Clinical Trial in Males With BPH (Enlarged Prostate)

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.

Completed

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Key information

Conditions

Urinary Retention Benign Prostatic Hypertrophy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urination Disorders Urogenital Diseases Urologic Diseases

Age range

55 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-aventis Administrative Office, Macquarie Park, Australia

Who can participate

Healthy volunteers accepted: No

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

Has been suffering for at least 6 months with any of the following symptoms:
daytime or nighttime urinary frequency
urgent feeling to urinate
difficulty starting urinary stream
interruption of urinary stream
feeling of incomplete urination
Has not had a previous episode of acute urinary retention
Has not been diagnosed with prostate cancer
Has not had previous prostate surgery
Is not an insulin-dependent diabetic

Treatment and study plan

alfuzosin (SL770499)

Drug

Primary outcomes

occurrence of first episode of acute urinary retention (AUR)

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Long-Term, Efficacy and Safety of Alfuzosin 10 MG OD on the Risk of Acute Urinary Retention and the Need for Surgery in Patients With BPH. A Two Year, Randomized, Multicenter, Double-Blind, Parallel Group, Placebo-Controlled Study.

Important dates

Study start: 2001
Study completion: 2005
First posted: Jan 24, 2002
Registry last updated: Jun 9, 2008

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.

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