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Women's Health Initiative (WHI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00000611
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : April 15, 2016
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Cancer Institute (NCI)
National Institute on Aging (NIA)
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
To address cardiovascular disease, cancer, and osteoporosis, the most common causes of death, disability, and impaired quality of life in postmenopausal women. The three major components of the WHI are: a randomized controlled clinical trial of hormone replacement therapy (HRT), dietary modification (DM), and calcium/vitamin D supplementation (CaD); an observational study (OS); and a community prevention study (CPS). On October 1, 1997, administration of the WHI was transferred to the NHLBI where it is conducted as a consortium effort led by the NHLBI in cooperation with the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Cancer Institute (NCI), and the National Institute on Aging (NIA).

Condition or disease Intervention/treatment Phase
Bone Diseases Breast Neoplasms Cardiovascular Diseases Colonic Neoplasms Coronary Disease Heart Diseases Myocardial Ischemia Osteoporosis Postmenopause Drug: hormone replacement therapy Drug: estrogens Drug: progestins Drug: estrogen replacement therapy Behavioral: diet, fat-restricted Drug: calcium Drug: vitamin D Behavioral: dietary supplements Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Prevention
Actual Primary Completion Date : March 2005




Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
Postmenopausal women ages 50 to 79.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000611


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Cancer Institute (NCI)
National Institute on Aging (NIA)
Investigators
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OverallOfficial: Ross Prentice Fred Hutchinson Cancer Center
Additional Information:
Publications of Results:

Other Publications:
Women's Health Initiative Steering Committee: Effects of Conjugated Equine Estrogen in Postmenopausal Women Having Undergone Hysterectomy: The Women's Health Initiative Randomized, Controlled Trials. Obstet Gynecol Surv, 59(8):599-600, 2004.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Interleukin-6 Receptor Mendelian Randomisation Analysis (IL6R MR) Consortium; Swerdlow DI, Holmes MV, Kuchenbaecker KB, Engmann JE, Shah T, Sofat R, Guo Y, Chung C, Peasey A, Pfister R, Mooijaart SP, Ireland HA, Leusink M, Langenberg C, Li KW, Palmen J, Howard P, Cooper JA, Drenos F, Hardy J, Nalls MA, Li YR, Lowe G, Stewart M, Bielinski SJ, Peto J, Timpson NJ, Gallacher J, Dunlop M, Houlston R, Tomlinson I, Tzoulaki I, Luan J, Boer JM, Forouhi NG, Onland-Moret NC, van der Schouw YT, Schnabel RB, Hubacek JA, Kubinova R, Baceviciene M, Tamosiunas A, Pajak A, Topor-Madry R, Malyutina S, Baldassarre D, Sennblad B, Tremoli E, de Faire U, Ferrucci L, Bandenelli S, Tanaka T, Meschia JF, Singleton A, Navis G, Mateo Leach I, Bakker SJ, Gansevoort RT, Ford I, Epstein SE, Burnett MS, Devaney JM, Jukema JW, Westendorp RG, Jan de Borst G, van der Graaf Y, de Jong PA, Mailand-van der Zee AH, Klungel OH, de Boer A, Doevendans PA, Stephens JW, Eaton CB, Robinson JG, Manson JE, Fowkes FG, Frayling TM, Price JF, Whincup PH, Morris RW, Lawlor DA, Smith GD, Ben-Shlomo Y, Redline S, Lange LA, Kumari M, Wareham NJ, Verschuren WM, Benjamin EJ, Whittaker JC, Hamsten A, Dudbridge F, Delaney JA, Wong A, Kuh D, Hardy R, Castillo BA, Connolly JJ, van der Harst P, Brunner EJ, Marmot MG, Wassel CL, Humphries SE, Talmud PJ, Kivimaki M, Asselbergs FW, Voevoda M, Bobak M, Pikhart H, Wilson JG, Hakonarson H, Reiner AP, Keating BJ, Sattar N, Hingorani AD, Casas JP. The interleukin-6 receptor as a target for prevention of coronary heart disease: a mendelian randomisation analysis. Lancet. 2012 Mar 31;379(9822):1214-24. doi: 10.1016/S0140-6736(12)60110-X. Epub 2012 Mar 14.

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ClinicalTrials.gov Identifier: NCT00000611    
Other Study ID Numbers: 114
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: January 2006
Additional relevant MeSH terms:
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Neoplasms
Breast Neoplasms
Colonic Neoplasms
Osteoporosis
Bone Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Metabolic Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases
Vascular Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Vitamin D
Calcium
Hormones
Estrogens
Progestins
Vitamins