E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
In this randomized controlled, multi-center trial we will investigate the non-inferiority of a topical IMQ treatment compared to surgical standard treatment in selected patients diagnosed with CIN 2/3. |
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E.1.1.1 | Medical condition in easily understood language |
In this trial we will compare topical Imiquimod treatment with surgical standard treatment in selected patients diagnosed with CIN 2/3. |
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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 |
This study investigates the non-inferiority of the new treatment, compared to surgical standard treatment. The primary endpoint is the rate of successful treatment, defined as negative HPV test result six months after treatment start. Six months after start of therapy the primary study endpoint is assessed using HPV genotyping (cobas® 4800 HPV Test, Roche). In addition clinical examinations including colposcopy, HPV genotyping, PAP smear, and if indicated colposcopy-guided biopsies of the uterine cervix will be performed. |
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E.2.2 | Secondary objectives of the trial |
In addition, rates of CIN persistence/recurrence 6, 12, 18, and 24 months after treatment start and rates of negative HPV test results 12 and 24 months after treatment start will be evaluated in both treatment groups. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Women aged ≥18 years diagnosed with histologically verified CIN 3 and women aged ≥ 30 years diagnosed with CIN 2 2) Satisfactory colposcopy 3) Signed informed consent 4) Negative pregnancy test 5) Appropriate contraception method for fertile women during active study period 6) Adequate compliance
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E.4 | Principal exclusion criteria |
1) Adenocarcinoma in situ 2) History of previous conization 3) Malignant disease at the time of inclusion 4) Coploscopy suspicious for invasive disease 5) Pregnancy and lactation period 6) Known allergy or intolerance to IMQ 7) Contraindications to conization or IMQ 8) Symptoms of a clinical relevant disease 9) Known HIV infection 10) Evidence of a clinically significant immunodeficiency 11) Participation in another experimental, interventional, protocol
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E.5 End points |
E.5.1 | Primary end point(s) |
Non inferiority of the new treatment. Successful treatment is defined as negative HPV test result 6 months after treatment start (assessed by cobas® 4800 HPV Test, Roche) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Six months after treatment start |
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E.5.2 | Secondary end point(s) |
1) Intention-to-treat non-inferiority analyses of rates of CIN persistence/recurrence 6,12, 18 and 24 months after treatment start (based on Cytology and/or Histology results) 2) Intention to treat non-inferiority analyses of rates of negative HPV test results 12 and 24 months after treatment start 3) Per-protocol non-inferiority analyses of negative HPV test results at 6, 12 and 24 months after treatment start, and rates of CIN persistence/recurrence 6, 12, 18 and 24 months after treatment start 4) Intention-to-treat non-inferiority analyses of negative HPV test results according to HPV16/18 infection
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
12, 18, and 24 months after treatment start |
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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 |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
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 | Yes |
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
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Clinical studies support office medical university of Vienna |
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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 | |
E.8.9.1 | In the Member State concerned months | 46 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 46 |