Pregnancy Pregnancy and Childbirth Pregnancy
Conditions
Interventions
To demonstrate bioequivalence a new generic co-packaged mifepristone (one tablet x 200 mg)/misoprostol (four tablets x 0.2 mg) product (SunPharma, India) with the original formulations of mifepristone
Sponsors
World Health Organization (WHO) (Switzerland)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Subjects admitted to the study will fulfil the following criteria: 1. Good general health 2. Older than the legal age of consent 3. On day one of the study (day of mifepristone administration) the duration of pregnancy is not more than 63 days (counted from the first day of the last menstrual period) in a normal 28-day cycle 4. The duration of the pregnancy corresponds to the length of amenorrhoea when verified by ultrasound; if the gestational length according to ultrasound measurements differ by more than four days, the ultrasound dating will be used 5. The pregnancy is single and intrauterine (single sac) 6. If treatment with misoprostol should fail, subject agrees to surgical termination of pregnancy 7. Willing and able to participate in the study once the objective and study requirements have been explained
Exclusion criteria
Exclusion criteria: Subjects will not be recruited if any of the following conditions are present: 1. Allergy towards mifepristone or misoprostol 2. A history or evidence of disorders that represent a contraindication to the use of mifepristone (chronic adrenal failure, severe asthma uncontrolled by corticosteroid therapy, inherited porphyria) 3. A history or evidence of disorders that represent a contraindication to the use of prostaglandins (mitral stenosis, glaucoma, sickle cell anaemia, diastolic pressure over 90 mmHg, bronchial asthma, arterial hypotension) 4. A history or evidence of thrombo-embolism, severe or recurrent liver disease or pruritus of pregnancy 5. Has any medical condition or disease that requires regular treatment with systemic drugs, care or precaution in conjunction with abortion 6. Tendency of abnormal bleeding (such as von Willebrandt's disease) 7. The presence of intrauterine device (IUD) in utero 8. Previous surgery of uterus/uterine cervix is a relative contraindication, however, previous low-segment caesarean section is not a contraindication 9. Suspicion of any pathology of pregnancy (e.g., molar, non-viable pregnancy, threatened abortion) 10. Suspected or known breast or genital neoplasia 11. Breast-feeding 12. Where difficulties are anticipated in follow-up
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome will be the efficacy (defined as the proportion of complete abortions in each study group) and side effects of each of the two product regimens. The complete abortion rate and the induction to abortion interval will also be compared. Adverse events, if any, will be analysed on an intention to treat basis. | — |
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study will be to ascertain the bioequivalence of each the two formulations of mifepristone and misoprostol, as determined by the measurement of the pharmacokinetic parameters, maximum serum concentration (Cmax), time to maximum serum concentration (tmax) and area under the curve (AUC) in each study group. | — |
Countries
Finland
Outcome results
None listed