This study examined the efficacy of trazodone 200 mg/day in patients with erectile dysfunction (ED) without major organic findings.
Patients and methods: Thirty-four patients with ED without major organic findings entered a double-blind, placebo-controlled, randomized two-centre trial comparing placebo and trazodone 200 mg/day. After a 2 week treatment-free, baseline period eligible patients entered a 4 week treatment-phase. Nocturnal erectile activity was measured before and after treatment by Rigiscan Plus. Sexual desire, quality of partner relation and depressive symptomatology were assessed with the derogatis sexual functioning inventory (DSFI), the dyadic adjustment scale (DAS) and the Hamilton depression rating scale (HDRS), respectively. Sexual function during the study period was assessed with patient diaries. Compliance was measured by trazodone serum concentrations. There were no significant differences between trazodone and placebo in total erection duration, change in sexual desire, report of morning erections or psychometric scales, except for the HDRS. Trazodone serum levels indicated that half of the patients were not compliant. In conclusion, Trazodone 200 mg/day has no effect on sexual function in men with ED without major organic findings and non-compliance was an important issue in the present study.