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Introduction: Phosphodiesterase type 5 inhibitor drugs produce vasodilatation by inhibiting the breakdown of cyclic guanosine monophosphate and have proven efficacy in treating erectile dysfunction (ED)., Aim: To evaluate the efficacy, safety, and tolerability of vardenafil in men with moderate to severe ED of broad etiology., Main Outcome Measures: The erectile function (EF) domain score, the response to Questions 13 and 14 of the International Index of Erectile Function (IIEF) questionnaire, and the proportion of "yes" responses to questions 2 and 3 of the Sexual Encounter Profile (SEP), a Global Assessment (GAQ), and Global Satisfaction Questions (GSQ) were compared at baseline and at 12 weeks of treatment with as-needed vardenafil., Methods: A total of 326 subjects with a mean age of 57.6 years and moderate to severe erectile dysfunction of various etiologies received vardenafil (5-20 mg) for 12 weeks in a prospective multicenter, open-label flexible-dose study., Results: Compared with baseline, vardenafil was superior in all efficacy outcomes. A significant mean improvement of 13.4 (P < 0.001) in the EF domain from baseline was obtained at week 12. Subjects who received 5, 10, and 20 mg vardenafil at week 12 experienced improvements of 11.9, 15.1, and 12.9 respectively in the EF domain score. Sexual intercourse was successfully completed (SEP3) in 76.3%, 80.1%, and 74.3% of subjects receiving 5, 10, and 20 mg vardenafil compared with 25.9%, 17.9%, and 19.2% at baseline, respectively. For all doses combined at week 12, the change in SEP3 from baseline was 56.7% (P < 0.001). Treatment with vardenafil was well tolerated, and headaches, flushing, nasal congestion, and dyspepsia were the most frequently observed adverse events., Conclusions: Vardenafil was effective and well tolerated in men with moderate to severe erectile dysfunction. Treatment with vardenafil was associated with a significantly higher IIEF erectile function domain score and completion of successful intercourse rate compared with baseline.