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.
Phase:
N/A
Details
Lead Sponsor:
Maastricht University Medical Center
Collaborators:
Clinical Trial Center Maastricht Clinical Trial Center Maastricht B.V.