The PEPI Trial is an important method of establishing, in as unambiguous a manner possible, the metabolic and clinical effects of estrogen/progestin combinations in post-menopausal women. This prospective randomized clinical trial will be the largest of its kind when the results are finally available. It may form the framework for a future and even larger study, regarding the effects of estrogen/progestin on disease outcome e.g., cardiovascular. Taken with this view the PEPI Trial assumes great importance. We have designed a clinical trial that compares two forms of estrogen preparations: Conjugated equine estrogen (CEE) and transdermal estradiol (TDE); and compares two forms of progestins: Medroxyprogesterone acetate (MPA) and micronized progesterone (P). First, post-menopausal women with intact uterus will be randomized to 6 groups: CEE + MPA; CEE + P; TDE + MPA; TDE + P; placebo patch + placebo pill; placebo pill + placebo pill. We can then compare the effect of different progestins in women on the same estrogen, and compare the effect of different estrogens in women on the same progestin. We can also compare each group against the placebo group. Second, past-menopausal women without uterus will be randomized of 3 groups; CEE, TDE, placebo (1/2 patch). From this group we can compare the effects of estrogen only to those with added progestin e.g., CEE + MPA vs VEE, and etc., estrogen only against placebo, and between the different estrogen preparations. This allows multiple comparisons of metabolic and clinical outcome variables. The investigators are excited and committed to the PEPI Trial because of its health importance. Our experience is considerable in the following areas: (1) Clinical trial protocol development, recruitment, maintenance and data quality; (2) establishment of population based normative data for bone density measurements; (3) presence of a fully functioning Lipid Research Clinic Care Lipid Laboratory and principal investigator interested in management of lipid disorders; (4) research in the psychological and sexual responses to illnesses; and (5) the presence of a first- rate epidemiological program.
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