Study Stopped
Slow accrual in the high BMI group
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
4 other identifiers
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 obesity
Started Sep 2009
Longer than P75 for phase_2 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 1, 2009
CompletedFirst Posted
Study publicly available on registry
October 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedDecember 13, 2019
April 1, 2015
10 months
October 1, 2009
December 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in urinary 2/16-hydroxyestrone ratio
8 weeks
Study Arms (1)
Indole-3-carbinol
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- woman aged from 30 - 50 years
- regular menstrual cycle
You may not qualify if:
- taking hormone replacement or hormonal contraception
- thyroid disorder
- uncontrolled asthma
- BMI under 18.5
- allergy to cruciferous vegetables
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph P Connor, MD
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2009
First Posted
October 2, 2009
Study Start
September 1, 2009
Primary Completion
July 1, 2010
Study Completion
January 1, 2014
Last Updated
December 13, 2019
Record last verified: 2015-04