The efficacy and tolerability of vardenafil, a new, oral, selective phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction: the first at-home clinical trial

Vardenafil, a novel selective phosphodiesterase type 5 inhibitor, was evalu ated in its first large-scale at-home trial. A total of 601 men with mild t o severe erectile dysfunction (ED) were enrolled in this multi-centre, rand omized, double-blind, placebo-controlled trial of 12 weeks of treatment wit h either placebo or 5, 10 and 20mg of vardenafil. Primary endpoints were Q3 (vaginal penetration) and Q4 (maintenance of erection) of the Internationa l Index of Erectile Function (IIEF). In the intent-to-treat population (n = 580), the changes from baseline for 5, 10 and 20 mg vardenafil (1.2, 1.3 a nd 1.5, respectively) were all improved (P < 0.001) over placebo (0.2) for Q3 and were similarly improved for Q4 (1.4, 1.5 and 1.7) compared to placeb o (0.5) (P < 0.001). All vardenafil doses improved all IIEF domains compare d to placebo (P < 0.001). The percentage of successful intercourses was bet ween 71 and 75% for the three vardenafil doses. For the 20 mg dose, 80% of the patients experienced improved erections (GAQ) compared to 30% for place bo. Most frequent treatment-emergent adverse events were headache (7-15%), flushing (10-11%) and up to 7% for dyspepsia or rhinitis. Vardenafil treatm ent resulted in a high efficacy and low adverse-event profile in a populati on with mixed ED etiologies.