Status:

COMPLETED

Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

Lead Sponsor:

Bayer

Collaborating Sponsors:

GlaxoSmithKline

Conditions:

Erectile Dysfunction

Eligibility:

MALE

18+ years

Phase:

PHASE2

PHASE3

Brief Summary

This study tested the hypothesis that vardenafil was both clinically effective and well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.

Eligibility Criteria

Inclusion

  • Men \>/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
  • History of unresponsiveness to sildenafil
  • Stable sexual relationship for \> 6 month

Exclusion

  • Primary hypoactive sexual desire
  • History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
  • Nitrate therapy

Key Trial Info

Start Date :

October 1 2002

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2003

Estimated Enrollment :

463 Patients enrolled

Trial Details

Trial ID

NCT00656188

Start Date

October 1 2002

End Date

May 1 2003

Last Update

October 10 2013

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