Oral Diindolylmethane (DIM) for the Treatment of Cervical Dysplasia

NCT00212381 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2017-03-29

No results posted yet for this study

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.

Conditions

  • Cervical Dysplasia

Interventions

DRUG

di indolylmethane (DIM)

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

DIETARY_SUPPLEMENT

Red rice bran

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

Sponsors & Collaborators

  • New York Presbyterian Hospital

    lead OTHER

Principal Investigators

  • Giuseppe Del Priore, M.D., M.P.H. · NY Downtown Hospital

  • Alan Arslan, M.D. · NYU School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-09-30
Primary Completion
2006-01-31
Completion
2010-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00212381 on ClinicalTrials.gov