E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
cervical dysplasia (CIN I or CIN II; Pap IIID in the history, confirmed HPV+ status) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008263 |
E.1.2 | Term | Cervical dysplasia |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the pharmacokinetic (PK) profile of Interferon alpha-2b Cream in women with cytological diagnosis of Papanicolaou (Pap) IIID and confirmed Human Papillomavirus positive (HPV+) status |
|
E.2.2 | Secondary objectives of the trial |
To investigate the efficacy and safety of Interferon alpha-2b Cream |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Female, pre-menopausal subjects aged 18 to 45 years inclusive - Cytological diagnosis of Pap IIID (Munich nomenclature II) not older than 12 months - Mild cervical dysplasia (CIN I) or moderate cervical dysplasia (CIN II) confirmed by histology - HPV+ status confirmed by Hybrid Capture® 2 HPV Deoxyribonucleic Acid (DNA)-Test (Digene®) - Subjects must be on stable hormonal contraception, which guarantees 29 consecutive days without menstruation
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E.4 | Principal exclusion criteria |
- No Ccytological diagnosis of Pap IIID within the last 12 months or at screening - Severe dysplasia (CIN III), carcinoma in situ or invasive carcinoma - History of abnormal Pap smears higher than Pap IIID - History of or current internal or external urogenital warts - History of frequently recurrent or current sexually-transmitted infection(s) or bacterial vaginosis - History or presence of other malignancies - History or presence of an immune-compromising disease, or a positive Human Immunodeficiency Virus (HIV) test result at screening - History of Hepatitis B or C, or a positive Hepatitis B or Hepatitis C test result at screening - Any other treatment of the cervical lesion during study participation (e.g. conization, laser ablation) - Contraindication for the use of hormonal contraceptives
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E.5 End points |
E.5.1 | Primary end point(s) |
Assessment of systemic levels of interferon alpha-2b |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
End of the trial is the last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |