ESTRADIOL DROSPIRENONE COMB--POSTMENOPAUS ENDOMETRIUM

$0M01FY2000RRNIH

University Of Pittsburgh At Pittsburgh, Pittsburgh PA

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Abstract

This study is designed to determine the dose of Drospirenone(DRSP), a new progestin with unique antimineralocorticoid activity that can be combined with Estradiol and which will prevent endometrial hyperplasia. It is expected that DRSP will have beneficial metabolic effects due to its antiandrogenic activity. A Health Questionnaire and Health Survey will be assessed. In order to compare treatment with two-sided hypothesis tests, and further estimate the dose response by calculating one-sided 95% confidence intervals within each treatment group, two complementary sample size calculations are provided: the larger estimate was chosen. A generalized Conchran-Mantel-Haenszel Test, adjusting for center, will be employed to test all groups for over all difference.

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