E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10046267 |
E.1.2 | Term | Unwanted pregnancy |
E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions |
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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 investigate if the efficacy of VEMA is non-inferior within a noninferiority margin of 3 percent to delayed abortion treatment initiated when an intrauterine pregnancy (IUP) can be confirmed on ultrasound? |
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E.2.2 | Secondary objectives of the trial |
1. Safety; Proportions of adverse events (AE), and serious AE (SAE)) includes bleeding, genital infections and complications to surgical interventions will be compared between the treatment groups. 2. Ectopic and other pathologic pregnancies (time point at diagnosis, treatment, numbers, percentage ruptured/unruptured). Defined as "outcome of special interest". 3. Any additional medical treatment of incomplete abortion or ongoing pregnancy, bleeding (days), pain (VAS score), surgical treatment for ongoing pregnancy, incomplete abortion or any other indications, unscheduled contacts and visits, acceptability with the time of the abortion treatment (early/delayed, would recommend to a friend yes/no) and initiation of postabortion contraception (yes/no, type). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Women 18 years of age or above eligible for medical abortion 2. No signs of pathological pregnancy 3. No confirmed IUP 4. Willing and able to participate after the study has been explained 5. Signed informed consent |
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E.4 | Principal exclusion criteria |
1. Allergy towards mifepristone or misoprostol 2. A medical condition or disease that requires special treatment, care or precaution (e.g. corticosteroid or anticoagulant therapy) in conjunction with abortion |
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E.5 End points |
E.5.1 | Primary end point(s) |
Complete abortion without surgical intervention |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
within 30 days of the abortion treatment |
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E.5.2 | Secondary end point(s) |
1. Safety; Proportions of adverse events (AE), and serious AE (SAE)) includes bleeding, genital infections and complications to surgical interventions will be compared between the treatment groups. 2. Ectopic and other pathologic pregnancies (time point at diagnosis, treatment, numbers, percentage ruptured/unruptured). Defined as "outcome of special interest". 3. Any additional medical treatment of incomplete abortion or ongoing pregnancy, bleeding (days), pain (VAS score), surgical treatment for ongoing pregnancy, incomplete abortion or any other indications, unscheduled contacts and visits, acceptability with the time of the abortion treatment (early/delayed, would recommend to a friend yes/no) and initiation of postabortion |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
within 30 days pf the abortion 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 | Yes |
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) | 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 | 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 |
Routine administration (delayed) of misoprostol |
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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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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 | No |
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 |
Australia |
Austria |
Finland |
Sweden |
Denmark |
Norway |
United Kingdom |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
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 | 2 |
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 |