Trial Condition(s):
Erectile Dysfunction, Sexual Dysfunction, Physiological
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:
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 | |
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Locations Universitätsklinikum Hamburg Eppendorf (UKE) Hamburg, Germany, 20246 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Marienhospital Herne Klinik Börnig Herne, Germany, 44627 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Osnabrück GmbH Osnabrück, Germany, 49076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Offenbach Offenbach, Germany, 63069 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Leverkusen gGmbH Leverkusen, Germany, 51375 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southmead Hospital Bristol, United Kingdom, BS10 5NB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wexham Park Hospital Slough, United Kingdom, SL2 4HL | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Taunton and Somerset Hospital Taunton, United Kingdom, TA1 5DA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Urological Associates of Lancaster Lancaster, United States, 17604 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Columbus Urology Research, LLC Columbus, United States, 43214-1419 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Iowa Clinic,PC/ Iowa Urololgy Des Moines, United States, 50309 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Claude Huriez - Lille LILLE, France, 59037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Henry Gabrielle - Saint Genis Laval Cedex SAINT GENIS LAVAL CEDEX, France, 69230 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Synergia - Carpentras CARPENTRAS, France, 84200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fondazione San Raffaele Milano, Italy, 20127 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Eberhard-Karls-Universität Tübingen Tübingen, Germany, 72076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Städtisches Klinikum Braunschweig gGmbH Braunschweig, Germany, 38118 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken Nordoberpfalz AG - Klinikum Weiden Weiden, Germany, 92637 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum rechts der Isar München, Germany, 81675 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Mannheim gGmbH Mannheim, Germany, 68167 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations LMU Klinikum der Universität München - Großhadern München, Germany, 81377 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Dortmund gGmbH Dortmund, Germany, 44137 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Charing Cross Hospital London, United Kingdom, W6 8RF | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal United Hospital Bath, United Kingdom, BA1 3NG | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Christie Hospital Manchester, United Kingdom, M20 4BX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Metropolitan Urology Associates, PC Jeffersonville, United States, 47130 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hudson Valley Urology Center Poughkeepsie, United States, 12601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations South Coast Urological Medical Group Laguna Hills, United States, 92653 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Urology Group Cincinnati, United States, 45212-2787 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Federico II Napoli, Italy, 80131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico Consorziale Bari, Italy, 70124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitari i Politècnic La Fe Valencia, Spain, 46026 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Regional Carlos Haya Málaga, Spain, 29010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Fundació Puigvert Barcelona, Spain, 08025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St.Joseph's Health Care-London London, Canada, N6A 4V2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Edmonton Prostate & Urological Centre Edmonton, Canada, T6G 2C8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Coburg Street Medical Clinic St. John, Canada, E2L 3J8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cente Hospitalier Universitaire de Sherbrooke-Fleurimont Fleurimont, Canada, J1H 5N4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sunnybrook Health Sciences Centre Toronto, Canada, M4N 3M5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique d'Urologie du Saguenay Chicoutimi, Canada, G7H 4A3 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CU Saint-Luc/UZ St-Luc BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique Saint-Jean/Kliniek Sint Jan BRUXELLES - BRUSSEL, Belgium, 1000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Leids Universitair Medisch Centrum Leiden, Netherlands, 2333 ZA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mississippi Urology Clinic Jackson, United States, 39202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Roger Fincher, MD Spokane, United States, 99202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oklahoma University Health Science Center Oklahoma City, United States, 73104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University Urological Research Institute Providence, United States, 02904 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Edouard Herriot - Lyon Cedex LYON CEDEX, France, 69437 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Carémeau - Nîmes NIMES, France, 30000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fondazione San Raffaele Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Ospedali Riuniti Trieste Trieste, Italy, 34149 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Careggi Firenze, Italy, 50139 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS A.O.U. San Martino – IST Ist. Nazionale Ricerca Cancro Genova, Italy, 16132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario "La Paz" Madrid, Spain, 28046 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Valenciano de Oncología Valencia, Spain, 46009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Policlínico de Vigo - Clínica Povisa Vigo, Spain, 36211 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Male Health Centres Oakville, Canada, L6H 3P1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Erasmus Medisch Centrum ROTTERDAM, Netherlands, 3015 GD | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sahlgrenska Universitetssjukhuset Göteborg, Sweden, 413 45 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Skånes Universitetssjukhus Lund, Sweden, 221 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lundby Sjukhus AB Göteborg, Sweden, 417 17 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Moelv Spesialistsenter Moelv, Norway, 2390 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sykehuset i Vestfold HF, Tønsberg Tønsberg, Norway, 3103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pretoria Urology Hospital PRETORIA, South Africa, 0083 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cape Town Medi-Clinic Cape Town, South Africa, 8001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Landeskrankenhaus Salzburg Salzburg, Austria, 5020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Suomen Terveystalo Oyj / Gynekologi- ja Urologikeskus Tampere, Finland, 33100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Terveystalo Oulu Oulu, Finland, FI-90100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oulun yliopistollinen sairaala Oulu, Finland, 90220 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Prostate Cancer Institute Calgary, Canada, T2V 4R6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CAN-MED Clinical Research, Inc Victoria, Canada, V8R 6T9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Male/Female Health & Research Centre Barrie, Canada, L4M 7G1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CHU de Liège LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr Van Renterghem HASSELT, Belgium, 3500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Antwerpen EDEGEM, Belgium, 2650 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitair Medisch Centrum St. Radboud NIJMEGEN, Netherlands, 6525 GA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Länssjukhuset Halmstad, Sweden, 301 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ED-Kliniken Skövde, Sweden, 541 30 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centrallasarettet Västerås, Sweden, 721 89 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Witwatersrand Johannesburg, South Africa, 2193 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Stellenbosch Cape Town, South Africa, 7505 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St Annes Hospital Medical Centre Pietermaritzburg, South Africa, 3200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Inselspital Bern 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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