Departments of Obstetrics and Gynecology and Epidemiology, University of Washington School of Medicine, the Group Health Research Institute, and the Data Coordinating Center, Fred Hutchinson Cancer Research Center, Seattle, Washington; the Departments of Psychiatry and Medicine, Brigham and Women's Hospital, the Departments of Psychiatry and Obstetrics and Gynecology, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts; and the Departments of Obstetrics and Gynecology and Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.
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OBJECTIVE:To evaluate sexual function in midlife women taking low-dose oral estradiol or venlafaxine for hot flushes.METHODS:In an 8-week randomized controlled trial among women aged 40–62 years, sexual function was compared between 0.5 mg oral estradiol per day or 75 mg venlafaxine per day (both compared with a placebo). Measures included composite and six domain scores from the Female Sexual Function Index and sexually related personal distress.RESULTS:Participants were aged 54.6 years (standard deviation [SD] 3.8) years, 59% white, with 8.1 (SD 5.3) daily hot flushes. Median composite baseline Female Sexual Function Index score was 16.3 (SD 11.9, n=256) for all women and 21.7 (SD 9.3, n=198) among sexually active women. Composite mean Female Sexual Function Index change from baseline to week 8 was 1.4 (95% confidence interval [CI] −0.4 to 3.2) for estradiol, 1.1 (95% CI −0.5 to 2.7) for venlafaxine, and −0.3 (95% CI −1.6 to 1.0) for placebo. Composite Female Sexual Function Index and sexually related distress change from baseline did not differ between estradiol and placebo (P=.38, P=.30) or venlafaxine and placebo (P=.79, P=.48). Among sexually active women, Female Sexual Function Index domain score change from baseline differences (active compared with placebo) in desire was 0.3 (95% CI 0.0–0.6) for estradiol, −0.6 (95% CI −1.2 to 0.0) in orgasm for venlafaxine, and 0.9 (95% CI 0.2–1.6) in penetration pain for venlafaxine. No women reported adverse events related to sexual dysfunction.CONCLUSION:Overall sexual function among nondepressed midlife women experiencing hot flushes did not change over 8 weeks with low-dose oral estradiol or venlafaxine (compared with placebo), although a subtle increase in desire (estradiol) and decreases in orgasm and pain (venlafaxine) may exist.CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, www.clinicaltrials.gov, NCT01418209.LEVEL OF EVIDENCE:I