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

Bayer222 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

222

Conditions

Benign Prostatic Hyperplasia

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

10 mg Vardenafil bid

PlaceboDRUG

Matching placebo

Eligibility

Sex: MALEMin age: 45 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (15)

Unnamed facility

Biberach, Baden-Württemberg / 277, Germany

Unnamed facility

München, Bayern / 280, Germany

Unnamed facility

Rosenheim, Bayern / 280, Germany

Outcomes

Primary Outcomes

International Prostate Symptom Score and maximal urinary flow

Time frame: 8 weeks

Secondary Outcomes

International Prostate Symptom Score, storing and voiding subscore

Time frame: 8 weeks

IIEF-EF domains score

Time frame: 8 weeks

Safety and tolerability

Time frame: 8 weeks

Data from ClinicalTrials.gov

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