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

This study has been completed.
Sponsor:
Information provided by:
Mithra Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01303328
First received: February 18, 2011
Last updated: February 15, 2013
Last verified: August 2012

February 18, 2011
February 15, 2013
March 2011
February 2013   (final data collection date for primary outcome measure)
  • Efficacy at week 12: change of histological and cytological parameters (success or not) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.
  • Efficacy at week 28: recurrence rate [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
    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.
  • Tolerance and Safety (AE reporting, changes of gynecological and biological parameters) [ Time Frame: during 30 weeks ] [ Designated as safety issue: Yes ]
    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.
Same as current
Complete list of historical versions of study NCT01303328 on ClinicalTrials.gov Archive Site
  • Virological status (infection) [ Time Frame: during 30 weeks ] [ Designated as safety issue: No ]
    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.
  • Changes in lesion (colposcopic changes) [ Time Frame: during 30 weeks ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of Antiviral Local Application to Treat High Grade Cervical Intraepithelial Lesions (CIN2/3)
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.

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Uterine Cervical Neoplasia
  • Cervix Intraepithelial Neoplasia
Drug: C1
Local application of the experimental gel or placebo gel.
  • Experimental: Treatment group
    Intervention: Drug: C1
  • Placebo Comparator: Placebo group
    Intervention: Drug: C1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01303328
MI-CI-C02, 2010-023271-26
No
Maud Jost, Mithra Pharmaceuticals
Mithra Pharmaceuticals
Not Provided
Principal Investigator: Philippe SIMON, MD, PhD, Professor Hôpital Erasme, service de gynécologie obstétrique
Mithra Pharmaceuticals
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP