Clinical trial NCT01303328: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uterine Cervical Neoplasia
Cervix Intraepithelial Neoplasia
Lead sponsor: Mithra Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-02-24
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Efficacy at week 12: change of histological and cytological parameters (success or not)
timeFrame: 12 weeks
measure: Efficacy at week 28: recurrence rate
timeFrame: 28 weeks
measure: Tolerance and Safety (AE reporting, changes of gynecological and biological parameters)
timeFrame: during 30 weeks
Secondary outcomes:
measure: Virological status (infection)
timeFrame: during 30 weeks
measure: Changes in lesion (colposcopic changes)
timeFrame: during 30 weeks
Other outcomes:
Locations:
city: Ixelles
country: Belgium
facility: HIS Ixelles
state: Bruxelles
city: Montigny-le-Tilleul
country: Belgium
facility: CHU Charleroi Site André Vésale
state: Charleroi
city: Chenee
country: Belgium
facility: CHU ND des Bruyères
state: Liege
city: Bruxelles
country: Belgium
facility: Hôpital Saint Pierre
city: Bruxelles
country: Belgium
facility: CHU Brugmann
city: Bruxelles
country: Belgium
facility: Hôpital Erasme
city: Charleroi
country: Belgium
facility: CHU Charleroi Hôpital Civil
city: La Louvière
country: Belgium
facility: CHU Tivoli
city: Liege
country: Belgium
facility: CHR Citadelle
Study officials:
affiliation: Hôpital Erasme, service de gynécologie obstétrique
name: Philippe SIMON, MD, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
References: