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OpenTrials
Completed

NCT Number: NCT00212381

Oral Diindolylmethane (DIM) for the Treatment of Cervical Dysplasia

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.

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Key information

Conditions

Cervical Dysplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

NYU School of Medicine

New York, 10016, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

di indolylmethane (DIM)

Drug

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

Red rice bran

Dietary Supplement

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

New York Presbyterian Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2006
Study completion
2010
First posted
Sep 21, 2005
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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