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Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions

NCT ID: NCT00989443

Last Updated: 2010-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Uterine Cervical Neoplasms Cervix Intraepithelial Neoplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cidofovir

Group Type EXPERIMENTAL

Cidofovir gel

Intervention Type DRUG

topical gel applied once a week for 3 weeks

Interventions

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Cidofovir gel

topical gel applied once a week for 3 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mithra Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Erasme Hospital

Principal Investigators

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Michel Bossens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasme Hospital - Laboratoire de recherche en reproduction humaine

Locations

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Erasme Hospital

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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EudraCT2009-012937-31

Identifier Type: -

Identifier Source: secondary_id

MI-COL-CI01

Identifier Type: -

Identifier Source: org_study_id