Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions

Uterine Cervical Neoplasms Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989443
• Other study ID #: MI-COL-CI01
• Secondary ID: EudraCT2009-0129
• Status: Completed
• Phase: Phase 1
• First received: October 2, 2009
• Last updated: October 20, 2010
• Start date: May 2010

Study information

• Verified date: October 2010
• Source: Mithra Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Cervix Intraepithelial Neoplasia
• Uterine Cervical Neoplasms

Intervention

Drug:
• Cidofovir gel
topical gel applied once a week for 3 weeks

Locations

Country	Name	City	State
Belgium	Erasme Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Mithra Pharmaceuticals

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse events		weeks 1, 2, 3 and 4	Yes