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Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions

Primary Purpose

Uterine Cervical Neoplasms, Cervix Intraepithelial Neoplasia

Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Cidofovir gel
Sponsored by
Mithra Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Cervical Neoplasms focused on measuring Cervix Intraepithelial Neoplasia grades 2 and 3

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Erasme Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cidofovir

Arm Description

Outcomes

Primary Outcome Measures

adverse events

Secondary Outcome Measures

Full Information

First Posted
October 2, 2009
Last Updated
October 20, 2010
Sponsor
Mithra Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00989443
Brief Title
Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Mithra Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 : evaluating the tolerance and safety of a cidofovir gel directly applied on the cervix exhibiting high grade CIN lesions; evaluating the pharmacokinetic (PK) profile of cidofovir after local application.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasms, Cervix Intraepithelial Neoplasia
Keywords
Cervix Intraepithelial Neoplasia grades 2 and 3

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cidofovir
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cidofovir gel
Intervention Description
topical gel applied once a week for 3 weeks
Primary Outcome Measure Information:
Title
adverse events
Time Frame
weeks 1, 2, 3 and 4

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Bossens, MD, PhD
Organizational Affiliation
Erasme Hospital - Laboratoire de recherche en reproduction humaine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasme Hospital
City
Brussels
ZIP/Postal Code
1070
Country
Belgium

12. IPD Sharing Statement

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Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions

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