Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions

Summary

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 the antiviral and anti-proliferative cidofovir would preserve the cervix of young subjects and reduce obstetrical morbidity induced by the conisation. This clinical study is aimed at : 1. evaluating the tolerance and safety of a cidofovir gel directly applied on the cervix exhibiting high grade CIN lesions; 2. evaluating the pharmacokinetic (PK) profile of cidofovir after local application.

Timeline

Start

2010-05

Primary completion

2010-09

Completion

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Drugs

Indications