Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT00179556
Status:
COMPLETED
Last Update Posted:
2017-03-14
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Soy Isoflavones on Menopausal Hot Flashes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019584', 'term': 'Hot Flashes'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-12', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hot flash frequency and severity'}], 'secondaryOutcomes': [{'measure': 'Menopausal quality of life'}]}, 'conditionsModule': {'keywords': ['Hot flashes', 'Menopausal symptoms', 'Soybean germ', 'Aglycones', 'Menopause'], 'conditions': ['Menopausal Symptoms']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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 placebo) once a day. This isoflavone-aglycone extract (Agly-Max TM, Nichimo, Shinagawa, Tokyo, Japan) is a product prepared from soybean germ fermentation with Koji fungus (Aspergliius awamori) producing ß-glycosidase efficiency, followed by ethanol and water extraction and purification by using a proprietary extraction procedure. The product is rich in daidzein (70% daidzein, 10% genistein, and 20% glycitein).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '38 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNo menstrual period for at least six months, Hot flashes at least four t imes per day, Ages 38-65\n\nExclusion Criteria:\n\nPregnant, 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'}, 'identificationModule': {'nctId': 'NCT00179556', 'briefTitle': 'Effects of Soy Isoflavones on Menopausal Hot Flashes', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Daidzein-rich Isoflavone-aglycones for Menopausal Symptoms', 'orgStudyIdInfo': {'id': '2002P000037'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Isoflavone supplement', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Hope Ricciotti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}, {'name': 'George Blackburn, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Beth Israel Deaconess Medical Center'}, {'name': 'Lalita Khaodhiar, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nichimo - Tokyo, Japan', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Obstetrics, Gynecology and Reproductive Biology', 'investigatorFullName': 'Hope Ricciotti', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}