Completed
Phase 3
Age: 45Years - 64Years
FEMALE
ID00000466
Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2016-05-13
N/A
Participants Needed
N/A
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Heart, Lung, and Blood Institute (NHLBI)
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Postmenopausal Estrogen/Progestin Interventions (PEPI)
Who Can Participate
Age: 45Years - 64Years
FEMALE
Eligibility Criteria
You may qualify if you...
Postmenopausal women, ages 45 to 64. One third of the subjects had had a hysterectomy.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Site Locations not provided
Location information for this trial is currently unavailable.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
N/A
Primary Purpose
PREVENTION
Number of Arms
0
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Published Research Related To This Trial
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.
https://pubmed.ncbi.nlm.nih.gov/7807658PEPI in perspective. Good answers spawn pressing questions.
B Healy
https://pubmed.ncbi.nlm.nih.gov/7807665Effects of hormone replacement therapy on endometrial histology in postmenopausal women. The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. The Writing Group for the PEPI Trial.
https://pubmed.ncbi.nlm.nih.gov/8569016The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. Introduction.
T L Bush, M A Espeland, I Mebane-Sims
https://pubmed.ncbi.nlm.nih.gov/7587216Rationale, design, and conduct of the PEPI Trial. Postmenopausal Estrogen/Progestin Interventions.
M A Espeland, T L Bush, I Mebane-Sims...
https://pubmed.ncbi.nlm.nih.gov/7587218Recruitment of postmenopausal women in the PEPI Trial. Postmenopausal Estrogen/Progestin Interventions.
S Johnson, I Mebane-Sims, P E Hogan...
https://pubmed.ncbi.nlm.nih.gov/7587217Physical and laboratory measurements in the PEPI Trial Postmenopausal Estrogen/Progestin Interventions.
P D Wood, G Kessler, K Lippel...
https://pubmed.ncbi.nlm.nih.gov/7587219Baseline characteristics of the PEPI participants. Postmenopausal Estrogen/Progestin Interventions.
V T Miller, R L Byington, M A Espeland...
https://pubmed.ncbi.nlm.nih.gov/7587220Distribution and correlates of plasma fibrinogen in middle-aged women. Initial findings of the Postmenopausal Estrogen/Progestin Interventions (PEPI) study.
M L Stefanick, C Legault, R P Tracy...
https://pubmed.ncbi.nlm.nih.gov/7489228