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Trial record 6 of 141 for:    women's health initiative

Women's Health Initiative (WHI)

This study has been completed.
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)
ClinicalTrials.gov Identifier:
NCT00000611
First received: October 27, 1999
Last updated: April 14, 2016
Last verified: January 2006
  Purpose
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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
Postmenopausal women ages 50 to 79.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
OverallOfficial: Ross Prentice Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
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.

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: WHI-CT
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: WHI-CT
Study Forms  This link exits the ClinicalTrials.gov site
Identifier: WHI-CT
Manual of Procedures  This link exits the ClinicalTrials.gov site
Identifier: WHI-CT
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: WHI-OS
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: WHI-OS
Study Forms  This link exits the ClinicalTrials.gov site
Identifier: WHI-OS
Manual of Procedures  This link exits the ClinicalTrials.gov site
Identifier: WHI-OS

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.

ClinicalTrials.gov Identifier: NCT00000611     History of Changes
Other Study ID Numbers: 114
Study First Received: October 27, 1999
Last Updated: April 14, 2016

Additional relevant MeSH terms:
Neoplasms
Cardiovascular Diseases
Heart Diseases
Osteoporosis
Ischemia
Breast Neoplasms
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Bone Diseases
Colonic Neoplasms
Bone Diseases, Metabolic
Musculoskeletal Diseases
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Vitamin D
Hormones

ClinicalTrials.gov processed this record on June 28, 2017