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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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Oct 2014

At a glance

  • Drugs Vardenafil (Primary)
  • Indications Erectile dysfunction
  • Focus Therapeutic Use
  • Acronyms POTENT-II
  • Sponsors Bayer
  • Most Recent Events

    • 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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