Overview

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

Status:
Completed
Trial end date:
2017-05-09
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
United States Naval Medical Center, San Diego
Treatments:
Imiquimod