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 populations 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 #
5U01HL040195-10
Application #
2028369
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 Iowa
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
041294109
City
Iowa City
State
IA
Country
United States
Zip Code
52242
Smith, E M; Johnson, S R; Ritchie, J M et al. (2004) Persistent HPV infection in postmenopausal age women. Int J Gynaecol Obstet 87:131-7
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
Greendale, G A; Wells, B; Marcus, R et al. (2000) How many women lose bone mineral density while taking hormone replacement therapy? Results from the Postmenopausal Estrogen/Progestin Interventions Trial. Arch Intern Med 160:3065-71
Barrett-Connor, E; Espeland, M A; Greendale, G A et al. (2000) Postmenopausal hormone use following a 3-year randomized clinical trial. J Womens Health Gend Based Med 9:633-43
Cushman, M; Legault, C; Barrett-Connor, E et al. (1999) Effect of postmenopausal hormones on inflammation-sensitive proteins: the Postmenopausal Estrogen/Progestin Interventions (PEPI) Study. Circulation 100:717-22
Legault, C; Stefanick, M L; Miller, V T et al. (1999) Effect of hormone replacement therapy on the validity of the Friedewald equation in postmenopausal women: the postmenopausal estrogen/progestins interventions (PEPI) trial. J Clin Epidemiol 52:1187-95
Barnabei, V M; Phillips, T M; Hsia, J (1999) Plasma homocysteine in women taking hormone replacement therapy: the Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. J Womens Health Gend Based Med 8:1167-72
Greendale, G A; Reboussin, B A; Sie, A et al. (1999) Effects of estrogen and estrogen-progestin on mammographic parenchymal density. Postmenopausal Estrogen/Progestin Interventions (PEPI) Investigators. Ann Intern Med 130:262-9
Greendale, G A; Reboussin, B A; Hogan, P et al. (1998) Symptom relief and side effects of postmenopausal hormones: results from the Postmenopausal Estrogen/Progestin Interventions Trial. Obstet Gynecol 92:982-8

Showing the most recent 10 out of 23 publications