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Diindolylmethane (DIM) Dietary Supplementation: A Nonsurgical Treatment for Cervical Intraepithelial Neoplasia (CIN)


Phase 3
18 Years
80 Years
Open (Enrolling)
Female
Cervical Dysplasia

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Trial Information

Diindolylmethane (DIM) Dietary Supplementation: A Nonsurgical Treatment for Cervical Intraepithelial Neoplasia (CIN)


To determine if the use of oral Diindolylmethane (DIM), a marketed cruciferous vegetable
based dietary supplement (BioResponse-DIMĀ®), is associated with the regression of cervical
dysplasia in otherwise healthy women. Additionally, the study aims to see how the use of the
BioResponse-DIM supplement correlates with cervical HPV colonization, and to asses the
tolerability of daily DIM supplementation


Inclusion Criteria:



- 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

Exclusion Criteria:

- Incompletely visible lesion

- Diethylstilbestrol (DES) exposure

- HIV seropositive

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Giuseppe Del Priore, M.D., M.P.H.

Investigator Role:

Study Director

Investigator Affiliation:

NY Downtown Hospital

Authority:

United States: Food and Drug Administration

Study ID:

9218

NCT ID:

NCT00212381

Start Date:

September 2000

Completion Date:

August 2005

Related Keywords:

  • Cervical Dysplasia
  • cervical dysplasia, diindolylmethane, pap smear
  • Uterine Cervical Dysplasia
  • Cervical Intraepithelial Neoplasia

Name

Location

NYU School of MedicineNew York, New York  10016