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Topical Imiquimod vs. LEEP for Women With Carcinoma In-situ of the Cervix

NCT02130323 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2017-06-27

No results posted yet for this study

Summary

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

  • Cervical Intraepithelial Neoplasia

Interventions

DRUG

Imiquimod

12.5mg (5%) once a week vaginally for 16 weeks

PROCEDURE

Loop Electrosurgical Excision Procedure

Patients with CIN 2-3 will be randomized to receive intervention, CKC or LEEP versus medical therapy with Imiquimod.

Sponsors & Collaborators

  • United States Naval Medical Center, San Diego

    lead FED

Principal Investigators

  • Addie N Alkhas, MD · United States Naval Medical Center, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-12-21
Completion
2017-05-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02130323 on ClinicalTrials.gov