Flexible-dose vardenafil in a community-based population of men affected by erectile dysfunction: A 12-week open-label, multicenter trial

Vincenzo Mirone, Alessandro Palmieri, Domenico Cucinotta, Fabio Parazzini, Patrizia Morelli, Carlo Bettocchi, Ferdinando Fusco, Francesco Montorsi

Research output: Contribution to journalArticlepeer-review


Aim. To evaluate the efficacy, safety, and tolerability of a flexible-dose regimen of vardenafil in a community-based population of men with erectile dysfunction (ED). Methods. This was a 12-week, open-label, flexible-dose, multicenter study of unselected men with ED of diverse origins and severity. Unlike previous studies, prostatectomy-induced ED and previous unresponsiveness to sildenafil were not exclusion criteria. After 4 weeks of treatment with 10 mg of vardenafil, the dose could be continued or titrated to 5 mg or 20 mg, depending on efficacy and tolerability. After 8 weeks, another dose change was possible. Efficacy was assessed with International Index of Erectile Function erectile function (IIEF-EF) domain scores, diary questions of the Sexual Encounter Profile (SEP), and a global assessment question (GAQ) about erection improve-ment during the previous 4 weeks. Results. Safety was evaluated in 497 patients, and 480 were suitable for intention-to-treat analysis. After 12 weeks of treatment, the mean per patient rate of successful intercourse, defined by an affirmative response to SEP questions 1-3, was 72%, and was related to age and ED duration. The overall success rate increased from 66% at week 4 to 77% at week 12. The mean IIEF-EF domain score of the whole population increased from 17.2 (baseline) to 24.4 (endpoint). At week 12, the best scores were obtained by patients taking 5 mg and 10 mg. At week 12, GAQ scores showed improved erection in 97.4%, 94.8%, and 78.8% of patients in the 5 mg, 10 mg, and 20 mg group, respectively. Safety was excellent: no serious drug-related event was reported, and only 2.2% of patients discontinued treatment because of side-effects. Conclusions. Vardenafil was effective and well tolerated in this community-based ED population that is truly representative of the general ED population. Dose titration meets the patient's needs and optimizes clinical outcome.

Original languageEnglish
Pages (from-to)842-847
Number of pages6
JournalJournal of Sexual Medicine
Issue number6
Publication statusPublished - Nov 2005


  • Erectile Dysfunction
  • Global Assessment Question
  • International Index of Erectile Function
  • Vardenafil

ASJC Scopus subject areas

  • Urology
  • Obstetrics and Gynaecology


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