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:

NCT00492635

EudraCT Number:

2004-002172-42

Study Completed

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
628
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Universitätsklinikum Hamburg Eppendorf (UKE)

Hamburg, Germany, 20246

Status
Completed
 
Locations

Marienhospital Herne Klinik Börnig

Herne, Germany, 44627

Status
Completed
 
Locations

Klinikum Osnabrück GmbH

Osnabrück, Germany, 49076

Status
Completed
 
Locations

Klinikum Offenbach

Offenbach, Germany, 63069

Status
Completed
 
Locations

Klinikum Leverkusen gGmbH

Leverkusen, Germany, 51375

Status
Completed
 
Locations

Southmead Hospital

Bristol, United Kingdom, BS10 5NB

Status
Completed
 
Locations

Wexham Park Hospital

Slough, United Kingdom, SL2 4HL

Status
Completed
 
Locations

Taunton and Somerset Hospital

Taunton, United Kingdom, TA1 5DA

Status
Completed
 
Locations

Urological Associates of Lancaster

Lancaster, United States, 17604

Status
Completed
 
Locations

Columbus Urology Research, LLC

Columbus, United States, 43214-1419

Status
Completed
 
Locations

Iowa Clinic,PC/ Iowa Urololgy

Des Moines, United States, 50309

Status
Completed
 
Locations

Hôpital Claude Huriez - Lille

LILLE, France, 59037

Status
Completed
 
Locations

Hôpital Henry Gabrielle - Saint Genis Laval Cedex

SAINT GENIS LAVAL CEDEX, France, 69230

Status
Completed
 
Locations

Synergia - Carpentras

CARPENTRAS, France, 84200

Status
Completed
 
Locations

IRCCS Fondazione San Raffaele

Milano, Italy, 20127

Status
Completed
 
Locations

Klinikum der Eberhard-Karls-Universität Tübingen

Tübingen, Germany, 72076

Status
Completed
 
Locations

Städtisches Klinikum Braunschweig gGmbH

Braunschweig, Germany, 38118

Status
Completed
 
Locations

Kliniken Nordoberpfalz AG - Klinikum Weiden

Weiden, Germany, 92637

Status
Completed
 
Locations

Klinikum rechts der Isar

München, Germany, 81675

Status
Completed
 
Locations

Klinikum Mannheim gGmbH

Mannheim, Germany, 68167

Status
Completed
 
Locations

LMU Klinikum der Universität München - Großhadern

München, Germany, 81377

Status
Completed
 
Locations

Klinikum Dortmund gGmbH

Dortmund, Germany, 44137

Status
Completed
 
Locations

Charing Cross Hospital

London, United Kingdom, W6 8RF

Status
Completed
 
Locations

Royal United Hospital

Bath, United Kingdom, BA1 3NG

Status
Completed
 
Locations

Christie Hospital

Manchester, United Kingdom, M20 4BX

Status
Completed
 
Locations

Metropolitan Urology Associates, PC

Jeffersonville, United States, 47130

Status
Completed
 
Locations

Hudson Valley Urology Center

Poughkeepsie, United States, 12601

Status
Completed
 
Locations

South Coast Urological Medical Group

Laguna Hills, United States, 92653

Status
Completed
 
Locations

The Urology Group

Cincinnati, United States, 45212-2787

Status
Completed
 
Locations

A.O.U. Federico II

Napoli, Italy, 80131

Status
Completed
 
Locations

A.O.U. Policlinico Consorziale

Bari, Italy, 70124

Status
Completed
 
Locations

Hospital Universitari i Politècnic La Fe

Valencia, Spain, 46026

Status
Completed
 
Locations

Hospital Regional Carlos Haya

Málaga, Spain, 29010

Status
Completed
 
Locations

Hospital Fundació Puigvert

Barcelona, Spain, 08025

Status
Completed
 
Locations

St.Joseph's Health Care-London

London, Canada, N6A 4V2

Status
Completed
 
Locations

Edmonton Prostate & Urological Centre

Edmonton, Canada, T6G 2C8

Status
Completed
 
Locations

Coburg Street Medical Clinic

St. John, Canada, E2L 3J8

Status
Completed
 
Locations

Cente Hospitalier Universitaire de Sherbrooke-Fleurimont

Fleurimont, Canada, J1H 5N4

Status
Completed
 
Locations

Sunnybrook Health Sciences Centre

Toronto, Canada, M4N 3M5

Status
Completed
 
Locations

Clinique d'Urologie du Saguenay

Chicoutimi, Canada, G7H 4A3

Status
Completed
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

Clinique Saint-Jean/Kliniek Sint Jan

BRUXELLES - BRUSSEL, Belgium, 1000

Status
Completed
 
Locations

Leids Universitair Medisch Centrum

Leiden, Netherlands, 2333 ZA

Status
Completed
 
Locations

Mississippi Urology Clinic

Jackson, United States, 39202

Status
Completed
 
Locations

Office of Dr. Roger Fincher, MD

Spokane, United States, 99202

Status
Completed
 
Locations

Oklahoma University Health Science Center

Oklahoma City, United States, 73104

Status
Completed
 
Locations

University Urological Research Institute

Providence, United States, 02904

Status
Completed
 
Locations

Hôpital Edouard Herriot - Lyon Cedex

LYON CEDEX, France, 69437

Status
Completed
 
Locations

Hopital Carémeau - Nîmes

NIMES, France, 30000

Status
Completed
 
Locations

IRCCS Fondazione San Raffaele

Milano, Italy, 20132

Status
Completed
 
Locations

A.O.U. Ospedali Riuniti Trieste

Trieste, Italy, 34149

Status
Completed
 
Locations

A.O.U. Careggi

Firenze, Italy, 50139

Status
Completed
 
Locations

IRCCS A.O.U. San Martino – IST Ist. Nazionale Ricerca Cancro

Genova, Italy, 16132

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

Hospital Universitario "La Paz"

Madrid, Spain, 28046

Status
Completed
 
Locations

Instituto Valenciano de Oncología

Valencia, Spain, 46009

Status
Completed
 
Locations

Hospital Policlínico de Vigo - Clínica Povisa

Vigo, Spain, 36211

Status
Completed
 
Locations

The Male Health Centres

Oakville, Canada, L6H 3P1

Status
Completed
 
Locations

Erasmus Medisch Centrum

ROTTERDAM, Netherlands, 3015 GD

Status
Completed
 
Locations

Sahlgrenska Universitetssjukhuset

Göteborg, Sweden, 413 45

Status
Completed
 
Locations

Skånes Universitetssjukhus

Lund, Sweden, 221 85

Status
Completed
 
Locations

Lundby Sjukhus AB

Göteborg, Sweden, 417 17

Status
Completed
 
Locations

Moelv Spesialistsenter

Moelv, Norway, 2390

Status
Completed
 
Locations

Sykehuset i Vestfold HF, Tønsberg

Tønsberg, Norway, 3103

Status
Completed
 
Locations

Pretoria Urology Hospital

PRETORIA, South Africa, 0083

Status
Completed
 
Locations

Cape Town Medi-Clinic

Cape Town, South Africa, 8001

Status
Completed
 
Locations

Landeskrankenhaus Salzburg

Salzburg, Austria, 5020

Status
Completed
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Completed
 
Locations

Suomen Terveystalo Oyj / Gynekologi- ja Urologikeskus

Tampere, Finland, 33100

Status
Completed
 
Locations

Terveystalo Oulu

Oulu, Finland, FI-90100

Status
Completed
 
Locations

Oulun yliopistollinen sairaala

Oulu, Finland, 90220

Status
Completed
 
Locations

Prostate Cancer Institute

Calgary, Canada, T2V 4R6

Status
Completed
 
Locations

CAN-MED Clinical Research, Inc

Victoria, Canada, V8R 6T9

Status
Completed
 
Locations

Male/Female Health & Research Centre

Barrie, Canada, L4M 7G1

Status
Completed
 
Locations

CHU de Liège

LIEGE, Belgium, 4000

Status
Completed
 
Locations

Dr Van Renterghem

HASSELT, Belgium, 3500

Status
Completed
 
Locations

UZ Antwerpen

EDEGEM, Belgium, 2650

Status
Completed
 
Locations

Universitair Medisch Centrum St. Radboud

NIJMEGEN, Netherlands, 6525 GA

Status
Completed
 
Locations

Länssjukhuset

Halmstad, Sweden, 301 85

Status
Completed
 
Locations

ED-Kliniken

Skövde, Sweden, 541 30

Status
Completed
 
Locations

Centrallasarettet

Västerås, Sweden, 721 89

Status
Completed
 
Locations

University of Witwatersrand

Johannesburg, South Africa, 2193

Status
Completed
 
Locations

University of Stellenbosch

Cape Town, South Africa, 7505

Status
Completed
 
Locations

St Annes Hospital Medical Centre

Pietermaritzburg, South Africa, 3200

Status
Completed
 
Locations

Inselspital Bern

Bern, Switzerland, 3010

Status
Completed
 

Trial Design