NCT00212381

Brief Summary

To determine if the use of oral Diindolylmethante (DIM), a marketed cruciferous vegetable based dietary supplement (Bioresponse-DIM), is associated with the regression of cervical dysplasia in otherwise healthy women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2000

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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, 2000

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

5.3 years

First QC Date

September 13, 2005

Last Update Submit

March 27, 2017

Conditions

Cervical Dysplasia

Keywords

cervical dysplasia, diindolylmethane, pap smear

Outcome Measures

Primary Outcomes (1)

  • Measure the regression of CIN in women by cytology, colposcopy, and biopsy,

    To determine if oral DIM is effective in promoting the regression of CIN in women

    3 months

Secondary Outcomes (2)

  • HPV colonization by commercial ELIZA test

    3 months

  • Adverse events reported by subjects and lab abnormalities i.e. CBC and SMA20

    one year

Study Arms (2)

oral DIM (Active agent)

EXPERIMENTAL

2mg/kg/day po of DIM

Drug: di indolylmethane (DIM)

Red rice bran (Placebo)

ACTIVE COMPARATOR

this agent is not generally thought to be active but may be

Dietary Supplement: Red rice bran

Interventions

di indolylmethane (DIM)DRUG

This is the agent being studies. Similar agents have been reported to have potential activity.

oral DIM (Active agent)
Red rice branDIETARY_SUPPLEMENT

this will act as the active comparator. The sponsor provided this as the "placebo" arm since it is a filler component of their DIM capsules

Red rice bran (Placebo)

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non pregnant women greater than or equal to 18 years of age able to consent
  • CIN II or III confirmed by histology
  • Karnofsky performance status \>= 80
  • No prior treatment for dysplasia in the past 4 months

You may not qualify if:

  • Incompletely visible lesion
  • Diethylstilbestrol (DES) exposure
  • HIV seropositive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

  • Del Priore G, Gudipudi DK, Montemarano N, Restivo AM, Malanowska-Stega J, Arslan AA. Oral diindolylmethane (DIM): pilot evaluation of a nonsurgical treatment for cervical dysplasia. Gynecol Oncol. 2010 Mar;116(3):464-7. doi: 10.1016/j.ygyno.2009.10.060. Epub 2009 Nov 24.

    PMID: 19939441RESULT

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Giuseppe Del Priore, M.D., M.P.H.

    NY Downtown Hospital

    STUDY DIRECTOR

  • Alan Arslan, M.D.

    NYU School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
central pharmacy dispenses based on sealed randomization table
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized double blind intervention trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

September 1, 2000

Primary Completion

January 1, 2006

Study Completion

July 1, 2010

Last Updated

March 29, 2017

Record last verified: 2017-03

Locations

US(1)