Study Evaluation the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction for 10 Weeks

Last updated: October 10, 2013
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Impotence

Infertility

Erectile Dysfunction

Treatment

N/A

Clinical Study ID

NCT00682019
100493
  • Ages > 18
  • Male

Study Summary

The aim of this international study was to determine if 10 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to the dummy drug (placebo) in Erectile dysfunction subjects of a broad etiology when dosed 8 (+/-2) hours prior to sexual intercourse. In addition it should have been determined, if subjects with ED from a broad etiology can tolerate 10 weeks of flexible-dose vardenafil therapy when dosed 8(+/-2) hours prior to sexual intercourse.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIHConsensus statement,

  • History of unresponsiveness to sildenafil

  • Stable sexual relationship for > 6 month.

Exclusion

Exclusion Criteria:

  • Primary hypoactive sexual desire

  • History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6month

  • Nitrate therapy.

Study Design

Total Participants: 383
Study Start date:
December 01, 2003
Estimated Completion Date:
August 31, 2004