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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00657839

Collaborator

(none)

222

Enrollment

Locations

Arms

Duration (Months)

14.8

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

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 :

Oct 1, 2005

Actual Study Completion Date :

Jun 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Levitra (Vardenafil, BAY38-9456) 10 mg Vardenafil bid
Placebo Comparator: Arm 2	Drug: Placebo Matching placebo

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: Levitra (Vardenafil, BAY38-9456)

10 mg Vardenafil bid

Placebo Comparator: Arm 2

Drug: Placebo

Matching placebo

Outcome Measures

Primary Outcome Measures

International Prostate Symptom Score and maximal urinary flow [8 weeks]

Secondary Outcome Measures

International Prostate Symptom Score, storing and voiding subscore [8 weeks]
IIEF-EF domains score [8 weeks]
Safety and tolerability [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 64 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Biberach	Baden-Württemberg / 277	Germany	88400
2	München	Bayern / 280	Germany	81925
3	Rosenheim	Bayern / 280	Germany	83022
4	Starnberg	Bayern / 280	Germany	82319
5	Weiden	Bayern / 280	Germany	92637
6	Hamburg	Hamburg / 287	Germany	20251
7	Hamburg	Hamburg / 287	Germany	20354
8	Marburg	Hessen / 307	Germany	35039
9	Tostedt	Niedersachsen / 292	Germany	21255
10	Osnabrück	Niedersachsen / 293	Germany	49076
11	Düsseldorf	Nordrhein-Westfalen / 296	Germany	40210
12	Leverkusen	Nordrhein-Westfalen / 331	Germany	51373
13	Mülheim	Nordrhein-Westfalen / 481	Germany	45468
14	Leipzig	Sachsen / 313	Germany	04105
15	Kiel	Schleswig-Holstein / 306	Germany	24105