Sexual frequency and pain in a randomized clinical trial of vaginal estradiol tablets, moisturizer, and placebo in postmenopausal women
| Autor: | Stacy Tessler Lindau, Caroline M. Mitchell, Bette J. Caan, Julia R. Heiman, Katherine A. Guthrie, Jan L. Shifren, Susan J. Diem, Susan D. Reed, Joseph C. Larson, Nancy Fugate Woods, Andrea Z. LaCroix |
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| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
Sexual Behavior General Mathematics medicine.medical_treatment Psychological intervention MEDLINE 030209 endocrinology & metabolism Placebo Article Vaginal estrogen law.invention 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial law Internal medicine medicine Humans Aged 030219 obstetrics & reproductive medicine Postmenopausal women Estradiol business.industry Applied Mathematics Obstetrics and Gynecology Estrogens Patient Preference Middle Aged Patient preference Postmenopause Administration Intravaginal Dyspareunia Vaginal Creams Foams and Jellies Female Moisturizer business |
| Zdroj: | Menopause |
| ISSN: | 1530-0374 1072-3714 |
| DOI: | 10.1097/gme.0000000000001341 |
| Popis: | To evaluate the efficacy of two common interventions for bothersome postmenopausal vaginal symptoms on improving sexual frequency and pain.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.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).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.Clinical trials.gov: NCT02516202. |
| Databáze: | OpenAIRE |
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