Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions

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.

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Key information

Conditions

Uterine Cervical Neoplasms Cervix Intraepithelial Neoplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Precancerous Conditions Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases Uterine Neoplasms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Erasme Hospital

Brussels, 1070, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cidofovir gel

Drug

topical gel applied once a week for 3 weeks

Primary outcomes

adverse events

Time frame: weeks 1, 2, 3 and 4

Sponsors and collaborators

Lead sponsor

Mithra Pharmaceuticals

Industry

Registry information

Official study 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)

Important dates

Study start: 2010
Primary completion: 2010
First posted: Oct 5, 2009
Registry last updated: Oct 21, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed