Skip to main content
OpenTrials
Completed

NCT Number: NCT01303328

Safety and Efficacy Study of Antiviral Local Application to Treat High Grade Cervical Intraepithelial Lesions (CIN2/3)

The purpose of this phase-II study is to evaluate the efficacy and safety of an aqueous gel containing an antiviral, administered directly on cervix exhibiting high grade squamous or glandular intraepithelial lesion (CIN 2 and 3) in comparison with a placebo treatment.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

CHU Brugmann, Brussels, Brussels Capital, Belgium

Loading trial locations.

About this study

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 antiviral would preserve the cervix of young subjects and reduce obstetrical morbidity induced by the conisation.

This clinical study is aimed at:

  • to evaluate the efficacy of a gel with antiviral directly applied on the cervix exhibiting high grade CIN lesions (CIN2/3): conisation is still indicated?
  • to evaluate the safety and tolerance after local application.

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
  • Informed consent signed
  • Cervical lesion classified CIN 2 or 3, on a biopsy made during the 60 days before inclusion
  • No sexual activity, or proved sterility, or use of effective mechanical, hormonal or intrauterine contraception during 30 days following inclusion (except vaginal ring Nuvaring, diaphragm and spermicide)

Exclusion criteria

  • Invasive or microinvasive cervical neoplasia
  • Pregnancy or breast feeding
  • Subtotal hysterectomy
  • Current renal impairment
  • Current immune disorder including serology HIV +
  • Current use of drugs interfering with renal function
  • Current use of oncologic treatment
  • Current use of immune treatment
  • Current use of anti-viral treatment
  • Current vaginal application of drugs or cosmetics
  • Prior treatment with the antiviral on the cervix
  • Local or general condition incompatible with the experimental treatment in the opinion of the principal investigator
  • Current or recent participation to another experimental study during the last 3 months before the screening visit

Treatment and study plan

C1

Drug

Local application of the experimental gel or placebo gel.

Primary outcomes

  1. Efficacy at week 12: change of histological and cytological parameters (success or not)

    Time frame: 12 weeks

    Efficacy will be measured by histological and cytological criteria at week 12 (disappearance of CIN 2+) in correlation with viral status (positive or negative) before and after treatment.

  2. Efficacy at week 28: recurrence rate

    Time frame: 28 weeks

    The recurrence rate will be assessed at week 28, by the same histological and cytological criteria in correlation with the viral status (positive or negative) before and after treatment.

  3. Tolerance and Safety (AE reporting, changes of gynecological and biological parameters)

    Time frame: during 30 weeks

    Safety will be measured by record of adverse events, changes in clinical biology test results; local tolerance will be measured by patient questioning and gynecological examination of vagina and cervix.

Secondary outcomes

  1. Virological status (infection)

    Time frame: during 30 weeks

    The viral load and genotypes of HPVhr will be determined before treatment, during follow-up and at the end of the study, by using a quantitative analysis.

  2. Changes in lesion (colposcopic changes)

    Time frame: during 30 weeks

    Colposcopic description of lesion will be done before, during and after treatment of the lesion, during follow up and at the end of the study.

Sponsors and collaborators

Lead sponsor

Mithra Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-blind, Multi-centre, Placebo Controlled Phase II Clinical Study to Evaluate the Efficacy, Tolerance and Safety of an Aqueous Gel Containing an Antiviral, Directly Applied on the Cervix Exhibiting High Grade Intraepithelial Lesion.

Acronym: Colvir-PhaseII

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 24, 2011
Registry last updated
Feb 18, 2013

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.

Related clinical trials

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