To assess the efficacy and tolerability of vardenafil in phosphodiesterase type-5 naïve men with erectile dysfunction (ED) and evaluate couples’ treatment satisfaction with vardenafil.

A 12-week, multicentre, randomised, double-blind, placebo-controlled study involving men aged ≥18 years with ED >6 months duration. The starting dose of vardenafil was 10 mg, which could be titrated to 5 mg or 20 mg at weeks 4 and 8. Efficacy measures included patient responses to the erectile function domain of the IIEF, and patient and partner responses to TSS questions.

Men (n=260; median age=55 years) were randomized to vardenafil (n=194) or placebo (n=66). Vardenafil significantly increased IIEF-EF scores compared with placebo (p<0.0001). At baseline, the overall mean IIEF-EF score was indicative of moderate ED. At LOCF, mean IIEF-EF scores were 23.5 (considered mild ED) and 15.8 (moderate ED) for patients treated with vardenafil and placebo, respectively. At LOCF, 56% of vardenafil-treated patients compared with 20% of placebo-treated patients had ‘normal’ erectile function, defined as an IIEF-EF score ≥26 (p<0.0001). For both men and their partners, vardenafil significantly (p<0.0001) improved TSS scores compared with placebo across all domains (satisfaction with orgasm, ease with erection, confidence, erectile function satisfaction and satisfaction with medication). Vardenafil was generally well tolerated.

Vardenafil significantly improved sexual function such that both men and their partners expressed a considerable and mutually agreed level of treatment satisfaction.

This study was supported financially by Bayer Healthcare.