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Background: In fixed-dose studies, vardenafil 5, 10, and 20 mg improves erectile function in men with erectile dysfunction (ED). Here, the efficacy and tolerability of vardenafil when used in a flexible-dose regimen was assessed.Methods: In this multicenter trial, 323 patients randomly received vardenafil 10 mg or placebo. After 4 weeks, patients could switch to 5 or 20 mg (or corresponding placebo), or remain on 10 mg for an additional 4 weeks; dose-switching was optional for the last 4 weeks. Efficacy variables included the IIEF-EF domain score, GAQ, and percentage of positive responses to SEP2/SEP3 questions.Results: The IIEF-EF domain score significantly improved from a baseline of moderate ED (12.6–13.1) to mild ED in men on vardenafil (21.0–24.2) compared with placebo (13.7–15.6) at weeks 4, 8, 12, and last observation carried forward (LOCF) (p<0.005 vs. placebo). A significantly greater proportion of men receiving vardenafil at weeks 4, 8, 12, and LOCF reported improved erections (80–86% vs. 21–36% for placebo, p<0.005). Successful SEP2 rates increased after vardenafil, reaching 84% at weeks 8 and 12 vs. 49–53% receiving placebo (p<0.005 vs. placebo). Vardenafil improved successful SEP3 rates ranging from 58% to 74% compared to 22–34% for placebo. The most common adverse events, flushing and headache, were generally mild and transient.Conclusion: In this flexible dose study, vardenafil was well-tolerated, and produced clinically relevant improvements in erectile function in men with ED. [Copyright &y& Elsevier]