- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00988845
Indole-3-Carbinol Effects on Estrogen Metabolism
December 12, 2019 updated by: University of Wisconsin, Madison
Effects of Dietary Indole-3-Carbinol on Estrogen Metabolites Across a Wide Range of Body Mass Index: Implications for the Prevention of Endometrial Cancer in Obese Women
This study will test a dietary supplement, indole-3-carbinol, for improving the estrogen profile in women across a range of body mass index.
Study Overview
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- woman aged from 30 - 50 years
- regular menstrual cycle
Exclusion Criteria:
- taking hormone replacement or hormonal contraception
- thyroid disorder
- uncontrolled asthma
- BMI under 18.5
- allergy to cruciferous vegetables
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Indole-3-carbinol
|
200 mg bid po X 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in urinary 2/16-hydroxyestrone ratio
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joseph P Connor, MD, University of Wisconsin, Madison
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
October 1, 2009
First Submitted That Met QC Criteria
October 1, 2009
First Posted (Estimate)
October 2, 2009
Study Record Updates
Last Update Posted (Actual)
December 13, 2019
Last Update Submitted That Met QC Criteria
December 12, 2019
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-2009-0093
- SMPH\OBSTET & GYNECOL\OB-GYN (Other Identifier: UW Madison)
- A532800 (Other Identifier: UW Madison)
- CC09709 (Other Identifier: UW Carbone Cancer Center)
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 Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Fundació Sant Joan de DéuNot yet recruitingObesity, Childhood | Obesity, AdolescentSpain
-
Consorcio Centro de Investigación Biomédica en...Maimónides Biomedical Research Institute of Córdoba; Instituto de Salud Carlos... and other collaboratorsActive, not recruiting
-
University of HoustonBaylor College of MedicineCompleted
Clinical Trials on Indole-3-carbinol
-
University of KansasNational Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Masonic Cancer Center, University of MinnesotaCompleted
-
Vanderbilt UniversityNational Cancer Institute (NCI)Completed
-
University of Kansas Medical CenterNational Cancer Institute (NCI)CompletedBreast CancerUnited States
-
SynCore Biotechnology Co., Ltd.TerminatedHead and Neck NeoplasmsTaiwan
-
ShireCompletedFriedreich's AtaxiaUnited States
-
University of PennsylvaniaRecruitingAlzheimer's DiseaseUnited States
-
University of PennsylvaniaAvid RadiopharmaceuticalsRecruiting
-
Constellation PharmaceuticalsCompleted
-
Newcastle-upon-Tyne Hospitals NHS TrustNational Institute for Health Research, United Kingdom; Alder Hey Children's...RecruitingHuman Papilloma Virus | Recurrent Respiratory PapillomatosisUnited Kingdom