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Oral Diindolylmethane (DIM) for the Treatment of Cervical Dysplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00212381
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : March 29, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Cervical Dysplasia Drug: di indolylmethane (DIM) Dietary Supplement: Red rice bran Phase 3

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized double blind intervention trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: central pharmacy dispenses based on sealed randomization table
Primary Purpose: Treatment
Official Title: Diindolylmethane (DIM) Dietary Supplementation: A Nonsurgical Treatment for Cervical Intraepithelial Neoplasia (CIN)
Study Start Date : September 2000
Primary Completion Date : January 2006
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: oral DIM (Active agent)
2mg/kg/day po of DIM
Drug: di indolylmethane (DIM)
This is the agent being studies. Similar agents have been reported to have potential activity.
Active Comparator: Red rice bran (Placebo)
this agent is not generally thought to be active but may be
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

Outcome Measures

Primary Outcome Measures :
  1. Measure the regression of CIN in women by cytology, colposcopy, and biopsy, [ Time Frame: 3 months ]
    To determine if oral DIM is effective in promoting the regression of CIN in women

Secondary Outcome Measures :
  1. HPV colonization by commercial ELIZA test [ Time Frame: 3 months ]
    To correlate the response to DIM with HPV colonization

  2. Adverse events reported by subjects and lab abnormalities i.e. CBC and SMA20 [ Time Frame: one year ]
    To assess for any adverse effects of oral DIM in women

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00212381

United States, New York
NYU School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
New York Presbyterian Hospital
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

Responsible Party: Giuseppe Del Priore, Professor, New York Presbyterian Hospital
ClinicalTrials.gov Identifier: NCT00212381     History of Changes
Obsolete Identifiers: NCT00206804
Other Study ID Numbers: 9218
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Giuseppe Del Priore, New York Presbyterian Hospital:
cervical dysplasia, diindolylmethane, pap smear

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