Context Antidepressant-associated sexual dysfunction isa common adverse effect that frequently results in prematuremedication treatment discontinuation and for which no treatmenthas demonstrated efficacy in women.

Objective To evaluate the efficacy of sildenafil for sexualdysfunction associated with selective and nonselective serotoninreuptake inhibitors (SRIs) in women.

Design, Setting, and Participants An 8-week prospective,parallel-group, randomized, double-blind, placebo-controlledclinical trial conducted between September 1, 2003, and January1, 2007, at 7 US research centers that included 98 previouslysexually functioning, premenopausal women (mean [SD] age 37.1[6] years) whose major depression was remitted by SRIs but whowere also experiencing sexual dysfunction.

Intervention Forty-nine patients were randomly assignedto take sildenafil or placebo at a flexible dose starting at50 mg adjustable to 100 mg before sexual activity.

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

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

Conclusion In this study population, sildenafil treatmentof sexual dysfunction in women taking SRIs was associated witha reduction in adverse sexual effects.

Source:JAMA. 2008;300(4):395-404.