NCT00989443

Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Mithra Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uterine Cervical Neoplasms
• Cervix Intraepithelial Neoplasia

Interventions

Type	Name	Description
DRUG	Cidofovir gel	topical gel applied once a week for 3 weeks

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-09-01
• First posted: 2009-10-05
• Last updated: 2010-10-21

Locations

1 site across 1 country: Belgium