Skip to main content
OpenTrials
Completed

NCT Number: NCT00657839

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

45 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Biberach, Baden-Württemberg / 277, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levitra (Vardenafil, BAY38-9456)

Drug

10 mg Vardenafil bid

Placebo

Drug

Matching placebo

Primary outcomes

  1. International Prostate Symptom Score and maximal urinary flow

    Time frame: 8 weeks

Secondary outcomes

  1. International Prostate Symptom Score, storing and voiding subscore

    Time frame: 8 weeks

  2. IIEF-EF domains score

    Time frame: 8 weeks

  3. Safety and tolerability

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2006
First posted
Apr 14, 2008
Registry last updated
Oct 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.