Pivotal phase III trial to investigate the efficacy and safety of an Orodispersible Tablet vardenafil versus placebo in the treatment of men with Erectile dysfunction (ED) - a fixed-dose, double-blind, raNdomized multi-center Trial - POTENT I

Registry ID

EUCTR2008-000536-40

Source registry

EUCTR

Status

Completed

Phase

PHASE3

Sponsor

Bayer HealthCare AG, D-51368 Leverkusen, Germany

Start date

2008-03-17

Completion date

2009-01-19

Last update

2026-08-16

Conditions

• Erectile Dysfunction (ED)
• Disfunción eréctil (DE) Erectile Dysfunction (ED)

Summary

The primary objective of this study is to compare the efficacy and safety of vardenafil ODT 10 mg (PRN) after 12 weeks of treatment or LOCF with placebo in a general population of men with erectile dysfunction. In this study, 50% of the men on active treatment have to be 65 years-of-age or older. Primary efficacy variables are: - IIEF-EF Domain score at visit 4 (week 12) or LOCF - SEP 2 (success rates of penetration) and SEP 3 (maintenance of erection) at visit 4 (week 12) overall (co-primary variable)

Locations

• , , Spain
• , , Belgium
• , , Germany
• , , France
• , , Netherlands

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