VASOMOTOR TSE 424 IN HEALTHY POSTMENOPAUSAL WOMEN

$0M01FY2000RRNIH

Virginia Commonwealth University, Richmond VA

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Abstract

An attempt is made to evaluate the effect of three doses of TSE-424, tissue select estrogen, versus a placebo on the incidence of subjects experiencing hot flushes in a non-flushing, postmenopausal population. This study aims to determine the effect of TSE-424 on the mean number of hot flushes, on the severity of hot flushes, on serum lipids, and on biochemical indices of bone metabolism. Also, it will try to evaluate the effect of raloxifene versus placebo on the incidence of subjects experiencing hot flushes in a non-flushing, postmenopausal population. In this double-blind, randomized, placebo and active controlled pilot study, there will be three phases. During the screening phase, postmenopausal subjects will keep a 14-day diary to record the number and severity of hot flushes. Those fulfilling the flushing criterion and other criteria and agreeing to participate will be assigned to receive either TSE-424, placebo, or raloxifene. Subjects will maintain a daily flush diary during 12 weeks of treatment. On visit one, the subject will have an exam including pelvic and pap smear, and a diary will be given to record hot flushes. The diaries will include the dates and times the study drugs are taken, any symptoms such as the number and severity of hot flushes, breast tenderness, bleeding or spotting, and any medications taken and any illnesses experienced during the study. On visit two, the diary will be reviewed and blood and urine will be taken to determine the general health of the subject. If a mammogram hasn't been done in the last 12 months, it will be done at the second visit. At visit three, the study drugs will be offered, one dose a day. Blood and urine samples will be taken, a questionnaire will be done, and the diary will be kept up. On visits four and five, blood pressure and weight will be measured, and health and the diary will be discussed. The empty pill pack will be exchanged for a full one. On the last visit, the last pill pack and the diary will be returned. The subject will have a physical exam and a transvaginal ultrasound, and a short quality of life questionnaire will be completed. Blood and urine samples will be taken.

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