Safety and Efficacy Study of Antiviral Local Application to Treat High Grade Cervical Intraepithelial Lesions (CIN2/3)

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.

The purpose of this phase-II study is to evaluate the efficacy and safety of an aqueous gel containing an antiviral, administered directly on cervix exhibiting high grade squamous or glandular intraepithelial lesion (CIN 2 and 3) in comparison with a placebo treatment.

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.

Inclusion Criteria:

• Women aged between 18 and 50 years old
• Informed consent signed
• Cervical lesion classified CIN 2 or 3, on a biopsy made during the 60 days before inclusion
• No sexual activity, or proved sterility, or use of effective mechanical, hormonal or intrauterine contraception during 30 days following inclusion (except vaginal ring Nuvaring, diaphragm and spermicide)

Exclusion Criteria:

• Invasive or microinvasive cervical neoplasia
• Pregnancy or breast feeding
• Subtotal hysterectomy
• Current renal impairment
• Current immune disorder including serology HIV +
• Current use of drugs interfering with renal function
• Current use of oncologic treatment
• Current use of immune treatment
• Current use of anti-viral treatment
• Current vaginal application of drugs or cosmetics
• Prior treatment with the antiviral on the cervix
• Local or general condition incompatible with the experimental treatment in the opinion of the principal investigator
• Current or recent participation to another experimental study during the last 3 months before the screening visit