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Int J Clin Pract. 2010 Apr;64(5):594-603. doi: 10.1111/j.1742-1241.2010.02358.x.

The POTENT II randomised trial: efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction.

Author information

1
Department of Urology, South Florida Medical Research, Aventura, FL, USA. mgittelman@southfloridamedicalresearch.com

Abstract

AIMS:

The aim of this study was to investigate the efficacy and safety of 10 mg vardenafil orodispersible tablet (ODT) vs. placebo in a general population of men with erectile dysfunction (ED).

METHODS:

This was a double-blind, multicentre, randomised, parallel-group, placebo-controlled study conducted at 35 centres in Australia, Canada, Mexico and the United States. Subjects aged > or =18 years, with ED for at least 6 months, were randomised to receive 12 weeks of on-demand treatment with either 10 mg vardenafil ODT or placebo. Each treatment group was stratified such that approximately half of the subjects were aged > or = 65 years. Primary efficacy variables were the erectile function domain of the International Index of Erectile Function (IIEF-EF) and Sexual Encounter Profile questions 2 (SEP2) and 3 (SEP3). Secondary variables included SEP diary questions 1, 4, 5 and 6, the patient version of the Treatment Satisfaction Scale (TSS) and the Global Assessment Question (GAQ).

RESULTS:

Of the 473 men enrolled in the study (51.4% aged > or =65 years), 331 were included in the intent-to-treat population (vardenafil ODT, n = 169; placebo, n = 162). Vardenafil ODT therapy was statistically significantly superior to placebo for all primary (i.e. IIEF-EF, SEP2, SEP3) and secondary efficacy variables (p < 0.0001). Treatment-emergent adverse events were mostly mild to moderate in severity, and comparable in both incidence and type with those of the film-coated tablet formulation.

CONCLUSIONS:

Treatment with 10 mg vardenafil ODT, taken on demand, significantly improved erectile function and was effective and well tolerated in a broad population of men with ED.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00655629.

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[Indexed for MEDLINE]

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