Imiquimod Treatment of High-grade CIN

This multi-center, open-label, non-randomized controlled intervention study aims to investigate the treatment efficacy, side-effects and quality of life associated with imiquimod treatment of high-grade CIN lesions, as an alternative to surgical treatment by Large Loop Excision of the Transformation Zone (LLETZ). Non-surgical treatment may prevent side-effects associated with surgical treatment, such as premature birth in subsequent pregnancies. The study hypothesis is that approximately 75% of patients with high-grade CIN will be adequately treated with imiquimod. 120 women with a histological diagnosis of CIN2 or CIN3 will be included and allocated to one of two treatment arms according to their preference: 1. Imiquimod treatment arm(60 patients). Patients in this group are treated with vaginal imiquimod 5% cream during 16 weeks. 2. Standard treatment arm (60 patients). Patients in this group will undergo LLETZ treatment.

Sex

Female

Minimum age

18 Years

Maximum age

99 Years

Inclusion Criteria:

* de novo CIN2 or CIN3 lesion, histologically confirmed by diagnostic biopsy
* age of 18 years or older

Exclusion Criteria:

* previous histologically confirmed high-grade CIN (CIN 2-3)
* concomitant vulvar and/or vaginal intraepithelial neoplasia
* previous cervical malignancy
* current malignant disease
* immunodeficiency (including HIV/AIDS and immunodepressive medication)
* pregnancy or lactation
* legal incapability

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