Oral Diindolylmethane (DIM) for the Treatment of Cervical Dysplasia
Conditions
Cervical Dysplasia
Conditions: official terms
Cervical Intraepithelial Neoplasia - Uterine Cervical Dysplasia
Conditions: Keywords
cervical dysplasia, diindolylmethane, pap smear
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention
Name: diindolylmethane (DIM)
Type: Drug
Overall Status
Recruiting
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.
Detailed Description
To determine if the use of oral Diindolylmethane (DIM), a marketed cruciferous vegetable based dietary supplement (BioResponse-DIM®), 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
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Female
Criteria: 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
Location
NYU School of Medicine
New York, New York, United States
Status: Recruiting
Contact: Alan Arslan, M.D. - 212-263-7792 - akhmea01@popmail.med.nyu.edu
Start Date
September 2000
Completion Date
August 2005
Sponsors
New York Downtown Hospital
Source
New York Downtown Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page