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Title: Phytoestrogen & Raloxifene EFfects on Endothelial Reactivity (PREFER): Double-blind, Placebo Controlled, Randomized Crossover Trial of Raloxifene versus Soy Phytoestrogens on Endothelial Reactivity in Healthy Post-Menopausal Women
Status: Completed
Topic: Cardiovascular Health / Endothelial Function*
Funding Source: Eli Lilly & Co., Inc.
Funding Period: 2/01-3/02
Study Design: Randomized, Double-Blind, Placebo-Controlled Crossover Trial
Purpose: Many women take natural products and/or pharmaceuticals for the treatment of menopause-related conditions. This study was designed to compare the effects of raloxifene (a commonly prescribed medication for the prevention of osteoporosis) and soy phytoestrogens on endothelial function in healthy post-menopausal women. Participants were also surveyed regarding their preference for natural vs. synthetic therapy both before and after the study.
Further Study Details:

A total of 25 women who participated in this study were assigned to three different treatments:

  • raloxifene (60 mg),
  • soy phytoestrogen (55 mg), and
  • placebo

in random order each for six weeks. Following each treatment assignment, participants underwent BARS and lipid profile testing.

Findings: Neither of the active treatments (raloxifene or soy phytoestrogens) was found to enhance endothelial function (i.e. provide a protective effect on vascular functioning) in this pilot study. With regard to cholesterol findings, all three treatments (including placebo) were found to significantly lower total cholesterol and LDL from baseline. Further study is required to determine if particular subgroups of postmenopausal women would experience cardiovascular benefit from the use of synthetic or natural forms of estrogen.
Eligibility: Healthy, post-menopausal woman not taking hormone replacement therapy

Changed at: 1/18/2011 5:13 AM Changed by: Judy Treu
Created at: 8/31/2010 9:22 AM Created by: Griffin Hospital