KEEPS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. KEEPS will be a randomized double-blinded prospective, multicenter clinical trial of estrogen replacement therapy in young and healthy perimenopausal women 40-55 years of age. Each of eight centers will enroll 90 patients, for a total of 720 patients for the trial. After meeting the eligibility criteria, women will be randomized to receive either conjugated estrogens (Premarin 0.45), transdermal 17 beta estradiol (Climara) or placebo (30 patients in each arm per center). The participants will be followed longitudinally for a period of 5 years. The primary endpoint of interest will be carotid intima-medial thickness (IMT) as measured by ultrasound every 18 months until completion of the study. Secondary endpoints will include coronary calcification as measured by EBT at baseline and at completion. Other secondary endpoints will include lipid risk factors (total LDL and HDL cholesterol: LDL subfractions, triglicerides and Lp(a); inflammatory risk factors including homocysteine, C-reactive protein and fibrinogen and markers of blood hypercoagulability including thrombin-antithrombin complexes (TAT's), prothrombin fragments F1.2, beta thromboglobulin and prothrombin activator inhibitor-1 (PAl-I) The study will compare oral with transdermal estrogen treatment to further elucidate the potential role of their different actions in mediating adverse effects of MHT: