A study to assess the efficacy of vardenafil, taken as a tablet both nightly or 'as needed'
(immediately before intended sexual activity) compared to placebo, to evaluate its
tolerability and if it can help in recovery of erections after a nerve sparing radical
prostatectomy.
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Male.
Inclusion Criteria:
At Screening
- 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:
Before being randomized subjects must still be meeting all Screening Inclusion Criteria,
as well as the following criteria:
- 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 nitrates or nitric oxide donors
- 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
Salzburg 5020, Austria
Bruxelles - Brussel 1000, Belgium
Bruxelles - Brussel 1200, Belgium
Edegem 2650, Belgium
Hasselt 3500, Belgium
Leuven 3000, Belgium
Liege 4000, Belgium
St. John E2L 3J8, Canada
Victoria V8R 6T9, Canada
Oulu FI-90100, Finland
Oulu 90220, Finland
Tampere 33100, Finland
Carpentras 84200, France
Lille 59037, France
Lyon Cedex 69437, France
Nimes 30000, France
Saint Genis Laval Cedex 69230, France
Hamburg 20246, Germany
Bari 70124, Italy
Firenze 50139, Italy
Genova 16132, Italy
Milano 20127, Italy
Milano 20132, Italy
Napoli 80131, Italy
Trieste 34149, Italy
Leiden 2333 ZA, Netherlands
Nijmegen 6525 GA, Netherlands
Rotterdam 3015 GD, Netherlands
Moelv 2390, Norway
Tønsberg 3103, Norway
Barcelona 08025, Spain
Barcelona 08036, Spain
Madrid 28046, Spain
Málaga 29010, Spain
Valencia 46009, Spain
Valencia 46026, Spain
Göteborg 417 17, Sweden
Göteborg 413 45, Sweden
Halmstad 301 85, Sweden
Lund 221 85, Sweden
Skövde 541 30, Sweden
Västerås 721 89, Sweden
Bern 3010, Switzerland
London W6 8RF, United Kingdom
Manchester M20 4BX, United Kingdom
Calgary, Alberta T2V 4R6, Canada
Edmonton, Alberta T6G 2C8, Canada
Bath, Avon BA1 3NG, United Kingdom
Bristol, Avon BS10 5NB, United Kingdom
Mannheim, Baden-Württemberg 68167, Germany
Tübingen, Baden-Württemberg 72076, Germany
München, Bayern 81377, Germany
München, Bayern 81675, Germany
Weiden, Bayern 92637, Germany
Slough, Berkshire SL2 4HL, United Kingdom
Laguna Hills, California 92653, United States
Johannesburg, Gauteng 2193, South Africa
Pretoria, Gauteng 0083, South Africa
Offenbach, Hessen 63069, Germany
Jeffersonville, Indiana 47130, United States
Des Moines, Iowa 50309, United States
Pietermaritzburg, Kwazulu-Natal 3200, South Africa
Jackson, Mississippi 39202, United States
Poughkeepsie, New York 12601, United States
Braunschweig, Niedersachsen 38118, Germany
Osnabrück, Niedersachsen 49076, Germany
Dortmund, Nordrhein-Westfalen 44137, Germany
Herne, Nordrhein-Westfalen 44627, Germany
Leverkusen, Nordrhein-Westfalen 51375, Germany
Cincinnati, Ohio 45212-2787, United States
Columbus, Ohio 43214-1419, United States
Oklahoma City, Oklahoma 73104, United States
Barrie, Ontario L4M 7G1, Canada
London, Ontario N6A 4V2, Canada
Oakville, Ontario L6H 3P1, Canada
Toronto, Ontario M4N 3M5, Canada
Lancaster, Pennsylvania 17604, United States
Vigo, Pontevedra 36211, Spain
Chicoutimi, Quebec G7H 4A3, Canada
Fleurimont, Quebec J1H 5N4, Canada
Providence, Rhode Island 02904, United States
Taunton, Somerset TA1 5DA, United Kingdom
Graz, Steiermark 8036, Austria
Spokane, Washington 99202, United States
Cape Town, Western Cape 7505, South Africa
Cape Town, Western Cape 8001, South Africa