Trial Profile

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

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 29 Aug 2023

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At a glance

06 Sep 2010 Primary endpoint 'International Index of Erectile Function' has been met.
06 Sep 2010 Secondary endpoint 'Sexual Encounter Profile' has been met.
06 Sep 2010 European Commission approves treatment in Europe, based on the results of the two POTENT studies, as reported in a Bayer Schering Plough media release

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