"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk (REDUCE)
August 17, 2016 updated by: GlaxoSmithKline
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8231
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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- GSK Investigational Site
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Buenos Aires, Argentina, C1416DRW
- GSK Investigational Site
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Buenos Aires
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Av Córdoba 2424, Buenos Aires, Argentina, 1120
- GSK Investigational Site
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Bahia Blanca, Buenos Aires, Argentina, 8001
- GSK Investigational Site
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Capital Federal, Buenos Aires, Argentina, 1425
- GSK Investigational Site
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Capital Federal, Buenos Aires, Argentina, 1437
- GSK Investigational Site
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1405BCH
- GSK Investigational Site
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Córdova
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Córdoba, Córdova, Argentina, 5000
- GSK Investigational Site
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Córdoba, Córdova, Argentina, 5016
- GSK Investigational Site
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Santa Fe
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Rosario, Santa Fe, Argentina, 2000
- GSK Investigational Site
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New South Wales
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Darlinghurst, New South Wales, Australia, 2010
- GSK Investigational Site
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Kogarah, New South Wales, Australia, 2217
- GSK Investigational Site
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Randwick, New South Wales, Australia, 2031
- GSK Investigational Site
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Westmead, New South Wales, Australia, 2145
- GSK Investigational Site
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Queensland
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Herston, Queensland, Australia, 4029
- GSK Investigational Site
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Kippa Ring, Queensland, Australia, 4021
- GSK Investigational Site
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Woolloongabba, Queensland, Australia, 4102
- GSK Investigational Site
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South Australia
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Adelaide, South Australia, Australia, 5000
- GSK Investigational Site
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Victoria
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Mentone, Victoria, Australia, 3194
- GSK Investigational Site
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Parkville, Victoria, Australia, 3050
- GSK Investigational Site
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Innsbruck, Austria, A-6020
- GSK Investigational Site
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Vienna, Austria, A-1090
- GSK Investigational Site
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Vienna, Austria, A-1180
- GSK Investigational Site
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Minsk, Belarus, 220036
- GSK Investigational Site
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Minsk, Belarus, 223052
- GSK Investigational Site
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Aalst, Belgium, 9300
- GSK Investigational Site
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Antwerpen, Belgium, 2020
- GSK Investigational Site
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Brussels, Belgium, 1070
- GSK Investigational Site
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Bruxelles, Belgium, 1200
- GSK Investigational Site
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Bruxelles, Belgium, 1000
- GSK Investigational Site
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Gent, Belgium, 9000
- GSK Investigational Site
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Hasselt, Belgium, 3500
- GSK Investigational Site
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Kortrijk, Belgium, 8500
- GSK Investigational Site
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Leuven, Belgium, 3000
- GSK Investigational Site
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Mons, Belgium, 7000
- GSK Investigational Site
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Turnhout, Belgium, 2300
- GSK Investigational Site
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Wilrijk, Belgium, 2610
- GSK Investigational Site
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Yvoir, Belgium, 5530
- GSK Investigational Site
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Rio de Janeiro, Brazil, 20 551-030
- GSK Investigational Site
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São Paulo, Brazil, 04122-000
- GSK Investigational Site
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Bahía
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Salvador, Bahía, Brazil, 40210-341
- GSK Investigational Site
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 30140-073
- GSK Investigational Site
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
- GSK Investigational Site
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Porto Alegre, Rio Grande Do Sul, Brazil, 90470-340
- GSK Investigational Site
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São Paulo
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Ribeirão Preto, São Paulo, Brazil, 14085-000
- GSK Investigational Site
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Sofia, Bulgaria, 1431
- GSK Investigational Site
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Sofia, Bulgaria, 1606
- GSK Investigational Site
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Sofia, Bulgaria, 1000
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Sofia, Bulgaria, 1756
- GSK Investigational Site
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Varna, Bulgaria, 9000
- GSK Investigational Site
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Quebec, Canada, G1R 2J6
- GSK Investigational Site
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Alberta
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Calgary, Alberta, Canada, T2V 4R6
- GSK Investigational Site
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Edmonton, Alberta, Canada, T5H 4B9
- GSK Investigational Site
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 2H4
- GSK Investigational Site
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Surrey, British Columbia, Canada, V3V 1N1
- GSK Investigational Site
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Vancouver, British Columbia, Canada, V5Z 1M9
- GSK Investigational Site
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Victoria, British Columbia, Canada, V8T 5G1
- GSK Investigational Site
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Victoria, British Columbia, Canada, V8V 3N1
- GSK Investigational Site
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New Brunswick
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Fredericton, New Brunswick, Canada, E3B 5B8
- GSK Investigational Site
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Miramichi, New Brunswick, Canada, E1V 1N9
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Saint John, New Brunswick, Canada, E2L 3J8
- GSK Investigational Site
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1Y6
- GSK Investigational Site
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Ontario
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Barrie, Ontario, Canada, L4M 7G1
- GSK Investigational Site
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Burlington, Ontario, Canada, L7N 3V2
- GSK Investigational Site
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Burlington, Ontario, Canada, L7S 1V2
- GSK Investigational Site
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Kingston, Ontario, Canada, K7L 2V7
- GSK Investigational Site
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Kitchener, Ontario, Canada, N2N 2B9
- GSK Investigational Site
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Markham, Ontario, Canada, L6B 1A1
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Newmarket, Ontario, Canada, L3X 1W1
- GSK Investigational Site
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Niagara Falls, Ontario, Canada, L2E 6A6
- GSK Investigational Site
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North Bay, Ontario, Canada, P1B 7K8
- GSK Investigational Site
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North York, Ontario, Canada, M3B 3P1
- GSK Investigational Site
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Oakville, Ontario, Canada, L6H 3P1
- GSK Investigational Site
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Orillia, Ontario, Canada, L3V 7V1
- GSK Investigational Site
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Richmond Hill, Ontario, Canada, L4C 1T6
- GSK Investigational Site
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Toronto, Ontario, Canada, M4N 3M5
- GSK Investigational Site
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Toronto, Ontario, Canada, M5G 2M9
- GSK Investigational Site
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Toronto, Ontario, Canada, M3H 5S4
- GSK Investigational Site
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Toronto, Ontario, Canada, M1S 4V5
- GSK Investigational Site
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Toronto, Ontario, Canada, M6A 3B5
- GSK Investigational Site
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Quebec
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Chicoutimi, Quebec, Canada, G7H 4A3
- GSK Investigational Site
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Granby, Quebec, Canada, J2G 8Z9
- GSK Investigational Site
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Greenfield Park, Quebec, Canada, J4V 2H3
- GSK Investigational Site
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Laval, Quebec, Canada, H7G 2E6
- GSK Investigational Site
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Montreal, Quebec, Canada, H3A 1A1
- GSK Investigational Site
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Montreal, Quebec, Canada, H1T 2M4
- GSK Investigational Site
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Montreal, Quebec, Canada, H2L 4M1
- GSK Investigational Site
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Montreal, Quebec, Canada, H2X 3J4
- GSK Investigational Site
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Montreal, Quebec, Canada, H3S 1Z1
- GSK Investigational Site
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Montreal, Quebec, Canada, H4A 1S9
- GSK Investigational Site
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Pointe-Claire, Quebec, Canada, H9R 4S3
- GSK Investigational Site
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Trois Rivieres, Quebec, Canada, G9A 3V7
- GSK Investigational Site
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Región Metro De Santiago
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Santiago, Región Metro De Santiago, Chile
- GSK Investigational Site
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Valparaíso
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Viña del Mar, Valparaíso, Chile
- GSK Investigational Site
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Zagreb, Croatia, 10000
- GSK Investigational Site
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Herlev, Denmark, 2730
- GSK Investigational Site
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Middelfart, Denmark, 5500
- GSK Investigational Site
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Nakskov, Denmark, 4900
- GSK Investigational Site
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Tallinn, Estonia, 13419
- GSK Investigational Site
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Tallinn, Estonia
- GSK Investigational Site
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Helsinki, Finland, 00029
- GSK Investigational Site
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Helsinki, Finland, 00180
- GSK Investigational Site
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Kuopio, Finland, 70100
- GSK Investigational Site
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Lahti, Finland, 15850
- GSK Investigational Site
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Lappeenranta, Finland, 53100
- GSK Investigational Site
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Oulu, Finland, 90100
- GSK Investigational Site
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Oulu, Finland, 90029
- GSK Investigational Site
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Rovaniemi, Finland, 96400
- GSK Investigational Site
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Seinajoki, Finland, 60220
- GSK Investigational Site
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Tampere, Finland, 33521
- GSK Investigational Site
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Turku, Finland, 20100
- GSK Investigational Site
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Amiens, France, 80094
- GSK Investigational Site
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Arcachon, France, 33120
- GSK Investigational Site
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Auch, France, 32000
- GSK Investigational Site
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Besancon Cedex, France, 25030
- GSK Investigational Site
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Bois Bernard, France, 62320
- GSK Investigational Site
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Bordeaux Cedex, France, 33073
- GSK Investigational Site
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Boujan sur Libron, France, 34760
- GSK Investigational Site
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Cabestany, France, 66330
- GSK Investigational Site
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Caen cedex, France, 14050
- GSK Investigational Site
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Cannes, France, 06400
- GSK Investigational Site
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Carpentras, France, 84200
- GSK Investigational Site
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Chalon Sur Saone, France, 71100
- GSK Investigational Site
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Cholet, France, 49300
- GSK Investigational Site
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Châlons-En-Champagne, France, 51000
- GSK Investigational Site
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Créteil Cedex, France, 94010
- GSK Investigational Site
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Dijon, France, 21000
- GSK Investigational Site
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Domarin, France, 38300
- GSK Investigational Site
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Dunkerque, France, 59240
- GSK Investigational Site
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Fourmies Cedex, France, 59611
- GSK Investigational Site
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Grande Synthe Cedex, France, 59760
- GSK Investigational Site
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Guilherand Granges, France, 07500
- GSK Investigational Site
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Le Havre, France, 76600
- GSK Investigational Site
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Le Raincy, France, 93340
- GSK Investigational Site
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Lille Cedex, France, 59037
- GSK Investigational Site
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Longjumeau, France, 91161
- GSK Investigational Site
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Lyon Cedex 03, France, 69437
- GSK Investigational Site
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Marseille, France, 13008
- GSK Investigational Site
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Marseille, France, 13274
- GSK Investigational Site
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Montauban, France, 82000
- GSK Investigational Site
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Montpellier, France, 34000
- GSK Investigational Site
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Nimes, France, 30900
- GSK Investigational Site
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Orleans, France, 45100
- GSK Investigational Site
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Orsay, France, 91401
- GSK Investigational Site
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Paris Cedex 10, France, 75475
- GSK Investigational Site
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Paris Cedex 18, France, 75877
- GSK Investigational Site
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Pau, France, 64000
- GSK Investigational Site
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Pierre Benite Cedex, France, 69495
- GSK Investigational Site
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Ploemeur, France, 56270
- GSK Investigational Site
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Poitiers Cedex, France, 86021
- GSK Investigational Site
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Reims, France, 51100
- GSK Investigational Site
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Rouen, France, 76000
- GSK Investigational Site
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Saint Cyr sur Loire, France, 37540
- GSK Investigational Site
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Saint Etienne, France, 42000
- GSK Investigational Site
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Saint Etienne Cedex 2, France, 42013
- GSK Investigational Site
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Saint Grégoire, France, 35760
- GSK Investigational Site
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Saint Martin d'Heres, France, 38400
- GSK Investigational Site
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Saint Nazaire, France, 44600
- GSK Investigational Site
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Saint Quentin Cedex, France, 02321
- GSK Investigational Site
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Suresnes, France, 92151
- GSK Investigational Site
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Toulouse Cedex 4, France, 31403
- GSK Investigational Site
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Tours, France, 37000
- GSK Investigational Site
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Tours, France, 37044
- GSK Investigational Site
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Troyes, France, 10000
- GSK Investigational Site
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Vannes, France, 56000
- GSK Investigational Site
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Berlin, Germany, 14057
- GSK Investigational Site
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Berlin, Germany, 10117
- GSK Investigational Site
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Berlin, Germany, 13187
- GSK Investigational Site
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Berlin, Germany, 10787
- GSK Investigational Site
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Berlin, Germany, 10249
- GSK Investigational Site
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Berlin, Germany, 10369
- GSK Investigational Site
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Berlin, Germany, 12627
- GSK Investigational Site
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Berlin, Germany, 10365
- GSK Investigational Site
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Berlin, Germany, 13507
- GSK Investigational Site
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Berlin, Germany, 12687
- GSK Investigational Site
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Berlin, Germany, 12099
- GSK Investigational Site
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Berlin, Germany, 10719
- GSK Investigational Site
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Berlin, Germany, 10713
- GSK Investigational Site
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Berlin, Germany, 12107
- GSK Investigational Site
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Hamburg, Germany, 22459
- GSK Investigational Site
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Hamburg, Germany, 22299
- GSK Investigational Site
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Hamburg, Germany, 21029
- GSK Investigational Site
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Hamburg, Germany, 22767
- GSK Investigational Site
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Hamburg, Germany, 22303
- GSK Investigational Site
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Hamburg, Germany, 22587
- GSK Investigational Site
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Baden-Wuerttemberg
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Backnang, Baden-Wuerttemberg, Germany, 71522
- GSK Investigational Site
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Bad Schoenborn, Baden-Wuerttemberg, Germany, 76669
- GSK Investigational Site
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Bruchsal, Baden-Wuerttemberg, Germany, 76646
- GSK Investigational Site
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Esslingen, Baden-Wuerttemberg, Germany, 73728
- GSK Investigational Site
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Freiburg, Baden-Wuerttemberg, Germany, 79106
- GSK Investigational Site
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Kleinblittersdorf, Baden-Wuerttemberg, Germany, 66271
- GSK Investigational Site
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Mannheim, Baden-Wuerttemberg, Germany, 68307
- GSK Investigational Site
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Neckargemuend, Baden-Wuerttemberg, Germany, 69151
- GSK Investigational Site
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Ostfildern, Baden-Wuerttemberg, Germany, 73760
- GSK Investigational Site
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Rheinfelden, Baden-Wuerttemberg, Germany, 79618
- GSK Investigational Site
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Waldkirch, Baden-Wuerttemberg, Germany, 79183
- GSK Investigational Site
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Bayern
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Aichach, Bayern, Germany, 86551
- GSK Investigational Site
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Augsburg, Bayern, Germany, 86156
- GSK Investigational Site
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Bad Griesbach, Bayern, Germany, 94086
- GSK Investigational Site
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Bamberg, Bayern, Germany, 96047
- GSK Investigational Site
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Dachau, Bayern, Germany, 85221
- GSK Investigational Site
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Ebersberg, Bayern, Germany, 85560
- GSK Investigational Site
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Forchheim, Bayern, Germany, 91301
- GSK Investigational Site
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Fuerth, Bayern, Germany, 90762
- GSK Investigational Site
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Garmisch-Partenkirchen, Bayern, Germany, 82467
- GSK Investigational Site
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Günzburg, Bayern, Germany, 89312
- GSK Investigational Site
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Herzogenaurach, Bayern, Germany, 91074
- GSK Investigational Site
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Hoechberg, Bayern, Germany, 97204
- GSK Investigational Site
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Kelheim, Bayern, Germany, 93309
- GSK Investigational Site
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Koenigsbrunn, Bayern, Germany, 86343
- GSK Investigational Site
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Muenchen, Bayern, Germany, 80336
- GSK Investigational Site
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Muenchen, Bayern, Germany, 80539
- GSK Investigational Site
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Muenchen, Bayern, Germany, 81927
- GSK Investigational Site
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Neumarkt, Bayern, Germany, 92318
- GSK Investigational Site
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Nuernberg, Bayern, Germany, 90402
- GSK Investigational Site
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Nuernberg, Bayern, Germany, 90441
- GSK Investigational Site
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Nuernberg, Bayern, Germany, 90489
- GSK Investigational Site
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Nuernberg, Bayern, Germany, 90482
- GSK Investigational Site
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Planegg, Bayern, Germany, 82152
- GSK Investigational Site
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Rosenheim, Bayern, Germany, 83022
- GSK Investigational Site
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Roth, Bayern, Germany, 91154
- GSK Investigational Site
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Starnberg, Bayern, Germany, 82310
- GSK Investigational Site
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Starnberg, Bayern, Germany, 82319
- GSK Investigational Site
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Weiden, Bayern, Germany, 92637
- GSK Investigational Site
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Weissenburg, Bayern, Germany, 91781
- GSK Investigational Site
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Wertheim, Bayern, Germany, 97877
- GSK Investigational Site
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Brandenburg
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Hagenow, Brandenburg, Germany, 19230
- GSK Investigational Site
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Hennigsdorf, Brandenburg, Germany, 16761
- GSK Investigational Site
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Oranienburg, Brandenburg, Germany, 16515
- GSK Investigational Site
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Schwedt, Brandenburg, Germany, 16303
- GSK Investigational Site
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Senftenberg, Brandenburg, Germany, 01968
- GSK Investigational Site
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Strausberg, Brandenburg, Germany, 15344
- GSK Investigational Site
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Hamburg
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Wedel, Hamburg, Germany, 22880
- GSK Investigational Site
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Hessen
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Bad Homburg, Hessen, Germany, 61348
- GSK Investigational Site
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Frankfurt, Hessen, Germany, 60326
- GSK Investigational Site
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Frankfurt, Hessen, Germany, 65929
- GSK Investigational Site
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Frankfurt, Hessen, Germany, 60594
- GSK Investigational Site
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Frankfurt, Hessen, Germany, 65933
- GSK Investigational Site
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Hochheim, Hessen, Germany, 65239
- GSK Investigational Site
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Kelkheim, Hessen, Germany, 65779
- GSK Investigational Site
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Marburg, Hessen, Germany, 35039
- GSK Investigational Site
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Neustadt, Hessen, Germany, 67434
- GSK Investigational Site
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Offenbach, Hessen, Germany, 63067
- GSK Investigational Site
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Seligenstadt, Hessen, Germany, 63500
- GSK Investigational Site
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Vellmar, Hessen, Germany, 34246
- GSK Investigational Site
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Wiesbaden, Hessen, Germany, 65185
- GSK Investigational Site
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Mecklenburg-Vorpommern
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Bad Doberan, Mecklenburg-Vorpommern, Germany, 18209
- GSK Investigational Site
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Ludwigslust, Mecklenburg-Vorpommern, Germany, 19288
- GSK Investigational Site
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Ribnitz-Damgarten, Mecklenburg-Vorpommern, Germany, 18311
- GSK Investigational Site
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Rostock, Mecklenburg-Vorpommern, Germany, 18109
- GSK Investigational Site
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Rostock, Mecklenburg-Vorpommern, Germany, 18069
- GSK Investigational Site
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Schwerin, Mecklenburg-Vorpommern, Germany, 19053
- GSK Investigational Site
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Schwerin, Mecklenburg-Vorpommern, Germany, 19057
- GSK Investigational Site
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Wismar, Mecklenburg-Vorpommern, Germany, 23970
- GSK Investigational Site
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Niedersachsen
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Braunschweig, Niedersachsen, Germany, 38100
- GSK Investigational Site
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Braunschweig, Niedersachsen, Germany, 38120
- GSK Investigational Site
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Bremervoerde, Niedersachsen, Germany, 27432
- GSK Investigational Site
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Buchholz, Niedersachsen, Germany, 21244
- GSK Investigational Site
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Buxtehude, Niedersachsen, Germany, 21614
- GSK Investigational Site
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Ganderkesee, Niedersachsen, Germany, 27777
- GSK Investigational Site
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Goettingen, Niedersachsen, Germany, 37073
- GSK Investigational Site
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Hildesheim, Niedersachsen, Germany, 31134
- GSK Investigational Site
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Holzminden, Niedersachsen, Germany, 37603
- GSK Investigational Site
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Leer, Niedersachsen, Germany, 26789
- GSK Investigational Site
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Salzgitter, Niedersachsen, Germany, 38226
- GSK Investigational Site
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Wolfsburg, Niedersachsen, Germany, 38440
- GSK Investigational Site
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Nordrhein-Westfalen
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Aachen, Nordrhein-Westfalen, Germany, 52078
- GSK Investigational Site
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Arnsberg, Nordrhein-Westfalen, Germany, 59821
- GSK Investigational Site
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Bocholt, Nordrhein-Westfalen, Germany, 46399
- GSK Investigational Site
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Bonn, Nordrhein-Westfalen, Germany, 53177
- GSK Investigational Site
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Borken, Nordrhein-Westfalen, Germany, 46325
- GSK Investigational Site
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Dortmund, Nordrhein-Westfalen, Germany, 44137
- GSK Investigational Site
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Duelmen, Nordrhein-Westfalen, Germany, 48249
- GSK Investigational Site
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Duesseldorf, Nordrhein-Westfalen, Germany, 40211
- GSK Investigational Site
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Duesseldorf, Nordrhein-Westfalen, Germany, 40229
- GSK Investigational Site
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Duesseldorf, Nordrhein-Westfalen, Germany, 40470
- GSK Investigational Site
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Duisburg, Nordrhein-Westfalen, Germany, 47051
- GSK Investigational Site
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Duisburg, Nordrhein-Westfalen, Germany, 47179
- GSK Investigational Site
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Duisburg, Nordrhein-Westfalen, Germany, 47198
- GSK Investigational Site
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Erkrath, Nordrhein-Westfalen, Germany, 40699
- GSK Investigational Site
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Essen, Nordrhein-Westfalen, Germany, 45130
- GSK Investigational Site
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Essen, Nordrhein-Westfalen, Germany, 45127
- GSK Investigational Site
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Gelsenkirchen, Nordrhein-Westfalen, Germany, 45883
- GSK Investigational Site
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Gelsenkirchen, Nordrhein-Westfalen, Germany, 45894
- GSK Investigational Site
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Kamp-Lintfort, Nordrhein-Westfalen, Germany, 47475
- GSK Investigational Site
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Kempen, Nordrhein-Westfalen, Germany, 47906
- GSK Investigational Site
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Koeln, Nordrhein-Westfalen, Germany, 50969
- GSK Investigational Site
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Koenigswinter, Nordrhein-Westfalen, Germany, 53639
- GSK Investigational Site
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Krefeld, Nordrhein-Westfalen, Germany, 47799
- GSK Investigational Site
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Krefeld, Nordrhein-Westfalen, Germany, 47805
- GSK Investigational Site
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Langenfeld, Nordrhein-Westfalen, Germany, 40764
- GSK Investigational Site
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Marl, Nordrhein-Westfalen, Germany, 45770
- GSK Investigational Site
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Moers, Nordrhein-Westfalen, Germany, 47445
- GSK Investigational Site
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Muelheim, Nordrhein-Westfalen, Germany, 45475
- GSK Investigational Site
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Oberhausen, Nordrhein-Westfalen, Germany, 46045
- GSK Investigational Site
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Paderborn, Nordrhein-Westfalen, Germany, 33098
- GSK Investigational Site
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Pulheim, Nordrhein-Westfalen, Germany, 50259
- GSK Investigational Site
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Wesseling, Nordrhein-Westfalen, Germany, 50389
- GSK Investigational Site
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Wuppertal, Nordrhein-Westfalen, Germany, 42103
- GSK Investigational Site
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Rheinland-Pfalz
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Bad Bergzabern, Rheinland-Pfalz, Germany, 76887
- GSK Investigational Site
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Bad Ems, Rheinland-Pfalz, Germany, 56130
- GSK Investigational Site
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Dierdorf, Rheinland-Pfalz, Germany, 56269
- GSK Investigational Site
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Koblenz, Rheinland-Pfalz, Germany, 56068
- GSK Investigational Site
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Nieder-Olm, Rheinland-Pfalz, Germany, 55268
- GSK Investigational Site
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Saarland
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Homburg, Saarland, Germany, 66424
- GSK Investigational Site
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Sachsen
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Bautzen, Sachsen, Germany, 02625
- GSK Investigational Site
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Chemnitz, Sachsen, Germany, 09119
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Chemnitz, Sachsen, Germany, 09126
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Doebeln, Sachsen, Germany, 04720
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Dresden, Sachsen, Germany, 01307
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Dresden, Sachsen, Germany, 01324
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Grimma, Sachsen, Germany, 04668
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Leipzig, Sachsen, Germany, 04229
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Leipzig, Sachsen, Germany, 04103
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Leipzig, Sachsen, Germany, 04105
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Leipzig, Sachsen, Germany, 04109
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Leipzig, Sachsen, Germany, 04179
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Markkleeberg, Sachsen, Germany, 04416
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Neustadt, Sachsen, Germany, 01844
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Oelsnitz, Sachsen, Germany, 08606
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Pirna, Sachsen, Germany, 01796
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Plauen, Sachsen, Germany, 08523
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Radebeul, Sachsen, Germany, 01445
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Schlema, Sachsen, Germany, 08301
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Schwarzenberg, Sachsen, Germany, 08340
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Wilkau-Hasslau, Sachsen, Germany, 08112
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Zwickau, Sachsen, Germany, 08060
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Sachsen-Anhalt
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Dessau, Sachsen-Anhalt, Germany, 06844
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Dessau, Sachsen-Anhalt, Germany, 06842
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Eisleben, Sachsen-Anhalt, Germany, 06295
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Gardelegen, Sachsen-Anhalt, Germany, 39638
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Halle, Sachsen-Anhalt, Germany, 06132
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Hettstedt, Sachsen-Anhalt, Germany, 06333
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Leuna, Sachsen-Anhalt, Germany, 06237
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Magdeburg, Sachsen-Anhalt, Germany, 39104
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Naumburg, Sachsen-Anhalt, Germany, 06618
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Weissenfels, Sachsen-Anhalt, Germany, 06667
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Wolmirstedt, Sachsen-Anhalt, Germany, 39326
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Schleswig-Holstein
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Ahrensburg, Schleswig-Holstein, Germany, 22926
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Bad Schwartau, Schleswig-Holstein, Germany, 23611
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Flensburg, Schleswig-Holstein, Germany, 24944
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Hemmoor, Schleswig-Holstein, Germany, 21745
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Husum, Schleswig-Holstein, Germany, 25813
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Itzehoe, Schleswig-Holstein, Germany, 25524
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Kiel, Schleswig-Holstein, Germany, 24143
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Lauenburg, Schleswig-Holstein, Germany, 21481
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Luebeck, Schleswig-Holstein, Germany, 23552
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Luebeck, Schleswig-Holstein, Germany, 23562
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Neumuenster, Schleswig-Holstein, Germany, 24534
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Ploen, Schleswig-Holstein, Germany, 24306
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Schleswig, Schleswig-Holstein, Germany, 24837
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Thueringen
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Gera, Thueringen, Germany, 07546
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Gotha, Thueringen, Germany, 99867
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Ilmenau, Thueringen, Germany, 98693
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Meiningen, Thueringen, Germany, 98617
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Waltershausen, Thueringen, Germany, 99880
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Athens, Greece, 10676
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Athens, Greece, 10552
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Athens, Greece, 115 22
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Athens, Greece, 11526
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Athens, Greece, 18537
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Athens, Greece, 106 82
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Heraklion, Crete, Greece, 71110
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Ioannina, Greece, 45 500
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Larisa, Greece, 41110
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Periohi Dragana, Alexandroupolis, Greece, 68100
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Rhodes, Greece, 85100
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Rio, Patras, Greece, 265 00
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Thessaloniki, Greece, 54642
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Thessaloniki, Greece, 56429
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Budapest, Hungary, 1204
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Budapest, Hungary, 1082
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Győr, Hungary, 9002
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Cork, Ireland
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Dublin, Ireland, 7
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Tallaght, Ireland
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Abruzzo
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Lanciano (CH), Abruzzo, Italy, 66034
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Campania
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Caserta, Campania, Italy, 81100
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Emilia-Romagna
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Forlì, Emilia-Romagna, Italy, 47100
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Roma, Lazio, Italy, 00161
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Lombardia
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Milano, Lombardia, Italy, 20132
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Puglia
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Bari, Puglia, Italy, 70124
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Sardegna
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Sicilia
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Catania, Sicilia, Italy, 95124
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Ragusa (CT), Sicilia, Italy, 97100
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Pisa, Toscana, Italy, 56126
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Veneto
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Isola della Scala (VR), Veneto, Italy, 37063
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Napoli, Veneto, Italy, 80131
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Chiba, Japan, 289-2511
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Fukuoka, Japan, 810-0001
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Hokkaido, Japan, 060-8543
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Ibaraki, Japan, 305-8576
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Nagasaki, Japan, 852-8501
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Oita, Japan, 874-0937
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Daugavpils, Latvia, LV5403
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Kaunas, Lithuania, LT-50009
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Vilnius, Lithuania, LT-05263
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Durango, Mexico, 34000
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Durango, Mexico, 34027
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Mexico, Mexico, 14000
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Mexico city, Mexico, 14000
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Mexico, D.F., Mexico, 06720
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México, City, Mexico, 06700
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Puebla, Mexico, 72500
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Jalisco
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Zapopan, Jalisco, Mexico, 45200
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Zapopan, Jalisco, Mexico, 45170
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Zapopan, Jalisco, Jalisco, Mexico, 45100
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Amsterdam, Netherlands, 1091 AC
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Amsterdam, Netherlands, 1061 AE
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Arnhem, Netherlands, 6815 AD
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Capelle Aan Den Ijssel, Netherlands, 2906 ZC
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Den Bosch, Netherlands, 5232 JL
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Den Haag, Netherlands, 2545 CH
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Den Haag, Netherlands, 2512 VA
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EDE, Netherlands, 6716 RP
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Eindhoven, Netherlands, 5623 EJ
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Harderwijk, Netherlands, 3844 DG
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Hengelo, Netherlands, 7555 DL
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Nieuwegein, Netherlands, 3435 CM
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Nijmegen, Netherlands, 6525 GA
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Nijmegen, Netherlands, 6532 SZ
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Roermond, Netherlands, 6040 AX
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Roosendaal, Netherlands, 4708 AE
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Rotterdam, Netherlands, 3015 GD
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Rotterdam, Netherlands, 3078 HT
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Stadskanaal, Netherlands, 9501 HE
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Tilburg, Netherlands, 5022 GC
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Auckland, New Zealand, 1142
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Christchurch, New Zealand, 8014
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Hamilton, New Zealand, 3204
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Nelson, New Zealand, 7010
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Tauranga, New Zealand, 3140
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Whangarei, New Zealand, 0112
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Arendal, Norway, N-4838
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Moelv, Norway, N-2390
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Oslo, Norway, 0257 OSLO
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Stavanger, Norway, N-4068
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Bydgoszcz, Poland, 85-168
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Bydgoszcz, Poland, 85-094
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Elblag, Poland, 82-300
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Gdansk, Poland, 80-462
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Inowroclaw, Poland, 88-100
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Katowice, Poland, 40-954
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Koscierzyna, Poland, 83-400
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Krakow, Poland, 31-531
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Lublin, Poland, 20-718
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Rzeszow, Poland, 35-055
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Szczecin, Poland, 70-111
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Warszawa, Poland, 02-781
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Warszawa, Poland, 04-749
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Warszawa, Poland, 02-005
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Wejherowo, Poland, 84-200
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Wroclaw, Poland, 51-124
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Almada, Portugal, 2805-267
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Amadora, Portugal, 2700
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Lisboa, Portugal
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Porto, Portugal, 4099-004
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Porto, Portugal
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Ponce, Puerto Rico, 00716
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San Juan, Puerto Rico, 00909-1711
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San Juan, Puerto Rico, 00921-3201
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Bucharest, Romania
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Moscow, Russian Federation, 105 229
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Moscow, Russian Federation
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Moscow, Russian Federation, 119 881
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Moscow, Russian Federation, 111 123
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Moscow, Russian Federation, 117 049
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Nizhniy Novgorod, Russian Federation, 603005
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Saratov, Russian Federation, 410012
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St. Petersburg, Russian Federation, 197 089
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St. Petersburg, Russian Federation, 198 013
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Bratislava, Slovakia, 833 05
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Martin, Slovakia, 036 59
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Celje, Slovenia, 3000
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Ljubljana, Slovenia, 1000
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Maribor, Slovenia, 2000
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Slovenj Gradec, Slovenia, 2380
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Cape Town, South Africa, 7505
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Cape Town, South Africa
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Capital Park, South Africa, 0002
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George, South Africa, 6529
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Johannesburg, South Africa, 2193
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Parktown, South Africa, 2193
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Pretoria, South Africa, 83
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Westville, Durban, South Africa, 3630
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Gauteng
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Rosebank, Gauteng, South Africa, 2196
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Alava, Spain, 01004
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Alcala De Henares (Madrid), Spain
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Alcorcon, Spain, 28922
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Badalona, Spain, 08916
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Barcelona, Spain, 08025
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Barcelona, Spain, 08036
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Barcelona, Spain, 08035
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Barcelona, Spain, 08003
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Barcelona, Spain, 8907
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Barcelona, Spain, 08024
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Bilbao, Spain, 48013
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Castellón, Spain, 12004
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Ciudad Real, Spain, 13600
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Don Benito (Badajoz), Spain, 06400
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Galdakano, Spain, 48960
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Granada, Spain, 18012
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Ibiza, Spain, 07800
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Jaen, Spain, 27007
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La Laguna (Santa Cruz de Tenerife), Spain, 38320
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Leganes, Spain
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Logroño, Spain, 26006
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Madrid, Spain, 28047
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Madrid, Spain, 28006
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Madrid, Spain, 28007
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Madrid, Spain, 28040
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Madrid, Spain, 28034
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Madrid, Spain, 28010
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Madrid, Spain, 28003
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Malaga, Spain, 29010
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Manacor, Spain, 07500
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Orihuela, Spain
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Oviedo, Spain, 33006
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Pamplona, Spain, 31008
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Sagunto, Spain, 46520
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San Juan De Alicante, Spain, 3550
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San Sebastian, Spain, 20014
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Santa Cruz de Tenerife, Spain, 38010
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Sevilla, Spain, 41013
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Sevilla, Spain, 41014
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Sevilla, Spain, 41071
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Sevilla, Spain, 41018
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Soria, Spain, 42002
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Valencia, Spain, 46010
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Valencia, Spain, 46009
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Valencia, Spain, 46014
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Valladolid, Spain, 47012
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Via-Real (Castellón), Spain, 12540
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Borås, Sweden, SE-503 32
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Eskilstuna, Sweden, SE-633 40
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Gävle, Sweden, SE-801 87
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Göteborg, Sweden, SE-412 55
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Göteborg, Sweden, SE-417 17
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Karlshamn, Sweden, SE-374 35
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Kristianstad, Sweden, SE-291 31
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Kristianstad, Sweden, SE-291 85
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Malmö, Sweden, SE-217 44
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Skärholmen, Sweden, SE-127 48
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Skövde, Sweden, SE-541 30
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Stockholm, Sweden, SE-118 83
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Umeå, Sweden, SE-901 85
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Vålberg, Sweden, SE-660 50
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Östersund, Sweden, SE-831 31
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Aarau, Switzerland, 5001
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Bern, Switzerland, 3000
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Biel, Switzerland, 2500
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Fribourg, Switzerland, 1700
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Genève, Switzerland, 1206
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Lausanne, Switzerland, 1003
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Olten, Switzerland, 4600
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Sarnen, Switzerland, 6060
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Zollikon, Switzerland, 8702
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Sfax, Tunisia, 3027
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Sousse, Tunisia, 4054
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Tunis, Tunisia, 1007
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Tunis, Tunisia, 1008
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Tunis, Tunisia, 1006
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Ankara, Turkey
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Capa/Istanbul, Turkey
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Istanbul, Turkey
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Izmir, Turkey
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Dnepropetrovsk, Ukraine, 49005
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Kharkiv, Ukraine, 61037
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Odesa, Ukraine, 65074
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Zaporizhzhya, Ukraine, 69103
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Bradford, United Kingdom, BD5 0NA
- GSK Investigational Site
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Bristol, United Kingdom, BS2 8HW
- GSK Investigational Site
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Clydebank, Glasgow, United Kingdom, G81 2DR
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Crewe, United Kingdom, CW1 4QJ
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Edgbaston, Birmingham, United Kingdom, B15 2SQ
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Falkirk, United Kingdom, FK1 5QE
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Leeds, United Kingdom, LS9 7TF
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London, United Kingdom, EC1 7BE
- GSK Investigational Site
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London, United Kingdom, NW3 2QG
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London, United Kingdom, SW17 0QT
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London, United Kingdom, W1P 7PN
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Manchester, United Kingdom, M15 6SX
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Sheffield, United Kingdom, S10 2JF
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Torquay, United Kingdom, TQ2 7AA
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Wakefield, United Kingdom, WF1 4DG
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Waterloo, Liverpool, United Kingdom, L22 0LG
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Wolverhampton, United Kingdom, WV10 9RU
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Aberdeenshire
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Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZD
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Ayrshire
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Ayr, Ayrshire, United Kingdom, KA6 6DX
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Berkshire
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Reading, Berkshire, United Kingdom, RG2 0TG
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Cheshire
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Stockport, Cheshire, United Kingdom, SK2 7JE
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Devon
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Exeter, Devon, United Kingdom, EX2 5DW
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Plymouth, Devon, United Kingdom, PL6 8DH
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Glamorgan
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Cardiff, Glamorgan, United Kingdom, CF14 5GJ
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Gloucestershire
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Bristol, Gloucestershire, United Kingdom, BS10 5NB
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Hampshire
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Portsmouth, Hampshire, United Kingdom, PO3 6AD
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Southampton, Hampshire, United Kingdom, SO16 6YD
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Hertfordshire
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Stevenage, Hertfordshire, United Kingdom, SG2 4AB
- GSK Investigational Site
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Lanarkshire
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Glasgow, Lanarkshire, United Kingdom, G51 4TF
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Lancashire
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Buckshaw Village, Chorley, Lancashire, United Kingdom, PR7 7NA
- GSK Investigational Site
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Lancs, Lancashire, United Kingdom, PR7 1PP
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Manchester, Lancashire, United Kingdom, M8 5RB
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Manchester, Lancashire, United Kingdom, M41 5SL
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Oldham, Lancashire, United Kingdom, OL1 2JH
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Leicestershire
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Leicester, Leicestershire, United Kingdom, LE5 4PW
- GSK Investigational Site
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London
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Leytonstone, London, United Kingdom, E11 1NR
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Merseyside
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Liverpool, Merseyside, United Kingdom, L7 8XP
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Liverpool, Merseyside, United Kingdom, L1 9AD
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Midlothian
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Edinburgh, Midlothian, United Kingdom, EH4 2XU
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Norfolk
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Norwich, Norfolk, United Kingdom, NR4 7FP
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Northumberland
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Newcastle Upon Tyne, Northumberland, United Kingdom, NE7 7DN
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Nottinghamshire
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Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
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Somerset
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Bath, Somerset, United Kingdom, BA1 1BX
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Tauton, Somerset, United Kingdom, TA1 5DA
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Staffordshire
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Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
- GSK Investigational Site
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Surrey
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Redhill, Surrey, United Kingdom, RH1 5RH
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Sussex West
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Chichester, Sussex West, United Kingdom, PO19 4SE
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Warwickshire
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Birmingham, Warwickshire, United Kingdom, B9 5SS
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Coventry, Warwickshire, United Kingdom, CV1 2TZ
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Alabama
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Birmingham, Alabama, United States, 35209
- GSK Investigational Site
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Homewood, Alabama, United States, 35209
- GSK Investigational Site
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Huntsville, Alabama, United States, 35801
- GSK Investigational Site
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Mobile, Alabama, United States, 36608
- GSK Investigational Site
-
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Alaska
-
Anchorage, Alaska, United States, 99508
- GSK Investigational Site
-
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Arizona
-
Phoenix, Arizona, United States, 85023
- GSK Investigational Site
-
Phoenix, Arizona, United States, 85032
- GSK Investigational Site
-
Phoenix, Arizona, United States, 85014
- GSK Investigational Site
-
Scottsdale, Arizona, United States, 85258
- GSK Investigational Site
-
Sun City, Arizona, United States, 85375
- GSK Investigational Site
-
Tucson, Arizona, United States, 85712
- GSK Investigational Site
-
Tucson, Arizona, United States, 85710
- GSK Investigational Site
-
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Arkansas
-
Little Rock, Arkansas, United States, 72205
- GSK Investigational Site
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Little Rock, Arkansas, United States, 72211
- GSK Investigational Site
-
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California
-
Anaheim, California, United States, 92801
- GSK Investigational Site
-
Atherton, California, United States, 94027
- GSK Investigational Site
-
Culver City, California, United States, 90232
- GSK Investigational Site
-
Encino, California, United States, 91316
- GSK Investigational Site
-
Fountain Valley, California, United States, 92708
- GSK Investigational Site
-
Fresno, California, United States, 93720
- GSK Investigational Site
-
Irvine, California, United States, 92618
- GSK Investigational Site
-
La Mesa, California, United States, 91942
- GSK Investigational Site
-
Laguna Hills, California, United States, 92653
- GSK Investigational Site
-
Long Beach, California, United States, 90806
- GSK Investigational Site
-
Los Angeles, California, United States, 90073
- GSK Investigational Site
-
Los Angeles, California, United States, 90048
- GSK Investigational Site
-
Los Angeles, California, United States, 90024
- GSK Investigational Site
-
Los Angeles, California, United States, 90033
- GSK Investigational Site
-
Los Angeles, California, United States, 90059
- GSK Investigational Site
-
Mather, California, United States, 95655
- GSK Investigational Site
-
Newport Beach, California, United States, 92660
- GSK Investigational Site
-
Orange, California, United States, 92869
- GSK Investigational Site
-
Pico Rivera, California, United States, 90660
- GSK Investigational Site
-
Poway, California, United States, 92064
- GSK Investigational Site
-
Sacramento, California, United States, 95816
- GSK Investigational Site
-
Salinas, California, United States, 93901
- GSK Investigational Site
-
San Bernardino, California, United States, 92404
- GSK Investigational Site
-
San Diego, California, United States, 92103
- GSK Investigational Site
-
San Diego, California, United States, 92120
- GSK Investigational Site
-
San Diego, California, United States, 92128
- GSK Investigational Site
-
San Diego, California, United States, 92103-6204
- GSK Investigational Site
-
San Francisco, California, United States, 94121
- GSK Investigational Site
-
San Francisco, California, United States, 94108
- GSK Investigational Site
-
San Ramon, California, United States, 94583
- GSK Investigational Site
-
Santa Monica, California, United States, 90404
- GSK Investigational Site
-
Stanford, California, United States, 94305
- GSK Investigational Site
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Temecula, California, United States, 92591
- GSK Investigational Site
-
Torrance, California, United States, 90505
- GSK Investigational Site
-
Upland, California, United States, 91786
- GSK Investigational Site
-
Van Nuys, California, United States, 91405
- GSK Investigational Site
-
Walnut Creek, California, United States, 94598
- GSK Investigational Site
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Westchester, California, United States, 90045
- GSK Investigational Site
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-
Colorado
-
Aurora, Colorado, United States, 80012
- GSK Investigational Site
-
Aurora, Colorado, United States, 80010
- GSK Investigational Site
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Denver, Colorado, United States, 80220
- GSK Investigational Site
-
Denver, Colorado, United States, 80211
- GSK Investigational Site
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Englewood, Colorado, United States, 80113
- GSK Investigational Site
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Longmont, Colorado, United States, 80501
- GSK Investigational Site
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Connecticut
-
Hartford, Connecticut, United States, 06106
- GSK Investigational Site
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Middlebury, Connecticut, United States, 06762
- GSK Investigational Site
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New Britain, Connecticut, United States, 06052
- GSK Investigational Site
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Trumbull, Connecticut, United States, 06611
- GSK Investigational Site
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District of Columbia
-
Washington, District of Columbia, United States, 20307-5001
- GSK Investigational Site
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Florida
-
Aventura, Florida, United States, 33180
- GSK Investigational Site
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Clearwater, Florida, United States, 33761
- GSK Investigational Site
-
Clearwater, Florida, United States, 33756
- GSK Investigational Site
-
Delray Beach, Florida, United States, 33484
- GSK Investigational Site
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Fort Myers, Florida, United States, 33916
- GSK Investigational Site
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Jacksonville, Florida, United States, 32216
- GSK Investigational Site
-
Jacksonville, Florida, United States, 32224
- GSK Investigational Site
-
Jacksonville, Florida, United States, 32257
- GSK Investigational Site
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Lake Worth, Florida, United States, 33461
- GSK Investigational Site
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Largo, Florida, United States, 33773
- GSK Investigational Site
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Longwood, Florida, United States, 32750
- GSK Investigational Site
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Margate, Florida, United States, 33063
- GSK Investigational Site
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Melbourne, Florida, United States, 32901
- GSK Investigational Site
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Miami, Florida, United States, 33156
- GSK Investigational Site
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New Port Richey, Florida, United States, 34652
- GSK Investigational Site
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Ocala, Florida, United States, 34471
- GSK Investigational Site
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Ocala, Florida, United States, 34474
- GSK Investigational Site
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Okeechobee, Florida, United States, 34972
- GSK Investigational Site
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Orange Park, Florida, United States, 32073
- GSK Investigational Site
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Orlando, Florida, United States, 32803
- GSK Investigational Site
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Panama City, Florida, United States, 32405
- GSK Investigational Site
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Plantation, Florida, United States, 33317
- GSK Investigational Site
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Sarasota, Florida, United States, 34237
- GSK Investigational Site
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South Daytona, Florida, United States, 32119
- GSK Investigational Site
-
St. Petersburg, Florida, United States, 33703
- GSK Investigational Site
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Stuart, Florida, United States, 34996
- GSK Investigational Site
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Tallahassee, Florida, United States, 32308
- GSK Investigational Site
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Tamarac, Florida, United States, 33321
- GSK Investigational Site
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West Palm Beach, Florida, United States, 33409
- GSK Investigational Site
-
-
Georgia
-
Atlanta, Georgia, United States, 30342
- GSK Investigational Site
-
Atlanta, Georgia, United States, 30309
- GSK Investigational Site
-
Atlanta, Georgia, United States, 30308
- GSK Investigational Site
-
Augusta, Georgia, United States, 30912
- GSK Investigational Site
-
Fayetteville, Georgia, United States, 30214
- GSK Investigational Site
-
Marietta, Georgia, United States, 30060
- GSK Investigational Site
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Roswell, Georgia, United States, 30076
- GSK Investigational Site
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Woodstock, Georgia, United States, 30189
- GSK Investigational Site
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96813
- GSK Investigational Site
-
-
Idaho
-
Coeur d'Alene, Idaho, United States, 83814
- GSK Investigational Site
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- GSK Investigational Site
-
Chicago, Illinois, United States, 60612
- GSK Investigational Site
-
Chicago, Illinois, United States, 60640
- GSK Investigational Site
-
Chicago, Illinois, United States, 60616
- GSK Investigational Site
-
Galesburg, Illinois, United States, 61401
- GSK Investigational Site
-
Kankakee, Illinois, United States, 60901
- GSK Investigational Site
-
Maywood, Illinois, United States, 60153
- GSK Investigational Site
-
Melrose Park, Illinois, United States, 60160
- GSK Investigational Site
-
Niles, Illinois, United States, 60714
- GSK Investigational Site
-
Springfield, Illinois, United States, 62781
- GSK Investigational Site
-
-
Indiana
-
Evansville, Indiana, United States, 47714
- GSK Investigational Site
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Fort Wayne, Indiana, United States, 46825
- GSK Investigational Site
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Indianapolis, Indiana, United States, 46202
- GSK Investigational Site
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Jeffersonville, Indiana, United States, 47130
- GSK Investigational Site
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-
Kansas
-
Kansas City, Kansas, United States, 66160
- GSK Investigational Site
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Overland Park, Kansas, United States, 66211
- GSK Investigational Site
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Wichita, Kansas, United States, 67208
- GSK Investigational Site
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-
Kentucky
-
Lexington, Kentucky, United States, 40508
- GSK Investigational Site
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-
Louisiana
-
Covington, Louisiana, United States, 70433
- GSK Investigational Site
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Gretna, Louisiana, United States, 70056
- GSK Investigational Site
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Houma, Louisiana, United States, 70360
- GSK Investigational Site
-
Lafayette, Louisiana, United States, 70503
- GSK Investigational Site
-
Metairie, Louisiana, United States, 70001
- GSK Investigational Site
-
New Orleans, Louisiana, United States, 70115
- GSK Investigational Site
-
New Orleans, Louisiana, United States, 70119
- GSK Investigational Site
-
New Orleans, Louisiana, United States, 70121
- GSK Investigational Site
-
Ruston, Louisiana, United States, 71270
- GSK Investigational Site
-
Shreveport, Louisiana, United States, 71106
- GSK Investigational Site
-
-
Maryland
-
Annapolis, Maryland, United States, 21401
- GSK Investigational Site
-
Baltimore, Maryland, United States, 21201
- GSK Investigational Site
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Greenbelt, Maryland, United States, 20770
- GSK Investigational Site
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Owings Mills, Maryland, United States, 21117
- GSK Investigational Site
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Rockville, Maryland, United States, 20850
- GSK Investigational Site
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Towson, Maryland, United States, 21204
- GSK Investigational Site
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Massachusetts
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Boston, Massachusetts, United States, 02115
- GSK Investigational Site
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Braintree, Massachusetts, United States, 02184
- GSK Investigational Site
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Haverhill, Massachusetts, United States, 01830
- GSK Investigational Site
-
Milford, Massachusetts, United States, 01757
- GSK Investigational Site
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Newton, Massachusetts, United States, 2462
- GSK Investigational Site
-
Springfield, Massachusetts, United States, 01107
- GSK Investigational Site
-
Waltham, Massachusetts, United States, 02453
- GSK Investigational Site
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Watertown, Massachusetts, United States, 02472
- GSK Investigational Site
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West Yarmouth, Massachusetts, United States, 02673
- GSK Investigational Site
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Wocester, Massachusetts, United States, 01608
- GSK Investigational Site
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Michigan
-
Ann Arbor, Michigan, United States, 48106
- GSK Investigational Site
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Detroit, Michigan, United States, 48202
- GSK Investigational Site
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Royal Oak, Michigan, United States, 48073
- GSK Investigational Site
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St. Joseph, Michigan, United States, 49085
- GSK Investigational Site
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Minnesota
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Chaska, Minnesota, United States, 55318
- GSK Investigational Site
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Edina, Minnesota, United States, 55435
- GSK Investigational Site
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Minneapolis, Minnesota, United States, 55404
- GSK Investigational Site
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Rochester, Minnesota, United States, 55905
- GSK Investigational Site
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St. Cloud, Minnesota, United States, 56303
- GSK Investigational Site
-
-
Mississippi
-
Hattiesburg, Mississippi, United States, 39401
- GSK Investigational Site
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Jackson, Mississippi, United States, 39202
- GSK Investigational Site
-
-
Missouri
-
Kansas City, Missouri, United States, 64114
- GSK Investigational Site
-
Springfield, Missouri, United States, 65807
- GSK Investigational Site
-
St. Louis, Missouri, United States, 63141
- GSK Investigational Site
-
St. Louis, Missouri, United States, 63136
- GSK Investigational Site
-
St. Louis, Missouri, United States, 63110-2539
- GSK Investigational Site
-
-
Montana
-
Billings, Montana, United States, 59102
- GSK Investigational Site
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-
Nebraska
-
Omaha, Nebraska, United States, 68131
- GSK Investigational Site
-
Omaha, Nebraska, United States, 68114
- GSK Investigational Site
-
-
Nevada
-
Henderson, Nevada, United States, 89014
- GSK Investigational Site
-
Las Vegas, Nevada, United States, 89106
- GSK Investigational Site
-
Las Vegas, Nevada, United States, 89148
- GSK Investigational Site
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Reno, Nevada, United States, 89502
- GSK Investigational Site
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Reno, Nevada, United States, 89511
- GSK Investigational Site
-
-
New Hampshire
-
Lebanon, New Hampshire, United States, 03756
- GSK Investigational Site
-
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New Jersey
-
Edison, New Jersey, United States, 08837
- GSK Investigational Site
-
Hackensack, New Jersey, United States, 07601
- GSK Investigational Site
-
Lawrencevill, New Jersey, United States, 08648
- GSK Investigational Site
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Marlton, New Jersey, United States, 08053
- GSK Investigational Site
-
Perth Amboy, New Jersey, United States, 08861
- GSK Investigational Site
-
Voorhees, New Jersey, United States, 08043
- GSK Investigational Site
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West Orange, New Jersey, United States, 07052
- GSK Investigational Site
-
-
New York
-
Albany, New York, United States, 12208
- GSK Investigational Site
-
Binghamton, New York, United States, 13901
- GSK Investigational Site
-
Bronx, New York, United States, 10467
- GSK Investigational Site
-
Brooklyn, New York, United States, 11234
- GSK Investigational Site
-
East Syracuse, New York, United States, 13057
- GSK Investigational Site
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Elmont, New York, United States, 11003
- GSK Investigational Site
-
Endwell, New York, United States, 13760
- GSK Investigational Site
-
Garden City, New York, United States, 11530
- GSK Investigational Site
-
Great Neck, New York, United States, 11021
- GSK Investigational Site
-
Mineola, New York, United States, 11501
- GSK Investigational Site
-
New York, New York, United States, 10021
- GSK Investigational Site
-
New York, New York, United States, 10016
- GSK Investigational Site
-
Orchard Park, New York, United States, 14127
- GSK Investigational Site
-
Poughkeepsie, New York, United States, 12601
- GSK Investigational Site
-
Rochester, New York, United States, 14642
- GSK Investigational Site
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Staten Island, New York, United States, 10304
- GSK Investigational Site
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Syracuse, New York, United States, 13210
- GSK Investigational Site
-
-
North Carolina
-
Cary, North Carolina, United States, 27518
- GSK Investigational Site
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Cary, North Carolina, United States, 27511
- GSK Investigational Site
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Chapel Hill, North Carolina, United States, 27599-7600
- GSK Investigational Site
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Charlotte, North Carolina, United States, 28262
- GSK Investigational Site
-
Charlotte, North Carolina, United States, 28211
- GSK Investigational Site
-
Charlotte, NC 28207, North Carolina, United States, 28207
- GSK Investigational Site
-
Concord, North Carolina, United States, 28025
- GSK Investigational Site
-
Durham, North Carolina, United States, 27710
- GSK Investigational Site
-
Greensboro, North Carolina, United States, 27403
- GSK Investigational Site
-
Greenville, North Carolina, United States, 27834
- GSK Investigational Site
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Raleigh, North Carolina, United States, 27607
- GSK Investigational Site
-
Raleigh, North Carolina, United States, 27612
- GSK Investigational Site
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Winston-Salem, North Carolina, United States, 27103
- GSK Investigational Site
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-
North Dakota
-
Bismarck, North Dakota, United States, 58501
- GSK Investigational Site
-
-
Ohio
-
Cincinnati, Ohio, United States, 45219
- GSK Investigational Site
-
Cincinnati, Ohio, United States, 45212
- GSK Investigational Site
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Columbus, Ohio, United States, 43214
- GSK Investigational Site
-
Columbus, Ohio, United States, 43235
- GSK Investigational Site
-
Columbus, Ohio, United States, 43220
- GSK Investigational Site
-
Elyria, Ohio, United States, 44035
- GSK Investigational Site
-
Kettering, Ohio, United States, 45429
- GSK Investigational Site
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Marion, Ohio, United States, 43302
- GSK Investigational Site
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Zanesville, Ohio, United States, 43701
- GSK Investigational Site
-
-
Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
- GSK Investigational Site
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Poca City, Oklahoma, United States, 74601
- GSK Investigational Site
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Tulsa, Oklahoma, United States, 74146
- GSK Investigational Site
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-
Oregon
-
Oregon City, Oregon, United States, 97045
- GSK Investigational Site
-
Portland, Oregon, United States, 97210
- GSK Investigational Site
-
Portland, Oregon, United States, 97213
- GSK Investigational Site
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Portland, Oregon, United States, 97205
- GSK Investigational Site
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Springfield, Oregon, United States, 97477
- GSK Investigational Site
-
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Pennsylvania
-
Bala Cynwyd, Pennsylvania, United States, 19004
- GSK Investigational Site
-
Bryn Mawr, Pennsylvania, United States, 19010
- GSK Investigational Site
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Camp Hill, Pennsylvania, United States, 17011
- GSK Investigational Site
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Harrisburg, Pennsylvania, United States, 17110
- GSK Investigational Site
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Hershey, Pennsylvania, United States, 17033-0850
- GSK Investigational Site
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Lancaster, Pennsylvania, United States, 17604
- GSK Investigational Site
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Lancaster, Pennsylvania, United States, 17601
- GSK Investigational Site
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Monroeville, Pennsylvania, United States, 15146
- GSK Investigational Site
-
Newton, Pennsylvania, United States, 18940
- GSK Investigational Site
-
Philadelphia, Pennsylvania, United States, 19107
- GSK Investigational Site
-
Philadelphia, Pennsylvania, United States, 19144
- GSK Investigational Site
-
Philadelphia, Pennsylvania, United States, 19152
- GSK Investigational Site
-
Philadelphia, Pennsylvania, United States, 19141
- GSK Investigational Site
-
Pittsburgh, Pennsylvania, United States, 15232
- GSK Investigational Site
-
Pittsburgh, Pennsylvania, United States, 15215
- GSK Investigational Site
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Rosemont, Pennsylvania, United States, 19010
- GSK Investigational Site
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Sellersville, Pennsylvania, United States, 18960
- GSK Investigational Site
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State College, Pennsylvania, United States, 16801
- GSK Investigational Site
-
-
Rhode Island
-
Cranston, Rhode Island, United States, 02920
- GSK Investigational Site
-
Providence, Rhode Island, United States, 02904
- GSK Investigational Site
-
West Warwick, Rhode Island, United States, 02893
- GSK Investigational Site
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- GSK Investigational Site
-
Greenville, South Carolina, United States, 29650
- GSK Investigational Site
-
Greer, South Carolina, United States, 29651
- GSK Investigational Site
-
Myrtle Beach, South Carolina, United States, 29572
- GSK Investigational Site
-
Simpsonville, South Carolina, United States, 29681
- GSK Investigational Site
-
-
South Dakota
-
Fort Pierre, South Dakota, United States, 57501
- GSK Investigational Site
-
-
Tennessee
-
Germantown, Tennessee, United States, 38138
- GSK Investigational Site
-
Knoxville, Tennessee, United States, 37920
- GSK Investigational Site
-
Memphis, Tennessee, United States, 38119
- GSK Investigational Site
-
Nashville, Tennessee, United States, 37209
- GSK Investigational Site
-
Nashville, Tennessee, United States, 37232-2765
- GSK Investigational Site
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-
Texas
-
Amarillo, Texas, United States, 79106
- GSK Investigational Site
-
Arlington, Texas, United States, 76017
- GSK Investigational Site
-
Austin, Texas, United States, 78757
- GSK Investigational Site
-
Dallas, Texas, United States, 75230
- GSK Investigational Site
-
Dallas, Texas, United States, 75231
- GSK Investigational Site
-
Dallas, Texas, United States, 75216
- GSK Investigational Site
-
Dallas, Texas, United States, 75235
- GSK Investigational Site
-
Dallas, Texas, United States, 75234
- GSK Investigational Site
-
Fort Worth, Texas, United States, 76104
- GSK Investigational Site
-
Fort Worth, Texas, United States, 76107
- GSK Investigational Site
-
Houston, Texas, United States, 77030
- GSK Investigational Site
-
Houston, Texas, United States, 77024
- GSK Investigational Site
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San Antonio, Texas, United States, 78229
- GSK Investigational Site
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Texarkana, Texas, United States, 75503
- GSK Investigational Site
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Utah
-
Salt Lake City, Utah, United States, 84107
- GSK Investigational Site
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Vermont
-
South Burlington, Vermont, United States, 05403
- GSK Investigational Site
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Virginia
-
Alexandria, Virginia, United States, 22302
- GSK Investigational Site
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Charlottesville, Virginia, United States, 22911
- GSK Investigational Site
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Fairfax, Virginia, United States, 22031
- GSK Investigational Site
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Harrisonburg, Virginia, United States, 22801
- GSK Investigational Site
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Mechanicsville, Virginia, United States, 23116
- GSK Investigational Site
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Norfolk, Virginia, United States, 23502
- GSK Investigational Site
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Richmond, Virginia, United States, 23249
- GSK Investigational Site
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Salem, Virginia, United States, 24153
- GSK Investigational Site
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Virginia Beach, Virginia, United States, 23454
- GSK Investigational Site
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Washington
-
Graham, Washington, United States, 98338
- GSK Investigational Site
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Seattle, Washington, United States, 98101
- GSK Investigational Site
-
Seattle, Washington, United States, 98195
- GSK Investigational Site
-
Seattle, Washington, United States, 98166
- GSK Investigational Site
-
Seattle, Washington, United States, 98122
- GSK Investigational Site
-
Seattle, Washington, United States, 98133
- GSK Investigational Site
-
Spokane, Washington, United States, 99202
- GSK Investigational Site
-
Tacoma, Washington, United States, 98405
- GSK Investigational Site
-
Tacoma, Washington, United States, 98499
- GSK Investigational Site
-
Tacoma, Washington, United States, 98431
- GSK Investigational Site
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Wisconsin
-
Madison, Wisconsin, United States, 53715
- GSK Investigational Site
-
Milwaukee, Wisconsin, United States, 53215
- GSK Investigational Site
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Milwaukee, Wisconsin, United States, 53209
- GSK Investigational Site
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-
Wyoming
-
Cheyenne, Wyoming, United States, 82001
- GSK Investigational Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo Arm
Eligible subjects will complete a 4-week placebo run-in followed by randomization to matched placebo in a 1:1 ratio.
|
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.
|
|
Experimental: dustasteride arm
Eligible subjects will complete a 4-week placebo run-in followed by randomization to 0.5mg dutasteride in a 1:1 ratio.
Randomization will be stratified by center.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach)
Time Frame: Years 1-2, Years 3-4, and Overall (Years 1-4)
|
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)
|
|
Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach)
Time Frame: Years 1-2, Years 3-4, and Overall (Years 1-4)
|
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)
|
|
Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach)
Time Frame: Years 1-2, Years 3-4, and Overall (Years 1-4)
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With the Indicated Gleason Score at Diagnosis
Time Frame: Baseline to Year 4
|
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
|
|
Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy
Time Frame: Baseline to Year 4
|
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
|
|
Volume of HGPIN at Biopsy
Time Frame: Baseline to Year 4
|
The amount of prostate biopsy tissue with HGPIN was measured.
|
Baseline to Year 4
|
|
Percentage of Core Involved at Diagnosis
Time Frame: Baseline to Year 4
|
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
|
|
Number of Cancer-positive Cores
Time Frame: Baseline to Year 4
|
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
|
|
Treatment Alteration Score
Time Frame: Baseline to Year 4
|
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
|
|
Number of Participants Undergoing Intervention (Surgical and Non-surgical) for Prostate Cancer Treatment
Time Frame: Baseline to Year 4
|
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
|
|
Adjusted Mean Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 48
Time Frame: Baseline to Year 4 (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)
|
|
Adjusted Mean Percentage Change From Baseline in Prostate Volume at Months 24 and 48
Time Frame: Baseline, Month 24, and Month 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
|
|
Adjusted Mean Change From Baseline in Maximum Urinary Flow (Qmax) at Months 12, 24, 36, and 48
Time Frame: Baseline and 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
|
|
Number of Participants Starting Alpha Blockers to Control Benign Prostatic Hyperplasia (BPH) Symptoms
Time Frame: Years 1-2, Overall (Years 1-4)
|
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)
|
|
Number of Participants With at Least One Event of Acute Urinary Retention (AUR)
Time Frame: Years 1-2 and Overall (Years 1-4)
|
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)
|
|
Number of Participants With at Least One Urinary Tract Infection (UTI)
Time Frame: Years 1-2, Years 3-4, and Overall (Years 1-4)
|
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)
|
|
Number of Participants With Post-biopsy Macroscopic Hematuria
Time Frame: Baseline to Year 4
|
Participants reported events of macroscopic hematuria (visible blood in the urine) throughout the study.
|
Baseline to Year 4
|
|
Number of Participants With Post-biopsy Macroscopic Hematospermia
Time Frame: Baseline through Year 4
|
Participants reported events of macroscopic hematospermia (visible blood in semen) throughout the study.
|
Baseline through Year 4
|
|
Overall Survival
Time Frame: From time informed consent is signed to 4-month Safety Follow-Up period
|
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
|
|
Adjusted Mean Change From Baseline in the Benign Prostatic Hypertrophy (BPH) Impact Index (BII) at Month 48
Time Frame: Baseline and 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
|
|
Adjusted Mean Change From Baseline in The Medical Outcomes Study Sleep Problems Index 6-item Standard Version (MOS Sleep-6S) at Month 48
Time Frame: Baseline and 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
|
|
Adjusted Mean Change From Baseline in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH CPSI) at Month 48
Time Frame: Baseline and 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
|
|
Adjusted Mean Change From Baseline in Quality of Life Question 8 (QOL Q8) at Month 48
Time Frame: Baseline and 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
|
|
Adjusted Mean Change From Baseline in the Problem Assessment Scale of the Sexual Function Index (PASSFI) at Month 48
Time Frame: Baseline and 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
|
|
Number of Participants With the Indicated Serum Dihydrotestosterone (DHT) Concentration at Month 48
Time Frame: 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
|
|
Mean Change From Baseline in Testosterone at Month 48
Time Frame: Baseline and Month 48
|
Testosterone, a male sex hormone, was measured by taking blood samples at screening and yearly thereafter.
|
Baseline and Month 48
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Thomas JA 2nd, Gerber L, Moreira DM, Hamilton RJ, Banez 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.
- 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.
- 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.
- 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.
- 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.
- Muller RL, Gerber L, Moreira DM, Andriole G, Castro-Santamaria R, Freedland SJ. Serum testosterone and dihydrotestosterone and prostate cancer risk in the placebo arm of the Reduction by Dutasteride of Prostate Cancer Events trial. Eur Urol. 2012 Nov;62(5):757-64. doi: 10.1016/j.eururo.2012.05.025. Epub 2012 May 18.
- 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.
- 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.
- 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, Banez 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.
- Vidal AC, Oyekunle T, Feng T, Freedland AR, Moreira D, Castro-Santamaria R, Andriole GL, Freedland SJ, Allott EH. Asian Race and Risk of Prostate Cancer: Results from the REDUCE Study. Cancer Epidemiol Biomarkers Prev. 2020 Nov;29(11):2165-2170. doi: 10.1158/1055-9965.EPI-20-0646. Epub 2020 Aug 20.
- Bliwise DL, Howard LE, Moreira DM, Andriole GL, Hopp ML, Freedland SJ. Nocturia and associated mortality: observational data from the REDUCE trial. Prostate Cancer Prostatic Dis. 2019 Mar;22(1):77-83. doi: 10.1038/s41391-018-0090-5. Epub 2018 Sep 13.
- Moreira DM, Andriole GL, Nickel JC, Roehrborn CG, Castro-Santamaria R, Freedland SJ. Dutasteride is associated with reduced risk of transrectal prostate biopsy-associated urinary tract infection and related hospitalizations. World J Urol. 2017 Oct;35(10):1525-1530. doi: 10.1007/s00345-017-2036-2. Epub 2017 Apr 10.
- Nickel JC, Roehrborn CG, Castro-Santamaria R, Freedland SJ, Moreira DM. Chronic Prostate Inflammation is Associated with Severity and Progression of Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms and Risk of Acute Urinary Retention. J Urol. 2016 Nov;196(5):1493-1498. doi: 10.1016/j.juro.2016.06.090. Epub 2016 Jul 1.
- Moreira DM, Nickel JC, Andriole GL, Castro-Santamaria R, Freedland SJ. Chronic baseline prostate inflammation is associated with lower tumor volume in men with prostate cancer on repeat biopsy: Results from the REDUCE study. Prostate. 2015 Sep;75(13):1492-8. doi: 10.1002/pros.23041. Epub 2015 Jul 17.
- Moreira DM, Bostwick DG, Andriole GL, Peterson BL, Cohen HJ, Castro-Santamaria R, Freedland SJ. Baseline Prostate Atrophy is Associated with Reduced Risk of Prostate Cancer in Men Undergoing Repeat Prostate Biopsy. J Urol. 2015 Nov;194(5):1241-6. doi: 10.1016/j.juro.2015.05.103. Epub 2015 Jul 10.
- Toren P, Margel D, Kulkarni G, Finelli A, Zlotta A, Fleshner N. Effect of dutasteride on clinical progression of benign prostatic hyperplasia in asymptomatic men with enlarged prostate: a post hoc analysis of the REDUCE study. BMJ. 2013 Apr 15;346:f2109. doi: 10.1136/bmj.f2109.
- Muller RL, Gerber L, Moreira DM, Andriole G Jr, Hamilton RJ, Fleshner N, Parsons JK, Freedland SJ. Obesity is associated with increased prostate growth and attenuated prostate volume reduction by dutasteride. Eur Urol. 2013 Jun;63(6):1115-21. doi: 10.1016/j.eururo.2013.02.038. Epub 2013 Mar 7.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2003
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
March 11, 2003
First Submitted That Met QC Criteria
March 12, 2003
First Posted (Estimate)
March 13, 2003
Study Record Updates
Last Update Posted (Estimate)
September 23, 2016
Last Update Submitted That Met QC Criteria
August 17, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- 5-alpha Reductase Inhibitors
- Dutasteride
Other Study ID Numbers
- ARI40006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
-
Study Protocol
Information identifier: ARI40006Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Individual Participant Data Set
Information identifier: ARI40006Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Clinical Study Report
Information identifier: ARI40006Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Annotated Case Report Form
Information identifier: ARI40006Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Dataset Specification
Information identifier: ARI40006Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Statistical Analysis Plan
Information identifier: ARI40006Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Informed Consent Form
Information identifier: ARI40006Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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