gender and Reproduction, Psychological and Brain Sciences, Indiana University, Bloomington, IN

9Departments of Obstetrics and Gynecology and Medicine-Geriatrics and Palliative Medicine, University of Chicago, Chicago, IL

10Department of Obstetrics and Gynecology, University of Washington, Seattle, WA.

Address correspondence to: Caroline M. Mitchell, MD, MPH, Vincent Center for Reproductive Biology, Massachusetts General Hospital, 55 Fruit St, Boston, MA 02114. E-mail: Caroline.Mitchell@mgh.harvard.edu

Received 14 January, 2019

Revised 12 February, 2019

Accepted 12 February, 2019

These data were presented in part at The North American Menopause Society Annual Meeting October 3-6, 2018, San Diego, CA.

Funding/support: This study was funded by the National Institutes of Health/National Institute on Aging: 5R01AG048209.

Financial disclosure/conflicts of interest: Dr Mitchell has served on scientific advisory boards for Lupin Pharmaceuticals and Scynexis Inc, and receives grant support from Merck. Dr Reed receives grant support from Bayer Pharmaceuticals. Dr Lindau is founder, co-owner, and Chief Innovation Officer of NowPow, LLC. All other authors have nothing to report.

Online date: April 15, 2019

© 2019 by The North American Menopause Society.