Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome
NCT ID: NCT00738400
Last Updated: 2015-11-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
150 participants
INTERVENTIONAL
2008-11-30
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Vardenafil (Levitra, BAY38-9456)
Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
Vardenafil (Levitra, BAY38-9456)
Vardenafil 10 mg tablets daily for 4 weeks, vardenafil 5 mg / 10 mg / 20 mg tablets for consecutive 4 weeks
Placebo
Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
Placebo
Matching placebo tablets daily for 4 weeks, placebo tablets daily for consecutive 4 weeks
Interventions
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Vardenafil (Levitra, BAY38-9456)
Vardenafil 10 mg tablets daily for 4 weeks, vardenafil 5 mg / 10 mg / 20 mg tablets for consecutive 4 weeks
Placebo
Matching placebo tablets daily for 4 weeks, placebo tablets daily for consecutive 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
64 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Cham, Bavaria, Germany
Regensburg, Bavaria, Germany
Hamburg, City state of Hamburg, Germany
Frankfurt am Main, Hesse, Germany
Marburg, Hesse, Germany
Stuhr, Lower Saxony, Germany
Bonn, North Rhine-Westphalia, Germany
Grevenbroich, North Rhine-Westphalia, Germany
Leverkusen, North Rhine-Westphalia, Germany
Mülheim, North Rhine-Westphalia, Germany
Wuppertal, North Rhine-Westphalia, Germany
Dierdorf, Rhineland-Palatinate, Germany
Koblenz, Rhineland-Palatinate, Germany
Trier, Rhineland-Palatinate, Germany
Homburg, Saarland, Germany
Dresden, Saxony, Germany
Leipzig, Saxony, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Countries
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References
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Schneider T, Gleissner J, Merfort F, Hermanns M, Beneke M, Ulbrich E. Efficacy and safety of vardenafil for the treatment of erectile dysfunction in men with metabolic syndrome: results of a randomized, placebo-controlled trial. J Sex Med. 2011 Oct;8(10):2904-11. doi: 10.1111/j.1743-6109.2011.02383.x. Epub 2011 Jul 19.
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2008-002140-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ED-METABOLIC
Identifier Type: OTHER
Identifier Source: secondary_id
13171
Identifier Type: -
Identifier Source: org_study_id
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