Clinical Trial in Males With BPH (Enlarged Prostate)

Phase 3

Completed

• Conditions: Urinary Retention; Prostatic Hyperplasia; Benign Prostatic Hypertrophy

• Registration Number: NCT00029822
• Lead Sponsor: Sanofi

Brief Summary

A study to determine the effect on prevention of Acute Urinary Retention (inability to urinate) in males with an enlarged prostate, also known as BPH.

* Free study-related medical care provided.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-05
• Study First Submitted: 2002-01-23
• Study First Submitted QC: 2002-01-23
• Study First Posted: 2002-01-24
• Study Completion: 2005-03
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-06
• Last Update Posted: 2008-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1522

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
occurrence of first episode of acute urinary retention (AUR)

Secondary Outcome Measures

Name	Time	Method
need for benign prostatic hyperplasia (BPH)-related surgery, international prostate symptoms score (IPSS)

Trial Locations

Locations (38)

Medical Affiliated Research Center, Inc; 🇺🇸 Huntsville, Alabama, United States

San Diego Urology Center; 🇺🇸 La Mesa, California, United States

San Bernardino Urology Associates; 🇺🇸 San Bernardino, California, United States

San Diego Urological Medical Group; 🇺🇸 San Diego, California, United States

Pacific Clinical Research; 🇺🇸 Santa Monica, California, United States

Urology Research Options; 🇺🇸 Aurora, Colorado, United States

Connecticut Clinical Research Center; 🇺🇸 Waterbury, Connecticut, United States

South Florida Medical Research; 🇺🇸 Aventura, Florida, United States

Tampa Bay Medical Research, Inc.; 🇺🇸 Clearwater, Florida, United States

Advanced Research Institute; 🇺🇸 New Port Richey, Florida, United States

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