The Postmenopausal Estrogen/Progestins Intervention (PEPI-1) trial of 875 participants followed at 7 centers for three years is the largest and longest randomized double-blind placebo-controlled clinical trial of hormone treatment in postmenopausal women -- and the only long-term trial of estrogen-progestin regimens. It is the only long-term trial designed to compare the effects of Estrogen Replacement Therapy (ERT) and combined (estrogen-progestin) hormone replacement therapy (HRT) on heart disease risk factors. It is also unique for the number of women who began ERT or HRT more than 5 years after the menopause. Details of the study design, hormone replacement regimens and study population are given in Project I, as are the major analyses of PEPI-1 data proposed for completion during the extended follow-up period. Project II, Studies of Repository Samples, was planned to utilize plasma, urine and other samples already collected but not analyzed by the close of PEPI-1. Both Project I and Project II, submitted by the Coordinating Center to reflect the centralized activity necessary for a multicenter project, will be conducted with the Clinical Investigators as a cooperative project. Project III, submitted in parallel from each of the 7 PEPI Clinical Centers, describes a three year prospective observational follow-up study designed to: ensure PEPI women's safety and learn more about possible delayed adverse hormone effects; study treatment choices, compliance and reasons related to these decisions; and monitor long-term effects on heart disease risk factors and bone density. All participants will be invited to an annual clinic visit, (conducted according to the established PEPI-1 protocol) which includes a medical history and limited examination, mammogram, endometrial biopsy, and standardized questions about quality of life, sexuality, symptomatology, and medication use. We will measure primary PEPI endpoints (HDL-cholesterol, blood pressure, insulin and fibrinogen) and their covariates, and bone density at the hip and spine.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HL040207-10
Application #
2028371
Study Section
Special Emphasis Panel (ZHL1-CCT-G (M2))
Project Start
1987-09-30
Project End
1998-07-31
Budget Start
1996-08-01
Budget End
1998-07-31
Support Year
10
Fiscal Year
1996
Total Cost
Indirect Cost
Name
University of California San Diego
Department
Family Medicine
Type
Schools of Medicine
DUNS #
077758407
City
La Jolla
State
CA
Country
United States
Zip Code
92093
Greendale, Gail A; Espeland, Mark; Slone, Stacey et al. (2002) Bone mass response to discontinuation of long-term hormone replacement therapy: results from the Postmenopausal Estrogen/Progestin Interventions (PEPI) Safety Follow-up Study. Arch Intern Med 162:665-72
Lindenfeld, Etta A; Langer, Robert D (2002) Bleeding patterns of the hormone replacement therapies in the postmenopausal estrogen and progestin interventions trial. Obstet Gynecol 100:853-63
Devor, M; Barrett-Connor, E; Renvall, M et al. (1992) Estrogen replacement therapy and the risk of venous thrombosis. Am J Med 92:275-82
Barrett-Connor, E (1991) Postmenopausal estrogen and prevention bias. Ann Intern Med 115:455-6