Overview

Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older.

Status:
Completed

Trial end date:
2009-02-01

Target enrollment:

Participant gender:

Summary

This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.

Phase:

Phase 3

Details

Lead Sponsor:

Bayer

Collaborators:

GlaxoSmithKline
Schering-Plough

Treatments:

Vardenafil Dihydrochloride