"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk

Neoplasms, Prostate Clinical Trial

— REDUCE  

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00056407
• Other study ID #: ARI40006
• Status: Completed
• Phase: Phase 3
• First received: March 11, 2003
• Last updated: April 23, 2015
• Start date: March 2003
• Est. completion date: May 2009

Study information

• Verified date: July 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaSweden: Medical Products AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8231
• Est. completion date: May 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

Inclusion criteria:

• Informed consent to participate in study.

• Have had a single negative prostate biopsy within 6 months prior to enrollment in study.

• Have a PSA (prostate specific antigen) between 2.5 and 10 if 50-60 years of age; or a PSA between 3.0 and 10 if over age 60.

• Ability and will to participate in study for 4 years.

Exclusion criteria:

• More than one previous negative prostate biopsy.

• History of prostate cancer.

• Previous prostate surgery.

• Inability to urinate requiring the need of a catheter during the previous 2 years.

• Any condition (other than benign prostatic hypertrophy) which may result in urinary symptoms or changes in urine flow rate.

• Cancer within previous 5 years (other than basal or squamous cell cancers of the skin).

• Any unstable serious medical condition.

• Use within the past 12 months of finasteride (Proscar or Propecia), dutasteride (Avodart), testosterone, or drugs that can block the action of male hormones.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Neoplasms, Prostate
• Prostatic Neoplasms

Intervention

Drug:
• Dutasteride
After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily dosing of 0.5mg of dutasteride orally for up to 4 years.
• Placebo
After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily orally for up to 4 years.

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Av Córdoba 2424	Buenos Aires
Argentina	GSK Investigational Site	Bahia Blanca	Buenos Aires
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Capital Federal	Buenos Aires
Argentina	GSK Investigational Site	Capital Federal	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Córdoba	Córdova
Argentina	GSK Investigational Site	Córdoba	Córdova
Argentina	GSK Investigational Site	Rosario	Santa Fe
Australia	GSK Investigational Site	Adelaide	South Australia
Australia	GSK Investigational Site	Darlinghurst	New South Wales
Australia	GSK Investigational Site	Herston	Queensland
Australia	GSK Investigational Site	Kippa Ring	Queensland
Australia	GSK Investigational Site	Kogarah	New South Wales
Australia	GSK Investigational Site	Mentone	Victoria
Australia	GSK Investigational Site	Parkville	Victoria
Australia	GSK Investigational Site	Randwick	New South Wales
Australia	GSK Investigational Site	Westmead	New South Wales
Australia	GSK Investigational Site	Woolloongabba	Queensland
Austria	GSK Investigational Site	Innsbruck
Austria	GSK Investigational Site	Vienna
Austria	GSK Investigational Site	Vienna
Belarus	GSK Investigational Site	Minsk
Belarus	GSK Investigational Site	Minsk
Belgium	GSK Investigational Site	Aalst
Belgium	GSK Investigational Site	Antwerpen
Belgium	GSK Investigational Site	Brussels
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Gent
Belgium	GSK Investigational Site	Hasselt
Belgium	GSK Investigational Site	Kortrijk
Belgium	GSK Investigational Site	Leuven
Belgium	GSK Investigational Site	Mons
Belgium	GSK Investigational Site	Turnhout
Belgium	GSK Investigational Site	Wilrijk
Belgium	GSK Investigational Site	Yvoir
Brazil	GSK Investigational Site	Belo Horizonte	Minas Gerais
Brazil	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul
Brazil	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul
Brazil	GSK Investigational Site	Ribeirão Preto	São Paulo
Brazil	GSK Investigational Site	Rio de Janeiro
Brazil	GSK Investigational Site	Salvador	Bahía
Brazil	GSK Investigational Site	São Paulo
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Varna
Canada	GSK Investigational Site	Barrie	Ontario
Canada	GSK Investigational Site	Burlington	Ontario
Canada	GSK Investigational Site	Burlington	Ontario
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Chicoutimi	Quebec
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Fredericton	New Brunswick
Canada	GSK Investigational Site	Granby	Quebec
Canada	GSK Investigational Site	Greenfield Park	Quebec
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Kelowna	British Columbia
Canada	GSK Investigational Site	Kingston	Ontario
Canada	GSK Investigational Site	Kitchener	Ontario
Canada	GSK Investigational Site	Laval	Quebec
Canada	GSK Investigational Site	Markham	Ontario
Canada	GSK Investigational Site	Miramichi	New Brunswick
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Newmarket	Ontario
Canada	GSK Investigational Site	Niagara Falls	Ontario
Canada	GSK Investigational Site	North Bay	Ontario
Canada	GSK Investigational Site	North York	Ontario
Canada	GSK Investigational Site	Oakville	Ontario
Canada	GSK Investigational Site	Orillia	Ontario
Canada	GSK Investigational Site	Pointe-Claire	Quebec
Canada	GSK Investigational Site	Quebec
Canada	GSK Investigational Site	Richmond Hill	Ontario
Canada	GSK Investigational Site	Saint John	New Brunswick
Canada	GSK Investigational Site	Surrey	British Columbia
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Trois Rivieres	Quebec
Canada	GSK Investigational Site	Vancouver	British Columbia
Canada	GSK Investigational Site	Victoria	British Columbia
Canada	GSK Investigational Site	Victoria	British Columbia
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Viña del Mar	Valparaíso
Croatia	GSK Investigational Site	Zagreb
Denmark	GSK Investigational Site	Herlev
Denmark	GSK Investigational Site	Middelfart
Denmark	GSK Investigational Site	Nakskov
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Kuopio
Finland	GSK Investigational Site	Lahti
Finland	GSK Investigational Site	Lappeenranta
Finland	GSK Investigational Site	Oulu
Finland	GSK Investigational Site	Oulu
Finland	GSK Investigational Site	Rovaniemi
Finland	GSK Investigational Site	Seinajoki
Finland	GSK Investigational Site	Tampere
Finland	GSK Investigational Site	Turku
France	GSK Investigational Site	Amiens
France	GSK Investigational Site	Arcachon
France	GSK Investigational Site	Auch
France	GSK Investigational Site	Besancon Cedex
France	GSK Investigational Site	Bois Bernard
France	GSK Investigational Site	Bordeaux Cedex
France	GSK Investigational Site	Boujan sur Libron
France	GSK Investigational Site	Cabestany
France	GSK Investigational Site	Caen cedex
France	GSK Investigational Site	Cannes
France	GSK Investigational Site	Carpentras
France	GSK Investigational Site	Chalon Sur Saone
France	GSK Investigational Site	Châlons-En-Champagne
France	GSK Investigational Site	Cholet
France	GSK Investigational Site	Créteil cedex
France	GSK Investigational Site	Dijon
France	GSK Investigational Site	Domarin
France	GSK Investigational Site	Dunkerque
France	GSK Investigational Site	Fourmies Cedex
France	GSK Investigational Site	Grande Synthe Cedex
France	GSK Investigational Site	Guilherand Granges
France	GSK Investigational Site	Le Havre
France	GSK Investigational Site	Le Raincy
France	GSK Investigational Site	Lille Cedex
France	GSK Investigational Site	Longjumeau
France	GSK Investigational Site	Lyon Cedex 03
France	GSK Investigational Site	Marseille
France	GSK Investigational Site	Marseille
France	GSK Investigational Site	Montauban
France	GSK Investigational Site	Montpellier
France	GSK Investigational Site	Nimes
France	GSK Investigational Site	Orleans
France	GSK Investigational Site	Orsay
France	GSK Investigational Site	Paris Cedex 10
France	GSK Investigational Site	Paris Cedex 18
France	GSK Investigational Site	Pau
France	GSK Investigational Site	Pierre Benite Cedex
France	GSK Investigational Site	Ploemeur
France	GSK Investigational Site	Poitiers Cedex
France	GSK Investigational Site	Reims
France	GSK Investigational Site	Rouen
France	GSK Investigational Site	Saint Cyr sur Loire
France	GSK Investigational Site	Saint Etienne
France	GSK Investigational Site	Saint Etienne Cedex 2
France	GSK Investigational Site	Saint Grégoire
France	GSK Investigational Site	Saint Martin d'Heres
France	GSK Investigational Site	Saint Nazaire
France	GSK Investigational Site	Saint Quentin Cedex
France	GSK Investigational Site	Suresnes
France	GSK Investigational Site	Toulouse Cedex 4
France	GSK Investigational Site	Tours
France	GSK Investigational Site	Tours
France	GSK Investigational Site	Troyes
France	GSK Investigational Site	Vannes
Germany	GSK Investigational Site	Aachen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Ahrensburg	Schleswig-Holstein
Germany	GSK Investigational Site	Aichach	Bayern
Germany	GSK Investigational Site	Arnsberg	Nordrhein-Westfalen
Germany	GSK Investigational Site	Augsburg	Bayern
Germany	GSK Investigational Site	Backnang	Baden-Wuerttemberg
Germany	GSK Investigational Site	Bad Bergzabern	Rheinland-Pfalz
Germany	GSK Investigational Site	Bad Doberan	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Bad Ems	Rheinland-Pfalz
Germany	GSK Investigational Site	Bad Griesbach	Bayern
Germany	GSK Investigational Site	Bad Homburg	Hessen
Germany	GSK Investigational Site	Bad Schoenborn	Baden-Wuerttemberg
Germany	GSK Investigational Site	Bad Schwartau	Schleswig-Holstein
Germany	GSK Investigational Site	Bamberg	Bayern
Germany	GSK Investigational Site	Bautzen	Sachsen
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bocholt	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bonn	Nordrhein-Westfalen
Germany	GSK Investigational Site	Borken	Nordrhein-Westfalen
Germany	GSK Investigational Site	Braunschweig	Niedersachsen
Germany	GSK Investigational Site	Braunschweig	Niedersachsen
Germany	GSK Investigational Site	Bremervoerde	Niedersachsen
Germany	GSK Investigational Site	Bruchsal	Baden-Wuerttemberg
Germany	GSK Investigational Site	Buchholz	Niedersachsen
Germany	GSK Investigational Site	Buxtehude	Niedersachsen
Germany	GSK Investigational Site	Chemnitz	Sachsen
Germany	GSK Investigational Site	Chemnitz	Sachsen
Germany	GSK Investigational Site	Dachau	Bayern
Germany	GSK Investigational Site	Dessau	Sachsen-Anhalt
Germany	GSK Investigational Site	Dessau	Sachsen-Anhalt
Germany	GSK Investigational Site	Dierdorf	Rheinland-Pfalz
Germany	GSK Investigational Site	Doebeln	Sachsen
Germany	GSK Investigational Site	Dortmund	Nordrhein-Westfalen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Duelmen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Duesseldorf	Nordrhein-Westfalen
Germany	GSK Investigational Site	Duesseldorf	Nordrhein-Westfalen
Germany	GSK Investigational Site	Duesseldorf	Nordrhein-Westfalen
Germany	GSK Investigational Site	Duisburg	Nordrhein-Westfalen
Germany	GSK Investigational Site	Duisburg	Nordrhein-Westfalen
Germany	GSK Investigational Site	Duisburg	Nordrhein-Westfalen
Germany	GSK Investigational Site	Ebersberg	Bayern
Germany	GSK Investigational Site	Eisleben	Sachsen-Anhalt
Germany	GSK Investigational Site	Erkrath	Nordrhein-Westfalen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Esslingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Flensburg	Schleswig-Holstein
Germany	GSK Investigational Site	Forchheim	Bayern
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Freiburg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Fuerth	Bayern
Germany	GSK Investigational Site	Ganderkesee	Niedersachsen
Germany	GSK Investigational Site	Gardelegen	Sachsen-Anhalt
Germany	GSK Investigational Site	Garmisch-Partenkirchen	Bayern
Germany	GSK Investigational Site	Gelsenkirchen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Gelsenkirchen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Gera	Thueringen
Germany	GSK Investigational Site	Goettingen	Niedersachsen
Germany	GSK Investigational Site	Gotha	Thueringen
Germany	GSK Investigational Site	Grimma	Sachsen
Germany	GSK Investigational Site	Günzburg	Bayern
Germany	GSK Investigational Site	Hagenow	Brandenburg
Germany	GSK Investigational Site	Halle	Sachsen-Anhalt
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hemmoor	Schleswig-Holstein
Germany	GSK Investigational Site	Hennigsdorf	Brandenburg
Germany	GSK Investigational Site	Herzogenaurach	Bayern
Germany	GSK Investigational Site	Hettstedt	Sachsen-Anhalt
Germany	GSK Investigational Site	Hildesheim	Niedersachsen
Germany	GSK Investigational Site	Hochheim	Hessen
Germany	GSK Investigational Site	Hoechberg	Bayern
Germany	GSK Investigational Site	Holzminden	Niedersachsen
Germany	GSK Investigational Site	Homburg	Saarland
Germany	GSK Investigational Site	Husum	Schleswig-Holstein
Germany	GSK Investigational Site	Ilmenau	Thueringen
Germany	GSK Investigational Site	Itzehoe	Schleswig-Holstein
Germany	GSK Investigational Site	Kamp-Lintfort	Nordrhein-Westfalen
Germany	GSK Investigational Site	Kelheim	Bayern
Germany	GSK Investigational Site	Kelkheim	Hessen
Germany	GSK Investigational Site	Kempen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Kiel	Schleswig-Holstein
Germany	GSK Investigational Site	Kleinblittersdorf	Baden-Wuerttemberg
Germany	GSK Investigational Site	Koblenz	Rheinland-Pfalz
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Koenigsbrunn	Bayern
Germany	GSK Investigational Site	Koenigswinter	Nordrhein-Westfalen
Germany	GSK Investigational Site	Krefeld	Nordrhein-Westfalen
Germany	GSK Investigational Site	Krefeld	Nordrhein-Westfalen
Germany	GSK Investigational Site	Langenfeld	Nordrhein-Westfalen
Germany	GSK Investigational Site	Lauenburg	Schleswig-Holstein
Germany	GSK Investigational Site	Leer	Niedersachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leuna	Sachsen-Anhalt
Germany	GSK Investigational Site	Ludwigslust	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Luebeck	Schleswig-Holstein
Germany	GSK Investigational Site	Luebeck	Schleswig-Holstein
Germany	GSK Investigational Site	Magdeburg	Sachsen-Anhalt
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Marburg	Hessen
Germany	GSK Investigational Site	Markkleeberg	Sachsen
Germany	GSK Investigational Site	Marl	Nordrhein-Westfalen
Germany	GSK Investigational Site	Meiningen	Thueringen
Germany	GSK Investigational Site	Moers	Nordrhein-Westfalen
Germany	GSK Investigational Site	Muelheim	Nordrhein-Westfalen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Naumburg	Sachsen-Anhalt
Germany	GSK Investigational Site	Neckargemuend	Baden-Wuerttemberg
Germany	GSK Investigational Site	Neumarkt	Bayern
Germany	GSK Investigational Site	Neumuenster	Schleswig-Holstein
Germany	GSK Investigational Site	Neustadt	Sachsen
Germany	GSK Investigational Site	Neustadt	Hessen
Germany	GSK Investigational Site	Nieder-Olm	Rheinland-Pfalz
Germany	GSK Investigational Site	Nuernberg	Bayern
Germany	GSK Investigational Site	Nuernberg	Bayern
Germany	GSK Investigational Site	Nuernberg	Bayern
Germany	GSK Investigational Site	Nuernberg	Bayern
Germany	GSK Investigational Site	Oberhausen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Oelsnitz	Sachsen
Germany	GSK Investigational Site	Offenbach	Hessen
Germany	GSK Investigational Site	Oranienburg	Brandenburg
Germany	GSK Investigational Site	Ostfildern	Baden-Wuerttemberg
Germany	GSK Investigational Site	Paderborn	Nordrhein-Westfalen
Germany	GSK Investigational Site	Pirna	Sachsen
Germany	GSK Investigational Site	Planegg	Bayern
Germany	GSK Investigational Site	Plauen	Sachsen
Germany	GSK Investigational Site	Ploen	Schleswig-Holstein
Germany	GSK Investigational Site	Pulheim	Nordrhein-Westfalen
Germany	GSK Investigational Site	Radebeul	Sachsen
Germany	GSK Investigational Site	Rheinfelden	Baden-Wuerttemberg
Germany	GSK Investigational Site	Ribnitz-Damgarten	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Rosenheim	Bayern
Germany	GSK Investigational Site	Rostock	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Rostock	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Roth	Bayern
Germany	GSK Investigational Site	Salzgitter	Niedersachsen
Germany	GSK Investigational Site	Schlema	Sachsen
Germany	GSK Investigational Site	Schleswig	Schleswig-Holstein
Germany	GSK Investigational Site	Schwarzenberg	Sachsen
Germany	GSK Investigational Site	Schwedt	Brandenburg
Germany	GSK Investigational Site	Schwerin	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Schwerin	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Seligenstadt	Hessen
Germany	GSK Investigational Site	Senftenberg	Brandenburg
Germany	GSK Investigational Site	Starnberg	Bayern
Germany	GSK Investigational Site	Starnberg	Bayern
Germany	GSK Investigational Site	Strausberg	Brandenburg
Germany	GSK Investigational Site	Vellmar	Hessen
Germany	GSK Investigational Site	Waldkirch	Baden-Wuerttemberg
Germany	GSK Investigational Site	Waltershausen	Thueringen
Germany	GSK Investigational Site	Wedel	Hamburg
Germany	GSK Investigational Site	Weiden	Bayern
Germany	GSK Investigational Site	Weissenburg	Bayern
Germany	GSK Investigational Site	Weissenfels	Sachsen-Anhalt
Germany	GSK Investigational Site	Wertheim	Bayern
Germany	GSK Investigational Site	Wesseling	Nordrhein-Westfalen
Germany	GSK Investigational Site	Wiesbaden	Hessen
Germany	GSK Investigational Site	Wilkau-Hasslau	Sachsen
Germany	GSK Investigational Site	Wismar	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Wolfsburg	Niedersachsen
Germany	GSK Investigational Site	Wolmirstedt	Sachsen-Anhalt
Germany	GSK Investigational Site	Wuppertal	Nordrhein-Westfalen
Germany	GSK Investigational Site	Zwickau	Sachsen
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Heraklion, Crete
Greece	GSK Investigational Site	Ioannina
Greece	GSK Investigational Site	Larisa
Greece	GSK Investigational Site	Periohi Dragana, Alexandroupolis
Greece	GSK Investigational Site	Rhodes
Greece	GSK Investigational Site	Rio, Patras
Greece	GSK Investigational Site	Thessaloniki
Greece	GSK Investigational Site	Thessaloniki
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Gyor
Hungary	GSK Investigational Site	Kecskemét
Hungary	GSK Investigational Site	Miskolc
Ireland	GSK Investigational Site	Cork
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Tallaght
Italy	GSK Investigational Site	Bari	Puglia
Italy	GSK Investigational Site	Cagliari	Sardegna
Italy	GSK Investigational Site	Caserta	Campania
Italy	GSK Investigational Site	Catania	Sicilia
Italy	GSK Investigational Site	Forlì	Emilia-Romagna
Italy	GSK Investigational Site	Isola della Scala (VR)	Veneto
Italy	GSK Investigational Site	Lanciano (CH)	Abruzzo
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Napoli	Campania
Italy	GSK Investigational Site	Napoli	Veneto
Italy	GSK Investigational Site	Pisa	Toscana
Italy	GSK Investigational Site	Ragusa (CT)	Sicilia
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Sassari	Sardegna
Italy	GSK Investigational Site	Voghera (PV)	Lombardia
Japan	GSK Investigational Site	Chiba
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Ibaraki
Japan	GSK Investigational Site	Nagasaki
Japan	GSK Investigational Site	Oita
Latvia	GSK Investigational Site	Daugavpils
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Lithuania	GSK Investigational Site	Kaunas
Lithuania	GSK Investigational Site	Siauliai
Lithuania	GSK Investigational Site	Vilnius
Lithuania	GSK Investigational Site	Vilnius
Lithuania	GSK Investigational Site	Vilnius
Mexico	GSK Investigational Site	Durango
Mexico	GSK Investigational Site	Durango
Mexico	GSK Investigational Site	Jalisco
Mexico	GSK Investigational Site	Mexico
Mexico	GSK Investigational Site	Mexico city
Mexico	GSK Investigational Site	México, City
Mexico	GSK Investigational Site	Mexico, D.F.
Mexico	GSK Investigational Site	Puebla
Mexico	GSK Investigational Site	Zapopan	Jalisco
Mexico	GSK Investigational Site	Zapopan, Jalisco	Jalisco
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Arnhem
Netherlands	GSK Investigational Site	Breda
Netherlands	GSK Investigational Site	Capelle Aan Den Ijssel
Netherlands	GSK Investigational Site	Den Bosch
Netherlands	GSK Investigational Site	Den Haag
Netherlands	GSK Investigational Site	Den Haag
Netherlands	GSK Investigational Site	EDE
Netherlands	GSK Investigational Site	Eindhoven
Netherlands	GSK Investigational Site	Harderwijk
Netherlands	GSK Investigational Site	Hengelo
Netherlands	GSK Investigational Site	Nieuwegein
Netherlands	GSK Investigational Site	Nijmegen
Netherlands	GSK Investigational Site	Nijmegen
Netherlands	GSK Investigational Site	Roermond
Netherlands	GSK Investigational Site	Roosendaal
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Stadskanaal
Netherlands	GSK Investigational Site	Tilburg
New Zealand	GSK Investigational Site	Auckland
New Zealand	GSK Investigational Site	Christchurch
New Zealand	GSK Investigational Site	Hamilton
New Zealand	GSK Investigational Site	Nelson
New Zealand	GSK Investigational Site	Tauranga
New Zealand	GSK Investigational Site	Whangarei
Norway	GSK Investigational Site	Arendal
Norway	GSK Investigational Site	Moelv
Norway	GSK Investigational Site	Oslo
Norway	GSK Investigational Site	Porsgrunn
Norway	GSK Investigational Site	Stavanger
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Checiny
Poland	GSK Investigational Site	Elblag
Poland	GSK Investigational Site	Gdansk
Poland	GSK Investigational Site	Inowroclaw
Poland	GSK Investigational Site	Katowice
Poland	GSK Investigational Site	Koscierzyna
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Rzeszow
Poland	GSK Investigational Site	Szczecin
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Wejherowo
Poland	GSK Investigational Site	Wroclaw
Portugal	GSK Investigational Site	Almada
Portugal	GSK Investigational Site	Amadora
Portugal	GSK Investigational Site	Lisboa
Portugal	GSK Investigational Site	Porto
Portugal	GSK Investigational Site	Porto
Puerto Rico	GSK Investigational Site	Ponce
Puerto Rico	GSK Investigational Site	San Juan
Puerto Rico	GSK Investigational Site	San Juan
Romania	GSK Investigational Site	Bucharest
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Nizhniy Novgorod
Russian Federation	GSK Investigational Site	Saratov
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	St. Petersburg
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Martin
Slovenia	GSK Investigational Site	Celje
Slovenia	GSK Investigational Site	Ljubljana
Slovenia	GSK Investigational Site	Maribor
Slovenia	GSK Investigational Site	Slovenj Gradec
South Africa	GSK Investigational Site	Cape Town
South Africa	GSK Investigational Site	Cape Town
South Africa	GSK Investigational Site	Capital Park
South Africa	GSK Investigational Site	George
South Africa	GSK Investigational Site	Johannesburg
South Africa	GSK Investigational Site	Parktown
South Africa	GSK Investigational Site	Pretoria
South Africa	GSK Investigational Site	Rosebank	Gauteng
South Africa	GSK Investigational Site	Westville, Durban
Spain	GSK Investigational Site	Alava
Spain	GSK Investigational Site	Alcala De Henares (Madrid)
Spain	GSK Investigational Site	Alcorcon
Spain	GSK Investigational Site	Badalona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Bilbao
Spain	GSK Investigational Site	Castellón
Spain	GSK Investigational Site	Ciudad Real
Spain	GSK Investigational Site	Don Benito (Badajoz)
Spain	GSK Investigational Site	Galdakano
Spain	GSK Investigational Site	Granada
Spain	GSK Investigational Site	Ibiza
Spain	GSK Investigational Site	Jaen
Spain	GSK Investigational Site	La Laguna (Santa Cruz de Tenerife)
Spain	GSK Investigational Site	Leganes
Spain	GSK Investigational Site	Logroño
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Malaga
Spain	GSK Investigational Site	Manacor
Spain	GSK Investigational Site	Orihuela
Spain	GSK Investigational Site	Oviedo
Spain	GSK Investigational Site	Pamplona
Spain	GSK Investigational Site	Sagunto
Spain	GSK Investigational Site	San Juan De Alicante
Spain	GSK Investigational Site	San Sebastian
Spain	GSK Investigational Site	Santa Cruz de Tenerife
Spain	GSK Investigational Site	Sevilla
Spain	GSK Investigational Site	Sevilla
Spain	GSK Investigational Site	Sevilla
Spain	GSK Investigational Site	Sevilla
Spain	GSK Investigational Site	Soria
Spain	GSK Investigational Site	Unknown
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valladolid
Spain	GSK Investigational Site	Via-Real (Castellón)
Sweden	GSK Investigational Site	Borås
Sweden	GSK Investigational Site	Eskilstuna
Sweden	GSK Investigational Site	Gävle
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Karlshamn
Sweden	GSK Investigational Site	Kristianstad
Sweden	GSK Investigational Site	Kristianstad
Sweden	GSK Investigational Site	Malmö
Sweden	GSK Investigational Site	Östersund
Sweden	GSK Investigational Site	Skärholmen
Sweden	GSK Investigational Site	Skövde
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Umeå
Sweden	GSK Investigational Site	Vålberg
Switzerland	GSK Investigational Site	Aarau
Switzerland	GSK Investigational Site	Bern
Switzerland	GSK Investigational Site	Biel
Switzerland	GSK Investigational Site	Fribourg
Switzerland	GSK Investigational Site	Genève
Switzerland	GSK Investigational Site	Lausanne
Switzerland	GSK Investigational Site	Olten
Switzerland	GSK Investigational Site	Sarnen
Switzerland	GSK Investigational Site	Zollikon
Tunisia	GSK Investigational Site	Sfax
Tunisia	GSK Investigational Site	Sousse
Tunisia	GSK Investigational Site	Tunis
Tunisia	GSK Investigational Site	Tunis
Tunisia	GSK Investigational Site	Tunis
Turkey	GSK Investigational Site	Ankara
Turkey	GSK Investigational Site	Capa/Istanbul
Turkey	GSK Investigational Site	Istanbul
Turkey	GSK Investigational Site	Izmir
Ukraine	GSK Investigational Site	Dnepropetrovsk
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Odesa
Ukraine	GSK Investigational Site	Zaporizhzhya
United Kingdom	GSK Investigational Site	Aberdeen	Aberdeenshire
United Kingdom	GSK Investigational Site	Ayr	Ayrshire
United Kingdom	GSK Investigational Site	Bath	Somerset
United Kingdom	GSK Investigational Site	Birmingham	Warwickshire
United Kingdom	GSK Investigational Site	Bradford
United Kingdom	GSK Investigational Site	Bristol
United Kingdom	GSK Investigational Site	Bristol	Gloucestershire
United Kingdom	GSK Investigational Site	Buckshaw Village, Chorley	Lancashire
United Kingdom	GSK Investigational Site	Cardiff	Glamorgan
United Kingdom	GSK Investigational Site	Chichester	Sussex West
United Kingdom	GSK Investigational Site	Clydebank, Glasgow
United Kingdom	GSK Investigational Site	Coventry	Warwickshire
United Kingdom	GSK Investigational Site	Crewe
United Kingdom	GSK Investigational Site	Edgbaston, Birmingham
United Kingdom	GSK Investigational Site	Edinburgh	Midlothian
United Kingdom	GSK Investigational Site	Exeter	Devon
United Kingdom	GSK Investigational Site	Falkirk
United Kingdom	GSK Investigational Site	Glasgow	Lanarkshire
United Kingdom	GSK Investigational Site	Lancs	Lancashire
United Kingdom	GSK Investigational Site	Leeds
United Kingdom	GSK Investigational Site	Leicester	Leicestershire
United Kingdom	GSK Investigational Site	Leytonstone	London
United Kingdom	GSK Investigational Site	Liverpool	Merseyside
United Kingdom	GSK Investigational Site	Liverpool	Merseyside
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Manchester
United Kingdom	GSK Investigational Site	Manchester	Lancashire
United Kingdom	GSK Investigational Site	Manchester	Lancashire
United Kingdom	GSK Investigational Site	Newcastle Upon Tyne	Northumberland
United Kingdom	GSK Investigational Site	Norwich	Norfolk
United Kingdom	GSK Investigational Site	Nottingham	Nottinghamshire
United Kingdom	GSK Investigational Site	Oldham	Lancashire
United Kingdom	GSK Investigational Site	Plymouth	Devon
United Kingdom	GSK Investigational Site	Portsmouth	Hampshire
United Kingdom	GSK Investigational Site	Reading	Berkshire
United Kingdom	GSK Investigational Site	Redhill	Surrey
United Kingdom	GSK Investigational Site	Sheffield
United Kingdom	GSK Investigational Site	Southampton	Hampshire
United Kingdom	GSK Investigational Site	Stevenage	Hertfordshire
United Kingdom	GSK Investigational Site	Stockport	Cheshire
United Kingdom	GSK Investigational Site	Stoke-on-Trent	Staffordshire
United Kingdom	GSK Investigational Site	Tauton	Somerset
United Kingdom	GSK Investigational Site	Torquay
United Kingdom	GSK Investigational Site	Wakefield
United Kingdom	GSK Investigational Site	Waterloo, Liverpool
United Kingdom	GSK Investigational Site	Wolverhampton
United States	GSK Investigational Site	Albany	New York
United States	GSK Investigational Site	Alexandria	Virginia
United States	GSK Investigational Site	Amarillo	Texas
United States	GSK Investigational Site	Anaheim	California
United States	GSK Investigational Site	Anchorage	Alaska
United States	GSK Investigational Site	Ann Arbor	Michigan
United States	GSK Investigational Site	Annapolis	Maryland
United States	GSK Investigational Site	Arlington	Texas
United States	GSK Investigational Site	Atherton	California
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Augusta	Georgia
United States	GSK Investigational Site	Aurora	Colorado
United States	GSK Investigational Site	Aurora	Colorado
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Aventura	Florida
United States	GSK Investigational Site	Bala Cynwyd	Pennsylvania
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Billings	Montana
United States	GSK Investigational Site	Binghamton	New York
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Bismarck	North Dakota
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Braintree	Massachusetts
United States	GSK Investigational Site	Bronx	New York
United States	GSK Investigational Site	Brooklyn	New York
United States	GSK Investigational Site	Bryn Mawr	Pennsylvania
United States	GSK Investigational Site	Camp Hill	Pennsylvania
United States	GSK Investigational Site	Cary	North Carolina
United States	GSK Investigational Site	Cary	North Carolina
United States	GSK Investigational Site	Chapel Hill	North Carolina
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Charlotte, NC 28207	North Carolina
United States	GSK Investigational Site	Charlottesville	Virginia
United States	GSK Investigational Site	Chaska	Minnesota
United States	GSK Investigational Site	Cheyenne	Wyoming
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Clearwater	Florida
United States	GSK Investigational Site	Clearwater	Florida
United States	GSK Investigational Site	Coeur d'Alene	Idaho
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Concord	North Carolina
United States	GSK Investigational Site	Covington	Louisiana
United States	GSK Investigational Site	Cranston	Rhode Island
United States	GSK Investigational Site	Culver City	California
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Delray Beach	Florida
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	East Syracuse	New York
United States	GSK Investigational Site	Edina	Minnesota
United States	GSK Investigational Site	Edison	New Jersey
United States	GSK Investigational Site	Elmont	New York
United States	GSK Investigational Site	Elyria	Ohio
United States	GSK Investigational Site	Encino	California
United States	GSK Investigational Site	Endwell	New York
United States	GSK Investigational Site	Englewood	Colorado
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Fairfax	Virginia
United States	GSK Investigational Site	Fayetteville	Georgia
United States	GSK Investigational Site	Fort Myers	Florida
United States	GSK Investigational Site	Fort Pierre	South Dakota
United States	GSK Investigational Site	Fort Wayne	Indiana
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Fountain Valley	California
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Galesburg	Illinois
United States	GSK Investigational Site	Garden City	New York
United States	GSK Investigational Site	Germantown	Tennessee
United States	GSK Investigational Site	Graham	Washington
United States	GSK Investigational Site	Great Neck	New York
United States	GSK Investigational Site	Greenbelt	Maryland
United States	GSK Investigational Site	Greensboro	North Carolina
United States	GSK Investigational Site	Greenville	North Carolina
United States	GSK Investigational Site	Greenville	South Carolina
United States	GSK Investigational Site	Greer	South Carolina
United States	GSK Investigational Site	Gretna	Louisiana
United States	GSK Investigational Site	Hackensack	New Jersey
United States	GSK Investigational Site	Harrisburg	Pennsylvania
United States	GSK Investigational Site	Harrisonburg	Virginia
United States	GSK Investigational Site	Hartford	Connecticut
United States	GSK Investigational Site	Hattiesburg	Mississippi
United States	GSK Investigational Site	Haverhill	Massachusetts
United States	GSK Investigational Site	Henderson	Nevada
United States	GSK Investigational Site	Hershey	Pennsylvania
United States	GSK Investigational Site	Homewood	Alabama
United States	GSK Investigational Site	Honolulu	Hawaii
United States	GSK Investigational Site	Houma	Louisiana
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Huntsville	Alabama
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Irvine	California
United States	GSK Investigational Site	Jackson	Mississippi
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jeffersonville	Indiana
United States	GSK Investigational Site	Kankakee	Illinois
United States	GSK Investigational Site	Kansas City	Kansas
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	Kettering	Ohio
United States	GSK Investigational Site	Knoxville	Tennessee
United States	GSK Investigational Site	La Mesa	California
United States	GSK Investigational Site	Lafayette	Louisiana
United States	GSK Investigational Site	Laguna Hills	California
United States	GSK Investigational Site	Lake Worth	Florida
United States	GSK Investigational Site	Lancaster	Pennsylvania
United States	GSK Investigational Site	Lancaster	Pennsylvania
United States	GSK Investigational Site	Largo	Florida
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Lawrencevill	New Jersey
United States	GSK Investigational Site	Lebanon	New Hampshire
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Longmont	Colorado
United States	GSK Investigational Site	Longwood	Florida
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Margate	Florida
United States	GSK Investigational Site	Marietta	Georgia
United States	GSK Investigational Site	Marion	Ohio
United States	GSK Investigational Site	Marlton	New Jersey
United States	GSK Investigational Site	Mather	California
United States	GSK Investigational Site	Maywood	Illinois
United States	GSK Investigational Site	Mechanicsville	Virginia
United States	GSK Investigational Site	Melbourne	Florida
United States	GSK Investigational Site	Melrose Park	Illinois
United States	GSK Investigational Site	Memphis	Tennessee
United States	GSK Investigational Site	Metairie	Louisiana
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Middlebury	Connecticut
United States	GSK Investigational Site	Milford	Massachusetts
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Mineola	New York
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Mobile	Alabama
United States	GSK Investigational Site	Monroeville	Pennsylvania
United States	GSK Investigational Site	Myrtle Beach	South Carolina
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	New Britain	Connecticut
United States	GSK Investigational Site	New Orleans	Louisiana
United States	GSK Investigational Site	New Orleans	Louisiana
United States	GSK Investigational Site	New Orleans	Louisiana
United States	GSK Investigational Site	New Port Richey	Florida
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Newport Beach	California
United States	GSK Investigational Site	Newton	Massachusetts
United States	GSK Investigational Site	Newton	Pennsylvania
United States	GSK Investigational Site	Niles	Illinois
United States	GSK Investigational Site	Norfolk	Virginia
United States	GSK Investigational Site	Ocala	Florida
United States	GSK Investigational Site	Ocala	Florida
United States	GSK Investigational Site	Okeechobee	Florida
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Orange	California
United States	GSK Investigational Site	Orange Park	Florida
United States	GSK Investigational Site	Orchard Park	New York
United States	GSK Investigational Site	Oregon City	Oregon
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Overland Park	Kansas
United States	GSK Investigational Site	Owings Mills	Maryland
United States	GSK Investigational Site	Panama City	Florida
United States	GSK Investigational Site	Perth Amboy	New Jersey
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Pico Rivera	California
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Plantation	Florida
United States	GSK Investigational Site	Poca City	Oklahoma
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Poughkeepsie	New York
United States	GSK Investigational Site	Poway	California
United States	GSK Investigational Site	Providence	Rhode Island
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Reno	Nevada
United States	GSK Investigational Site	Reno	Nevada
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Rochester	Minnesota
United States	GSK Investigational Site	Rockville	Maryland
United States	GSK Investigational Site	Rosemont	Pennsylvania
United States	GSK Investigational Site	Roswell	Georgia
United States	GSK Investigational Site	Royal Oak	Michigan
United States	GSK Investigational Site	Ruston	Louisiana
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	Salem	Virginia
United States	GSK Investigational Site	Salinas	California
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Bernardino	California
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	San Ramon	California
United States	GSK Investigational Site	Santa Monica	California
United States	GSK Investigational Site	Sarasota	Florida
United States	GSK Investigational Site	Scottsdale	Arizona
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Sellersville	Pennsylvania
United States	GSK Investigational Site	Shreveport	Louisiana
United States	GSK Investigational Site	Simpsonville	South Carolina
United States	GSK Investigational Site	South Burlington	Vermont
United States	GSK Investigational Site	South Daytona	Florida
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Springfield	Oregon
United States	GSK Investigational Site	Springfield	Illinois
United States	GSK Investigational Site	Springfield	Missouri
United States	GSK Investigational Site	Springfield	Massachusetts
United States	GSK Investigational Site	St. Cloud	Minnesota
United States	GSK Investigational Site	St. Joseph	Michigan
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	St. Petersburg	Florida
United States	GSK Investigational Site	Stanford	California
United States	GSK Investigational Site	State College	Pennsylvania
United States	GSK Investigational Site	Staten Island	New York
United States	GSK Investigational Site	Stuart	Florida
United States	GSK Investigational Site	Sun City	Arizona
United States	GSK Investigational Site	Syracuse	New York
United States	GSK Investigational Site	Tacoma	Washington
United States	GSK Investigational Site	Tacoma	Washington
United States	GSK Investigational Site	Tacoma	Washington
United States	GSK Investigational Site	Tallahassee	Florida
United States	GSK Investigational Site	Tamarac	Florida
United States	GSK Investigational Site	Temecula	California
United States	GSK Investigational Site	Texarkana	Texas
United States	GSK Investigational Site	Torrance	California
United States	GSK Investigational Site	Towson	Maryland
United States	GSK Investigational Site	Trumbull	Connecticut
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Tulsa	Oklahoma
United States	GSK Investigational Site	Upland	California
United States	GSK Investigational Site	Van Nuys	California
United States	GSK Investigational Site	Virginia Beach	Virginia
United States	GSK Investigational Site	Voorhees	New Jersey
United States	GSK Investigational Site	Walnut Creek	California
United States	GSK Investigational Site	Waltham	Massachusetts
United States	GSK Investigational Site	Washington	District of Columbia
United States	GSK Investigational Site	Watertown	Massachusetts
United States	GSK Investigational Site	West Orange	New Jersey
United States	GSK Investigational Site	West Palm Beach	Florida
United States	GSK Investigational Site	West Warwick	Rhode Island
United States	GSK Investigational Site	West Yarmouth	Massachusetts
United States	GSK Investigational Site	Westchester	California
United States	GSK Investigational Site	Wichita	Kansas
United States	GSK Investigational Site	Winston-Salem	North Carolina
United States	GSK Investigational Site	Wocester	Massachusetts
United States	GSK Investigational Site	Woodstock	Georgia
United States	GSK Investigational Site	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belarus,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Croatia,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Japan,  Latvia,  Lithuania,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  Slovakia,  Slovenia,  South Africa,  Spain,  Sweden,  Switzerland,  Tunisia,  Turkey,  Ukraine,  United Kingdom, 

References & Publications (19)

Andriole GL, Bostwick D, Brawley OW, Gomella L, Marberger M, Montorsi F, Pettaway C, Tammela TL, Teloken C, Tindall D, Freedland SJ, Somerville MC, Wilson TH, Fowler I, Castro R, Rittmaster RS; REDUCE Study Group. The effect of dutasteride on the usefulness of prostate specific antigen for the diagnosis of high grade and clinically relevant prostate cancer in men with a previous negative biopsy: results from the REDUCE study. J Urol. 2011 Jan;185(1):126-31. doi: 10.1016/j.juro.2010.09.011. Epub 2010 Nov 12. — View Citation

Andriole GL, Bostwick DG, Brawley OW, Gomella LG, Marberger M, Montorsi F, Pettaway CA, Tammela TL, Teloken C, Tindall DJ, Somerville MC, Wilson TH, Fowler IL, Rittmaster RS; REDUCE Study Group. Effect of dutasteride on the risk of prostate cancer. N Engl J Med. 2010 Apr 1;362(13):1192-202. doi: 10.1056/NEJMoa0908127. — View Citation

Aubin SM, Reid J, Sarno MJ, Blase A, Aussie J, Rittenhouse H, Rittmaster R, Andriole GL, Groskopf J. PCA3 molecular urine test for predicting repeat prostate biopsy outcome in populations at risk: validation in the placebo arm of the dutasteride REDUCE trial. J Urol. 2010 Nov;184(5):1947-52. doi: 10.1016/j.juro.2010.06.098. Epub 2010 Sep 17. — View Citation

Aubin SM, Reid J, Sarno MJ, Blase A, Aussie J, Rittenhouse H, Rittmaster RS, Andriole GL, Groskopf J. Prostate cancer gene 3 score predicts prostate biopsy outcome in men receiving dutasteride for prevention of prostate cancer: results from the REDUCE trial. Urology. 2011 Aug;78(2):380-5. doi: 10.1016/j.urology.2011.03.033. — View Citation

Bostwick DG, Qian J, Drewnowska K, Varvel S, Bostwick KC, Marberger M, Rittmaster RS. Prostate needle biopsy quality in reduction by dutasteride of prostate cancer events study: worldwide comparison of improvement with investigator training and centralized laboratory processing. Urology. 2010 Jun;75(6):1406-10. doi: 10.1016/j.urology.2009.07.1348. Epub 2009 Nov 25. — View Citation

Crawford ED, Andriole GL, Marberger M, Rittmaster RS. Reduction in the risk of prostate cancer: future directions after the Prostate Cancer Prevention Trial. Urology. 2010 Mar;75(3):502-9. doi: 10.1016/j.urology.2009.05.099. Epub 2009 Dec 29. Review. — View Citation

Kader AK, Sun J, Reck BH, Newcombe PJ, Kim ST, Hsu FC, D'Agostino RB Jr, Tao S, Zhang Z, Turner AR, Platek GT, Spraggs CF, Whittaker JC, Lane BR, Isaacs WB, Meyers DA, Bleecker ER, Torti FM, Trent JM, McConnell JD, Zheng SL, Condreay LD, Rittmaster RS, Xu J. Potential impact of adding genetic markers to clinical parameters in predicting prostate biopsy outcomes in men following an initial negative biopsy: findings from the REDUCE trial. Eur Urol. 2012 Dec;62(6):953-61. doi: 10.1016/j.eururo.2012.05.006. Epub 2012 May 12. — View Citation

Kattan MW, Earnshaw SR, McDade CL, Black LK, Andriole GL. Cost effectiveness of chemoprevention for prostate cancer with dutasteride in a high-risk population based on results from the REDUCE clinical trial. Appl Health Econ Health Policy. 2011 Sep 1;9(5):305-15. doi: 10.2165/11592200-000000000-00000. — View Citation

Marberger M, Freedland SJ, Andriole GL, Emberton M, Pettaway C, Montorsi F, Teloken C, Rittmaster RS, Somerville MC, Castro R. Usefulness of prostate-specific antigen (PSA) rise as a marker of prostate cancer in men treated with dutasteride: lessons from the REDUCE study. BJU Int. 2012 Apr;109(8):1162-9. doi: 10.1111/j.1464-410X.2011.10373.x. Epub 2011 Jun 23. — View Citation

Marberger M, McConnell JD, Fowler I, Andriole GL, Bostwick DG, Somerville MC, Rittmaster RS. Biopsy misidentification identified by DNA profiling in a large multicenter trial. J Clin Oncol. 2011 May 1;29(13):1744-9. doi: 10.1200/JCO.2010.32.1646. Epub 2011 Mar 28. — View Citation

Marberger M, Wilson TH, Rittmaster RS. Low serum testosterone levels are poor predictors of sexual dysfunction. BJU Int. 2011 Jul;108(2):256-62. doi: 10.1111/j.1464-410X.2010.09766.x. Epub 2010 Oct 18. — View Citation

Muller RL, Gerber L, Moreira DM, Andriole G, Castro R, Freedland SJ. Baseline Serum Testosterone and DHT Levels and the Risk of Prostate Cancer Detection in the Placebo Arm of the REDUCE Trial. [Eur Urol [E-pub 18 May]]. 2012;

Newcombe PJ, Reck BH, Sun J, Platek GT, Verzilli C, Kader AK, Kim ST, Hsu FC, Zhang Z, Zheng SL, Mooser VE, Condreay LD, Spraggs CF, Whittaker JC, Rittmaster RS, Xu J. A comparison of Bayesian and frequentist approaches to incorporating external information for the prediction of prostate cancer risk. Genet Epidemiol. 2012 Jan;36(1):71-83. doi: 10.1002/gepi.21600. — View Citation

Nickel JC, Roehrborn C, Montorsi F, Wilson TH, Rittmaster RS. Dutasteride reduces prostatitis symptoms compared with placebo in men enrolled in the REDUCE study. J Urol. 2011 Oct;186(4):1313-8. doi: 10.1016/j.juro.2011.05.071. Epub 2011 Aug 17. — View Citation

Roehrborn CG, Nickel JC, Andriole GL, Gagnier RP, Black L, Wilson TH, Rittmaster RS. Dutasteride improves outcomes of benign prostatic hyperplasia when evaluated for prostate cancer risk reduction: secondary analysis of the REduction by DUtasteride of prostate Cancer Events (REDUCE) trial. Urology. 2011 Sep;78(3):641-6. doi: 10.1016/j.urology.2011.03.063. Epub 2011 Jul 20. — View Citation

Stephen J. Freedland, Leah Gerber, Lionel Banez, Daniel Moreira, Gerald L. Andriole, and Roger S. Rittmaster on behalf of the REDUCE Study Group. Statin Use and the Risk of Prostate Cancer and High-grade Prostate Cancer: Results from the REDUCE study. [AUA 2011 Annual Meeting]. 2011;185(4 Suppl):e135.

Thomas JA 2nd, Gerber L, Bañez LL, Moreira DM, Rittmaster RS, Andriole GL, Freedland SJ. Prostate cancer risk in men with baseline history of coronary artery disease: results from the REDUCE Study. Cancer Epidemiol Biomarkers Prev. 2012 Apr;21(4):576-81. doi: 10.1158/1055-9965.EPI-11-1017. Epub 2012 Feb 7. — View Citation

Thomas JA 2nd, Gerber L, Moreira DM, Hamilton RJ, Bañez LL, Castro-Santamaria R, Andriole GL, Isaacs WB, Xu J, Freedland SJ. Prostate cancer risk in men with prostate and breast cancer family history: results from the REDUCE study (R1). J Intern Med. 2012 Jul;272(1):85-92. doi: 10.1111/j.1365-2796.2011.02504.x. Epub 2012 Jan 16. — View Citation

Wu C, Moreira DM, Gerber L, Rittmaster RS, Andriole GL, Freedland SJ. Diabetes and prostate cancer risk in the REDUCE trial. Prostate Cancer Prostatic Dis. 2011 Dec;14(4):326-31. doi: 10.1038/pcan.2011.28. Epub 2011 Jun 28. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach)	Study biopsies consisted of 10 biopsy samples (cores) in a pre-defined pattern. Biopsies were read at the central pathology laboratory (CPL, which processed the majority, 94%, of biopsies). Biopsy cases that were positive for prostate cancer or precancerous lesions (high-grade prostatic intraepithelial neoplasia[HGPIN] or typical small acinar proliferation [ASAP]) and prostate surgeries were reviewed by the lead pathologist.	Years 1-2, Years 3-4, and Overall (Years 1-4)	No
Primary	Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach)	Study biopsies (biop.) consisted of 10 biop. samples (cores) in a pre-defined pattern and were read at the central pathology laboratory. Biop. cases that were positive for prostate cancer or precancerous lesions (HGPIN or ASAP) and prostate surgeries were reviewed by the lead pathologist. Participants included in the risk sets at Years 1-2 and Years 3-4 included those with a positive biop. at Years 1-2 or a biop. after Months 18-24, and those with a positive biop. at Years 3-4 or a biop. after Month 42, respectively. Overall included participants with a positive biop. or biop. after Month 42.	Years 1-2, Years 3-4, and Overall (Years 1-4)	No
Primary	Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach)	Study biopsies consisted of 10 biopsy samples (cores) in a pre-defined pattern. Biopsies were read at the central pathology laboratory (which processed the majority, 94%, of biopsies). Biopsy cases that were positive for prostate cancer or precancerous lesions (HGPIN or ASAP) and prostate surgeries were reviewed by the lead pathologist. Participants included in the risk set at Years 1-2, Years 3-4, and Overall (Years 1-4) were those who had a biopsy during the specified time period.	Years 1-2, Years 3-4, and Overall (Years 1-4)	No
Secondary	Number of Participants With the Indicated Gleason Score at Diagnosis	Gleason score was determined by examining prostate biopsies and surgical samples. The Gleason scoring system sums the two most common Gleason grade patterns in order to predict the likelihood of a participant doing well or badly with their cancer. Gleason grades range from 1 (normal) to 5 (advanced cancer). The lowest Gleason score is 2 (1+1), and the highest Gleason score is 10 (5+5). A Gleason score of 2-6 is a low-grade cancer; a Gleason score of 7-10 is high-grade cancer. The most severe high-grade cancers are the subset of Gleason scores 8-10.	Baseline to Year 4	No
Secondary	Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy	The occurrence and quantity of high-grade prostatic intraepithelial neoplasia (HGPIN) and atypical small acinar proliferation (ASAP) at biopsy were measured. HGPIN and ASAP are considered precancerous conditions. A participant diagnosed with prostate cancer only (i.e., no HGPIN or ASAP) was counted in both the first category ("HGPIN or prostate cancer diagnosis") and again in the last category ("HGPIN, ASAP, or prostate cancer diagnosis").	Baseline to Year 4	No
Secondary	Volume of HGPIN at Biopsy	The amount of prostate biopsy tissue with HGPIN was measured.	Baseline to Year 4	No
Secondary	Percentage of Core Involved at Diagnosis	The average amount of cancer seen by the pathologist in the prostate tissue samples taken during the biopsy was measured. A core is a prostate biopsy sample.	Baseline to Year 4	No
Secondary	Number of Cancer-positive Cores	The average number of prostate biopsy samples (cores) determined to be cancerous by the pathologist was measured. Normally, 10 cores were taken per biopsy for each participant.	Baseline to Year 4	No
Secondary	Treatment Alteration Score	The treatment alteration score is a measure of the cellular changes due to treatment (effect of male hormone withdrawal) on the nucleus and cytoplasm of the prostate cancer cell. The treatment alteration score is the sum of two scores (the nuclear alteration score and the cytoplasmic architectural score), each ranging from 0 to 3, with 0 indicating no change and 3 indicating severe changes.	Baseline to Year 4	No
Secondary	Number of Participants Undergoing Intervention (Surgical and Non-surgical) for Prostate Cancer Treatment	The number of participants who received treatment for prostate cancer was measured. Prostate cancer interventions included surgical interventions (e.g., prostatectomy, adenomectomy, transurethral resection) and non-surgical interventions (e.g., chemotherapy, hormone therapy, radiation therapy).	Baseline to Year 4	No
Secondary	Adjusted Mean Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 48	The IPSS is a 7-item questionnaire that measures urinary symptoms. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. Each of the 7 questions has a 6-point response scale (0=none/not at all to 5=almost always) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). Estimates are based on adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment.	Baseline to Year 4 (Month 48)	No
Secondary	Adjusted Mean Percentage Change From Baseline in Prostate Volume at Months 24 and 48	Prostate volume was measured by transrectal ultrasound (TRUS) when biopsies were performed at Year 2 and Year 4. The investigator calculated the prostate volume using three prostate measurements (anteroposterior, cephalocaudal, and transverse diameters). Estimates are based on the adjusted means from the general linear model: log(Post-Baseline/Baseline value) = treatment and cluster and log (baseline value).	Baseline, Month 24, and Month 48	No
Secondary	Adjusted Mean Change From Baseline in Maximum Urinary Flow (Qmax) at Months 12, 24, 36, and 48	Maximum urinary flow was measured at selected sites using a Dantec Uroflow meter with a Thompson filter. Change from baseline was calculated as Month 12, 24, 36, and 48 values minus the baseline value. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline Qmax and treatment. This measurement was performed at selected centers.	Baseline and Months 12, 24, 36, and 48	No
Secondary	Number of Participants Starting Alpha Blockers to Control Benign Prostatic Hyperplasia (BPH) Symptoms	Medication taken during the study, including alpha blockers, was recorded at each 6-month study visit and during phone calls that occurred 3 months after each visit.	Years 1-2, Overall (Years 1-4)	No
Secondary	Number of Participants With at Least One Event of Acute Urinary Retention (AUR)	A participant was considered to have AUR when he reported being unable to urinate and required catherization. Participants were asked to report any events of AUR during the study.	Years 1-2 and Overall (Years 1-4)	No
Secondary	Number of Participants With at Least One Urinary Tract Infection (UTI)	A participant was considered to have a UTI if the investigator noted that the participant had UTI symptoms and had been prescribed antibiotics. Participants were asked to report any events of UTI during the study.	Years 1-2, Years 3-4, and Overall (Years 1-4)	No
Secondary	Number of Participants With Post-biopsy Macroscopic Hematuria	Participants reported events of macroscopic hematuria (visible blood in the urine) throughout the study.	Baseline to Year 4	No
Secondary	Number of Participants With Post-biopsy Macroscopic Hematospermia	Participants reported events of macroscopic hematospermia (visible blood in semen) throughout the study.	Baseline through Year 4	No
Secondary	Overall Survival	Overall survival is assessed as the number of deaths reported throughout the study.	From time informed consent is signed to 4-month Safety Follow-Up period	No
Secondary	Adjusted Mean Change From Baseline in the Benign Prostatic Hypertrophy (BPH) Impact Index (BII) at Month 48	The BII is a 4-item questionnaire that rates the level of BPH-related physical discomfort, worry, and interference with normal activities the participant has experienced. The total BII score ranges from 1 (no impact on symptoms) to 13 (major impact on symptoms). Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model:change from baseline = baseline value and cluster and treatment.	Baseline and Month 48	No
Secondary	Adjusted Mean Change From Baseline in The Medical Outcomes Study Sleep Problems Index 6-item Standard Version (MOS Sleep-6S) at Month 48	The MOS Sleep-6S is a 6-item questionnaire measuring quality of sleep. Scores range from 1 (all of the time) to 6 (none of the time) and are converted to a 1-100 scale and then averaged; a higher score indicates greater negative impact, which indicates more sleep disturbance. Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from baseline=baseline value and cluster and treatment.	Baseline and Month 48	No
Secondary	Adjusted Mean Change From Baseline in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH CPSI) at Month 48	The NIH CSPI is a 9-item questionnaire that measures chronic prostatitis symptoms. The total score ranges from 0 to 43. A higher score indicates greater negative impact of prostatitis. Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from Baseline = Baseline Value and Cluster and Treatment.	Baseline and Month 48	No
Secondary	Adjusted Mean Change From Baseline in Quality of Life Question 8 (QOL Q8) at Month 48	The QOL Q8 is the last question of the IPSS Questionnaire. It is a question about the participant's quality of life as it relates to prostate symptoms. Responses range from 0 (most positive) to 6 (most negative). A higher score indicates worse quality of life. Participants completed the questionnaire at Screening, Baseline, and at each 6-month visit. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment.	Baseline and Month 48	No
Secondary	Adjusted Mean Change From Baseline in the Problem Assessment Scale of the Sexual Function Index (PASSFI) at Month 48	The PASSFI is a 3-item questionnaire that measures sexual function. Responses range from 0 (big problem) to 4 (no problem), with a total score of 12. A higher score indicates fewer problems with sexual functioning. Participants completed the questionnaire at Baseline and then yearly . Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment.	Baseline and Month 48	No
Secondary	Number of Participants With the Indicated Serum Dihydrotestosterone (DHT) Concentration at Month 48	Number of participants whose DHT, the active form of the male sex hormone testosterone, was less than 0.555 nanomoles/liter and below the level of detection at Month 48 was measured. It was measured by taking blood samples at screening and yearly thereafter.	Month 48	No
Secondary	Mean Change From Baseline in Testosterone at Month 48	Testosterone, a male sex hormone, was measured by taking blood samples at screening and yearly thereafter.	Baseline and Month 48	No