Objectives

Methods

A 10-week, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose study of vardenafil (5, 10 or 20 mg) was conducted in men with ED for >6 months who failed ≥50 % of intercourse attempts during a 4-week treatment-free run-in period. Sexual Encounter Profile Question 3 (SEP3) was the primary efficacy measure; secondary measures included SEP2, International Index of Erectile Function-Erectile Function (IIEF-EF) domain score, Global Assessment Question (GAQ), Global Confidence Question (GCQ) and Erection Quality Scale (EQS). Adverse-event and safety monitoring were conducted throughout.

Results

383 patients were randomized to vardenafil (n = 194) or placebo (n = 189). Patients treated with vardenafil 8 hours before sexual activity achieved clinically meaningful (≥18 % ) and statistically significantly greater least-squares mean per-patient SEP3 and SEP2 success rates over weeks 2–10, compared with patients receiving placebo (SEP3 69 % vs 34 % ; SEP2 81 % vs 51 % ; both p < 0.001). SEP3 and SEP2 measures demonstrated the significant superiority of vardenafil over placebo from week 2 onwards (p < 0.001). Measurements of IIEF-EF domain score, GAQ, GCQ and EQS showed that vardenafil led to significantly greater improvements in erectile function, compared with placebo (all p < 0.001). Vardenafil was generally well tolerated.

Conclusions

The extended duration of efficacy of vardenafil up to 8 hours postdose may provide couples with more flexibility in their sexual life than anticipated.