Vardenafil in the treatment of erectile dysfunction in outpatients with chronic schizophrenia: a flexible-dose, open-label study.

Objective: The aim of this study was to evaluate the safety and efficacy of vardenafil in outpatients with chronic schizophrenia and erectile dysfunction and to investigate any effect on quality of life in this population.

Method: In this 12-week, open-label, flexible-dose study, 25 outpatients with chronic schizophrenia (DSM-IV criteria) and erectile dysfunction received vardenafil 10 mg as needed (at a maximum of 1 dose per day) with the option to maintain current dose or to titrate to 5 mg or 20 mg at 4 and 8 weeks. Assessment was performed with the International Index of Erectile Function (IIEF) at base line and at weeks 4, 8, and 12.