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Study Description

The Women's Health Initiative (WHI) is a long-term national health study that has focused on strategies for preventing heart disease, breast and colorectal cancer, and osteoporotic fractures in postmenopausal women. The original WHI study included 161,808 postmenopausal women enrolled between 1993 and 1998. The Fred Hutchinson Cancer Research Center in Seattle, WA serves as the WHI Clinical Coordinating Center for data collection, management, and analysis of the WHI.

The WHI has two major parts: a partial factorial randomized Clinical Trial (CT) and an Observational Study (OS); both were conducted at 40 Clinical Centers nationwide.

The CT enrolled 68,132 postmenopausal women between the ages of 50-79 into trials testing three prevention strategies. If eligible, women could choose to enroll in one, two, or all three of the trial components. The components are:

  • Hormone Therapy Trials (HT): This double-blind component examined the effects of combined hormones or estrogen alone on the prevention of coronary heart disease and osteoporotic fractures, and associated risk for breast cancer. Women participating in this component with an intact uterus were randomized to estrogen plus progestin (conjugated equine estrogens [CEE], 0.625 mg/d plus medroxyprogesterone acetate [MPA] 2.5 mg/d] or a matching placebo. Women with prior hysterectomy were randomized to CEE or placebo. Both trials were stopped early, in July 2002 and March 2004, respectively, based on adverse effects. All HT participants continued to be followed without intervention until close-out.
  • Dietary Modification Trial (DM): The Dietary Modification component evaluated the effect of a low-fat and high fruit, vegetable and grain diet on the prevention of breast and colorectal cancers and coronary heart disease. Study participants were randomized to either their usual eating pattern or a low-fat dietary pattern.
  • Calcium/Vitamin D Trial (CaD): This double-blind component began 1 to 2 years after a woman joined one or both of the other clinical trial components. It evaluated the effect of calcium and vitamin D supplementation on the prevention of osteoporotic fractures and colorectal cancer. Women in this component were randomized to calcium (1000 mg/d) and vitamin D (400 IU/d) supplements or a matching placebo.

The Observational Study (OS) examines the relationship between lifestyle, environmental, medical and molecular risk factors and specific measures of health or disease outcomes. This component involves tracking the medical history and health habits of 93,676 women not participating in the CT. Recruitment for the observational study was completed in 1998 and participants were followed annually for 8 to 12 years.

The original protocol allowed for follow-up until March 2005, after which participants were invited to enroll in the WHI Extension Study for follow-up through 2010. As of August 2007 there were 115,400 women enrolled in the Extension Study. Genetic samples from 12,157 WHI African American and Hispanic participants were evaluated with a genome-wide scan for inclusion in the dbGaP. Data is available on 12,008 of these subjects. Data are not provided for approximately 1% of the genetic samples that did not pass quality control (e.g., did not pass lab QC/could not be genotyped, low call rate, abnormalities of sex chromosomes, or samples that were probably mislabeled).

Authorized Access
Publicly Available Data (Public ftp)
Study Inclusion/Exclusion Criteria

All women enrolled in the WHI were between 50 and 79 years old and were postmenopausal at the time of enrollment. In addition, eligibility criteria for the clinical trial (CT) and observational study (OS) included ability and willingness to provide written informed consent and an intention to reside in the area for at least 3 years after enrollment. Component specific exclusion criteria are listed in Table 1 of the Baseline Monograph paper (available at http://www.whiscience.org/about/baseline/baseline_Recruitment.pdf). SHARe participants are women enrolled in WHI whose self-reported ethnicity was African American or Hispanic.

Molecular Data
TypeVendor/PlatformNumber of Oligos/SNPsSNP Batch IdComment
Whole Genome Genotyping AFFYMETRIX AFFY_6.0 934940 52074
Study History

  • October 1992 - Clinical Coordinating Center operations begin
  • March 1993 - 16 Clinical Centers selected
  • September 1993 - Recruitment of participants for 2 Hormone Therapy Trials (HT) trials and the Dietary Modification Trial (DM) begins
  • September 1994 - 24 additional Clinical Centers selected; Recruitment of participants for the Observational Study (OS) begins
  • June 1995 - CaD randomization begins
  • August 1998 - Randomization of participants for the DM ends
  • October 1998 - Randomization of participants for the HT ends
  • December 1998 - Recruitment of participants for the OS ends
  • September 2000 - Randomization of participants for the CaD ends
  • July 2002 - Estrogen plus Progestin HT was stopped early and main results published
  • March 2004 - Estrogen-Alone HT was stopped early
  • April 2004 - Main results of Estrogen-Alone HT published; Closeout of OS begins
  • October 2004 - Closeout of clinical trials (HT, DM, and CaD) begins
  • March 2005 - Study close-out ends
  • April 2005 - Extension study begins
  • September 2005 - Final WHI outcomes obtained and WHI database closed
  • February 2006 - Main results of DM and CaD published
  • September 2010 - Extension study scheduled to close

Selected publications
Diseases Related to Study (MESH terms)
Authorized Data Access Requests
Study Attribution
  • Study Leadership
    • Jacques Rossouw, Branch Chief. Women's Health Initiative, National Institutes of Health, Bethesda, MD, USA
    • Shari Ludlam, Project Officer. Women's Health Initiative, National Institutes of Health, Bethesda, MD, USA
    • Peggy Mills, Contracts Team Leader. Women's Health Initiative, National Institutes of Health, Bethesda, MD, USA
    • George Papanicolaou, WHI SHARe Project Officer. DCVS, National Institutes of Health, Bethesda, MD, USA
  • Coordinating Center
    • Ross Prentice, Dual Principal Investigator. Fred Hutchinson Cancer Research Center, Seattle, WA, USA
    • Garnet Anderson, Dual Principal Investigator. Fred Hutchinson Cancer Research Center, Seattle, WA, USA
    • Andrea LaCroix, Co-Principal Investigator. Fred Hutchinson Cancer Research Center, Seattle, WA, USA
    • Charles Kooperberg, Outcomes Director. Fred Hutchinson Cancer Research Center, Seattle, WA, USA
    • Susan Anderson, Coordinating Center Manager. Fred Hutchinson Cancer Research Center, Seattle, WA, USA
    • Bernedine Lund, Technical Director. Fred Hutchinson Cancer Research Center, Seattle, WA, USA
  • Principal Investigators
    • Garnet Anderson. Fred Hutchinson Cancer Research Center, Seattle, WA, USA
    • Shirley Beresford. University of Washington, Seattle, WA, USA
    • Robert Brunner. University of Nevada, Reno, NV, USA
    • Robert Brzyski. University of Texas Health Science Center, San Antonio, TX, USA
    • Bette Caan. Kaiser Permanente - Division of Research, Oakland, CA, USA
    • Rowan Chlebowski. University of California - Torrance, Torrance, CA, USA
    • J. David Curb. University of Hawaii at Manoa, Honolulu, HI, USA
    • Charles Eaton. Memorial Hospital of Rhode Island, Pawtucket, RI, USA
    • Margery Gass. University of Cincinnati College of Medicine, Cincinnati, OH, USA
    • Gerardo Heiss. University of North Carolina - Chapel Hill, Chapel Hill, NC, USA
    • Barbara Howard. Medstar Research Center, Hyattsville, MD, USA
    • F. Allan Hubbell. University of California - Irvine, Irvine, CA, USA
    • Rebecca Jackson. Ohio State University, Columbus, OH, USA
    • Karen Johnson. University of Tennessee Health Science Center, Memphis, TN, USA
    • Charles Kooperberg. Fred Hutchinson Cancer Research Center, Seattle, WA, USA
    • Jane Morley Kotchen. Medical College of Wisconsin, Milwaukee, WI, USA
    • Lewis Kuller. University of Pittsburgh, Pittsburgh, PA, USA
    • Andrea LaCroix. Fred Hutchinson Cancer Research Center, Seattle, WA, USA
    • Dorothy Lane. SUNY at Stony Brook, Stony Brook, NY, USA
    • Norman Lasser. University of Medicine and Dentistry of New Jersey, Newark, NJ, USA
    • Cora (Beth) Lewis. Univeristy of Alabama at Birmingham, Birmingham, AL, USA
    • Marian Limacher. University of Florida, Gainesville, FL, USA
    • JoAnn Manson. Brigham and Women's Hospital, Boston, MA, USA
    • Karen Margolis. HealthPartners Research Foundation, Bloomington, MN, USA
    • Lisa Martin. George Washington University Lipid Research Clinic, Washington, DC, USA
    • Yvonne Michael. Oregon Health and Science University, Portland, OR, USA
    • Lauren Nathan. University of California - Los Angeles, Los Angeles, CA, USA
    • Judith Ockene. University of Massachusetts Medical School, Worcester, MA, USA
    • Mary Jo O'Sullivan. University of Miami, Miami, FL, USA
    • Larry Phillips. Emory University, Decatur, GA, USA
    • Lynda Powell. Rush University Medical Center, Chicago, IL, USA
    • Ross Prentice. Fred Hutchinson Cancer Research Center, Seattle, WA, USA
    • Aleksandar Rajkovic. Baylor College of Medicine, Houston, TX, USA
    • John Robbins. University of California at Davis, Sacramento, CA, USA
    • Gloria Sarto. University of Wisonsin, Madison, WI, USA
    • Sally Shumaker. Wake Forest University Health Sciences, Winston Salem, NC, USA
    • Michael Simon. Karmanos Cancer Institute, Detroit, MI, USA
    • Marcia Stefanick. Stanford University School of Medicine, Stanford, CA, USA
    • Cynthia Thomson. University of Arizona - Tucson, Tucson, AZ, USA
    • Linda Van Horn. Northwestern University, Chicago, IL, USA
    • Mara Vitolins. Wake Forest Univeristy Health Sciences, Winston Salem, NC, USA
    • Jean Wactawski-Wende. University of Buffalo, Buffalo, NY, USA
    • Robert Wallace. University of Iowa, Iowa City, IA, USA
    • Sylvia Wassertheil-Smoller. Albert Einstein College of Medicine, Bronx, NY, USA
  • Funding Source - WHI Program
    • N01WH22110. National Heart, Lung, and Blood Institute, National Institutes of Health, U. S. Department of Health and Human Services
    • 24152. National Heart, Lung, and Blood Institute, National Institutes of Health, U. S. Department of Health and Human Services
    • 32100-2. National Heart, Lung, and Blood Institute, National Institutes of Health, U. S. Department of Health and Human Services
    • 32105-6. National Heart, Lung, and Blood Institute, National Institutes of Health, U. S. Department of Health and Human Services
    • 32108-9. National Heart, Lung, and Blood Institute, National Institutes of Health, U. S. Department of Health and Human Services
    • 32111-13. National Heart, Lung, and Blood Institute, National Institutes of Health, U. S. Department of Health and Human Services
    • 32115. National Heart, Lung, and Blood Institute, National Institutes of Health, U. S. Department of Health and Human Services
    • 32118. National Heart, Lung, and Blood Institute, National Institutes of Health, U. S. Department of Health and Human Services
    • 32119. National Heart, Lung, and Blood Institute, National Institutes of Health, U. S. Department of Health and Human Services
    • 32122. National Heart, Lung, and Blood Institute, National Institutes of Health, U. S. Department of Health and Human Services
    • 42107-26. National Heart, Lung, and Blood Institute, National Institutes of Health, U. S. Department of Health and Human Services
    • 42129-32. National Heart, Lung, and Blood Institute, National Institutes of Health, U. S. Department of Health and Human Services
    • 44221. National Heart, Lung, and Blood Institute, National Institutes of Health, U. S. Department of Health and Human Services
  • SHARe Genotyping Funding Source - Affymetrix, Inc
    • N02-HL-6-4278. National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA