Indole-3-Carbinol Effects on Estrogen Metabolism

This study has been terminated.
(Slow accrual in the high BMI group)
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00988845
First received: October 1, 2009
Last updated: April 7, 2015
Last verified: April 2015

October 1, 2009
April 7, 2015
September 2009
July 2010   (final data collection date for primary outcome measure)
Change in urinary 2/16-hydroxyestrone ratio [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00988845 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Indole-3-Carbinol Effects on Estrogen Metabolism
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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Obesity
Dietary Supplement: Indole-3-carbinol
200 mg bid po X 8 weeks
Experimental: Indole-3-carbinol
Intervention: Dietary Supplement: Indole-3-carbinol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
38
January 2014
July 2010   (final data collection date for primary outcome measure)

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
Female
30 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00988845
H-2009-0093, CC09709
Yes
Not Provided
Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Joseph P Connor, MD University of Wisconsin, Madison
University of Wisconsin, Madison
April 2015

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