- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00179556
Effects of Soy Isoflavones on Menopausal Hot Flashes
Daidzein-rich Isoflavone-aglycones for Menopausal Symptoms
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Hot flash frequency and severity
|
Secondary Outcome Measures
Outcome Measure |
---|
Menopausal quality of life
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Hope Ricciotti, MD, Beth Israel Deaconess Medical Center
- Study Chair: George Blackburn, MD, PhD, Beth Israel Deaconess Medical Center
- Study Director: Lalita Khaodhiar, MD, Beth Israel Deaconess Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2002P000037
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Menopausal Symptoms
-
Angelica Lindén HirschbergRecruiting
-
Center for Epidemiology and Health Research, GermanyBayerCompletedMenopausal SymptomsGermany
-
Northumbria UniversityDoctor SeaweedCompletedMenopausal Syndrome | Menopausal DepressionUnited Kingdom
-
Adiyaman University Research HospitalCompleted
-
Guang'anmen Hospital of China Academy of Chinese...Ministry of Science and Technology of the People´s Republic of ChinaCompletedMenopausal SyndromeChina
-
University PotiguarFederal University of São Paulo; InBios International, Inc.Completed
-
EstetraICON Clinical ResearchCompletedVasomotor Symptoms | Menopausal SymptomsUnited States, Canada
-
BayerNerre Therapeutics Ltd.CompletedPost-menopausal Vasomotor SymptomsUnited States
-
Novo Nordisk A/SCompletedMenopause | Menopausal Vasomotor SymptomsDenmark, United Kingdom, Sweden, Belgium, Switzerland, Germany, France, Finland, Austria, Norway
Clinical Trials on Isoflavone supplement
-
University of East AngliaCompletedCardiovascular Disease Risk ReductionUnited Kingdom
-
American Lung Association Asthma Clinical Research...National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health...Completed
-
Wageningen UniversityCompleted
-
Imam Abdulrahman Bin Faisal UniversityCompletedBone Density Increased | Bone Density, Low | Soy Isoflavone EffectSaudi Arabia
-
Seoul National University HospitalCompletedAgeing | Photo-agingKorea, Republic of
-
National Nutrition and Food Technology InstituteCompleted
-
National Nutrition and Food Technology InstituteUnknownPeritoneal Dialysis PatientsIran, Islamic Republic of
-
National Cancer Institute (NCI)CompletedRecurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell Carcinoma | Recurrent Lip and Oral Cavity Squamous Cell Carcinoma | Recurrent Laryngeal Verrucous Carcinoma | Recurrent Oral Cavity Verrucous Carcinoma | Tongue... and other conditionsUnited States
-
National Health Research Institutes, TaiwanGenovate Biotechnology Co., Ltd.,; Taiwan Biotech Co., Ltd.Unknown
-
Northwestern UniversityRespiratory Health Association of Metropolitan ChicagoCompleted