The Postmenopausal Estrogen/Progestins Intervention (PEPI) trial, conducted and seven clinical centers around the United States, is a randomized double-blind placebo-controlled trial of hormone treatment in 875 postmenopausal women. Women were recruited from the community during a 16 month period, and will be treated for three years. Treatment aims are 1) placebo; 2) unopposed Premarin; 3) Premarin plus cyclic Provera; 4) Premarin plus continuous Provera; and 5) Premarin plus micronized progesterone. The primary endpoints are HDL-cholesterol, postchallenge insulin, fibrinogen and systolic blood pressure -- in the context of their metabolic and physiologic covariates. Additional major outcomes of interest include bone mineral density, quality of well-being, and endometrial pathology. As a cooperative agreement, PEPI employs standardized methods, central laboratories and a single coordinating center.
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| 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 |
