Assessment of Efficacy of Vardenafil in the Treatment of Subjects With Symptomatic Benign Prostatic Hyperplasia - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00657839

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 II

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:

Drug Information available for: Vardenafil Vardenafil dihydrochloride

U.S. FDA Resources

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 ml
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

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, 20354

Hamburg, Hamburg / 287, Germany, 20251

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:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Vital GmbH
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:	April 12, 2010
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:

Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Vardenafil
Vasodilator Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012