Oral Diindolylmethane (DIM) for the Treatment of Cervical Dysplasia

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00212381

Enrollment

Registered

2005-09-21

Start date

2000-09-30

Completion date

2010-07-31

Last updated

2017-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Dysplasia

Keywords

cervical dysplasia, diindolylmethane, pap smear

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.

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

Interventions

DRUGdi indolylmethane (DIM)

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

DIETARY_SUPPLEMENTRed 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

central pharmacy dispenses based on sealed randomization table

Intervention model description

randomized double blind intervention trial

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Measure the regression of CIN in women by cytology, colposcopy, and biopsy,	3 months	To determine if oral DIM is effective in promoting the regression of CIN in women

Secondary

Measure	Time frame	Description
HPV colonization by commercial ELIZA test	3 months	To correlate the response to DIM with HPV colonization
Adverse events reported by subjects and lab abnormalities i.e. CBC and SMA20	one year	To assess for any adverse effects of oral DIM in women

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026