Indole-3-Carbinol Effects on Estrogen Metabolism

• ClinicalTrials.gov Identifier: NCT00988845
• Recruitment Status: Terminated
• First Posted: October 2, 2009
• Last Update Posted: December 13, 2019
• Sponsor: University of Wisconsin, Madison
• Information provided by (Responsible Party): University of Wisconsin, Madison

Tracking Information

• First Submitted Date: October 1, 2009
• First Posted Date: October 2, 2009
• Last Update Posted Date: December 13, 2019
• Study Start Date: September 2009
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 1, 2009): Change in urinary 2/16-hydroxyestrone ratio [ Time Frame: 8 weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Indole-3-Carbinol Effects on Estrogen Metabolism
• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Obesity

Intervention

Dietary Supplement: Indole-3-carbinol

200 mg bid po X 8 weeks

Study Arms

Experimental: Indole-3-carbinol

Intervention: Dietary Supplement: Indole-3-carbinol

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 7, 2015): 38
• Original Estimated Enrollment (submitted: October 1, 2009): 40
• Actual Study Completion Date: January 2014
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 30 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00988845
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: University of Wisconsin, Madison
• Original Responsible Party: Joseph P. Connor, MD, University of Wisconsin
• Current Study Sponsor: University of Wisconsin, Madison
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Joseph P Connor, MD; University of Wisconsin, Madison

• PRS Account: University of Wisconsin, Madison
• Verification Date: April 2015