A Phase 2 interventional study of C1 in Uterine Cervical Neoplasia and Cervix Intraepithelial Neoplasia, sponsored by Mithra Pharmaceuticals. Completed at 9 sites in Belgium. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2013-02-18.
Sponsored by Mithra Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
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:
367 studies on the registry are indexed under Uterine Cervical Dysplasia; 70 are open to participants now.
This study's planned enrollment of 200 is above the median of 166 across 253 interventional studies indexed under Uterine Cervical Dysplasia.
Browse Uterine Cervical Dysplasia studies →Mithra Pharmaceuticals is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: C1
Drug: C1
Local application of the experimental gel or placebo gel.
Efficacy at week 12: change of histological and cytological parameters (success or not)
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.
Time frame: 12 weeks
Efficacy at week 28: recurrence rate
The recurrence rate will be assessed at week 28, by the same histological and cytological criteria in correlation with the viral status (positive or negative) before and after treatment.
Time frame: 28 weeks
Tolerance and Safety (AE reporting, changes of gynecological and biological parameters)
Safety will be measured by record of adverse events, changes in clinical biology test results; local tolerance will be measured by patient questioning and gynecological examination of vagina and cervix.
Time frame: during 30 weeks
Virological status (infection)
The viral load and genotypes of HPVhr will be determined before treatment, during follow-up and at the end of the study, by using a quantitative analysis.
Time frame: during 30 weeks
Changes in lesion (colposcopic changes)
Colposcopic description of lesion will be done before, during and after treatment of the lesion, during follow up and at the end of the study.
Time frame: during 30 weeks
The record gives a start of Mar 2011, a primary completion of Feb 2013 and a completion of Feb 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Mithra Pharmaceuticals