Oral Diindolylmethane (DIM) for the Treatment of Cervical Dysplasia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by New York Downtown Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
New York Downtown Hospital
ClinicalTrials.gov Identifier:
NCT00212381
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Cervical Dysplasia
Drug: diindolylmethane (DIM)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Diindolylmethane (DIM) Dietary Supplementation: A Nonsurgical Treatment for Cervical Intraepithelial Neoplasia (CIN)

Resource links provided by NLM:


Further study details as provided by New York Downtown Hospital:

Primary Outcome Measures:
  • To determine if oral DIM is effective in promoting the regression of CIN in women

Secondary Outcome Measures:
  • To correlate the response to DIM with HPV colonization
  • To assess for any adverse effects of oral DIM in women

Estimated Enrollment: 62
Study Start Date: September 2000
Estimated Study Completion Date: August 2005
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212381

Contacts
Contact: Roopa R Chakkappan, M.P.H 212-312-5268 roopa.chakkappan@downtownhospital.org

Locations
United States, New York
NYU School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Alan Arslan, M.D.    212-263-7792    akhmea01@popmail.med.nyu.edu   
Contact: Giuseppe Del Priore, M.D, M.P.H.    212-312-5268    giuseppe.delpriore@downtownhospital.org   
Sponsors and Collaborators
New York Downtown Hospital
Investigators
Study Director: Giuseppe Del Priore, M.D., M.P.H. NY Downtown Hospital
Principal Investigator: Alan Arslan, M.D. NYU School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00212381     History of Changes
Obsolete Identifiers: NCT00206804
Other Study ID Numbers: 9218
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by New York Downtown Hospital:
cervical dysplasia, diindolylmethane, pap smear

Additional relevant MeSH terms:
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 26, 2014