Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
UNC Lineberger Comprehensive Cancer Center
With
OBJECTIVES: * Compare the effects of genistein vs placebo on DNA damage and apoptosis by conducting COMET, TUNEL, Caspase-3, and AP site assays in healthy postmenopausal women. * Compare the effects of these drugs on gene expression in an estrogen-sensitive tissue by oligoarray profiling in these participants. * Determine the effect of genistein on estrogenic effects by self-reported side effects, measurement of sex hormone-binding globulin, follicle-stimulating hormone, luteinizing hormone, and estrogen levels, and expression of known estrogen-sensitive genes in these participants. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Participants are stratified according to their study ID numbers. Participants are randomized to 1 of 2 treatment arms. * Arm I: Participants receive oral genistein twice daily on days 1-84. * Arm II: Participants receive oral placebo twice daily on days 1-84. In both arms, treatment continues in the absence of dysplasia, malignancy, unacceptable toxicity, or gross noncompliance. Participants are followed at days 7, 14, 28, 56, and 84 during study treatment and at day 28 after completion of study treatment. PROJECTED ACCRUAL: A total of 30 participants (20 for arm I and 10 for arm II) will be accrued for this study.
Age
45–70
Sex
FEMALE
Healthy volunteers
Accepted
