Objective: To evaluate the efficacy and safety of vardenafil on men with erectile dysfunction (ED) of various etiologies.
Methods: A total of 88 men with mild to severe erectile dysfunction were enrolled in the randomized, double-blind, placebo-controlled, fixed-dose trial of 12 weeks of treatment with either placebo or 5, 10 and 20 mg of vardenafil.
Results: This study indicated that vardenafil dosages of 5, 10 and 20 mg were significantly superior to placebo for the treatment of ED, on the basis of the primary study endpoints of the EF domain score of the IIEF, diary-recorded success rates for penetration and maintenance of erection during the intercourse and the GAQ. Vardenafil was well tolerated. The incidence of adverse events was higher for vardenafil than for placebo.
Conclusion: Oral vardenafil therapy has a high efficacy and a low incidence of adverse events for ED patients with mixed etiologies.