Clinical trial · Interventional
Oral Diindolylmethane (DIM) for the Treatment of Cervical Dysplasia
Diindolylmethane (DIM) Dietary Supplementation: A Nonsurgical Treatment for Cervical Intraepithelial Neoplasia (CIN)
NCT00212381CI-TRIAL-00026677completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| di indolylmethane (DIM) | Drug | — | UNRESOLVED |
| Red rice bran | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- oral DIM (Active agent)
- description
- 2mg/kg/day po of DIM
- interventionNames
- Drug: di indolylmethane (DIM)
- type
- ACTIVE_COMPARATOR
- label
- Red rice bran (Placebo)
- description
- this agent is not generally thought to be active but may be
- interventionNames
- Dietary Supplement: Red rice bran
Primary outcomes (1)
- measure
- Measure the regression of CIN in women by cytology, colposcopy, and biopsy,
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTDel Priore G, Gudipudi DK, Montemarano N, Restivo AM, Malanowska-Stega J, Arslan AA. Oral diindolylmethane (DIM): pilot evaluation of a nonsurgical treatment for cervical dysplasia. Gynecol Oncol. 2010 Mar;116(3):464-7. doi: 10.1016/j.ygyno.2009.10.060. Epub 2009 Nov 24. PMID 19939441