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Indole-3-Carbinol Effects on Estrogen Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00988845
Recruitment Status : Terminated (Slow accrual in the high BMI group)
First Posted : October 2, 2009
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE October 1, 2009
First Posted Date  ICMJE October 2, 2009
Last Update Posted Date December 13, 2019
Study Start Date  ICMJE September 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2009)
Change in urinary 2/16-hydroxyestrone ratio [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Indole-3-Carbinol Effects on Estrogen Metabolism
Official Title  ICMJE 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
Brief Summary This study will test a dietary supplement, indole-3-carbinol, for improving the estrogen profile in women across a range of body mass index.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Obesity
Intervention  ICMJE Dietary Supplement: Indole-3-carbinol
200 mg bid po X 8 weeks
Study Arms  ICMJE Experimental: Indole-3-carbinol
Intervention: Dietary Supplement: Indole-3-carbinol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 7, 2015)
38
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2009)
40
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00988845
Other Study ID Numbers  ICMJE H-2009-0093
CC09709 ( Other Identifier: UW Carbone Cancer Center )
A532800 ( Other Identifier: UW Madison )
SMPH\OBSTET & GYNECOL\OB-GYN ( Other Identifier: UW Madison )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Wisconsin, Madison
Original Responsible Party Joseph P. Connor, MD, University of Wisconsin
Current Study Sponsor  ICMJE University of Wisconsin, Madison
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joseph P Connor, MD University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP