Trazodone: a double-blind, placebo-controlled, randomized study of its effects in patients with erectile dysfunction without major organic findings

This study examined the efficacy of trazodone 200 mg/day in patients with e rectile dysfunction (ED) without major organic findings. Patients and methods: Thirty-four patients with ED without major organic fi ndings entered a double-blind, placebo-controlled, randomized two-centre tr ial comparing placebo and trazodone 200 mg/day. After a 2 week treatment-fr ee, baseline period eligible patients entered a 4 week treatment-phase. Noc turnal erectile activity was measured before and after treatment by Rigisca n Plus(R). Sexual desire, quality of partner relation and depressive sympto matology were assessed with the derogatis sexual functioning inventory (DSF I), the dyadic adjustment scale (DAS) and the Hamilton depression rating sc ale (HDRS), respectively. Sexual function during the study period was asses sed with patient diaries. Compliance was measured by trazodone serum concen trations. There were no significant differences between trazodone and placebo in tota l erection duration, change in sexual desire, report of morning erections o r psychometric scales, except for the HDRS. Trazodone serum levels indicate d 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.