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