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

Mithra Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Cervix Intraepithelial Neoplasia

Uterine Cervical Neoplasia

Treatments

Drug: C1

Study type

Interventional

Funder types

Industry

Identifiers

NCT01303328

2010-023271-26 (EudraCT Number)

MI-CI-C02

Details and patient eligibility

About

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.

Full description

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.

Enrollment

200 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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