Postmenopausal Estrogen/Progestin Interventions (PEPI)

ClinicalTrials.gov Identifier:
NCT00000466
First received: October 27, 1999
Last updated: July 20, 2005
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
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00000466

Sponsors and Collaborators
Investigators
Investigator: 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
Study First Received: October 27, 1999
Last Updated: July 20, 2005
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on September 18, 2014