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:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Klinikum der Christian-Albrechts-Universität Kiel, Germany, 24105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. S. Szymula Leipzig, Germany, 04105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Klunder/Stephan-Odenthal Leverkusen, Germany, 51373 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Urologische Praxis Hr. Dr. H.-J. Compter Biberach, Germany, 88400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Weiden Weiden, Germany, 92637 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. W. Grohmann München, Germany, 81925 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitäts-Krankenhaus Eppendorf Hamburg, Germany, 20251 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. W. te Breuil Düsseldorf, Germany, 40210 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Drs. T. Schneider /B. Schneider Mülheim, Germany, 45468 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Prof. Dr. H. Porst Hamburg, Germany, 20354 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. J. Franz Tostedt, Germany, 21255 | 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 Praxis Hr. Dr. A. von Keitz Marburg, Germany, 35039 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. Dierkopf Starnberg, Germany, 82319 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. P. Gratzke Rosenheim, Germany, 83022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A randomized, double-blind, placebo-controlled, multi-center, parallel group study to assess the efficacy of vardenafil in the treatment of subjects with symptomatic Benign Prostatic Hyperplasia
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- International Prostate Symptom Score and maximal urinary flowTimeframe: 8 weeks
Secondary Outcome
- International Prostate Symptom Score, storing and voiding subscoreTimeframe: 8 weeks
- IIEF-EF domains scoreTimeframe: 8 weeks
- Safety and tolerabilityTimeframe: 8 weeks
Additional Information
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