Spots Global Cancer Trial Database for Safety and Efficacy Study of Antiviral Local Application to Treat High Grade Cervical Intraepithelial Lesions (CIN2/3)
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Trial Identification
Brief Title: Safety and Efficacy Study of Antiviral Local Application to Treat High Grade Cervical Intraepithelial Lesions (CIN2/3)
Official Title: 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.
Study ID: NCT01303328
Interventions
Study Description
Brief Summary: 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.
Detailed 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
HIS Ixelles, Ixelles, Bruxelles, Belgium
CHU Charleroi Site André Vésale, Montigny-le-Tilleul, Charleroi, Belgium
CHU ND des Bruyères, Chenee, Liege, Belgium
Hôpital Saint Pierre, Bruxelles, , Belgium
CHU Brugmann, Bruxelles, , Belgium
Hôpital Erasme, Bruxelles, , Belgium
CHU Charleroi Hôpital Civil, Charleroi, , Belgium
CHU Tivoli, La Louvière, , Belgium
CHR Citadelle, Liege, , Belgium
Contact Details
Name: Philippe SIMON, MD, PhD, Professor
Affiliation: Hôpital Erasme, service de gynécologie obstétrique
Role: PRINCIPAL_INVESTIGATOR
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