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

Primary Purpose

Benign Prostatic Hyperplasia

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Levitra (Vardenafil, BAY38-9456)

Placebo

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Benign Prostate Hyperplasia, Vardenafil, Genital Disease, Male: Signs and symptoms of Benign Prostate Hyperplasia

Eligibility Criteria

45 Years - 64 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

International Prostate Symptom Score and maximal urinary flow

Secondary Outcome Measures

International Prostate Symptom Score, storing and voiding subscore

IIEF-EF domains score

Safety and tolerability

Full Information

NCT ID

NCT00657839

First Posted

April 9, 2008

Last Updated

October 27, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00657839

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostatic Hyperplasia

Keywords

Benign Prostate Hyperplasia, Vardenafil, Genital Disease, Male: Signs and symptoms of Benign Prostate Hyperplasia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

222 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Levitra (Vardenafil, BAY38-9456)

Intervention Description

10 mg Vardenafil bid

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo

Primary Outcome Measure Information:

Title

International Prostate Symptom Score and maximal urinary flow

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

International Prostate Symptom Score, storing and voiding subscore

Time Frame

8 weeks

Title

IIEF-EF domains score

Time Frame

8 weeks

Title

Safety and tolerability

Time Frame

8 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Biberach

State/Province

Baden-Württemberg / 277

ZIP/Postal Code

88400

Country

Germany

City

München

State/Province

Bayern / 280

ZIP/Postal Code

81925

Country

Germany

City

Rosenheim

State/Province

Bayern / 280

ZIP/Postal Code

83022

Country

Germany

City

Starnberg

State/Province

Bayern / 280

ZIP/Postal Code

82319

Country

Germany

City

Weiden

State/Province

Bayern / 280

ZIP/Postal Code

92637

Country

Germany

City

Hamburg

State/Province

Hamburg / 287

ZIP/Postal Code

20251

Country

Germany

City

Hamburg

State/Province

Hamburg / 287

ZIP/Postal Code

20354

Country

Germany

City

Marburg

State/Province

Hessen / 307

ZIP/Postal Code

35039

Country

Germany

City

Tostedt

State/Province

Niedersachsen / 292

ZIP/Postal Code

21255

Country

Germany

City

Osnabrück

State/Province

Niedersachsen / 293

ZIP/Postal Code

49076

Country

Germany

City

Düsseldorf

State/Province

Nordrhein-Westfalen / 296

ZIP/Postal Code

40210

Country

Germany

City

Leverkusen

State/Province

Nordrhein-Westfalen / 331

ZIP/Postal Code

51373

Country

Germany

City

Mülheim

State/Province

Nordrhein-Westfalen / 481

ZIP/Postal Code

45468

Country

Germany

City

Leipzig

State/Province

Sachsen / 313

ZIP/Postal Code

04105

Country

Germany

City

Kiel

State/Province

Schleswig-Holstein / 306

ZIP/Postal Code

24105

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://www.clinicaltrialsregister.eu/

Description

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Learn more about this trial

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

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