Status:
COMPLETED
Study Evaluating the Efficacy and Safety of Flexible-dose Vardenafil in Subjects With Erectile Dysfunction
Lead Sponsor:
Bayer
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Erectile Dysfunction
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
Study to investigate the efficacy and safety of Vardenafil
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
- Other exclusion criteria apply according to the US Product Information
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
463 Patients enrolled
Trial Details
Trial ID
NCT00658177
Start Date
June 1 2003
End Date
February 1 2004
Last Update
December 2 2014
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