Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions

October 20, 2010 updated by: Mithra Pharmaceuticals

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Erasme hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women aged between 18 and 50 years old
  • volunteers
  • informed consent signed
  • cervical lesion classified CIN 2 or 3, on a biopsy made during the 6 preceding weeks
  • no sexual activity or use of effective mechanical, hormonal or intrauterine contraception (except hormonal vaginal ring)

Exclusion Criteria:

  • pregnancy or breast feeding
  • subtotal hysterectomy
  • current or ancient renal impairment
  • current immune disorder
  • current use of drugs interfering with renal function
  • current treatment for any cancer
  • current use of treatment interfering with immunity
  • current use of anti-viral treatment
  • current or recent participation to another experimental study during the last 3 months before the screening visit
  • current vaginal application of drugs or cosmetics
  • local or general condition incompatible with the experimental treatment in the opinion of the principal investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cidofovir
Drug: Cidofovir gel
topical gel applied once a week for 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
adverse events
Time Frame: weeks 1, 2, 3 and 4
weeks 1, 2, 3 and 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mithra Pharmaceuticals

Investigators

  • Principal Investigator: Michel Bossens, MD, PhD, Erasme Hospital - Laboratoire de recherche en reproduction humaine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

September 1, 2010

Study Registration Dates

First Submitted

October 2, 2009

First Submitted That Met QC Criteria

October 2, 2009

First Posted (ESTIMATE)

October 5, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 21, 2010

Last Update Submitted That Met QC Criteria

October 20, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MI-COL-CI01
  • EudraCT2009-012937-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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