E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
High grade cervical intraepithelial neoplasia. |
Hooggradige cervicale intraepitheliale neoplasie. |
|
E.1.1.1 | Medical condition in easily understood language |
Premalignant lesions of the uterine cervix. |
Premaligne afwijkingen van de baarmoedermond. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
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 investigate the effectiveness of imiquimod 5% cream for the treatment of CIN2-3 lesions. |
|
E.2.2 | Secondary objectives of the trial |
- Development of a biomarker prediction model to identify CIN2-3 lesions that will regress spontaneously and CIN2-3 lesions that will regress during immunotherapy.
- To assess health-related quality of life before, during and after treatment.
- To assess the incidence and severity of adverse effects of imiquimod and LLETZ treatment.
- To assess long-term recurrence of disease after treatment, by cytological examinations. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- de novo, CIN2 or CIN3 lesion, histologically confirmed by diagnostic biopsy,
- 18 years or older |
|
E.4 | Principal exclusion criteria |
- immuno-compromised women,
- pregnant or lactating women,
- legally incapable women,
- previous high-grade CIN lesions |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The endpoint of the study is regression-or-not of CIN2 or CIN 3 lesions after imiquimod or observational management, defined as regression to CIN 1 or less, at 20 weeks. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- Development of a biomarker prediction model to identify CIN2-3 lesions that will regress spontaneously and CIN2-3 lesions that will regress during immunotherapy.
- Health-related quality of life before, during and after treatment.
- incidence and severity of adverse effects of imiquimod and LLETZ treatment.
- long-term recurrence of disease after treatment, by cytological examinations |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Biomarker model: baseline.
- quality of life: baseline, 20 weeks and one year
- adverse effects: 6, 10, 16 and 20 weeks.
- recurrence: 6, 12 and 24 months. |
|
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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Chirurgische behandeling een expectatieve behandeling |
Surgical treatment and conservative treatment |
|
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
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 |