Oral trazodone is not effective therapy for erectile dysfunction: a double-blind, placebo controlled trial.
OBJECTIVE
The unusual side effect of priapism associated with the antidepressant trazodone has led researchers to evaluate its use for the treatment of erectile dysfunction. Previous studies have shown nearly 70% efficacy in patients. Unfortunately, these studies have been anecdotal, retrospective or of combination therapy with yohimbine. A placebo controlled, fixed dose, double-blind crossover study was performed to evaluate the safety and efficacy of oral trazodone for the treatment of erectile dysfunction.


METHODS
A total of 51 patients with at least 3 months of complete erectile dysfunction were randomized in a double-blind fashion to receive 50 mg. trazodone or placebo at bedtime. Evaluation consisted of a history, physical examination and laboratory studies, including hormonal evaluation, nocturnal penile tumescence evaluation, penile Doppler ultrasound and the Index of Sexual Satisfaction. Patients were followed at monthly intervals with an in clinic interview. After a 3-month treatment interval patients were reevaluated with index scores and crossed over after a 3-week washout period. Study end points included patient diary evaluations and index scores at the beginning of the study interval and the end of the first treatment period.


RESULTS
Of the 51 patients who enrolled in the study 48 completed both phases. Mean patient age was 65 years (range 31 to 80). After the first 3-month treatment interval 19% of patients receiving trazodone had improved erections compared to 24% receiving placebo (p < 0.50). Of the trazodone group 35% had improvement in sex drive compared to 20% of the placebo group (p < 0.36). Mean Index of Sexual Satisfaction scores changed after treatment from 31.7 to 27.5 for the trazodone group (p < 0.50) and from 28.5 to 30.8 for the placebo group (p < 0.49). Side effects included drowsiness in 31% of the patients, dry mouth in 1% and fatigue in 19%.


CONCLUSIONS
Trazodone is no more effective than placebo in improving erections and sexual function in patients with severe physiological erectile dysfunction.
Costabile
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Department of Surgery, Uniformed Services University, Walter Reed Army Medical Center, Washington, D.C., USA.
Spevak
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D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018687:Antidepressive Agents, Second-Generation / Q000008:administration & dosage*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D007172:Erectile Dysfunction; D006801:Humans; D008875:Middle Aged; D017060:Patient Satisfaction; D014196:Trazodone / Q000008:administration & dosage*; D017211:Treatment Failure
D018687:Antidepressive Agents, Second-Generation; D014196:Trazodone