Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil vs Vardenafil PRN vs Placebo in Men Immediately After Nerve-sparing Prostatectomy for Improving ED
NCT ID: NCT00492635
Last Updated: 2014-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
628 participants
INTERVENTIONAL
2004-12-31
2007-09-30
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
TRIPLE
Study Groups
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Arm 1
Levitra (Vardenafil, BAY38-9456)
9 months DAILY dosage (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication
Arm 2
Levitra (Vardenafil, BAY38-9456)
9 months PRN dosage (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication
Arm 3
Placebo
9 months placebo (double blind)2 months single-blind placebo wash-out period (subject only is blinded)2 months open-label PRN treatment with active medication
Interventions
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Levitra (Vardenafil, BAY38-9456)
9 months DAILY dosage (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication
Levitra (Vardenafil, BAY38-9456)
9 months PRN dosage (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication
Placebo
9 months placebo (double blind)2 months single-blind placebo wash-out period (subject only is blinded)2 months open-label PRN treatment with active medication
Eligibility Criteria
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Inclusion Criteria
* Males 18-64 years of age
* Scheduled to undergo bilateral nerve-sparing radical retropubic BNSRRP, as selected according to the investigator's usual clinical practice
* Surgery scheduled within about 1 month of screening (Visit 1)
* Expressed an interest in resuming sexual activity as soon as possible after prostatectomy
* Heterosexual relationship
* No pre-operative erectile dysfunction:
* International Index of Erectile Function (IIEF) Erectile Function Domain Score score EF domain =26 at screening without any therapy/devices for improvement of erections
* No perforation of the prostate capsule by tumor
At Randomization:
* bilateral nerve-sparing during the retropubic prostatectomy documented on the operating report
* BNSRRP occurred within approximately 1 month post screening (Visit 1)
* No perforation of the prostate capsule by tumor:
No positive tumor margins confirmed after surgery: =T2 stage on pathology report from the surgery
Exclusion Criteria
* Subjects who are taking the following inhibitors of cytochrome P 450 CYP 3A4: very potent HIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed) or erythromycin
* Known hypersensitivity to Vardenafil
* Presence of significant penile anatomical abnormalities (e.g. penile fibrosis or Peyronie's disease)
* History of retinitis pigmentosa
* Unstable angina pectoris
* History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
* Severe chronic or acute liver disease
* Symptomatic postural hypotension in the past 6 months
* NYHA Class III or IV heart failure
* Life expectancy \<3 years
* Clinical diagnosis of significant untreated sleep apnea or working night shifts (e.g. 23:00h to 7:00 h)
* Anti-androgens use
* Residual prostate cancer, or requirement for radiotherapy or ADT after surgery
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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Laguna Hills, California, United States
Jeffersonville, Indiana, United States
Des Moines, Iowa, United States
Jackson, Mississippi, United States
Poughkeepsie, New York, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Lancaster, Pennsylvania, United States
Providence, Rhode Island, United States
Spokane, Washington, United States
Salzburg, Salzburg, Austria
Graz, Styria, Austria
Bruxelles - Brussel, , Belgium
Bruxelles - Brussel, , Belgium
Edegem, , Belgium
Hasselt, , Belgium
Leuven, , Belgium
Liège, , Belgium
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Barrie, Ontario, Canada
London, Ontario, Canada
Oakville, Ontario, Canada
Toronto, Ontario, Canada
Chicoutimi, Quebec, Canada
Fleurimont, Quebec, Canada
St. John's, , Canada
Victoria, , Canada
Oulu, , Finland
Oulu, , Finland
Tampere, , Finland
Carpentras, , France
Lille, , France
Lyon, , France
Nîmes, , France
Saint-Genis-Laval, , France
Mannheim, Baden-Wurttemberg, Germany
Tübingen, Baden-Wurttemberg, Germany
München, Bavaria, Germany
München, Bavaria, Germany
Weiden, Bavaria, Germany
Hamburg, City state of Hamburg, Germany
Offenbach, Hesse, Germany
Braunschweig, Lower Saxony, Germany
Osnabrück, Lower Saxony, Germany
Dortmund, North Rhine-Westphalia, Germany
Herne, North Rhine-Westphalia, Germany
Leverkusen, North Rhine-Westphalia, Germany
Bari, , Italy
Florence, , Italy
Genova, , Italy
Milan, , Italy
Milan, , Italy
Napoli, , Italy
Trieste, , Italy
Leiden, , Netherlands
Nijmegen, , Netherlands
Rotterdam, , Netherlands
Moelv, , Norway
Tønsberg, , Norway
Johannesburg, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pietermaritzburg, KwaZulu-Natal, South Africa
Cape Town, Western Cape, South Africa
Cape Town, Western Cape, South Africa
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Madrid, Madrid, Spain
Málaga, Málaga, Spain
Vigo, Pontevedra, Spain
Valencia, Valencia, Spain
Valencia, Valencia, Spain
Gothenburg, , Sweden
Gothenburg, , Sweden
Halmstad, , Sweden
Lund, , Sweden
Skövde, , Sweden
Västerås, , Sweden
Bern, Canton of Bern, Switzerland
Bath, Avon, United Kingdom
Bristol, Avon, United Kingdom
Slough, Berkshire, United Kingdom
London, London, United Kingdom
Manchester, Manchester, United Kingdom
Taunton, Somerset, United Kingdom
Countries
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Related Links
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Click here and search for information of Bayer products for Europe
Other Identifiers
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2004-002172-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
11336
Identifier Type: -
Identifier Source: org_study_id
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