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Indole-3-Carbinol Effects on Estrogen Metabolism

This study has been terminated.
(Slow accrual in the high BMI group)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00988845
First Posted: October 2, 2009
Last Update Posted: April 9, 2015
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.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
This study will test a dietary supplement, indole-3-carbinol, for improving the estrogen profile in women across a range of body mass index.

Condition Intervention Phase
Obesity Dietary Supplement: Indole-3-carbinol Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Change in urinary 2/16-hydroxyestrone ratio [ Time Frame: 8 weeks ]

Enrollment: 38
Study Start Date: September 2009
Study Completion Date: January 2014
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indole-3-carbinol Dietary Supplement: Indole-3-carbinol
200 mg bid po X 8 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00988845


Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Joseph P Connor, MD University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00988845     History of Changes
Other Study ID Numbers: H-2009-0093
CC09709
First Submitted: October 1, 2009
First Posted: October 2, 2009
Last Update Posted: April 9, 2015
Last Verified: April 2015

Keywords provided by University of Wisconsin, Madison:
dietary supplement
indole 3 carbinol
estrogen

Additional relevant MeSH terms:
Estrogens
Indole-3-carbinol
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents