Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction
NCT ID: NCT00631969
Last Updated: 2014-12-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
362 participants
INTERVENTIONAL
2008-04-30
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Vardenafil ODT (STAXYN, BAY38-9456)
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Vardenafil ODT (STAXYN, BAY38-9456)
Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10mg orodispersible tablet (ODT)
Placebo
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Placebo
Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet
Interventions
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Vardenafil ODT (STAXYN, BAY38-9456)
Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10mg orodispersible tablet (ODT)
Placebo
Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet
Eligibility Criteria
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Inclusion Criteria
* Stable, heterosexual relationship for at least 6 months
* A history of erectile dysfunction (ED) for at least 6 months
Exclusion Criteria
* History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to visit 1
* Uncontrolled atrial fibrillation / flutter at screening
* History of surgical prostatectomy for prostate cancer
* Hereditary degenerative retinal disorders
* History of loss of vision because of Non-arteritic anterior ischemic optic neuropathy (NAION), temporary or permanent loss of vision
* Presence of penile anatomical abnormalities
* Subjects who have been confirmed with phenylketonuria (PKU)
* Spinal cord injury
* Resting or postural hypotension or hypertension
* Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha- blockers, medication known to prolong QT interval, Human immunodeficiency virus (HIV) protease inhibitors, itraconazole or ketoconazole, an clarithromycin and erythromycin
* Use of any treatment for ED within 7 days of Visit 1
* History of congenital QT prolongation
* History of syncope within the last 6 months prior to entry into the study
18 Years
MALE
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Schering-Plough
INDUSTRY
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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Antwerp, , Belgium
Bruxelles - Brussel, , Belgium
Bruxelles - Brussel, , Belgium
Bruxelles - Brussel, , Belgium
Genk, , Belgium
Ghent, , Belgium
Liège, , Belgium
Lille, , France
Lyon, , France
Lyon, , France
Marseille, , France
Marseille, , France
Mont-de-Marsan, , France
Paris, , France
München, Bavaria, Germany
Weiden, Bavaria, Germany
Hamburg, City state of Hamburg, Germany
Hamburg, City state of Hamburg, Germany
Osnabrück, Lower Saxony, Germany
Mönchengladbach, North Rhine-Westphalia, Germany
Mülheim, North Rhine-Westphalia, Germany
Bautzen, Saxony, Germany
Leipzig, Saxony, Germany
Meissen, Saxony, Germany
Arnhem, , Netherlands
Deurne, , Netherlands
Leiden, , Netherlands
Losser, , Netherlands
Maastricht, , Netherlands
Nijverdal, , Netherlands
Centurion, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Krugersdorp, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Durban, KwaZulu-Natal, South Africa
Durban, KwaZulu-Natal, South Africa
Durban, KwaZulu-Natal, South Africa
Cape Town, Western Cape, South Africa
Cape Town, Western Cape, South Africa
Alicante, Alicante, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
San Cristóbal de La Laguna, La Laguna, Spain
Valencia, Valencia, Spain
Vigo, Vigo, Spain
Countries
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References
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Debruyne FM, Gittelman M, Sperling H, Borner M, Beneke M. Time to onset of action of vardenafil: a retrospective analysis of the pivotal trials for the orodispersible and film-coated tablet formulations. J Sex Med. 2011 Oct;8(10):2912-23. doi: 10.1111/j.1743-6109.2011.02462.x. Epub 2011 Aug 30.
Sperling H, Debruyne F, Boermans A, Beneke M, Ulbrich E, Ewald S. The POTENT I randomized trial: efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction. J Sex Med. 2010 Apr;7(4 Pt 1):1497-507. doi: 10.1111/j.1743-6109.2010.01806.x. Epub 2010 Mar 3.
Heinig R, Weimann B, Dietrich H, Bottcher MF. Pharmacokinetics of a new orodispersible tablet formulation of vardenafil: results of three clinical trials. Clin Drug Investig. 2011;31(1):27-41. doi: 10.2165/11584950-000000000-00000.
Sperling H, Gittelman M, Norenberg C, Ulbrich E, Ewald S. Efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction in elderly men and those with underlying conditions: an integrated analysis of two pivotal trials. J Sex Med. 2011 Jan;8(1):261-71. doi: 10.1111/j.1743-6109.2010.02005.x. Epub 2010 Aug 30.
Related Links
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Click here and search for information of Bayer products for Europe
Other Identifiers
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2008-000536-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12093
Identifier Type: -
Identifier Source: org_study_id