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

Status

Terminated

Conditions

Intervention / Treatment

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

  • United States
    • 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
Dietary supplement: 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

University of Wisconsin, Madison

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.

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