Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions

Uterine Cervical Neoplasms Clinical Trial

Official title: A Phase I Clinical Study to Evaluate the Tolerance and Safety of an Aqueous Gel Containing 2% (w/w) of Cidofovir, Directly Applied on the Cervix Exhibiting High Grade Squamous Intraepithelial Lesion(s) (CIN 2 and 3)

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Cervix Intraepithelial Neoplasia
• Uterine Cervical Neoplasms

• NCT number: NCT00989443
• Study type: Interventional
• Source: Mithra Pharmaceuticals
• Status: Completed
• Phase: Phase 1
• Start date: May 2010