Spots Global Cancer Trial Database for Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions
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Trial Identification
Brief Title: Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions
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)
Study ID: NCT00989443
Interventions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Erasme Hospital, Brussels, , Belgium
Contact Details
Name: Michel Bossens, MD, PhD
Affiliation: Erasme Hospital - Laboratoire de recherche en reproduction humaine
Role: PRINCIPAL_INVESTIGATOR
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