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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Uterine Cervical Neoplasia Cervix Intraepithelial Neoplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment group

Group Type EXPERIMENTAL

C1

Intervention Type DRUG

Local application of the experimental gel or placebo gel.

Placebo group

Group Type PLACEBO_COMPARATOR

C1

Intervention Type DRUG

Local application of the experimental gel or placebo gel.

Interventions

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C1

Local application of the experimental gel or placebo gel.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No