NCT01303328

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

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Mithra Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uterine Cervical Neoplasia
• Cervix Intraepithelial Neoplasia

Interventions

Type	Name	Description
DRUG	C1	Local application of the experimental gel or placebo gel.

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2011-02-24
• Last updated: 2013-02-18

Locations

9 sites across 1 country: Belgium