Status:
COMPLETED
Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome
Lead Sponsor:
Bayer
Conditions:
Erectile Dysfunction
Metabolic Syndrome
Eligibility:
MALE
18-64 years
Phase:
PHASE4
Brief Summary
This is a controlled, randomized, multi-center prospective study of vardenafil to determine efficacy on Erectile Dysfunction (ED), tolerability and safety in men with ED and Metabolic Syndrome. This s...
Eligibility Criteria
Inclusion
- Stable heterosexual relationship
- History of erectile dysfunction for at least 6 months
- IIEF- EF Domain entry score (at Visit 2): \>21 points
- Documented metabolic syndrome according to the IDF (International Diabetes Foundation)
- Subjects motivated for erectile dysfunction treatment
- Documented, dated, written informed consent
Exclusion
- Any underlying cardiovascular condition
- History of myocardial infarction
- Uncontrolled atrial fibrillation
- Resting hypotension
- Postural hypotension within 6 months of Visit 1
- History of congenital QT prolongation
- Bleeding disorder
- History of prostatectomy because of prostate cancer
- Hereditary degenerative retinal disorders
- History of loss of vision because of NAION (non-arteritic anterior ischemic optic neuropathy)
- 29 Additional Exclusion Criteria
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00738400
Start Date
November 1 2008
End Date
October 1 2009
Last Update
November 16 2015
Active Locations (19)
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1
Cham, Bavaria, Germany, 93413
2
Regensburg, Bavaria, Germany, 93055
3
Hamburg, Hamburg, Germany, 20354
4
Frankfurt am Main, Hesse, Germany, 60385