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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: May 12, 2016
Last verified: July 2005
  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:


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

Ages Eligible for Study:   45 Years to 64 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 
Study First Received: October 27, 1999
Last Updated: May 12, 2016
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
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
Estrogens, Conjugated (USP)
Estrogens
Medroxyprogesterone
Medroxyprogesterone Acetate
Progestins

ClinicalTrials.gov processed this record on September 27, 2016