Trial Condition(s):

Benign Prostatic Hyperplasia

Assessment of efficacy of vardenafil in the treatment of subjects with symptomatic Benign Prostatic Hyperplasia

Bayer Identifier:

11863

ClinicalTrials.gov Identifier:

NCT00657839

EudraCT Number:

Not Available

Study Completed

Trial Purpose

Assessment of efficacy of vardenafil in the treatment of subjects with symptomatic Benign Prostatic Hyperplasia.The purpose of this study is to find out whether vardenafil can improve the lower urinary tract symptoms of benign prostatic hyperplasia after 8 weeks of daily administration of 10 mg BID.

Inclusion Criteria
- Males 45 to  64 years of age 
 - Lower urinary tract symptoms > 6 months
 - International Prostate Symptom Score > 12
Exclusion Criteria
- Prostate Specific Antigen > 3 ng/ml
 - Residual urine volume > 150 m
 - History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
 - Nitrate use
 - Other exclusion criteria apply acc. to Summary of Product Characteristics

Trial Summary

Enrollment Goal
222
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Klinikum der Christian-Albrechts-Universität

Kiel, Germany, 24105

Status
Completed
 
Locations

Praxis Dr. S. Szymula

Leipzig, Germany, 04105

Status
Completed
 
Locations

Praxis Klunder/Stephan-Odenthal

Leverkusen, Germany, 51373

Status
Completed
 
Locations

Urologische Praxis Hr. Dr. H.-J. Compter

Biberach, Germany, 88400

Status
Completed
 
Locations

Klinikum Weiden

Weiden, Germany, 92637

Status
Completed
 
Locations

Praxis Hr. Dr. W. Grohmann

München, Germany, 81925

Status
Completed
 
Locations

Universitäts-Krankenhaus Eppendorf

Hamburg, Germany, 20251

Status
Completed
 
Locations

Praxis Hr. Dr. W. te Breuil

Düsseldorf, Germany, 40210

Status
Completed
 
Locations

Praxis Drs. T. Schneider /B. Schneider

Mülheim, Germany, 45468

Status
Completed
 
Locations

Praxis Hr. Prof. Dr. H. Porst

Hamburg, Germany, 20354

Status
Completed
 
Locations

Praxis Hr. Dr. J. Franz

Tostedt, Germany, 21255

Status
Completed
 
Locations

Klinikum Osnabrück GmbH

Osnabrück, Germany, 49076

Status
Completed
 
Locations

Praxis Hr. Dr. A. von Keitz

Marburg, Germany, 35039

Status
Completed
 
Locations

Praxis Hr. Dr. Dierkopf

Starnberg, Germany, 82319

Status
Completed
 
Locations

Praxis Hr. Dr. P. Gratzke

Rosenheim, Germany, 83022

Status
Completed
 

Trial Design