Phase I Multiple Dose Clinical Study of Soy Isoflavones in Healthy, Post-Menopausal Women
- 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
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
- 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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention
Efficacy of genistein on DNA and apoptosis
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.
Steven H. Zeisel, MD, PhD
UNC Lineberger Comprehensive Cancer Center
United States: Institutional Review Board
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|