Indole-3-Carbinol Effects on Estrogen Metabolism | NCT00988845

Studies
Indole-3-Carbinol Effects on Estrogen Metabolism

NCT00988845

Sponsor

University of Wisconsin, Madison

Status

Terminated

Last Update Posted

Dec 13, 2019Actual

Enrollment

38Actual

Phase

Phase 2

Conditions

Obesity

Interventions

Indole-3-carbinol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
CC09709	Other Identifier	UW Carbone Cancer Center
A532800	Other Identifier	UW Madison
SMPH\OBSTET & GYNECOL\OB-GYN	Other Identifier	UW Madison

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow accrual in the high BMI group

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Jul 2010Actual

Completion Date

Jan 2014Actual

First Submitted Date

Oct 1, 2009

First Submission Date that Met QC Criteria

Oct 1, 2009

First Posted Date

Oct 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2019

Last Update Posted Date

Dec 13, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Indole-3-carbinol	Experimental		Dietary Supplement: Indole-3-carbinol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Indole-3-carbinol	Dietary Supplement	200 mg bid po X 8 weeks	Indole-3-carbinol

Measure	Description	Time Frame
Change in urinary 2/16-hydroxyestrone ratio		8 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph P Connor, MD	University of Wisconsin, Madison	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin		Madison	Wisconsin	53792	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C016517	indole-3-carbinol

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided