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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00657839
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : October 28, 2014
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2005
Actual Study Completion Date : June 2006

Arm Intervention/treatment
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
10 mg Vardenafil bid

Placebo Comparator: Arm 2 Drug: Placebo
Matching placebo

Primary Outcome Measures :
  1. International Prostate Symptom Score and maximal urinary flow [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. International Prostate Symptom Score, storing and voiding subscore [ Time Frame: 8 weeks ]
  2. IIEF-EF domains score [ Time Frame: 8 weeks ]
  3. Safety and tolerability [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00657839

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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
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Study Director: Bayer Study Director Bayer
Additional Information:
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Responsible Party: Bayer Identifier: NCT00657839    
Other Study ID Numbers: 11863
EudraCT No. 2005-002796-32
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014
Keywords provided by Bayer:
Benign Prostate Hyperplasia
Genital Disease
Male: Signs and symptoms of Benign Prostate Hyperplasia
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents