High Grade of Cervical Intraepithelial Neoplasia (CIN). MedDRA version: 14.1 Level: LLT Classification code 10007494 Term: Carcinoma uterine cervix in situ System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: 2% (w/w) cidofovir gel
Product Code: CID
Pharmaceutical Form: Vaginal gel
INN or Proposed INN: CIDOFOVIR
CAS Number: 113852-37-2
Other descriptive name: (S)-1-[3-hydroxy-2-(phosphonylmet
Sponsors
Mithra Pharmaceuticals SA
Eligibility
Sex/Gender
All
Inclusion 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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint of efficacy will be mean change of histological and cytological parameters in each treatment group (cidofovir vs placebo) and the comparison between them -At week 12, the success, partial success and failure rates in term of histological and cytological signs of disappearance of the CIN2+ lesion will be evaluated in each group. Abnormal cytological results are considered only if HPVhr are present in the sample. -At week 28 (study end), the recurrence rate of CIN 1 and CIN 2/3 will be measured in the population of partial and complete success at week 12 (population who continue in the study), according the same criteria as at week 12. The primary endpoints of safety and local tolerance will be: -the adverse events reporting; -the absence of renal impairment (blood creatinine level); -the absence of inflammation markers in plasma (CRP, differential leukocyte count); -the local tolerance (local symptoms and gynecological examination).;Timepoint(s) of evaluation of this end point: Efficacy: 12 and 28 weeks Safety: each day during the protocol.;Main Objective: To evaluate the efficacy and the 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).;Secondary Objective: To evaluate the colopsocopic and the virological changes after the local application of the aqueous gel containing 2 % (w/w) of cidofovir, directly on the cervix exhibiting high grade intraepithelial lesion(s) (CIN 2 and 3). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The viral load and genotypes of HPVhr will be determined before treatment. Colposcopic : colposcopic change at the study end will be classified as: “progression, unchanged, partial regression, or total regression”. ;Timepoint(s) of evaluation of this end point: Virology: at weeks 4 and 12, and at the end of the study (week 28). Coloposcopy: before, during and after treatment of the lesion, during follow up and at the end of the study. | — |
Countries
Belgium
Outcome results
None listed