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Postmenopausal Estrogen/Progestin Interventions (PEPI)

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ClinicalTrials.gov Identifier: NCT00000466
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : May 13, 2016
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)

Brief Summary:
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 or disease Intervention/treatment 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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Study Start Date : September 1987
Actual Study Completion Date : October 2000

Resource links provided by the National Library of Medicine

Drug Information available for: Estrogens





Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
Postmenopausal women, ages 45 to 64. One third of the subjects had had a hysterectomy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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OverallOfficial: Mark Espeland Bowman Gray School of Medicine

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

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ClinicalTrials.gov Identifier: NCT00000466     History of Changes
Other Study ID Numbers: 55
U01HL040232 ( U.S. NIH Grant/Contract )
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: July 2005
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases
Heart Diseases
Thrombosis
Coronary Disease
Myocardial Ischemia
Hypercholesterolemia
Ischemia
Cardiovascular Diseases
Vascular Diseases
Pathologic Processes
Bone Diseases, Metabolic
Musculoskeletal Diseases
Metabolic Diseases
Embolism and Thrombosis
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Medroxyprogesterone Acetate
Medroxyprogesterone
Progesterone
Estrogens, Conjugated (USP)
Estrogens
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female