Effects of Soy Isoflavones on Menopausal Hot Flashes
Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Sep 13, 2005
Trial Information
Current as of September 25, 2025
Completed
Keywords
ClinConnect Summary
Hot flashes occur in 75% of menopausal women and impact quality of life. Interest has arisen in isoflavones, found in rich supply in soy products, as therapy for hot flashes. The effect of a daidzein-rich isoflavone-aglycone supplement from soy germ fermentation with Koji fungus, on the severity and frequency of hot flashes in postmenopausal women is being examined in a randomized, placebo controlled, double-blinded clinical trial. The study is a 13 week trial in which subjects record their hot flash frequency and severity in a diary. Subjects are given 40 mg or 60 mg of isoflavones (or pla...
Gender
FEMALE
Eligibility 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
About Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center (BIDMC) is a leading academic medical center located in Boston, Massachusetts, affiliated with Harvard Medical School. Renowned for its commitment to cutting-edge research and innovation in healthcare, BIDMC fosters a collaborative environment that integrates patient care, education, and scientific investigation. The center actively sponsors clinical trials across a variety of disciplines, aiming to advance medical knowledge and improve patient outcomes. With a focus on translational medicine, BIDMC's research initiatives engage multidisciplinary teams to address complex health challenges and translate findings into effective therapeutic strategies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Patients applied
Trial Officials
Hope Ricciotti, MD
Principal Investigator
Beth Israel Deaconess Medical Center
George Blackburn, MD, PhD
Study Chair
Beth Israel Deaconess Medical Center
Lalita Khaodhiar, MD
Study Director
Beth Israel Deaconess Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials