Clinical trial · Interventional
Topical Imiquimod vs. LEEP for Women With Carcinoma In-situ of the Cervix
Phase 3 Randomized Controlled Trial of Non-inferiority of Topical Imiquimod vs. LEEP for Women With Carcinoma In-situ of the Cervix
- 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)
OBJECTIVE: The standard of care for high grade cervical intraepithelial neoplasia grade 2 to 3 (CIN 2-3) has been the excision of the cervical transformation zone by way of a loop electrosurgical excision procedure (LEEP) or cold knife conization (CKC). However, it has been recognized that these procedures can increase the risks for pre-term labor in women who still desire to conceive. Recent studies have shown that medical treatment with Imiquimod, a topical immune response modulator, has significant effects on histological regression of CIN 2-3 when compared with placebo. The investigators propose that treatment with Imiquimod may be preferable offering similar outcomes on histological regression when compared with excision or ablation while potentially avoiding or reducing the number of surgical procedure that places them at risk for future pregnancies.
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 Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imiquimod | Drug | Imiquimod | ALIAS |
| Loop Electrosurgical Excision Procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Loop Electrosurgical Excision Procedure
- description
- Excision of the cervical transformation zone by way of the loop electrosurgical excision procedure (LEEP) or cold knife conization (CKC).
- interventionNames
- Procedure: Loop Electrosurgical Excision Procedure
- type
- EXPERIMENTAL
- label
- Imiquimod
- description
- Imiquimod 12.5mg intravaginally once weekly for 16 weeks
- interventionNames
- Drug: Imiquimod
Primary outcomes (1)
- measure
- Human Papillomavirus(HPV) Clearance
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Healthy women older than age 21, military or civilian * Negative pregnancy test results * Confirmed CIN 2-3 on cervical biopsy with a negative endocervical curettage (ECC) and satisfactory colposcopy visualizing the complete transformation zone of the cervix. * The patient will be available and in the San Diego area for 6 months after enrollment to complete the clinic visits and follow up. Exclusion Criteria: * Positive CIN 2-3 on ECC * Presence of cancer * Pregnancy or lactation * Immuno-compromised (systemic lupus erythematosus, kidney transplant) * Hepatitis * Hypersensitivity to Imiquimod * Ulcerative colitis * Crohn's disease * Human Immunodeficiency virus
References
Publications (0)
Data not yet available