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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00657839

Enrollment

222

Registered

2008-04-14

Start date

2005-10-31

Completion date

2006-06-30

Last updated

2014-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

Keywords

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

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.

Interventions

DRUGLevitra (Vardenafil, BAY38-9456)

10 mg Vardenafil bid

DRUGPlacebo

Matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

45 Years to 64 Years

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

Design outcomes

Primary

Measure	Time frame
International Prostate Symptom Score and maximal urinary flow	8 weeks

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026