The Efficacy and Safety of Flexible-Dose Vardenafil (Levitra ®) in a Broad Population of European Men

Dimitrios Hatzichristou, Francesco Montorsi, Jacques Buvat, Nicole Laferriere, Tiemo Joerg Bandel, Hartmut Porst

Research output: Contribution to journalArticlepeer-review

Abstract

Background: In fixed-dose studies, vardenafil 5, 10, and 20mg improves erectile function in men with erectile dysfunction (ED). Here, the efficacy and tolerability of vardenafil when used in a flexible-dose regimen was assessed. Methods: In this multicenter trial, 323 patients randomly received vardenafil 10mg or placebo. After 4 weeks, patients could switch to 5 or 20mg (or corresponding placebo), or remain on 10mg for an additional 4 weeks; dose-switching was optional for the last 4 weeks. Efficacy variables included the IIEF-EF domain score, GAQ, and percentage of positive responses to SEP2/SEP3 questions. Results: The IIEF-EF domain score significantly improved from a baseline of moderate ED (12.6-13.1) to mild ED in men on vardenafil (21.0-24.2) compared with placebo (13.7-15.6) at weeks 4, 8, 12, and last observation carried forward (LOCF) (p

Original languageEnglish
Pages (from-to)634-641
Number of pages8
JournalEuropean Urology
Volume45
Issue number5
DOIs
Publication statusPublished - May 2004

Keywords

  • Clinical trials
  • Erectile dysfunction
  • Phosphodiesterase type 5 inhibitors
  • Vardenafil

ASJC Scopus subject areas

  • Urology

Fingerprint

Dive into the research topics of 'The Efficacy and Safety of Flexible-Dose Vardenafil (Levitra <sup>®</sup>) in a Broad Population of European Men'. Together they form a unique fingerprint.

Cite this