Assessment of Efficacy of Vardenafil in the Treatment of Subjects With Symptomatic Benign Prostatic Hyperplasia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00657839
First received: April 9, 2008
Last updated: October 13, 2014
Last verified: October 2014
  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.


Condition Intervention Phase
Benign Prostatic Hyperplasia
Drug: Levitra (Vardenafil, BAY38-9456)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • International Prostate Symptom Score and maximal urinary flow [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • International Prostate Symptom Score, storing and voiding subscore [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • IIEF-EF domains score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 222
Study Start Date: October 2005
Study Completion Date: June 2006
Arms Assigned Interventions
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
10 mg Vardenafil bid
Placebo Comparator: Arm 2 Drug: Placebo
Matching placebo

  Eligibility

Ages Eligible for Study:   45 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657839

Locations
Germany
Biberach, Baden-Württemberg / 277, Germany, 88400
München, Bayern / 280, Germany, 81925
Rosenheim, Bayern / 280, Germany, 83022
Starnberg, Bayern / 280, Germany, 82319
Weiden, Bayern / 280, Germany, 92637
Hamburg, Hamburg / 287, Germany, 20251
Hamburg, Hamburg / 287, Germany, 20354
Marburg, Hessen / 307, Germany, 35039
Tostedt, Niedersachsen / 292, Germany, 21255
Osnabrück, Niedersachsen / 293, Germany, 49076
Düsseldorf, Nordrhein-Westfalen / 296, Germany, 40210
Leverkusen, Nordrhein-Westfalen / 331, Germany, 51373
Mülheim, Nordrhein-Westfalen / 481, Germany, 45468
Leipzig, Sachsen / 313, Germany, 04105
Kiel, Schleswig-Holstein / 306, Germany, 24105
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00657839     History of Changes
Other Study ID Numbers: 11863, EudraCT No. 2005-002796-32
Study First Received: April 9, 2008
Last Updated: October 13, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Benign Prostate Hyperplasia
Vardenafil
Genital Disease
Male: Signs and symptoms of Benign Prostate Hyperplasia

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Vardenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on October 19, 2014