Caroline M Mitchell1, Katherine A Guthrie2, Joseph Larson2, Susan Diem3,4, Andrea Z LaCroix5, Bette Caan6, Jan L Shifren1, Nancy F Woods7, Julia R Heiman8, Stacy T Lindau9, Susan D Reed2,10. 1. Vincent Obstetrics and Gynecology, Massachusetts General Hospital and Harvard Medical School, Boston, MA. 2. Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA. 3. Departments of Medicine and Epidemiology and Community Health, University of Minnesota, Minneapolis, MN. 4. Department of Medicine, Minneapolis VA Health Care System, Minneapolis, MN. 5. Department of Family Medicine and Public Health, University of California at San Diego, La Jolla, CA. 6. Division of Research, Kaiser Permanente, Oakland of Northern California, CA. 7. University of Washington School of Nursing, Seattle, WA. 8. Kinsey Institute for Research in Sex, Gender and Reproduction, Psychological and Brain Sciences, Indiana University, Bloomington, IN. 9. Departments of Obstetrics and Gynecology and Medicine-Geriatrics and Palliative Medicine, University of Chicago, Chicago, IL. 10. Department of Obstetrics and Gynecology, University of Washington, Seattle, WA.
Abstract
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 μgestradiol 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.
RCT Entities:
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.
Authors: Susan J Diem; Katherine A Guthrie; Caroline M Mitchell; Susan D Reed; Joseph C Larson; Kristine E Ensrud; Andrea Z LaCroix Journal: Menopause Date: 2018-10 Impact factor: 2.953
Authors: Vicki Wang; Colin A Depp; Jennifer Ceglowski; Wesley K Thompson; David Rock; Dilip V Jeste Journal: Am J Geriatr Psychiatry Date: 2014-03-19 Impact factor: 4.105
Authors: Stacy Tessler Lindau; L Philip Schumm; Edward O Laumann; Wendy Levinson; Colm A O'Muircheartaigh; Linda J Waite Journal: N Engl J Med Date: 2007-08-23 Impact factor: 91.245
Authors: Caroline M Mitchell; Susan D Reed; Susan Diem; Joseph C Larson; Katherine M Newton; Kristine E Ensrud; Andrea Z LaCroix; Bette Caan; Katherine A Guthrie Journal: JAMA Intern Med Date: 2018-05-01 Impact factor: 21.873
Authors: Janet S Carpenter; Susan D Reed; Katherine A Guthrie; Joseph C Larson; Katherine M Newton; R Jane Lau; Lee A Learman; Jan L Shifren Journal: Sex Med Date: 2015-03 Impact factor: 2.523
Authors: Susan D Reed; Janet S Carpenter; Joseph Larson; Caroline M Mitchell; Jan Shifren; Julia Heiman; Nancy Fugate Woods; Stacy Tessler Lindau; Andrea Z LaCroix; Katherine A Guthrie Journal: Menopause Date: 2022-01-31 Impact factor: 3.310