Trial Condition(s):

Erectile Dysfunction

Vardenafil ODT versus placebo in males with erectile dysfunction

Bayer Identifier:

12093

ClinicalTrials.gov Identifier:

NCT00631969

EudraCT Number:

2008-000536-40

Study Completed

Trial Purpose

This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.

Inclusion Criteria
- Males 18 years-of-age or older
  - Stable, heterosexual relationship for at least 6 months
  - A history of erectile dysfunction (ED) for at least 6 months
Exclusion Criteria
- Any underlying cardiovascular condition, including unstable angina pectoris
  - History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to visit 1
  - Uncontrolled atrial fibrillation / flutter at screening
  - History of surgical prostatectomy for prostate cancer
  - Hereditary degenerative retinal disorders
  - History of loss of vision because of Non-arteritic anterior ischemic optic neuropathy (NAION), temporary or permanent loss of vision
  - Presence of penile anatomical abnormalities
  - Subjects who have been confirmed with  phenylketonuria (PKU)
  - Spinal cord injury
  - Resting or postural hypotension or hypertension
  - Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha- blockers, medication known to prolong QT interval, Human immunodeficiency virus (HIV) protease inhibitors, itraconazole  or ketoconazole, an clarithromycin and erythromycin
  - Use of any treatment for ED within 7 days of Visit 1
  - History of congenital QT prolongation
  - History of syncope within the last 6 months prior to entry into the study

Trial Summary

Enrollment Goal
362
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Vardenafil ODT (BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Klinikum Osnabrück GmbH

Osnabrück, Germany, 49076

Status
Completed
 
Locations

Praxis Hr. Dr. J. Willgerodt

Leipzig, Germany, 04109

Status
Completed
 
Locations

Urologische Praxis Dr. D. Müller

Bautzen, Germany, 02625

Status
Completed
 
Locations

Universitätsklinikum Hamburg Eppendorf (UKE)

Hamburg, Germany, 20246

Status
Completed
 
Locations

Praxis Hr. Prof. Dr. H. Porst

Hamburg, Germany, 20354

Status
Completed
 
Locations

Praxis Hr. Dr. D. Hennig

Meißen, Germany, 01662

Status
Completed
 
Locations

Kliniken Nordoberpfalz AG - Klinikum Weiden

Weiden, Germany, 92637

Status
Terminated
 
Locations

Cabinet Médical - Morgiou - Marseille

MARSEILLE, France, 13009

Status
Completed
 
Locations

Cabinet Médical - Gambetta - Lyon

LYON, France, 69000

Status
Completed
 
Locations

Cabinet Medical Rue de Cannes

LILLE, France, 59000

Status
Completed
 
Locations

Hôpital Edouard Herriot - Lyon Cedex

LYON CEDEX, France, 69437

Status
Completed
 
Locations

Cabinet Médical - Martinon - Mont de Marsan

MONT-DE-MARSAN, France, 40000

Status
Completed
 
Locations

Cabinet medical Magellan

PARIS, France, 75008

Status
Completed
 
Locations

Hospital Universitario de Canarias

La Laguna, Spain, 38320

Status
Completed
 
Locations

Hospital del Mar

Barcelona, Spain, 08003

Status
Completed
 
Locations

Kliniken Maria Hilf GmbH

Mönchengladbach, Germany, 41063

Status
Completed
 
Locations

Praxis Drs. Tim Schneider /B. Schneider

Mülheim, Germany, 45468

Status
Completed
 
Locations

Praxis Hr. Dr. W. Grohmann

München, Germany, 81925

Status
Completed
 
Locations

Cabinet Médical - Puget - Marseille

MARSEILLE, France, 13006

Status
Completed
 
Locations

CETPARP - Carolus - Lille

LILLE, France, 59000

Status
Completed
 
Locations

Hospital General Universitario de Alicante

Alicante, Spain, 03010

Status
Terminated
 
Locations

CAP Sarrià

Barcelona, Spain, 08034

Status
Terminated
 
Locations

CHU de Liège

LIEGE, Belgium, 4000

Status
Completed
 
Locations

AZ St-Lucas Campus St-Lucas

GENT, Belgium, 9000

Status
Completed
 
Locations

Clinique Saint-Jean/Kliniek Sint Jan

BRUXELLES - BRUSSEL, Belgium, 1000

Status
Completed
 
Locations

Andros Mannenkliniek Arnhem

ARNHEM, Netherlands, 6836 BH

Status
Completed
 
Locations

huisartsenpraktijk Systole

LOSSER, Netherlands, 7581 BV

Status
Completed
 
Locations

Entabeni Hospital

Durban, South Africa, 4001

Status
Completed
 
Locations

Florence Medical Centre

Johannesburg, South Africa, 1818

Status
Completed
 
Locations

Centre for Diabetes & Endocrinology

Johannesburg, South Africa, 2198

Status
Completed
 
Locations

Hospital Policlínico de Vigo - Clínica Povisa

Vigo, Spain, 36211

Status
Completed
 
Locations

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Status
Terminated
 
Locations

Hôpital Erasme/Erasmus Ziekenhuis

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Terminated
 
Locations

CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Terminated
 
Locations

Dr Bongaerts - Dr Denier

GENK, Belgium, 3600

Status
Completed
 
Locations

ZNA Middelheim

ANTWERPEN, Belgium, 2020

Status
Terminated
 
Locations

Huisartsenmaatschap L.S.V.

NIJVERDAL, Netherlands, 7442 LS

Status
Completed
 
Locations

Huisartsenpraktijk Bierens en van Cleef

Deurne, Netherlands, 5751 XJ

Status
Completed
 
Locations

Andros Mannenkliniek Leiden

LEIDEN, Netherlands, 2316 ZL

Status
Completed
 
Locations

Andros Mannenkliniek Maastricht

MAASTRICHT, Netherlands, 6212 XN

Status
Terminated
 
Locations

I. Engelbrecht Reseach (Pty) Ltd

Centurion, South Africa, 0140

Status
Completed
 
Locations

Randles Road Medical Centre

Durban, South Africa, 4091

Status
Completed
 
Locations

DJW Navorsing

Krugersdorp, South Africa, 1739

Status
Completed
 
Locations

Quatro Clinical Trials Institute

Cape Town, South Africa, 7463

Status
Completed
 
Locations

Mary Seeber Private Practice

Pretoria, South Africa, 0083

Status
Completed
 
Locations

Zuid Afrikaans Hospital

Pretoria, South Africa, 0001

Status
Completed
 
Locations

Newkwa Medical Centre

Durban, South Africa, 4037

Status
Completed
 
Locations

Intercare Medical and Dental Centre Bellville

Cape Town, South Africa, 7530

Status
Completed
 
Locations

Intercare Medical and Dental Centre Bellville

Cape Town, South Africa, 7530

Status
Terminated
 

Trial Design