A Randomized, Double-blind, Multi-centre, Placebo Controlled Phase II Clinical Study to Evaluate the Efficacy, Tolerance and Safety of an Aqueous Gel Containing an Antiviral, Directly Applied on the Cervix Exhibiting High Grade Intraepithelial Lesion.
Human Papilloma Virus (HPV) infections induce cervical intraepithelial neoplasia (CIN) of
cervix. To reduce incidence of invasive tumor associated with high grade CIN lesions, the
standard treatment is the conisation of cervix (surgical act). A local treatment with
antiviral would preserve the cervix of young subjects and reduce obstetrical morbidity
induced by the conisation.
This clinical study is aimed at:
- to evaluate the efficacy of a gel with antiviral directly applied on the cervix
exhibiting high grade CIN lesions (CIN2/3): conisation is still indicated?
- to evaluate the safety and tolerance after local application.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Efficacy at week 12: change of histological and cytological parameters (success or not)
Efficacy will be measured by histological and cytological criteria at week 12 (disappearance of CIN 2+) in correlation with viral status (positive or negative) before and after treatment.
Philippe SIMON, MD, PhD, Professor
Hôpital Erasme, service de gynécologie obstétrique
Belgium: AFMPS (FAMHP: Federal Agency for Medicines and Health Products)