A study published in the European Urology journal shows that Bayer's Levitra (vardenafil HCI) is highly effective in men with erectile dysfunction even shortly after radical nerve-sparing prostatectomy. This landmark study was a double-blind, randomized, placebo-controlled multicenter trial, investigating the tolerability and efficacy of the agent taken once nightly as a prophylactic treatment versus Levitra taken when needed vs placebo after a bilateral, nerve-sparing, radical retropubic prostatectomy.
In the first, double-blind phase of the study, 36% of men taking Levitra on demand (on demand vs placebo p<0.0001), 20% taking Levitra nightly (p<0.01) and 17% of males on placebo reported normal erectile function, defined as an International Index of Erectile Function of greater than or equal to 26, measured at last observation carried forward.
Over the entire double-blind period, the mean per patient success rates for a successful intercourse were 46% for Levitra on demand (vs placebo, p<0.0001), 34.5% for the drug nightly and 25% on placebo as measured by one question of the diary-based sexual encounter profile. However, the study did not support its primary endpoint, the concept of maintaining erectile function by an early intervention with nightly dosing of Levitra after nerve-sparing prostatectomy.
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