Trial | NCT00989443  Report issue

Title

Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions
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)

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    cidofovir ...

  • Study Participants

    6
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.
Study Started
May 31
2010
Primary Completion
Sep 30
2010
Last Update
Oct 21
2010
Estimate

Drug Cidofovir gel

topical gel applied once a week for 3 weeks

Cidofovir Experimental

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
No Results Posted