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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023271-26 | EudraCT Number |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental |
| |
| Placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C1 | Drug | Local application of the experimental gel or placebo gel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | during 30 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during 30 weeks |
| Changes in lesion (colposcopic changes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe SIMON, MD, PhD, Professor | Hôpital Erasme, service de gynécologie obstétrique | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint Pierre | Brussels | Brussels Capital | 1000 | Belgium | ||
| CHU Brugmann |
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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.
| during 30 weeks |
| Brussels |
| Brussels Capital |
| 1020 |
| Belgium |
| Hôpital Erasme | Brussels | Brussels Capital | 1070 | Belgium |
| HIS Ixelles | Ixelles-Elsene | Brussels Capital | 1050 | Belgium |
| CHU Charleroi Hôpital Civil | Charleroi | Charleroi | 6000 | Belgium |
| CHU Charleroi Site André Vésale | Montigny-le-Tilleul | Charleroi | 6110 | Belgium |
| CHU Tivoli | La Louvière | La Louvière | 7100 | Belgium |
| CHU ND des Bruyères | Chênée | Liege | 4032 | Belgium |
| CHR Citadelle | Liège | Liege | 4000 | Belgium |
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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