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A Randomized Controlled Trial

H. George Nurnberg, MD; Paula L. Hensley, MD; Julia R. Heiman, PhD; Harry A. Croft, MD; Charles Debattista, MD; Susan Paine, MPH

JAMA. 2008;300(4):395-404.

Context  Antidepressant-associated sexual dysfunction is a common adverse effect that frequently results in premature medication treatment discontinuation and for which no treatment has demonstrated efficacy in women.

Objective  To evaluate the efficacy of sildenafil for sexual dysfunction associated with selective and nonselective serotonin reuptake inhibitors (SRIs) in women.

Design, Setting, and Participants  An 8-week prospective, parallel-group, randomized, double-blind, placebo-controlled clinical trial conducted between September 1, 2003, and January 1, 2007, at 7 US research centers that included 98 previously sexually functioning, premenopausal women (mean [SD] age 37.1 [6] years) whose major depression was remitted by SRIs but who were also experiencing sexual dysfunction.

Intervention  Forty-nine patients were randomly assigned to take sildenafil or placebo at a flexible dose starting at 50 mg adjustable to 100 mg before sexual activity.

Main Outcome Measures  The primary outcome measure was the mean difference in change from baseline to study end (ie, lower ordinal score) on the Clinical Global Impression sexual function scale. Secondary measures included the Female Sexual Function Questionnaire, the Arizona Sexual Experience scale-female version, the University of New Mexico Sexual Function Inventory-female version, a sexual activity event log, and the Hamilton Depression Rating scale. Hormone levels were also assessed.

Results  In an intention-to-treat analysis, women treated with sildenafil had a mean Clinical Global Impression–sexual function score of 1.9 (95% confidence interval [CI], 1.6-2.3) compared with those taking placebo (1.1; 95% CI, 0.8-1.5), with a mean end point difference of 0.8 (95% CI, 0.6-1.0; P = .001). Assigning baseline values carried forward to the 22% of patients who prematurely discontinued resulted in a mean end point in the sexual function score of 1.5 (95% CI, 1.1-1.9) among women taking sildenafil compared with 0.9 (95% CI, 0.6-1.3) among women taking placebo with a mean end point difference of 0.6 (95% CI, 0.3-0.8; P = .03). Baseline endocrine levels were within normal limits and did not differ between groups. The mean (SD) Hamilton scores for depression remained consistent with remission in both groups (4.0 [3.6]; P = .90). Headache, flushing, and dyspepsia were reported frequently during treatment, but no patients withdrew because of serious adverse effects.

Conclusion  In this study population, sildenafil treatment of sexual dysfunction in women taking SRIs was associated with a reduction in adverse sexual effects.

Trial Registration  clinicaltrials.gov Identifier: NCT00375297

Author Affiliations: Department of Psychiatry, Health Sciences Center, University of New Mexico School of Medicine, Albuquerque (Drs Nurnberg and Hensley, and Ms Paine); The Croft Group, San Antonio, Texas (Dr Croft); the Kinsey Institute for Research in Sex, Gender, and Reproduction, Indiana University, Bloomington (Dr Heiman); and Stanford University School of Medicine, Palo Alto, California (Dr Debattista).

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