A randomized, double-blind, multi-centre, placebo controlled phase II clinical study to evaluate the efficacy, tolerance and safety of an aqueous gel containing 2% (w/w) of cidofovir, directly applied on the cervix exhibiting high grade intraepithelial lesion(s) (CIN 2 and 3) - Colvir-Phase II

Phase 1

• Conditions: High Grade of Cervical Intraepithelial Neoplasia (CIN).; MedDRA version: 14.1Level: LLTClassification code 10007494Term: Carcinoma uterine cervix in situSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-023271-26-BE
• Lead Sponsor: Mithra Pharmaceuticals SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-20
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

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 preceding days;
-no sexual activity or proved sterility or use of effective mechanical, hormonal or intrauterine contraception (except vaginal ring Nuvaring, diaphragm and spermicide).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 132
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-invasive or microinvasive cervical neoplasia;
-pregnancy or breast feeding;
-subtotal hysterectomy;
-current renal impairment;
-current immune disorder including serology HIV+;
-current systemic use of drugs interfering with renal function (intravenous contrast media, aminoglycosides, glycopeptides)
-current systemic treatment for any cancer;
-current systemic use of treatment interfering with immunity (table 2), except vaccines;
-current systemic use of anti-viral treatment (table 2)
-current vaginal application of drugs or cosmetics;
-previous topical treatment of the cervix by cidofovir;
-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified