Trial Condition(s):
Erectile Dysfunction
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
Bayer Identifier:
11336
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Hamburg, Germany, 20246 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Herne, Germany, 44627 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osnabrück, Germany, 49076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Offenbach, Germany, 63069 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leverkusen, Germany, 51375 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bristol, United Kingdom, BS10 5NB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Slough, United Kingdom, SL2 4HL | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taunton, United Kingdom, TA1 5DA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lancaster, United States, 17604 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbus, United States, 43214-1419 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Des Moines, United States, 50309 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LILLE, France, 59037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site SAINT GENIS LAVAL CEDEX, France, 69230 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CARPENTRAS, France, 84200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20127 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tübingen, Germany, 72076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Braunschweig, Germany, 38118 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Weiden, Germany, 92637 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 81675 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mannheim, Germany, 68167 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 81377 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dortmund, Germany, 44137 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, W6 8RF | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bath, United Kingdom, BA1 3NG | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Manchester, United Kingdom, M20 4BX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jeffersonville, United States, 47130 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Poughkeepsie, United States, 12601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Laguna Hills, United States, 92653 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cincinnati, United States, 45212-2787 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Napoli, Italy, 80131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bari, Italy, 70124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valencia, Spain, 46026 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Málaga, Spain, 29010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, Canada, N6A 4V2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Edmonton, Canada, T6G 2C8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. John, Canada, E2L 3J8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fleurimont, Canada, J1H 5N4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M4N 3M5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chicoutimi, Canada, G7H 4A3 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leiden, Netherlands, 2333 ZA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jackson, United States, 39202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Spokane, United States, 99202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oklahoma City, United States, 73104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Providence, United States, 02904 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LYON CEDEX, France, 69437 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NIMES, France, 30000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Trieste, Italy, 34149 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Firenze, Italy, 50139 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genova, Italy, 16132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28046 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valencia, Spain, 46009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vigo, Spain, 36211 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oakville, Canada, L6H 3P1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ROTTERDAM, Netherlands, 3015 GD | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göteborg, Sweden, 413 45 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lund, Sweden, 221 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göteborg, Sweden, 417 17 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moelv, Norway, 2390 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tønsberg, Norway, 3103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PRETORIA, South Africa, 0083 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cape Town, South Africa, 8001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Salzburg, Austria, 5020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Graz, Austria, 8036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tampere, Finland, 33100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oulu, Finland, FI-90100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oulu, Finland, 90220 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Calgary, Canada, T2V 4R6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Victoria, Canada, V8R 6T9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barrie, Canada, L4M 7G1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site HASSELT, Belgium, 3500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site EDEGEM, Belgium, 2650 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NIJMEGEN, Netherlands, 6525 GA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Halmstad, Sweden, 301 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Skövde, Sweden, 541 30 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Västerås, Sweden, 721 89 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Johannesburg, South Africa, 2193 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cape Town, South Africa, 7505 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pietermaritzburg, South Africa, 3200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bern, Switzerland, 3010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A randomized, double-blind, double-dummy, multicenter parallel group study to compare the tolerability and efficacy of once daily vardenafil versus vardenafil PRN versus placebo in men immediately after nerve-sparing prostatectomy for improving erectile function
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Determine whether early, NIGHTLY dosing with vardenafil Significantly improves recovery of erectile function after surgery as compared to placebo, and whether early PRN dosing with vardenafil also improves recovery of function as compared to placeboTimeframe: 9 months
Secondary Outcome
- Assess whether early dosing of either NIGHTLY or PRN vardenafil over 9 months, followed by 2 months of withdrawal, increases efficacy of subsequent PRN use significantly better than placeboTimeframe: 13 months
Additional Information
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