E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Women aged above 18 years with early pregnancy failure, 6-14 weeks postmenstrual. |
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E.1.1.1 | Medical condition in easily understood language |
Women with a miscarriage. |
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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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068522 |
E.1.2 | Term | Non-surgical treatment |
E.1.2 | System Organ Class | 100000004865 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027650 |
E.1.2 | Term | Miscarriage of pregnancy |
E.1.2 | System Organ Class | 100000004868 |
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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 |
This study will compare sequential mifepristone and misoprostol (“M&M”) treatment versus misoprostol treatment alone, which is currently the standard medical treatment in the Netherlands. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are patient satisfaction, side effects and complications. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Early pregnancy failure, 6-14 weeks postmenstrual with a o Crown-rump length ≥ 6mm and no cardiac activity OR o Gestational sac without embryonic pole, confirmed by a second ultrasound at least one week later • At least one week after diagnosis OR a discrepancy of at least one week between crown-rump length and calendar gestational age • Intra-uterine pregnancy • Women aged above 18 years • Hemodynamic stable patient • No signs of infection • No signs of incomplete abortion • No contraindications for mifepristone or misoprostol • No high risk of thrombosis |
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E.4 | Principal exclusion criteria |
Patient does not meet inclusion criteria, discovered after randomization |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome will be complete evacuation of the products of conception from the uterus, which is determined by routinely ultrasonography six to nine days after treatment. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
One week after treatment. |
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E.5.2 | Secondary end point(s) |
The secondary objectives are patient satisfaction, side effects and complications. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Six weeks after treatment. |
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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 | 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 | 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.8.2.4 | 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 | 2 |
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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For all studies there is a Data Safety Monitoring Committee following O’Brien-Fleming stopping rules. This means that if the treatment is particularly beneficial or harmful compared to the control group, the sponsor will be able to make a deliberate consideration of terminating the study earlier than planned or to reduce the total number of patients. |
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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 | |
E.8.9.1 | In the Member State concerned days | |