check_circleStudy Completed

Benign Prostatic Hyperplasia

Bayer Identifier:

11863

ClinicalTrials.gov Identifier:

NCT00657839

EudraCT Number:

Not Available

EU CT Number:

Not Available
Assessment of efficacy of vardenafil in the treatment of subjects with symptomatic Benign Prostatic Hyperplasia

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.

Key Participants Requirements

Sex

Male

Age

45 - 64 Years
  • - Males 45 to 64 years of age
    - Lower urinary tract symptoms > 6 months
    - International Prostate Symptom Score > 12
  • - 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
October 2005 - June 2006
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Klinikum der Christian-Albrechts-UniversitätKiel, 24105, Germany
Completed
Praxis Dr. S. SzymulaLeipzig, 04105, Germany
Completed
Praxis Klunder/Stephan-OdenthalLeverkusen, 51373, Germany
Completed
Urologische Praxis Hr. Dr. H.-J. CompterBiberach, 88400, Germany
Completed
Klinikum WeidenWeiden, 92637, Germany
Completed
Praxis Hr. Dr. W. GrohmannMünchen, 81925, Germany
Completed
Universitäts-Krankenhaus EppendorfHamburg, 20251, Germany
Completed
Praxis Hr. Dr. W. te BreuilDüsseldorf, 40210, Germany
Completed
Praxis Drs. T. Schneider /B. SchneiderMülheim, 45468, Germany
Completed
Praxis Hr. Prof. Dr. H. PorstHamburg, 20354, Germany
Completed
Praxis Hr. Dr. J. FranzTostedt, 21255, Germany
Completed
Klinikum Osnabrück GmbHOsnabrück, 49076, Germany
Completed
Praxis Dr. S. SzymulaLeipzig, 04105, Germany
Completed
Praxis Hr. Dr. A. von KeitzMarburg, 35039, Germany
Completed
Praxis Hr. Dr. DierkopfStarnberg, 82319, Germany
Completed
Praxis Hr. Dr. P. GratzkeRosenheim, 83022, Germany

Primary Outcome

  • International Prostate Symptom Score and maximal urinary flow
    date_rangeTime Frame:
    8 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • International Prostate Symptom Score, storing and voiding subscore
    date_rangeTime Frame:
    8 weeks
    enhanced_encryption
    Safety Issue:
    No
  • IIEF-EF domains score
    date_rangeTime Frame:
    8 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Safety and tolerability
    date_rangeTime Frame:
    8 weeks
    enhanced_encryption
    Safety Issue:
    Yes

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

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.Click here to find information about studies related to Bayer Healthcare products conducted in Europe