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Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions

2014-08-27 03:18:53 | BioPortfolio

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.

Study Design

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

Conditions

Uterine Cervical Neoplasms

Intervention

Cidofovir gel

Location

Erasme Hospital
Brussels
Belgium
1070

Status

Recruiting

Source

Mithra Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:53-0400

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Medical and Biotech [MESH] Definitions

Tumors or cancer of the UTERINE CERVIX.

A cytological test finding often from PAP SMEARS that shows abnormal lesions of SQUAMOUS EPITHELIAL CELLS of the CERVIX. It is a diagnostic criterion used in the Bethesda System for UTERINE CERVICAL NEOPLASMS and represents the PAP TEST result that is abnormal. Although squamous intraepithelial lesions test result does not mean UTERINE CERVICAL NEOPLASMS it requires follow-ups (e.g., HPV DNA TESTS; and COLPOSCOPY).

Incompetent UTERINE CERVIX is usually diagnosed in the second trimester of PREGNANCY. It is characterized by passive painless cervical dilation in the absence of UTERINE CONTRACTION; BLEEDING; INFECTION; and sometimes with the amniotic sac (AMNIOTIC MEMBRANE) bulging through the partially dilated cervix. Left untreated, this condition may lead to premature pregnancy loss, such as HABITUAL ABORTION.

Abnormal development of immature squamous EPITHELIAL CELLS of the UTERINE CERVIX, a term used to describe premalignant cytological changes in the cervical EPITHELIUM. These atypical cells do not penetrate the epithelial BASEMENT MEMBRANE.

A parameter usually used in PRENATAL ULTRASONOGRAPHY to measure the length of the uterine neck (CERVIX UTERI). Cervical length or its shortening is used to identify and prevent early cervical opening and PRETERM BIRTH.

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