Clinical Trial in Males With BPH (Enlarged Prostate)

NCT ID: NCT00029822

Last Updated: 2008-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1522 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Study Completion Date

2005-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Retention Prostatic Hyperplasia Benign Prostatic Hypertrophy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Acute Urinary Retention AUR Benign Prostatic Hyperplasia Benign Prostatic Hypertrophy BPH Enlarged Prostate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alfuzosin (SL770499)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
Minimum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

sanofi-aventis

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical Affiliated Research Center, Inc

Huntsville, Alabama, United States

Site Status

San Diego Urology Center

La Mesa, California, United States

Site Status

San Bernardino Urology Associates

San Bernardino, California, United States

Site Status

San Diego Urological Medical Group

San Diego, California, United States

Site Status

Pacific Clinical Research

Santa Monica, California, United States

Site Status

Urology Research Options

Aurora, Colorado, United States

Site Status

Connecticut Clinical Research Center

Waterbury, Connecticut, United States

Site Status

South Florida Medical Research

Aventura, Florida, United States

Site Status

Tampa Bay Medical Research, Inc.

Clearwater, Florida, United States

Site Status

Advanced Research Institute

New Port Richey, Florida, United States

Site Status

Renstar Medical Research

Ocala, Florida, United States

Site Status

Renstar Medical Research

Plantation, Florida, United States

Site Status

Urology Associates

Marietta, Georgia, United States

Site Status

Northwestern Center for Clinical Research

Chicago, Illinois, United States

Site Status

Welborn Clinic

Evansville, Indiana, United States

Site Status

Northeast Indiana Research

Fort Wayne, Indiana, United States

Site Status

Urology of Indiana, LLC

Indianapolis, Indiana, United States

Site Status

Maryland Prostate Cancer

Baltimore, Maryland, United States

Site Status

Maryland Urology Association

Towson, Maryland, United States

Site Status

Newton Wellesley Urology

Newton, Massachusetts, United States

Site Status

Lakeside Urology, P.C.

Saint Joseph, Michigan, United States

Site Status

Se Urology Network

Southaven, Mississippi, United States

Site Status

Weill Cornell Medical Center

New York, New York, United States

Site Status

Advanced Clinical Trials

Eugene, Oregon, United States

Site Status

Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States

Site Status

Center for Urologic Care

West Reading, Pennsylvania, United States

Site Status

Matrix Research

Greenville, South Carolina, United States

Site Status

Ut Medical Group, Inc.

Memphis, Tennessee, United States

Site Status

Murfreesboro Medical Center

Murfreesboro, Tennessee, United States

Site Status

nTouch Research Corporation

Dallas, Texas, United States

Site Status

Urology Consultants, P.A.

San Antonio, Texas, United States

Site Status

Urology Associates

Fredericksburg, Virginia, United States

Site Status

Jeffrey Frankel

Seattle, Washington, United States

Site Status

University of Wisconsin Hospital & Clinics

Madison, Wisconsin, United States

Site Status

Midwest Research Specialists, LLC

Milwaukee, Wisconsin, United States

Site Status

Sanofi-aventis Administrative Office

Macquarie Park, , Australia

Site Status

Sanofi-aventis Administrative Office

Sofia, , Bulgaria

Site Status

Sanofi-aventis Administrative Office

Laval, , Canada

Site Status

Sanofi-aventis Administrative Office

Hørsholm, , Denmark

Site Status

Sanofi-aventis Administrative Office

Helsinki, , Finland

Site Status

Sanofi-aventis Administrative Office

Athens, , Greece

Site Status

Sanofi-aventis Administrative Office

Budapest, , Hungary

Site Status

Edith Wolfson Hospital

Holon, , Israel

Site Status

Sapir Med. Center - Meir General Hospital

Kfar Saba, , Israel

Site Status

Rabin Medical Center-Golda Campus

Petah Tikvah, , Israel

Site Status

Sourasky Med. Center-Ichilov Hospital

Tel Aviv, , Israel

Site Status

Sanofi-aventis Administrative Office

Gouda, , Netherlands

Site Status

Sanofi-aventis Administrative Office

Lysaker, , Norway

Site Status

Sanofi-aventis Administrative Office

Warsaw, , Poland

Site Status

Sanofi-aventis Administrative Office

Porto Salvo, , Portugal

Site Status

Sanofi-aventis Administrative Office

Bucharest, , Romania

Site Status

Sanofi-aventis Administrative Office

Midrand, , South Africa

Site Status

Sanofi-aventis Administrative Office

Barcelona, , Spain

Site Status

Sanofi-aventis Administrative Office

Bromma, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Bulgaria Canada Denmark Finland Greece Hungary Israel Netherlands Norway Poland Portugal Romania South Africa Spain Sweden

References

Explore related publications, articles, or registry entries linked to this study.

Roehrborn CG. Alfuzosin 10 mg once daily prevents overall clinical progression of benign prostatic hyperplasia but not acute urinary retention: results of a 2-year placebo-controlled study. BJU Int. 2006 Apr;97(4):734-41. doi: 10.1111/j.1464-410X.2006.06110.x.

Reference Type RESULT
PMID: 16536764 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SL770499

Identifier Type: -

Identifier Source: secondary_id

EFC4485

Identifier Type: -

Identifier Source: org_study_id