Women's Health Initiative (WHI)

This study has been completed.

Study NCT00000611 Information provided by National Heart, Lung, and Blood Institute (NHLBI)

First Received: October 27, 1999 Last Updated: November 27, 2006 History of Changes

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Study Status:	This study has been completed.
Estimated Study Completion Date:	No date given
Estimated Primary Completion Date:	No date given

Publications:

Stefanick ML, Anderson GL, Margolis KL, Hendrix SL, Rodabough RJ, Paskett ED, Lane DS, Hubbell FA, Assaf AR, Sarto GE, Schenken RS, Yasmeen S, Lessin L, Chlebowski RT; WHI Investigators. Effects of conjugated equine estrogens on breast cancer and mammography screening in postmenopausal women with hysterectomy. JAMA. 2006 Apr 12;295(14):1647-57.

Jackson RD, LaCroix AZ, Gass M, Wallace RB, Robbins J, Lewis CE, Bassford T, Beresford SA, Black HR, Blanchette P, Bonds DE, Brunner RL, Brzyski RG, Caan B, Cauley JA, Chlebowski RT, Cummings SR, Granek I, Hays J, Heiss G, Hendrix SL, Howard BV, Hsia J, Hubbell FA, Johnson KC, Judd H, Kotchen JM, Kuller LH, Langer RD, Lasser NL, Limacher MC, Ludlam S, Manson JE, Margolis KL, McGowan J, Ockene JK, O'Sullivan MJ, Phillips L, Prentice RL, Sarto GE, Stefanick ML, Van Horn L, Wactawski-Wende J, Whitlock E, Anderson GL, Assaf AR, Barad D; Women's Health Initiative Investigators. Calcium plus vitamin D supplementation and the risk of fractures. N Engl J Med. 2006 Feb 16;354(7):669-83. Erratum in: N Engl J Med. 2006 Mar 9;354(10):1102.

Howard BV, Van Horn L, Hsia J, Manson JE, Stefanick ML, Wassertheil-Smoller S, Kuller LH, LaCroix AZ, Langer RD, Lasser NL, Lewis CE, Limacher MC, Margolis KL, Mysiw WJ, Ockene JK, Parker LM, Perri MG, Phillips L, Prentice RL, Robbins J, Rossouw JE, Sarto GE, Schatz IJ, Snetselaar LG, Stevens VJ, Tinker LF, Trevisan M, Vitolins MZ, Anderson GL, Assaf AR, Bassford T, Beresford SA, Black HR, Brunner RL, Brzyski RG, Caan B, Chlebowski RT, Gass M, Granek I, Greenland P, Hays J, Heber D, Heiss G, Hendrix SL, Hubbell FA, Johnson KC, Kotchen JM. Low-fat dietary pattern and risk of cardiovascular disease: the Women's Health Initiative Randomized Controlled Dietary Modification Trial. JAMA. 2006 Feb 8;295(6):655-66.

Beresford SA, Johnson KC, Ritenbaugh C, Lasser NL, Snetselaar LG, Black HR, Anderson GL, Assaf AR, Bassford T, Bowen D, Brunner RL, Brzyski RG, Caan B, Chlebowski RT, Gass M, Harrigan RC, Hays J, Heber D, Heiss G, Hendrix SL, Howard BV, Hsia J, Hubbell FA, Jackson RD, Kotchen JM, Kuller LH, LaCroix AZ, Lane DS, Langer RD, Lewis CE, Manson JE, Margolis KL, Mossavar-Rahmani Y, Ockene JK, Parker LM, Perri MG, Phillips L, Prentice RL, Robbins J, Rossouw JE, Sarto GE, Stefanick ML, Van Horn L, Vitolins MZ, Wactawski-Wende J, Wallace RB, Whitlock E. Low-fat dietary pattern and risk of colorectal cancer: the Women's Health Initiative Randomized Controlled Dietary Modification Trial. JAMA. 2006 Feb 8;295(6):643-54.

Prentice RL, Caan B, Chlebowski RT, Patterson R, Kuller LH, Ockene JK, Margolis KL, Limacher MC, Manson JE, Parker LM, Paskett E, Phillips L, Robbins J, Rossouw JE, Sarto GE, Shikany JM, Stefanick ML, Thomson CA, Van Horn L, Vitolins MZ, Wactawski-Wende J, Wallace RB, Wassertheil-Smoller S, Whitlock E, Yano K, Adams-Campbell L, Anderson GL, Assaf AR, Beresford SA, Black HR, Brunner RL, Brzyski RG, Ford L, Gass M, Hays J, Heber D, Heiss G, Hendrix SL, Hsia J, Hubbell FA, Jackson RD, Johnson KC, Kotchen JM, LaCroix AZ, Lane DS, Langer RD, Lasser NL, Henderson MM. Low-fat dietary pattern and risk of invasive breast cancer: the Women's Health Initiative Randomized Controlled Dietary Modification Trial. JAMA. 2006 Feb 8;295(6):629-42.

Howard BV, Manson JE, Stefanick ML, Beresford SA, Frank G, Jones B, Rodabough RJ, Snetselaar L, Thomson C, Tinker L, Vitolins M, Prentice R. Low-fat dietary pattern and weight change over 7 years: the Women's Health Initiative Dietary Modification Trial. JAMA. 2006 Jan 4;295(1):39-49.

Yasmeen S, Romano PS, Pettinger M, Johnson SR, Hubbell FA, Lane DS, Hendrix SL. Incidence of cervical cytological abnormalities with aging in the women's health initiative: a randomized controlled trial. Obstet Gynecol. 2006 Aug;108(2):410-9.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Interleukin-6 Receptor Mendelian Randomisation Analysis (IL6R MR) Consortium, 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. Epub 2012 Mar 14.

Anderson GL, Chlebowski RT, Aragaki AK, Kuller LH, Manson JE, Gass M, Bluhm E, Connelly S, Hubbell FA, Lane D, Martin L, Ockene J, Rohan T, Schenken R, Wactawski-Wende J. Conjugated equine oestrogen and breast cancer incidence and mortality in postmenopausal women with hysterectomy: extended follow-up of the Women's Health Initiative randomised placebo-controlled trial. Lancet Oncol. 2012 May;13(5):476-86. Epub 2012 Mar 7.

Rossouw JE, Johnson KC, Pettinger M, Cushman M, Sandset PM, Kuller L, Rosendaal F, Rosing J, Wasserthal-Smoller S, Martin LW, Manson JE, Lakshminarayan K, Merino JG, Lynch J. Tissue factor pathway inhibitor, activated protein C resistance, and risk of ischemic stroke due to postmenopausal hormone therapy. Stroke. 2012 Apr;43(4):952-7. Epub 2012 Feb 23.

Tinker LF, Sarto GE, Howard BV, Huang Y, Neuhouser ML, Mossavar-Rahmani Y, Beasley JM, Margolis KL, Eaton CB, Phillips LS, Prentice RL. Biomarker-calibrated dietary energy and protein intake associations with diabetes risk among postmenopausal women from the Women's Health Initiative. Am J Clin Nutr. 2011 Dec;94(6):1600-6. Epub 2011 Nov 9.

Eaton CB, Young A, Allison MA, Robinson J, Martin LW, Kuller LH, Johnson KC, Curb JD, Van Horn L, McTiernan A, Liu S, Manson JE. Prospective association of vitamin D concentrations with mortality in postmenopausal women: results from the Women's Health Initiative (WHI). Am J Clin Nutr. 2011 Dec;94(6):1471-8. Epub 2011 Oct 26.

Bolland MJ, Grey A, Gamble GD, Reid IR. Calcium and vitamin D supplements and health outcomes: a reanalysis of the Women's Health Initiative (WHI) limited-access data set. Am J Clin Nutr. 2011 Oct;94(4):1144-9. Epub 2011 Aug 31.

Prentice RL, Mossavar-Rahmani Y, Huang Y, Van Horn L, Beresford SA, Caan B, Tinker L, Schoeller D, Bingham S, Eaton CB, Thomson C, Johnson KC, Ockene J, Sarto G, Heiss G, Neuhouser ML. Evaluation and comparison of food records, recalls, and frequencies for energy and protein assessment by using recovery biomarkers. Am J Epidemiol. 2011 Sep 1;174(5):591-603. Epub 2011 Jul 15.

Eaton CB, Hochberg MC, Assaf A, Cryer BL, Lu B, Sands G, Rodriguez B, LaCroix A, Lessin L, Limacher MC, Fugate Woods N, Connelly S, Chen Z. The cross-sectional relationship of hemoglobin levels and functional outcomes in women with self-reported osteoarthritis: results from the Women's Health Initiative. Semin Arthritis Rheum. 2011 Dec;41(3):406-14. Epub 2011 Jul 2.

Olsen CM, Pandeya N, Green AC, Webb PM, Whiteman DC; Australian Cancer Study. Population attributable fractions of adenocarcinoma of the esophagus and gastroesophageal junction. Am J Epidemiol. 2011 Sep 1;174(5):582-90. Epub 2011 Jun 30.

Harrow BS, Eaton CB, Roberts MB, Assaf AR, Luo X, Chen Z. Health utilities associated with hemoglobin levels and blood loss in postmenopausal women: the Women's Health Initiative. Value Health. 2011 Jun;14(4):555-63. Epub 2011 Apr 30.

Chacko SA, Song Y, Manson JE, Van Horn L, Eaton C, Martin LW, McTiernan A, Curb JD, Wylie-Rosett J, Phillips LS, Plodkowski RA, Liu S. Serum 25-hydroxyvitamin D concentrations in relation to cardiometabolic risk factors and metabolic syndrome in postmenopausal women. Am J Clin Nutr. 2011 Jul;94(1):209-17. Epub 2011 May 25.

Shikany JM, Margolis KL, Pettinger M, Jackson RD, Limacher MC, Liu S, Phillips LS, Tinker LF. Effects of a low-fat dietary intervention on glucose, insulin, and insulin resistance in the Women's Health Initiative (WHI) Dietary Modification trial. Am J Clin Nutr. 2011 Jul;94(1):75-85. Epub 2011 May 11.

Wallace RB, Wactawski-Wende J, O'Sullivan MJ, Larson JC, Cochrane B, Gass M, Masaki K. Urinary tract stone occurrence in the Women's Health Initiative (WHI) randomized clinical trial of calcium and vitamin D supplements. Am J Clin Nutr. 2011 Jul;94(1):270-7. Epub 2011 Apr 27.

LaCroix AZ, Chlebowski RT, Manson JE, Aragaki AK, Johnson KC, Martin L, Margolis KL, Stefanick ML, Brzyski R, Curb JD, Howard BV, Lewis CE, Wactawski-Wende J; WHI Investigators. Health outcomes after stopping conjugated equine estrogens among postmenopausal women with prior hysterectomy: a randomized controlled trial. JAMA. 2011 Apr 6;305(13):1305-14.

Gaussoin SA, Espeland MA, Absher J, Howard BV, Jones BM, Rapp SR. Ascertaining dementia-related outcomes for deceased or proxy-dependent participants: an overview of the Women's Health Initiative Memory Study supplemental case ascertainment protocol. Int J Geriatr Psychiatry. 2012 Feb;27(2):205-14. Epub 2011 Mar 18.

Carty CL, Kooperberg C, Neuhouser ML, Tinker L, Howard B, Wactawski-Wende J, Beresford SA, Snetselaar L, Vitolins M, Allison M, Budrys N, Prentice R, Peters U. Low-fat dietary pattern and change in body-composition traits in the Women's Health Initiative Dietary Modification Trial. Am J Clin Nutr. 2011 Mar;93(3):516-24. Epub 2010 Dec 22.

Orchard TS, Cauley JA, Frank GC, Neuhouser ML, Robinson JG, Snetselaar L, Tylavsky F, Wactawski-Wende J, Young AM, Lu B, Jackson RD. Fatty acid consumption and risk of fracture in the Women's Health Initiative. Am J Clin Nutr. 2010 Dec;92(6):1452-60. Epub 2010 Oct 27.

Chlebowski RT, Anderson GL, Gass M, Lane DS, Aragaki AK, Kuller LH, Manson JE, Stefanick ML, Ockene J, Sarto GE, Johnson KC, Wactawski-Wende J, Ravdin PM, Schenken R, Hendrix SL, Rajkovic A, Rohan TE, Yasmeen S, Prentice RL; WHI Investigators. Estrogen plus progestin and breast cancer incidence and mortality in postmenopausal women. JAMA. 2010 Oct 20;304(15):1684-92.

Rajpathak SN, Xue X, Wassertheil-Smoller S, Van Horn L, Snetselaar L, Martin LW, Rohan TE. Effect of long term low-fat dietary intervention on change in hemostatic factors: results from the Women's Health Initiative. Nutr Metab Cardiovasc Dis. 2012 Apr;22(4):337-9. Epub 2010 Sep 29.

Chlebowski RT, Menon R, Chaisanguanthum RM, Jackson DM. Prospective evaluation of two recruitment strategies for a randomized controlled cancer prevention trial. Clin Trials. 2010 Dec;7(6):744-8. Epub 2010 Sep 10.

Kuller LH, Margolis KL, Gaussoin SA, Bryan NR, Kerwin D, Limacher M, Wassertheil-Smoller S, Williamson J, Robinson JG; Women's Health Initiative Memory Study Research Group. Relationship of hypertension, blood pressure, and blood pressure control with white matter abnormalities in the women's health initiative memory study (WHIMS)-MRI trial. J Clin Hypertens (Greenwich). 2010 Mar;12(3):203-12.

Robinson JG, Wallace R, Safford MM, Pettinger M, Cochrane B, Ko MG, O'Sullivan MJ, Masaki K, Petrovich H. Another treatment gap: restarting secondary prevention medications: the Women's Health Initiative. J Clin Lipidol. 2010 Jan-Feb;4(1):36-45.

Rajpathak SN, Xue X, Wassertheil-Smoller S, Van Horn L, Robinson JG, Liu S, Allison M, Martin LW, Ho GY, Rohan TE. Effect of 5 y of calcium plus vitamin D supplementation on change in circulating lipids: results from the Women's Health Initiative. Am J Clin Nutr. 2010 Apr;91(4):894-9. Epub 2010 Feb 24.

Hsia J, Rodabough RJ, Manson JE, Liu S, Freiberg MS, Graettinger W, Rosal MC, Cochrane B, Lloyd-Jones D, Robinson JG, Howard BV; Women's Health Initiative Research Group. Evaluation of the American Heart Association cardiovascular disease prevention guideline for women. Circ Cardiovasc Qual Outcomes. 2010 Mar;3(2):128-34. Epub 2010 Feb 16.

Toh S, Hernández-Díaz S, Logan R, Rossouw JE, Hernán MA. Coronary heart disease in postmenopausal recipients of estrogen plus progestin therapy: does the increased risk ever disappear? A randomized trial. Ann Intern Med. 2010 Feb 16;152(4):211-7.

Prentice RL, Huang Y, Hinds DA, Peters U, Cox DR, Beilharz E, Chlebowski RT, Rossouw JE, Caan B, Ballinger DG. Variation in the FGFR2 gene and the effect of a low-fat dietary pattern on invasive breast cancer. Cancer Epidemiol Biomarkers Prev. 2010 Jan;19(1):74-9.

Prentice RL, Huang Y, Hinds DA, Peters U, Pettinger M, Cox DR, Beilharz E, Chlebowski RT, Rossouw JE, Caan B, Ballinger DG. Variation in the FGFR2 gene and the effects of postmenopausal hormone therapy on invasive breast cancer. Cancer Epidemiol Biomarkers Prev. 2009 Nov;18(11):3079-85. Epub 2009 Oct 27.

Crandall CJ, Aragaki AK, Chlebowski RT, McTiernan A, Anderson G, Hendrix SL, Cochrane BB, Kuller LH, Cauley JA. New-onset breast tenderness after initiation of estrogen plus progestin therapy and breast cancer risk. Arch Intern Med. 2009 Oct 12;169(18):1684-91.

Chlebowski RT, Schwartz AG, Wakelee H, Anderson GL, Stefanick ML, Manson JE, Rodabough RJ, Chien JW, Wactawski-Wende J, Gass M, Kotchen JM, Johnson KC, O'Sullivan MJ, Ockene JK, Chen C, Hubbell FA; Women's Health Initiative Investigators. Oestrogen plus progestin and lung cancer in postmenopausal women (Women's Health Initiative trial): a post-hoc analysis of a randomised controlled trial. Lancet. 2009 Oct 10;374(9697):1243-51. Epub 2009 Sep 18.

Kabat GC, Kim M, Adams-Campbell LL, Caan BJ, Chlebowski RT, Neuhouser ML, Shikany JM, Rohan TE; WHI Investigators. Longitudinal study of serum carotenoid, retinol, and tocopherol concentrations in relation to breast cancer risk among postmenopausal women. Am J Clin Nutr. 2009 Jul;90(1):162-9. Epub 2009 May 27.

Prentice RL, Pettinger M, Beresford SA, Wactawski-Wende J, Hubbell FA, Stefanick ML, Chlebowski RT. Colorectal cancer in relation to postmenopausal estrogen and estrogen plus progestin in the Women's Health Initiative clinical trial and observational study. Cancer Epidemiol Biomarkers Prev. 2009 May;18(5):1531-7.

McTiernan A, Wactawski-Wende J, Wu L, Rodabough RJ, Watts NB, Tylavsky F, Freeman R, Hendrix S, Jackson R; Women's Health Initiative Investigators. Low-fat, increased fruit, vegetable, and grain dietary pattern, fractures, and bone mineral density: the Women's Health Initiative Dietary Modification Trial. Am J Clin Nutr. 2009 Jun;89(6):1864-76. Epub 2009 Apr 29.

LaCroix AZ, Kotchen J, Anderson G, Brzyski R, Cauley JA, Cummings SR, Gass M, Johnson KC, Ko M, Larson J, Manson JE, Stefanick ML, Wactawski-Wende J. Calcium plus vitamin D supplementation and mortality in postmenopausal women: the Women's Health Initiative calcium-vitamin D randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2009 May;64(5):559-67. Epub 2009 Feb 16.

Neuhouser ML, Wassertheil-Smoller S, Thomson C, Aragaki A, Anderson GL, Manson JE, Patterson RE, Rohan TE, van Horn L, Shikany JM, Thomas A, LaCroix A, Prentice RL. Multivitamin use and risk of cancer and cardiovascular disease in the Women's Health Initiative cohorts. Arch Intern Med. 2009 Feb 9;169(3):294-304.

Hsia J, Larson JC, Ockene JK, Sarto GE, Allison MA, Hendrix SL, Robinson JG, LaCroix AZ, Manson JE; Women's Health Initiative Research Group. Resting heart rate as a low tech predictor of coronary events in women: prospective cohort study. BMJ. 2009 Feb 3;338:b219.

Thomson CA, Neuhouser ML, Shikany JM, Caan BJ, Monk BJ, Mossavar-Rahmani Y, Sarto G, Parker LM, Modugno F, Anderson GL. The role of antioxidants and vitamin A in ovarian cancer: results from the Women's Health Initiative. Nutr Cancer. 2008;60(6):710-9.

Rossouw JE, Cushman M, Greenland P, Lloyd-Jones DM, Bray P, Kooperberg C, Pettinger M, Robinson J, Hendrix S, Hsia J. Inflammatory, lipid, thrombotic, and genetic markers of coronary heart disease risk in the women's health initiative trials of hormone therapy. Arch Intern Med. 2008 Nov 10;168(20):2245-53.

Tinker LF, Bonds DE, Margolis KL, Manson JE, Howard BV, Larson J, Perri MG, Beresford SA, Robinson JG, Rodríguez B, Safford MM, Wenger NK, Stevens VJ, Parker LM; Women's Health Initiative. Low-fat dietary pattern and risk of treated diabetes mellitus in postmenopausal women: the Women's Health Initiative randomized controlled dietary modification trial. Arch Intern Med. 2008 Jul 28;168(14):1500-11.

Zheng Z, Margolis KL, Liu S, Tinker LF, Ye W; Women's Health Initiative Investigators. Effects of estrogen with and without progestin and obesity on symptomatic gastroesophageal reflux. Gastroenterology. 2008 Jul;135(1):72-81. Epub 2008 Mar 25.

Bray PF, Larson JC, Lacroix AZ, Manson J, Limacher MC, Rossouw JE, Lasser NL, Lawson WE, Stefanick ML, Langer RD, Margolis KL; Women's Health Initiative Investigators. Usefulness of baseline lipids and C-reactive protein in women receiving menopausal hormone therapy as predictors of treatment-related coronary events. Am J Cardiol. 2008 Jun 1;101(11):1599-1605. Epub 2008 Apr 2.

Heiss G, Wallace R, Anderson GL, Aragaki A, Beresford SA, Brzyski R, Chlebowski RT, Gass M, LaCroix A, Manson JE, Prentice RL, Rossouw J, Stefanick ML; WHI Investigators. Health risks and benefits 3 years after stopping randomized treatment with estrogen and progestin. JAMA. 2008 Mar 5;299(9):1036-45.

Chlebowski RT, Anderson G, Pettinger M, Lane D, Langer RD, Gillian MA, Walsh BW, Chen C, McTiernan A; Women's Health Initiative Investigators. Estrogen plus progestin and breast cancer detection by means of mammography and breast biopsy. Arch Intern Med. 2008 Feb 25;168(4):370-7; quiz 345.

de Boer IH, Tinker LF, Connelly S, Curb JD, Howard BV, Kestenbaum B, Larson JC, Manson JE, Margolis KL, Siscovick DS, Weiss NS; Women's Health Initiative Investigators. Calcium plus vitamin D supplementation and the risk of incident diabetes in the Women's Health Initiative. Diabetes Care. 2008 Apr;31(4):701-7. Epub 2008 Jan 30.

Prentice RL, Thomson CA, Caan B, Hubbell FA, Anderson GL, Beresford SA, Pettinger M, Lane DS, Lessin L, Yasmeen S, Singh B, Khandekar J, Shikany JM, Satterfield S, Chlebowski RT. Low-fat dietary pattern and cancer incidence in the Women's Health Initiative Dietary Modification Randomized Controlled Trial. J Natl Cancer Inst. 2007 Oct 17;99(20):1534-43. Epub 2007 Oct 9.

Manson JE, Allison MA, Rossouw JE, Carr JJ, Langer RD, Hsia J, Kuller LH, Cochrane BB, Hunt JR, Ludlam SE, Pettinger MB, Gass M, Margolis KL, Nathan L, Ockene JK, Prentice RL, Robbins J, Stefanick ML; WHI and WHI-CACS Investigators. Estrogen therapy and coronary-artery calcification. N Engl J Med. 2007 Jun 21;356(25):2591-602.

Rossouw JE, Prentice RL, Manson JE, Wu L, Barad D, Barnabei VM, Ko M, LaCroix AZ, Margolis KL, Stefanick ML. Postmenopausal hormone therapy and risk of cardiovascular disease by age and years since menopause. JAMA. 2007 Apr 4;297(13):1465-77.

Denes P, Larson JC, Lloyd-Jones DM, Prineas RJ, Greenland P. Major and minor ECG abnormalities in asymptomatic women and risk of cardiovascular events and mortality. JAMA. 2007 Mar 7;297(9):978-85.