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Postmenopausal Estrogen/Progestin Interventions (PEPI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000466
First Posted: October 28, 1999
Last Update Posted: May 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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)
  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
Primary Purpose: Prevention

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

Study Start Date: September 1987
Study Completion Date: October 2000
  Show Detailed Description

  Eligibility

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.
  Contacts and Locations
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
OverallOfficial: Mark Espeland Bowman Gray School of Medicine
  More Information

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

ClinicalTrials.gov Identifier: NCT00000466     History of Changes
Other Study ID Numbers: 55
U01HL040232 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: May 13, 2016
Last Verified: July 2005

Additional relevant MeSH terms:
Estrogens, Conjugated (USP)
Estrogens
Diabetes Mellitus
Cardiovascular Diseases
Heart Diseases
Osteoporosis
Ischemia
Thrombosis
Hypercholesterolemia
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Bone Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Arteriosclerosis
Arterial Occlusive Diseases
Progesterone
Medroxyprogesterone
Medroxyprogesterone Acetate
Progestins