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Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions

NCT00989443 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2010-10-21

No results posted yet for this study

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

DRUG

Cidofovir gel

topical gel applied once a week for 3 weeks

Sponsors & Collaborators

  • Mithra Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Michel Bossens, MD, PhD · Erasme Hospital - Laboratoire de recherche en reproduction humaine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-09-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00989443 on ClinicalTrials.gov