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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.


Phase 2
18 Years
50 Years
Not Enrolling
Female
Uterine Cervical Neoplasia, Cervix Intraepithelial Neoplasia

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Trial Information

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.


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Philippe SIMON, MD, PhD, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hôpital Erasme, service de gynécologie obstétrique

Authority:

Belgium: AFMPS (FAMHP: Federal Agency for Medicines and Health Products)

Study ID:

MI-CI-C02

NCT ID:

NCT01303328

Start Date:

March 2011

Completion Date:

February 2013

Related Keywords:

  • Uterine Cervical Neoplasia
  • Cervix Intraepithelial Neoplasia
  • Neoplasms
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ

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