Women's Health Initiative (WHI) - Full Text View

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
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

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 III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Placebo Control

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Bone Diseases Breast Cancer Calcium Cancer Coronary Artery Disease Dietary Supplements Diets Heart Disease in Women Heart Diseases Hormone Replacement Therapy Osteoporosis Skin Conditions Women's Health

Drug Information available for: Vitamin D

U.S. FDA Resources

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

Show Detailed Description

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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.

Rossouw JE, Hurd S. The Women's Health Initiative: recruitment complete--looking back and looking forward. J Womens Health. 1999 Jan-Feb;8(1):3-5. No abstract available.

[No authors listed] Design of the Women's Health Initiative clinical trial and observational study. The Women's Health Initiative Study Group. Control Clin Trials. 1998 Feb;19(1):61-109.

Patterson RE, Kristal AR, Tinker LF, Carter RA, Bolton MP, Agurs-Collins T. Measurement characteristics of the Women's Health Initiative food frequency questionnaire. Ann Epidemiol. 1999 Apr;9(3):178-87.

McGowan JA, Pottern L. Commentary on the Women's Health Initiative. Maturitas. 2000 Feb 15;34(2):109-12.

Wassertheil-Smoller S, Anderson G, Psaty BM, Black HR, Manson J, Wong N, Francis J, Grimm R, Kotchen T, Langer R, Lasser N. Hypertension and its treatment in postmenopausal women: baseline data from the Women's Health Initiative. Hypertension. 2000 Nov;36(5):780-9.

Wilcox S, Shumaker SA, Bowen DJ, Naughton MJ, Rosal MC, Ludlam SE, Dugan E, Hunt JR, Stevens S. Promoting adherence and retention to clinical trials in special populations: a women's health initiative workshop. Control Clin Trials. 2001 Jun;22(3):279-89.

Gottesman R. Medical care for minors without parental consent. Child Today. 1975 Mar-Apr;4(2):30-1. No abstract available.

Hsia J, Kemper E, Sofaer S, Bowen D, Kiefe CI, Zapka J, Mason E, Lillington L, Limacher M. Is insurance a more important determinant of healthcare access than perceived health? Evidence from the Women's Health Initiative. J Womens Health Gend Based Med. 2000 Oct;9(8):881-9.

Valanis BG, Bowen DJ, Bassford T, Whitlock E, Charney P, Carter RA. Sexual orientation and health: comparisons in the women's health initiative sample. Arch Fam Med. 2000 Sep-Oct;9(9):843-53.

Hsia J, Kemper E, Kiefe C, Zapka J, Sofaer S, Pettinger M, Bowen D, Limacher M, Lillington L, Mason E. The importance of health insurance as a determinant of cancer screening: evidence from the Women's Health Initiative. Prev Med. 2000 Sep;31(3):261-70.

Larkey LK, Staten LK, Ritenbaugh C, Hall RA, Buller DB, Bassford T, Altimari BR. Recruitment of Hispanic women to the Women's Health Initiative. the case of Embajadoras in Arizona. Control Clin Trials. 2002 Jun;23(3):289-98.

Tinker LF, Perri MG, Patterson RE, Bowen DJ, McIntosh M, Parker LM, Sevick MA, Wodarski LA. The effects of physical and emotional status on adherence to a low-fat dietary pattern in the Women's Health Initiative. J Am Diet Assoc. 2002 Jun;102(6):789-800, 888.

Hendrix SL, Clark A, Nygaard I, Aragaki A, Barnabei V, McTiernan A. Pelvic organ prolapse in the Women's Health Initiative: gravity and gravidity. Am J Obstet Gynecol. 2002 Jun;186(6):1160-6.

[No authors listed] Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA. 2002 Jul 17;288(3):321-33.

Fletcher SW, Colditz GA. Failure of estrogen plus progestin therapy for prevention. JAMA. 2002 Jul 17;288(3):366-8. No abstract available.

Pradhan AD, Manson JE, Rossouw JE, Siscovick DS, Mouton CP, Rifai N, Wallace RB, Jackson RD, Pettinger MB, Ridker PM. Inflammatory biomarkers, hormone replacement therapy, and incident coronary heart disease: prospective analysis from the Women's Health Initiative observational study. JAMA. 2002 Aug 28;288(8):980-7.

Manson JE, Greenland P, LaCroix AZ, Stefanick ML, Mouton CP, Oberman A, Perri MG, Sheps DS, Pettinger MB, Siscovick DS. Walking compared with vigorous exercise for the prevention of cardiovascular events in women. N Engl J Med. 2002 Sep 5;347(10):716-25.

Shikany JM, Patterson RE, Agurs-Collins T, Anderson G. Antioxidant supplement use in Women's Health Initiative participants. Prev Med. 2003 Mar;36(3):379-87.

Hays J, Ockene JK, Brunner RL, Kotchen JM, Manson JE, Patterson RE, Aragaki AK, Shumaker SA, Brzyski RG, LaCroix AZ, Granek IA, Valanis BG; Women's Health Initiative Investigators. Effects of estrogen plus progestin on health-related quality of life. N Engl J Med. 2003 May 8;348(19):1839-54. Epub 2003 Mar 17.

Rapp SR, Espeland MA, Shumaker SA, Henderson VW, Brunner RL, Manson JE, Gass ML, Stefanick ML, Lane DS, Hays J, Johnson KC, Coker LH, Dailey M, Bowen D; WHIMS Investigators. Effect of estrogen plus progestin on global cognitive function in postmenopausal women: the Women's Health Initiative Memory Study: a randomized controlled trial. JAMA. 2003 May 28;289(20):2663-72.

Shumaker SA, Legault C, Thal L, Wallace RB, Ockene JK, Hendrix SL, Jones BN 3rd, Assaf AR, Jackson RD, Kotchen JM, Wassertheil-Smoller S, Wactawski-Wende J; WHIMS Investigators. Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women: the Women's Health Initiative Memory Study: a randomized controlled trial. JAMA. 2003 May 28;289(20):2651-62.

Wassertheil-Smoller S, Hendrix SL, Limacher M, Heiss G, Kooperberg C, Baird A, Kotchen T, Curb JD, Black H, Rossouw JE, Aragaki A, Safford M, Stein E, Laowattana S, Mysiw WJ; WHI Investigators. Effect of estrogen plus progestin on stroke in postmenopausal women: the Women's Health Initiative: a randomized trial. JAMA. 2003 May 28;289(20):2673-84.

Chlebowski RT, Hendrix SL, Langer RD, Stefanick ML, Gass M, Lane D, Rodabough RJ, Gilligan MA, Cyr MG, Thomson CA, Khandekar J, Petrovitch H, McTiernan A. Influence of Estrogen Plus Progestin on Breast Cancer and Mammography in Healthy Postmenopausal Women: The Women's Health Initiative Randomized Trial. JAMA. 2003 Jun 25;289(24):3243-53.

Gann PH, Morrow M. Combined hormone therapy and breast cancer: a single-edged sword. JAMA. 2003 Jun 25;289(24):3304-6. No abstract available.

Jackson M, Berman N, Huber M, Snetselaar L, Granek I, Boe K, Milas C, Spivak J, Chlebowski RT. Research staff turnover and participant adherence in the Women's Health Initiative. Control Clin Trials. 2003 Aug;24(4):422-35.

Howard BV, Criqui MH, Curb JD, Rodabough R, Safford MM, Santoro N, Wilson AC, Wylie-Rosett J. Risk factor clustering in the insulin resistance syndrome and its relationship to cardiovascular disease in postmenopausal white, black, hispanic, and Asian/Pacific Islander women. Metabolism. 2003 Mar;52(3):362-71.

Hsia J, Barad D, Margolis K, Rodabough R, McGovern PG, Limacher MC, Oberman A, Smoller S; Women's Health Initiative Research Group. Usefulness of prior hysterectomy as an independent predictor of Framingham risk score (The Women's Health Initiative). Am J Cardiol. 2003 Aug 1;92(3):264-9.

LaCroix AZ, Cauley JA, Pettinger M, Hsia J, Bauer DC, McGowan J, Chen Z, Lewis CE, McNeeley SG, Passaro MD, Jackson RD. Statin use, clinical fracture, and bone density in postmenopausal women: results from the Women's Health Initiative Observational Study. Ann Intern Med. 2003 Jul 15;139(2):97-104.

Cauley JA, Robbins J, Chen Z, Cummings SR, Jackson RD, LaCroix AZ, LeBoff M, Lewis CE, McGowan J, Neuner J, Pettinger M, Stefanick ML, Wactawski-Wende J, Watts NB; Women's Health Initiative Investigators. Effects of estrogen plus progestin on risk of fracture and bone mineral density: the Women's Health Initiative randomized trial. JAMA. 2003 Oct 1;290(13):1729-38.

Anderson GL, Judd HL, Kaunitz AM, Barad DH, Beresford SA, Pettinger M, Liu J, McNeeley SG, Lopez AM; Women's Health Initiative Investigators. Effects of estrogen plus progestin on gynecologic cancers and associated diagnostic procedures: the Women's Health Initiative randomized trial. JAMA. 2003 Oct 1;290(13):1739-48.

Chen Z, Pettinger MB, Ritenbaugh C, LaCroix AZ, Robbins J, Caan BJ, Barad DH, Hakim IA. Habitual tea consumption and risk of osteoporosis: a prospective study in the women's health initiative observational cohort. Am J Epidemiol. 2003 Oct 15;158(8):772-81.

Hsia J, Criqui MH, Rodabough RJ, Langer RD, Resnick HE, Phillips LS, Allison M, Bonds DE, Masaki K, Caralis P, Kotchen JM; Women's Health Initiative Investigators. Estrogen plus progestin and the risk of peripheral arterial disease: the Women's Health Initiative. Circulation. 2004 Feb 10;109(5):620-6.

Chlebowski RT, Wactawski-Wende J, Ritenbaugh C, Hubbell FA, Ascensao J, Rodabough RJ, Rosenberg CA, Taylor VM, Harris R, Chen C, Adams-Campbell LL, White E; Women's Health Initiative Investigators. Estrogen plus progestin and colorectal cancer in postmenopausal women. N Engl J Med. 2004 Mar 4;350(10):991-1004.

Hebert JR, Patterson RE, Gorfine M, Ebbeling CB, St Jeor ST, Chlebowski RT. Differences between estimated caloric requirements and self-reported caloric intake in the women's health initiative. Ann Epidemiol. 2003 Oct;13(9):629-37.

Ritenbaugh C, Patterson RE, Chlebowski RT, Caan B, Fels-Tinker L, Howard B, Ockene J. The Women's Health Initiative Dietary Modification trial: overview and baseline characteristics of participants. Ann Epidemiol. 2003 Oct;13(9 Suppl):S87-97. No abstract available.

Harris RE, Chlebowski RT, Jackson RD, Frid DJ, Ascenseo JL, Anderson G, Loar A, Rodabough RJ, White E, McTiernan A; Women's Health Initiative. Breast cancer and nonsteroidal anti-inflammatory drugs: prospective results from the Women's Health Initiative. Cancer Res. 2003 Sep 15;63(18):6096-101.

Morimoto LM, White E, Chen Z, Chlebowski RT, Hays J, Kuller L, Lopez AM, Manson J, Margolis KL, Muti PC, Stefanick ML, McTiernan A. Obesity, body size, and risk of postmenopausal breast cancer: the Women's Health Initiative (United States). Cancer Causes Control. 2002 Oct;13(8):741-51.

Hsia J, Aragaki A, Bloch M, LaCroix AZ, Wallace R; WHI Investigators. Predictors of angina pectoris versus myocardial infarction from the Women's Health Initiative Observational Study. Am J Cardiol. 2004 Mar 15;93(6):673-8.

Khurana C, Rosenbaum CG, Howard BV, Adams-Campbell LL, Detrano RC, Klouj A, Hsia J. Coronary artery calcification in black women and white women. Am Heart J. 2003 Apr;145(4):724-9.

Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford SA, Black H, Bonds D, Brunner R, Brzyski R, Caan B, Chlebowski R, Curb D, Gass M, Hays J, Heiss G, Hendrix S, Howard BV, Hsia J, Hubbell A, Jackson R, Johnson KC, Judd H, Kotchen JM, Kuller L, LaCroix AZ, Lane D, Langer RD, Lasser N, Lewis CE, Manson J, Margolis K, Ockene J, O'Sullivan MJ, Phillips L, Prentice RL, Ritenbaugh C, Robbins J, Rossouw JE, Sarto G, Stefanick ML, Van Horn L, Wactawski-Wende J, Wallace R, Wassertheil-Smoller S; Women's Health Initiative Steering Committee. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA. 2004 Apr 14;291(14):1701-12.

Hulley SB, Grady D. The WHI estrogen-alone trial--do things look any better? JAMA. 2004 Apr 14;291(14):1769-71. No abstract available.

Espeland MA, Rapp SR, Shumaker SA, Brunner R, Manson JE, Sherwin BB, Hsia J, Margolis KL, Hogan PE, Wallace R, Dailey M, Freeman R, Hays J; Women's Health Initiative Memory Study. Conjugated equine estrogens and global cognitive function in postmenopausal women: Women's Health Initiative Memory Study. JAMA. 2004 Jun 23;291(24):2959-68.

Shumaker SA, Legault C, Kuller L, Rapp SR, Thal L, Lane DS, Fillit H, Stefanick ML, Hendrix SL, Lewis CE, Masaki K, Coker LH; Women's Health Initiative Memory Study. Conjugated equine estrogens and incidence of probable dementia and mild cognitive impairment in postmenopausal women: Women's Health Initiative Memory Study. JAMA. 2004 Jun 23;291(24):2947-58.

Schneider LS. Estrogen and dementia: insights from the Women's Health Initiative Memory Study. JAMA. 2004 Jun 23;291(24):3005-7. No abstract available.

Pradhan AD, LaCroix AZ, Langer RD, Trevisan M, Lewis CE, Hsia JA, Oberman A, Kotchen JM, Ridker PM. Tissue plasminogen activator antigen and D-dimer as markers for atherothrombotic risk among healthy postmenopausal women. Circulation. 2004 Jul 20;110(3):292-300. Epub 2004 Jul 06.

Fouad MN, Corbie-Smith G, Curb D, Howard BV, Mouton C, Simon M, Talavera G, Thompson J, Wang CY, White C, Young R. Special populations recruitment for the Women's Health Initiative: successes and limitations. Control Clin Trials. 2004 Aug;25(4):335-52.

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. 2004 Aug;59(8):599-600.

Margolis KL, Bonds DE, Rodabough RJ, Tinker L, Phillips LS, Allen C, Bassford T, Burke G, Torrens J, Howard BV. Effect of oestrogen plus progestin on the incidence of diabetes in postmenopausal women: results from the Women's Health Initiative Hormone Trial. Diabetologia. 2004 Jul;47(7):1175-87. Epub 2004 Jul 14.

Naftolin F, Taylor HS, Karas R, Brinton E, Newman I, Clarkson TB, Mendelsohn M, Lobo RA, Judelson DR, Nachtigall LE, Heward CB, Hecht H, Jaff MR, Harman SM; Women's Health Initiative. The Women's Health Initiative could not have detected cardioprotective effects of starting hormone therapy during the menopausal transition. Fertil Steril. 2004 Jun;81(6):1498-501.

Chen Z, Kooperberg C, Pettinger MB, Bassford T, Cauley JA, LaCroix AZ, Lewis CE, Kipersztok S, Borne C, Jackson RD. Validity of self-report for fractures among a multiethnic cohort of postmenopausal women: results from the Women's Health Initiative observational study and clinical trials. Menopause. 2004 May-Jun;11(3):264-74.

Women's Health Initiative Study Group. Dietary adherence in the Women's Health Initiative Dietary Modification Trial. J Am Diet Assoc. 2004 Apr;104(4):654-8.

Cushman M, Kuller LH, Prentice R, Rodabough RJ, Psaty BM, Stafford RS, Sidney S, Rosendaal FR; Women's Health Initiative Investigators. Estrogen plus progestin and risk of venous thrombosis. JAMA. 2004 Oct 6;292(13):1573-80.

Heckbert SR, Kooperberg C, Safford MM, Psaty BM, Hsia J, McTiernan A, Gaziano JM, Frishman WH, Curb JD. Comparison of Self-Report, Hospital Discharge Codes, and Adjudication of Cardiovascular Events in the Women's Health Initiative. Am J Epidemiol. 2004 Dec 15;160(12):1152-8.

Wassertheil-Smoller S, Psaty B, Greenland P, Oberman A, Kotchen T, Mouton C, Black H, Aragaki A, Trevisan M. Association between cardiovascular outcomes and antihypertensive drug treatment in older women. JAMA. 2004 Dec 15;292(23):2849-59.

Espeland MA, Gu L, Masaki KH, Langer RD, Coker LH, Stefanick ML, Ockene J, Rapp SR. Association between Reported Alcohol Intake and Cognition: Results from the Women's Health Initiative Memory Study. Am J Epidemiol. 2005 Feb 1;161(3):228-38.

Howard BV, Adams-Campbell L, Allen C, Black H, Passaro M, Rodabough RJ, Rodriguez BL, Safford M, Stevens VJ, Wagenknecht LE. Insulin resistance and weight gain in postmenopausal women of diverse ethnic groups. Int J Obes Relat Metab Disord. 2004 Aug;28(8):1039-47.

Hendrix SL, Cochrane BB, Nygaard IE, Handa VL, Barnabei VM, Iglesia C, Aragaki A, Naughton MJ, Wallace RB, McNeeley SG. Effects of estrogen with and without progestin on urinary incontinence. JAMA. 2005 Feb 23;293(8):935-48.

Curb JD, McTiernan A, Heckbert SR, Kooperberg C, Stanford J, Nevitt M, Johnson KC, Proulx-Burns L, Pastore L, Criqui M, Daugherty S; WHI Morbidity and Mortality Committee. Outcomes ascertainment and adjudication methods in the Women's Health Initiative. Ann Epidemiol. 2003 Oct;13(9 Suppl):S122-8. No abstract available.

Hsia J, Wu L, Allen C, Oberman A, Lawson WE, Torrens J, Safford M, Limacher MC, Howard BV; Women's Health Initiative Research Group. Physical activity and diabetes risk in postmenopausal women. Am J Prev Med. 2005 Jan;28(1):19-25.

Cirillo DJ, Wallace RB, Rodabough RJ, Greenland P, LaCroix AZ, Limacher MC, Larson JC. Effect of estrogen therapy on gallbladder disease. JAMA. 2005 Jan 19;293(3):330-9.

Margolis KL, Manson JE, Greenland P, Rodabough RJ, Bray PF, Safford M, Grimm RH Jr, Howard BV, Assaf AR, Prentice R; Women's Health Initiative Research Group. Leukocyte count as a predictor of cardiovascular events and mortality in postmenopausal women: the Women's Health Initiative Observational Study. Arch Intern Med. 2005 Mar 14;165(5):500-8.

Howard BV, Kuller L, Langer R, Manson JE, Allen C, Assaf A, Cochrane BB, Larson JC, Lasser N, Rainford M, Van Horn L, Stefanick ML, Trevisan M. Risk of cardiovascular disease by hysterectomy status, with and without oophorectomy: the Women's Health Initiative Observational Study. Circulation. 2005 Mar 29;111(12):1462-70. Epub 2005 Mar 21.

Langer RD, Pradhan AD, Lewis CE, Manson JE, Rossouw JE, Hendrix SL, LaCroix AZ, Ridker PM. Baseline associations between postmenopausal hormone therapy and inflammatory, haemostatic, and lipid biomarkers of coronary heart disease. The Women's Health Initiative Observational Study. Thromb Haemost. 2005 Jun;93(6):1108-16.

Ockene JK, Barad DH, Cochrane BB, Larson JC, Gass M, Wassertheil-Smoller S, Manson JE, Barnabei VM, Lane DS, Brzyski RG, Rosal MC, Wylie-Rosett J, Hays J. Symptom experience after discontinuing use of estrogen plus progestin. JAMA. 2005 Jul 13;294(2):183-93.

Chen Z, Maricic M, Bassford TL, Pettinger M, Ritenbaugh C, Lopez AM, Barad DH, Gass M, Leboff MS. Fracture risk among breast cancer survivors: results from the Women's Health Initiative Observational Study. Arch Intern Med. 2005 Mar 14;165(5):552-8.

Fugate Woods N, Lacroix AZ, Gray SL, Aragaki A, Cochrane BB, Brunner RL, Masaki K, Murray A, Newman AB. Frailty: Emergence and Consequences in Women Aged 65 and Older in the Women's Health Initiative Observational Study. J Am Geriatr Soc. 2005 Aug;53(8):1321-30.

Michael YL, Perrin N, Bowen D, Cochrane BB, Wisdom JP, Brzyski R, Ritenbaugh C. Expression and ambivalence over expression of negative emotion:psychometric analysis in the Women's Health Initiative. J Women Aging. 2005;17(1-2):5-18.

Barnabei VM, Cochrane BB, Aragaki AK, Nygaard I, Williams RS, McGovern PG, Young RL, Wells EC, O'Sullivan MJ, Chen B, Schenken R, Johnson SR; Women's Health Initiative Investigators. Menopausal symptoms and treatment-related effects of estrogen and progestin in the Women's Health Initiative. Obstet Gynecol. 2005 May;105(5 Pt 1):1063-73.

Stefanick ML, Prentice RL, Anderson G, Gass M, Manson JE, Hendrix SL, Vista-Deck D, McNeeley G; Women's Health Initiative Steering Committee. Reanalysis of the Women's Health Initiative oral contraceptive data reveals no evidence of delayed cardiovascular benefit. Fertil Steril. 2005 Apr;83(4):853-4. Review.

Brunner RL, Gass M, Aragaki A, Hays J, Granek I, Woods N, Mason E, Brzyski R, Ockene J, Assaf A, LaCroix A, Matthews K, Wallace R; Women's Health Initiative Investigators. Effects of conjugated equine estrogen on health-related quality of life in postmenopausal women with hysterectomy: results from the Women's Health Initiative Randomized Clinical Trial. Arch Intern Med. 2005 Sep 26;165(17):1976-86.

Wampler NS, Chen Z, Jacobsen C, Henderson JA, Howard BV, Rossouw JE. Bone mineral density of American Indian and Alaska Native women compared with non-Hispanic white women: results from the Women's Health Initiative Study. Menopause. 2005 September/October;12(5):536-544. Epub 2005 Sep 1.

Prentice RL, Langer R, Stefanick ML, Howard BV, Pettinger M, Anderson G, Barad D, Curb JD, Kotchen J, Kuller L, Limacher M, Wactawski-Wende J. Combined Postmenopausal Hormone Therapy and Cardiovascular Disease: Toward Resolving the Discrepancy between Observational Studies and the Women's Health Initiative Clinical Trial. Am J Epidemiol. 2005 Sep 1;162(5):404-14. Epub 2005 Jul 20.

Chen Z, Bassford T, Green SB, Cauley JA, Jackson RD, LaCroix AZ, Leboff M, Stefanick ML, Margolis KL. Postmenopausal hormone therapy and body composition--a substudy of the estrogen plus progestin trial of the Women's Health Initiative. Am J Clin Nutr. 2005 Sep;82(3):651-6.

Wolf RL, Cauley JA, Pettinger M, Jackson R, Lacroix A, Leboff MS, Lewis CE, Nevitt MC, Simon JA, Stone KL, Wactawski-Wende J. Lack of a relation between vitamin and mineral antioxidants and bone mineral density: results from the Women's Health Initiative. Am J Clin Nutr. 2005 Sep;82(3):581-8.

Barad D, Kooperberg C, Wactawski-Wende J, Liu J, Hendrix SL, Watts NB. Prior oral contraception and postmenopausal fracture: a Women's Health Initiative observational cohort study. Fertil Steril. 2005 Aug;84(2):374-83.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	114
Study First Received:	October 27, 1999
Last Updated:	November 27, 2006
ClinicalTrials.gov Identifier:	NCT00000611 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Gastrointestinal Diseases
Myocardial Ischemia
Physiological Effects of Drugs
Colonic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Arteriosclerosis
Hormones
Bone Diseases
Pathologic Processes
Neoplasms by Site
Musculoskeletal Diseases
Vitamins
Progestins
Cardiovascular Diseases

Micronutrients
Breast Diseases
Arterial Occlusive Diseases
Estrogens
Heart Diseases
Digestive System Neoplasms
Skin Diseases
Growth Substances
Vascular Diseases
Osteoporosis
Breast Neoplasms
Bone Diseases, Metabolic
Ischemia
Intestinal Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 05, 2009

Ages Eligible for Study:	50 Years to 79 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No