Improvement in Duration of Erection with Vardenafil treatment in Men with Erectile Dysfunction: findings of the Endurance Study
The objectives of this study were to evaluate the efficacy of vardenafil in men with erectile dysfunction (ED) by measurement of duration of erection leading to successful intercourse. This was a randomised, multicentre, double-blind, placebo-controlled, crossover study.
Inclusion criteria: men aged 18–64 years; ED >6 months‟ duration; International Index of Erectile Function, erectile function domain (IIEF-EF) score >5 and <26. Patients completed a 4-week runing period and were then randomised to 4 weeks‟ treatment with fixed-dose vardenafil 10 mg or placebo. After a 1-week washout period, patients were crossed over to the alternate study medication. Primary efficacy measure: stopwatch-assessed duration of erection (measured from time erection perceived hard enough for penetration until withdrawal from partner‟s vagina) leading to successful intercourse (measured by Sexual Encounter Profile question 3 [SEP3]). Secondary efficacy measures included: IIEF-EF, SEP2 and SEP3.
Intent-to-treat (ITT) population = 191 patients. Patients had ED of varying aetiology and severity (moderate/severe ED, 73%). Baseline underlying conditions included hypertension (32%), diabetes (7%) and hyperlipidemia (10%).
Over 4 weeks’ treatment, least squares mean duration of erection leading to successful intercourse was significantly longer for vardenafil than for placebo (12.81 min vs 5.45 min; p<0.001). Treatment with vardenafil was also superior to placebo in IIEF-EF, SEP2 and SEP3 measures. Vardenafil was well tolerated; the nature and incidence of adverse events were consistent with the previously demonstrated safety profile of vardenafil. Compared with placebo, vardenafil treatment produced a significantly superior duration of erection leading to successful intercourse in men with ED of broad aetiology.
