Status:
COMPLETED
Assessing Efficacy and Safety of Flexible Dosing With Vardenafil in Subjects With Erectile Dysfunction and Hyperlipidemia
Lead Sponsor:
Bayer
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Erectile Dysfunction
Eligibility:
MALE
18-65 years
Phase:
PHASE4
Brief Summary
This study is being conducted in US to obtain information on the efficacy, safety, and duration of erection of flexible-dose regime of vardenafil compared to placebo (dummy medication with no pharmaco...
Eligibility Criteria
Inclusion
- Males with ED for more than 6 months, according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
- Stable heterosexual relationship for more than 6 months
- Between 18 and \<65 years of age
- Diagnosed dyslipidemia and treated with a stable dose of a statin (or generic equivalent) \>/=3 months at Screening. In addition, the subject must have remained on this stable dose of statin (or its generic equivalent) throughout the study and no additional therapy to treat dyslipidemia was initiated
- InternationaI Index of Erectile Function - Erectile Function domain score of \<25, denoting mild to severe ED at Visit 2
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 :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
395 Patients enrolled
Trial Details
Trial ID
NCT00663845
Start Date
May 1 2006
End Date
April 1 2007
Last Update
October 11 2013
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