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
Price :
$35
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At a glance
- Drugs Vardenafil (Primary)
- Indications Erectile dysfunction
- Focus Therapeutic Use
- Acronyms POTENT-II
- Sponsors Bayer
- 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