Efficacy and safety of sildenafil in men with serotonergic anti-depressant-associated erectile dysfunction: Results from a randomized, double-blind, placebo-controlled trial.

Objective: To evaluate the efficacy of short-term treatment with sildenafil citrate in men with serotonin reuptake inhibitor (SRI)-associated erectile dysfunction (ED). Method: Men (aged 18 years) with major depressive disorder (MDD; DSM-IV criteria) in remission and taking SRIs who experienced SRI-associated ED were enrolled in this multicenter, 6-week, randomized, flexille-dose, double, blind, placebo-controlled trial. The primary study measures were questions 3 (Q3: frequency of penetration) and 4 (Q4: frequency of maintained erections after penetration) of the International Index of Erectile Function (IIEF) questionnaire. Secondary study measures were all other questions and domains of the IIEF, the Erectile Dysfunction Index of Treatment Satisfaction (EDITS), a global A efficacy questionnaire (GEQ), and a patient maintained event log of sexual activity. Results: Patients receiving sildenafil (N = 71) versus placebo (N = 71) reported significantly higher mean SE scores on Q3 (3.9 +/- 0.2 vs. 3.1 +/- 0.2, p = .003) and Q4 (3.7 +/- 0.2 vs. 2.8 +/- 0.2, p < .001) of the IIEF and significantly higher scores on all domains of the HER Patients receiving sildenafil also reported significantly improved scores on all questions of the EDITS questionnaire (p < .02) and the GEQ (p < .0001) and an increased number of successful sexual intercourse attempts per week (p < .0001) compared with patients receiving placebo. All patients remained in MDD remission (score ! 10 on the Hamilton Rating Scale for Depression). Adverse events in patients taking sildenafil (vs. placebo) were headache (9% vs. 9%), dyspepsia (9% vs. 1%), anxiety (6% vs. 4%), and abnormal vision (3% vs. 0%). Conclusions: Short-term (6-week) administration of sildenafil was well tolerated and significantly improved erectile function and overall sexual satisfaction in men with ED associated with SRI therapy for MDD. Sildenafil may be successfully used to treat SRI-associated ED without interruption of antidepressant therapy.