Trial Condition(s):

Erectile Dysfunction, Metabolic Syndrome

Study of vardenafil in patients suffering from erectile dysfunction and metabolic syndrome

Bayer Identifier:

13171

ClinicalTrials.gov Identifier:

NCT00738400

EudraCT Number:

2008-002140-41

Study Completed

Trial Purpose

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 study will explore the rate of patients who do need to switch to the highest dosage based upon the expectation that most men can stay on vardenafil 10 mg PRN (pro re nata)

Inclusion Criteria
- 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 Criteria
- 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

Trial Summary

Enrollment Goal
150
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Praxis Drs. Tim Schneider /B. Schneider

Mülheim, Germany, 45468

Status
Completed
 
Locations

Praxis Drs. F. Merfort / M. Stammen / S. van Haag

Grevenbroich, Germany, 41515

Status
Completed
 
Locations

Praxis Klunder/Stephan-Odenthal

Leverkusen, Germany, 51373

Status
Completed
 
Locations

Praxis Hr. Dr. G. Böhm

Bonn, Germany, 53119

Status
Terminated
 
Locations

Praxis Hr. Dr. M. Indig

Trier, Germany, 54290

Status
Completed
 
Locations

Praxis Hr. Dr. A. von Keitz

Marburg, Germany, 35039

Status
Completed
 
Locations

Praxis Drs. Böhm & Linnè

Dresden, Germany, 01307

Status
Terminated
 
Locations

Praxis Hr. Dr. J. Gleißner

Wuppertal, Germany, 42103

Status
Completed
 
Locations

Praxis Drs. Netzer/Sachse

Homburg, Germany, 66424

Status
Completed
 
Locations

Praxis Drs. Popp/Hanika

Regensburg, Germany, 93055

Status
Completed
 
Locations

Praxis Drs. Bickeböller & Rachel GbR

Frankfurt, Germany, 60385

Status
Terminated
 
Locations

Praxis Hr. Dr. A. Rollenhagen

Berlin, Germany, 12107

Status
Completed
 
Locations

Urologische Gemeinschaftspraxis

Berlin, Germany, 14197

Status
Terminated
 
Locations

Praxis Hr. Dr. H.-P. Fischer

Koblenz, Germany, 56068

Status
Completed
 
Locations

Praxis Hr. Prof. Dr. H. Porst

Hamburg, Germany, 20354

Status
Completed
 
Locations

Praxis Hr. Dr. R. Ostwald

Dierdorf, Germany, 56269

Status
Terminated
 
Locations

Praxis Hr. Dr. J. Willgerodt

Leipzig, Germany, 04109

Status
Completed
 
Locations

Gemeinschaftspraxis Dres. M. Brandl, M. Fichtlscherer,

Cham, Germany, 93413

Status
Completed
 
Locations

Praxisgemeinschaft Stuhr-Brinkum

Stuhr, Germany, 28816

Status
Completed
 

Trial Design