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Completed Phase 3 Interventional Results available

Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment

ClinicalTrials.gov ID: NCT00090103

Public ClinicalTrials.gov record NCT00090103. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 5:18 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-blind, Parallel Group Study to Investigate the Efficacy and Safety of Treatment With Dutasteride (0.5mg) and Tamsulosin (0.4mg), Administered Once Daily for 4 Years, Alone and Combination, on the Improvement of Symptoms and Clinical Outcome in Men With Moderate to Severe Symptomatic Benign Prostatic Hyperplasia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually.

Study identification

NCT ID
NCT00090103
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
GlaxoSmithKline
Industry
Enrollment
4,844 participants

Conditions and interventions

Eligibility (public fields only)

Age range
50 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 2003 (Type not available)
Primary completion
Apr 2009 (Actual)
Completion
Apr 2009 (Actual)
Last update posted
Feb 28, 2017

2003 – 2009

United States locations

U.S. sites
113
U.S. states
34
U.S. cities
101
Facility City State ZIP Site status
GSK Investigational Site Birmingham Alabama 35209 —
GSK Investigational Site Birmingham Alabama 35234 —
GSK Investigational Site Birmingham Alabama 35242 —
GSK Investigational Site Birmingham Alabama 35294 —
GSK Investigational Site Columbiana Alabama 35051 —
GSK Investigational Site Hoover Alabama 35216 —
GSK Investigational Site Anchorage Alaska 99508 —
GSK Investigational Site Phoenix Arizona 85032 —
GSK Investigational Site Phoenix, Arizona Arizona 86106 —
GSK Investigational Site Beverly Hills California 90212 —
GSK Investigational Site Concord California 94520 —
GSK Investigational Site Glendora California 91741 —
GSK Investigational Site Greenbrae California 94904 —
GSK Investigational Site Irvine California 92618 —
GSK Investigational Site La Jolla California 92093 —
GSK Investigational Site Laguna Woods California 92637 —
GSK Investigational Site Los Angelas California 90017 —
GSK Investigational Site Los Angeles California 90048 —
GSK Investigational Site Los Angeles California 90057 —
GSK Investigational Site Modesto California 95350 —
GSK Investigational Site Sacramento California 95821 —
GSK Investigational Site San Diego California 91405 —
GSK Investigational Site San Diego California 92103 —
GSK Investigational Site San Diego California 92108 —
GSK Investigational Site Torrance California 90506 —
GSK Investigational Site Vista California 92084 —
GSK Investigational Site Aventura Florida 33180 —
GSK Investigational Site Bay Pines Florida 33744 —
GSK Investigational Site Coral Gables Florida 33134 —
GSK Investigational Site Daytona Beach Florida 32114 —
GSK Investigational Site Lake Worth Florida 33461 —
GSK Investigational Site Miami Florida 33156 —
GSK Investigational Site New Smyrna Beach Florida 32168 —
GSK Investigational Site Ocala Florida 34471 —
GSK Investigational Site Orange City Florida 32763 —
GSK Investigational Site Pensacola Florida 32503 —
GSK Investigational Site Pinecrest Florida 33156 —
GSK Investigational Site Saint Augustine Florida 32086 —
GSK Investigational Site Spring Hill Florida 34609 —
GSK Investigational Site St. Petersburg Florida 33702 —
GSK Investigational Site St. Petersburg Florida 33710 —
GSK Investigational Site Stuart Florida 34996 —
GSK Investigational Site Tallahassee Florida 32308 —
GSK Investigational Site Wellington Florida 33414 —
GSK Investigational Site West Palm Beach Florida 33407 —
GSK Investigational Site Atlanta Georgia 30342 —
GSK Investigational Site Blue Ridge Georgia 30513 —
GSK Investigational Site Calhoun Georgia 30701 —
GSK Investigational Site Decatur Georgia 30033 —
GSK Investigational Site Marietta Georgia 30066 —
GSK Investigational Site Meridian Idaho 83642 —
GSK Investigational Site Belleville Illinois 62220 —
GSK Investigational Site Peoria Illinois 61602 —
GSK Investigational Site Peoria Illinois 61614 —
GSK Investigational Site Wheaton Illinois 60187 —
GSK Investigational Site Winfield Illinois 60190 —
GSK Investigational Site Evansville Indiana 47714 —
GSK Investigational Site Jeffersonville Indiana 47130 —
GSK Investigational Site Newburgh Indiana 47630 —
GSK Investigational Site South Bend Indiana 46601 —
GSK Investigational Site Des Moines Iowa 50309 —
GSK Investigational Site Wichita Kansas 67207 —
GSK Investigational Site Murray Kentucky 42071 —
GSK Investigational Site Bossier City Louisiana 71111 —
GSK Investigational Site Laurel Maryland 20724 —
GSK Investigational Site Minneapolis Minnesota 55417 —
GSK Investigational Site Picayune Mississippi 39466 —
GSK Investigational Site Kansas City Missouri 64114 —
GSK Investigational Site Missoula Montana 59802 —
GSK Investigational Site Omaha Nebraska 68102 —
GSK Investigational Site Henderson Nevada 89014 —
GSK Investigational Site Hillsborough New Jersey 08844 —
GSK Investigational Site Perth Amboy New Jersey 08861 —
GSK Investigational Site Somerville New Jersey 08876 —
GSK Investigational Site Albuquerque New Mexico 87108 —
GSK Investigational Site Bay Shore New York 11706 —
GSK Investigational Site Garden City New York 11530 —
GSK Investigational Site Great Neck New York 11021 —
GSK Investigational Site Lewiston New York 14092 —
GSK Investigational Site Asheboro North Carolina 27203 —
GSK Investigational Site Cary North Carolina 27511 —
GSK Investigational Site Charlotte North Carolina 28262 —
GSK Investigational Site Durham North Carolina 27710 —
GSK Investigational Site Fayetteville North Carolina 28304 —
GSK Investigational Site Greensboro North Carolina 27403 —
GSK Investigational Site Salisbury North Carolina 28144 —
GSK Investigational Site Bismarck North Dakota 58501 —
GSK Investigational Site Bellbrook Ohio 45305 —
GSK Investigational Site Cincinnati Ohio 45249 —
GSK Investigational Site Columbus Ohio 43212 —
GSK Investigational Site Columbus Ohio 43214 —
GSK Investigational Site Portland Oregon 97239 —
GSK Investigational Site Fleetwood Pennsylvania 19522 —
GSK Investigational Site Providence Rhode Island 02904 —
GSK Investigational Site Nashville Tennessee 37203 —
GSK Investigational Site Athes Texas 75751 —
GSK Investigational Site Dallas Texas 75230 —
GSK Investigational Site Dallas Texas 75234 —
GSK Investigational Site Dallas Texas 75390 —
GSK Investigational Site Fort Worth Texas 76107 —
GSK Investigational Site Houston Texas 77024 —
GSK Investigational Site Houston Texas 77030 —
GSK Investigational Site New Brunfels Texas 78130 —
GSK Investigational Site San Antonio Texas 78229 —
GSK Investigational Site Temple Texas 76508 —
GSK Investigational Site Texarkana Texas 75503 —
GSK Investigational Site Salt Lake City Utah 84132 —
GSK Investigational Site Alexandria Virginia 22304 —
GSK Investigational Site Bellevue Washington 98004 —
GSK Investigational Site Mountlake Terrace Washington 98043 —
GSK Investigational Site Seattle Washington 98104 —
GSK Investigational Site Spokane Washington 99204 —
GSK Investigational Site Tacoma Washington 98405 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 390 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00090103, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 28, 2017 · Synced Oct 17, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00090103 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →