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

Phase 2

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Drug: Placebo; Drug: Levitra (Vardenafil, BAY38-9456)

• Registration Number: NCT00657839
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study Completion: 2006-06
• Study First Submitted: 2008-04-09
• Study First Submitted QC: 2008-04-09
• Study First Posted: 2008-04-14
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-27
• Last Update Posted: 2014-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 222

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Placebo	-
Arm 1	Levitra (Vardenafil, BAY38-9456)	-

Primary Outcome Measures

Name	Time	Method
International Prostate Symptom Score and maximal urinary flow	8 weeks

Secondary Outcome Measures

Name	Time	Method
International Prostate Symptom Score, storing and voiding subscore	8 weeks
IIEF-EF domains score	8 weeks
Safety and tolerability	8 weeks