E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Termination of early pregnancy |
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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 |
The main objective of the present randomized trial is to compare four misoprostol regimens when administered either sublingually or vaginally 36-48 hours after 200 mg of mifepristone, among women with a gestational age of up to 63 days. The four regimens will be compared in respect of the following main outcomes (i) their effectiveness to induce complete abortion; (ii) induction-to-abortion interval, when possible: (iii) the occurrence of side-effects; and (iv) women's perceptions. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- good general health - older than the age of legal consent - requesting abortion and eligible for legal termination of pregnancy - on Day 1 of the study (day of mifepristone administration) the duration of pregnancy not more than 63 days (counted from the first day of the last menstrual period) in a normal 28-day cycle - the duration of the pregnancy corresponds to the length of amenorrhoea when verified with ultrasound, if the gestational length according to ultrasound measurements differ more than 4 days, the ultrasound dating should be used - the pregnancy is single and intrauterine (single sac) - if treatment with misoprostol should fail agrees to surgical termination of pregnancy - willing and able to participate (return to follow-up) after the study has been explained - haemoglobin higher than 90 g/l. ed |
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E.4 | Principal exclusion criteria |
Any indication of serious past or present ill health will be considered a contraindication for recruitment to the study. In particular: - allergy towards mifepristone or misoprostol - a history or evidence of disorders that represent a contraindication to the use of mifepristone (chronic adrenal failure, known allergy to mifepristone, severe asthma uncontrolled by corticosteroid therapy, inherited porphyria) or prostaglandins (mitral stenosis, sickle cell anaemia, diastolic pressure over 90 mm Hg, systolic blood pressure lower than 90 mm Hg measured with a traditional instrument) - a history or evidence of thrombo-embolism, severe or recurrent liver disease - has a medical condition or disease that requires special treatment, care or precaution (e.g. corticosteroid or anticoagulant therapy) in conjunction with abortion - uterine fibroids are relative contraindications (women with fibroids that are likely to affect bleeding or contractility should be excluded) - the presence of an IUD in utero - breastfeeding - previous surgery of uterus/uterine cervix is a relative contraindication. However, previous low-segment caesarean section does not need to be a contra-indication - suspicion of any pathology of pregnancy (e.g. mola, non-viable pregnancy, threatened abortion) - in case difficulties are anticipated in the follow-up of the woman (e.g. lives too far).
Women older than 35 years can be recruited for the present trial provided they do not smoke, their diastolic blood pressure is <90mmHg and have no known risk facgtor for cardiovascular disease. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Termination of pregnancy
Women will be followed up for six weeks after the treatment.
For those who require vacuum aspiration, the study will end on the day of the procedure. |
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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 | Yes |
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 | Yes |
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 | Yes |
E.7.1.3.1 | Other trial type description |
Comparative efficacy trial |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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 | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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Women are followed up to 6 weeks after treatment unless they need surgical treatment; trial will end when all 3008 women have completed the study |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |