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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 Sep 2, 2026, 12:16 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
Oct 31, 2003
Primary completion
Mar 31, 2009
Completion
Mar 31, 2009
Last update posted
Feb 27, 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 27, 2017 · Synced Sep 2, 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 protocol, eligibility criteria, and contact information for NCT00090103 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →