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Indole-3-Carbinol Effects on Estrogen Metabolism

This study has been terminated.
(Slow accrual in the high BMI group)
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00988845
First received: October 1, 2009
Last updated: July 8, 2010
Last verified: July 2010
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 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

Ages Eligible for Study:   30 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Joseph P. Connor, MD, University of Wisconsin
ClinicalTrials.gov Identifier: NCT00988845     History of Changes
Other Study ID Numbers: H-2009-0093, CC09709
Study First Received: October 1, 2009
Last Updated: July 8, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 27, 2014