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

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Brief Title

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

Official 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.

Brief Summary

      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.
    

Detailed Description

      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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Virological status (infection)

Condition

Uterine Cervical Neoplasia

Intervention

C1

Study Arms / Comparison Groups

 Treatment group
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

200

Start Date

March 2011

Completion Date

February 2013

Primary Completion Date

February 2013

Eligibility Criteria

        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
      

Gender

Female

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

No

Contacts

Philippe SIMON, MD, PhD, Professor, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT01303328

Organization ID

MI-CI-C02

Secondary IDs

2010-023271-26


Study Sponsor

Mithra Pharmaceuticals


Study Sponsor

Philippe SIMON, MD, PhD, Professor, Principal Investigator, Hôpital Erasme, service de gynécologie obstétrique


Verification Date

August 2012