Postmenopausal Estrogen/Progestin Interventions (PEPI)

This study has been completed.

Sponsor:

Collaborators:

National Institute on Aging (NIA)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by:

National Heart, Lung, and Blood Institute (NHLBI)

ClinicalTrials.gov Identifier:

NCT00000466

First received: October 27, 1999

Last updated: July 20, 2005

Last verified: July 2005

History of Changes

Purpose

To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.

Condition	Intervention	Phase
Bone Diseases Cardiovascular Diseases Coronary Disease Diabetes Mellitus Heart Diseases Hypercholesterolemia Hypertension Myocardial Ischemia Osteoporosis Thrombosis Postmenopause	Drug: estrogens, conjugated Drug: medroxyprogesterone Drug: progesterone Drug: estrogen replacement therapy	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Bone Diseases Cholesterol Coronary Artery Disease Diabetes Heart Diseases High Blood Pressure Osteoporosis

Drug Information available for: Progesterone Medroxyprogesterone acetate Estrogens, conjugated

U.S. FDA Resources

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

Study Start Date:	September 1987
Estimated Study Completion Date:	October 2000

Show Detailed Description

Eligibility

Ages Eligible for Study:	45 Years to 64 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Postmenopausal women, ages 45 to 64. One third of the subjects had had a hysterectomy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000466

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

National Institute on Aging (NIA)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigator:

Mark Espeland

Bowman Gray School of Medicine

More Information

Publications:

Abrams FR. The Postmenopausal Estrogen/Progestin Interventions Trial. JAMA. 1995 Dec 6;274(21):1675; author reply 1676. No abstract available.

[No authors listed] Effects of hormone therapy on bone mineral density: results from the postmenopausal estrogen/progestin interventions (PEPI) trial. The Writing Group for the PEPI. JAMA. 1996 Nov 6;276(17):1389-96.

[No authors listed] Effects of estrogen or estrogen/progestin regimens on heart disease risk factors in postmenopausal women. The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. The Writing Group for the PEPI Trial. JAMA. 1995 Jan 18;273(3):199-208. Erratum in: JAMA 1995 Dec 6;274(21):1676.

Healy B. PEPI in perspective. Good answers spawn pressing questions. JAMA. 1995 Jan 18;273(3):240-1. No abstract available.

National Heart , Lung and Blood Institute. Hormone replacement therapy and heart disease: The PEPI trial. DHHS. NIH Publication No.95-3277. August 1995

[No authors listed] Effects of hormone replacement therapy on endometrial histology in postmenopausal women. The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. The Writing Group for the PEPI Trial. JAMA. 1996 Feb 7;275(5):370-5.

Bush TL, Espeland MA, Mebane-Sims I. The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. Introduction. Control Clin Trials. 1995 Aug;16(4 Suppl):1S-2S. No abstract available.

Espeland MA, Bush TL, Mebane-Sims I, Stefanick ML, Johnson S, Sherwin R, Waclawiw M. Rationale, design, and conduct of the PEPI Trial. Postmenopausal Estrogen/Progestin Interventions. Control Clin Trials. 1995 Aug;16(4 Suppl):3S-19S.

Johnson S, Mebane-Sims I, Hogan PE, Stoy DB. Recruitment of postmenopausal women in the PEPI Trial. Postmenopausal Estrogen/Progestin Interventions. Control Clin Trials. 1995 Aug;16(4 Suppl):20S-35S. No abstract available.

Wood PD, Kessler G, Lippel K, Stefanick ML, Wasilauskas CH, Wells HB. Physical and laboratory measurements in the PEPI Trial Postmenopausal Estrogen/Progestin Interventions. Control Clin Trials. 1995 Aug;16(4 Suppl):36S-53S. No abstract available.

Miller VT, Byington RL, Espeland MA, Langer R, Marcus R, Shumaker S, Stern MP. Baseline characteristics of the PEPI participants. Postmenopausal Estrogen/Progestin Interventions. Control Clin Trials. 1995 Aug;16(4 Suppl):54S-65S. No abstract available.

Stefanick ML, Legault C, Tracy RP, Howard G, Kessler CM, Lucas DL, Bush TL. Distribution and correlates of plasma fibrinogen in middle-aged women. Initial findings of the Postmenopausal Estrogen/Progestin Interventions (PEPI) study. Arterioscler Thromb Vasc Biol. 1995 Dec;15(12):2085-93.

Marcus R, Greendale G, Blunt BA, Bush TL, Sherman S, Sherwin R, Wahner H, Wells B. Correlates of bone mineral density in the postmenopausal estrogen/progestin interventions trial. J Bone Miner Res. 1994 Sep;9(9):1467-76.

Greendale GA, Bodin-Dunn L, Ingles S, Haile R, Barrett-Connor E. Leisure, home, and occupational physical activity and cardiovascular risk factors in postmenopausal women. The Postmenopausal Estrogens/Progestins Intervention (PEPI) Study. Arch Intern Med. 1996 Feb 26;156(4):418-24.

Garg A. The Postmenopausal Estrogen/Progestin Interventions Trial. JAMA. 1995 Dec 6;274(21):1675-6. No abstract available.

Barrett-Connor E, Schrott HG, Greendale G, Kritz-Silverstein D, Espeland MA, Stern MP, Bush T, Perlman JA. Factors associated with glucose and insulin levels in healthy postmenopausal women. Diabetes Care. 1996 Apr;19(4):333-40.

Greendale GA, James MK, Espeland MA, Barrett-Connor E. Can we measure prior postmenopausal estrogen/progestin use? The Postmenopausal Estrogen/Progestin Interventions Trial. The PEPI Investigators. Am J Epidemiol. 1997 Nov 1;146(9):763-70.

Langer RD, Pierce JJ, O'Hanlan KA, Johnson SR, Espeland MA, Trabal JF, Barnabei VM, Merino MJ, Scully RE. Transvaginal ultrasonography compared with endometrial biopsy for the detection of endometrial disease. Postmenopausal Estrogen/Progestin Interventions Trial. N Engl J Med. 1997 Dec 18;337(25):1792-8.

Barrett-Connor E, Slone S, Greendale G, Kritz-Silverstein D, Espeland M, Johnson SR, Waclawiw M, Fineberg SE. The Postmenopausal Estrogen/Progestin Interventions Study: primary outcomes in adherent women. Maturitas. 1997 Jul;27(3):261-74.

Smith EM, Johnson SR, Figuerres EJ, Mendoza M, Fedderson D, Haugen TH, Turek LP. The frequency of human papillomavirus detection in postmenopausal women on hormone replacement therapy. Gynecol Oncol. 1997 Jun;65(3):441-6.

Espeland MA, Stefanick ML, Kritz-Silverstein D, Fineberg SE, Waclawiw MA, James MK, Greendale GA. Effect of postmenopausal hormone therapy on body weight and waist and hip girths. Postmenopausal Estrogen-Progestin Interventions Study Investigators. J Clin Endocrinol Metab. 1997 May;82(5):1549-56.

Espeland MA, Marcovina SM, Miller V, Wood PD, Wasilauskas C, Sherwin R, Schrott H, Bush TL. Effect of postmenopausal hormone therapy on lipoprotein(a) concentration. PEPI Investigators. Postmenopausal Estrogen/Progestin Interventions. Circulation. 1998 Mar 17;97(10):979-86.

Legault C, Espeland MA, Wasilauskas CH, Bush TL, Trabal J, Judd HL, Johnson SR, Greendale GA. Agreement in assessing endometrial pathology: the Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. J Womens Health. 1998 May;7(4):435-42.

Greendale GA, Reboussin BA, Sie A, Singh HR, Olson LK, Gatewood O, Bassett LW, Wasilauskas C, Bush T, Barrett-Connor E. Effects of estrogen and estrogen-progestin on mammographic parenchymal density. Postmenopausal Estrogen/Progestin Interventions (PEPI) Investigators. Ann Intern Med. 1999 Feb 16;130(4 Pt 1):262-9.

Espeland MA, Hogan PE, Fineberg SE, Howard G, Schrott H, Waclawiw MA, Bush TL. Effect of postmenopausal hormone therapy on glucose and insulin concentrations. PEPI Investigators. Postmenopausal Estrogen/Progestin Interventions. Diabetes Care. 1998 Oct;21(10):1589-95.

Hall SL, Greendale GA. The relation of dietary vitamin C intake to bone mineral density: results from the PEPI study. Calcif Tissue Int. 1998 Sep;63(3):183-9.

Greendale GA, Reboussin BA, Hogan P, Barnabei VM, Shumaker S, Johnson S, Barrett-Connor E. Symptom relief and side effects of postmenopausal hormones: results from the Postmenopausal Estrogen/Progestin Interventions Trial. Obstet Gynecol. 1998 Dec;92(6):982-8.

Cushman M, Legault C, Barrett-Connor E, Stefanick ML, Kessler C, Judd HL, Sakkinen PA, Tracy RP. Effect of postmenopausal hormones on inflammation-sensitive proteins: the Postmenopausal Estrogen/Progestin Interventions (PEPI) Study. Circulation. 1999 Aug 17;100(7):717-22.

Marcus R, Holloway L, Wells B, Greendale G, James MK, Wasilauskas C, Kelaghan J. The relationship of biochemical markers of bone turnover to bone density changes in postmenopausal women: results from the Postmenopausal Estrogen/Progestin Interventions (PEPI) trial. J Bone Miner Res. 1999 Sep;14(9):1583-95.

Whiteman MK, Cui Y, Flaws JA, Espeland M, Bush TL. Low fibrinogen level: A predisposing factor for venous thromboembolic events with hormone replacement therapy. Am J Hematol. 1999 Aug;61(4):271-3.

Barnabei VM, Phillips TM, Hsia J. Plasma homocysteine in women taking hormone replacement therapy: the Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. J Womens Health Gend Based Med. 1999 Nov;8(9):1167-72.

Legault C, Stefanick ML, Miller VT, Marcovina SM, Schrott HG. Effect of hormone replacement therapy on the validity of the Friedewald equation in postmenopausal women: the postmenopausal estrogen/progestins interventions (PEPI) trial. J Clin Epidemiol. 1999 Dec;52(12):1187-95.

Greendale GA, Espeland M, Slone S, Marcus R, Barrett-Connor E. Bone mass response to discontinuation of long-term hormone replacement therapy: results from the Postmenopausal Estrogen/Progestin Interventions (PEPI) Safety Follow-up Study. Arch Intern Med. 2002 Mar 25;162(6):665-72.

Simon JA, Symons JP. Bleeding patterns of the hormone replacement therapies in the postmenopausal estrogen and progestin interventions trial. Obstet Gynecol. 2003 May;101(5 Pt 1):1020; author reply 1020-1. No abstract available.

Lindenfeld EA, Langer RD. Bleeding patterns of the hormone replacement therapies in the postmenopausal estrogen and progestin interventions trial. Obstet Gynecol. 2002 Nov;100(5 Pt 1):853-63.

Hu P, Greendale GA, Palla SL, Reboussin BA, Herrington DM, Barrett-Connor E, Reuben DB. The effects of hormone therapy on the markers of inflammation and endothelial function and plasma matrix metalloproteinase-9 level in postmenopausal women: The postmenopausal estrogen progestin intervention (PEPI) trial. Atherosclerosis. 2005 Jul 13; [Epub ahead of print]

ClinicalTrials.gov Identifier:	NCT00000466 History of Changes
Other Study ID Numbers:	55
Study First Received:	October 27, 1999
Last Updated:	July 20, 2005
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Bone Diseases
Cardiovascular Diseases
Myocardial Ischemia
Coronary Artery Disease
Coronary Disease
Diabetes Mellitus
Heart Diseases
Hypercholesterolemia
Hypertension
Ischemia
Osteoporosis
Thrombosis
Musculoskeletal Diseases
Vascular Diseases
Arteriosclerosis

Arterial Occlusive Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Pathologic Processes
Bone Diseases, Metabolic
Embolism and Thrombosis
Estrogens, Conjugated (USP)
Estrogens
Progesterone
Medroxyprogesterone
Medroxyprogesterone Acetate

ClinicalTrials.gov processed this record on May 16, 2013

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