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NCT00657839 Clinical Trial

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

Benign Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00657839
Other study ID # 11863
Secondary ID EudraCT No. 2005
Status Completed
Phase Phase 2
First received April 9, 2008
Last updated October 27, 2014
Start date October 2005
Est. completion date June 2006

Study information
Verified date October 2014
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 222
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 45 Years to 64 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Levitra (Vardenafil, BAY38-9456)
10 mg Vardenafil bid
• Placebo
Matching placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary International Prostate Symptom Score and maximal urinary flow 8 weeks No
Secondary International Prostate Symptom Score, storing and voiding subscore 8 weeks No
Secondary IIEF-EF domains score 8 weeks No
Secondary Safety and tolerability 8 weeks Yes
See also
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Not yet recruiting NCT04245566 - Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH Phase 3
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Completed NCT01454349 - Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH) Phase 1/Phase 2
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Active, not recruiting NCT00400894 - Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma N/A
Completed NCT00224133 - The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months Phase 3
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Completed NCT00701779 - Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia Phase 4
Terminated NCT02962674 - To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH. N/A
Active, not recruiting NCT05415748 - Deprescribing Tamsulosin in Older Men Phase 4
Recruiting NCT04853914 - Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound. N/A

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