Overview
Effects of Soy Isoflavones on Menopausal Hot Flashes
Status:
Completed
Completed
Trial end date:
2005-09-01
2005-09-01
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
Hot flashes occur in three quarters of menopausal women, and can negatively impact quality of life. Interest has arisen in isoflavones, found in rich supply in soy products, as therapy for hot flashes. The study examines the effect of a new soy supplement, as compared to a placebo, in menopausal women on hot flash symptoms.Phase:
Phase 2/Phase 3Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Beth Israel Deaconess Medical CenterCollaborator:
Nichimo - Tokyo, Japan
Criteria
Inclusion Criteria:No menstrual period for at least six months, Hot flashes at least four t imes per day, Ages
38-65
Exclusion Criteria:
Pregnant, BMI>45, History of breast cancer or other estrogen dependent tumors, Abnormal
uterine bleeding, Heart, renal, or liver disease, Diabetes, Women taking hormone
replacement therapy or serotonin reuptake inhibitors, Women taking any dietary supplements
for the treatment of hot flashes (ex. soy supplements, vitamin E, flaxseed, red clover
extract) within the past 30 days