A comparative pharmacokinetic study of oral mifepristone and vaginal misoprostol in pregnant women
| ISRCTN | ISRCTN35300716 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35300716 |
| Secondary identifying numbers | A65037 |
- Submission date
- 15/05/2008
- Registration date
- 15/05/2008
- Last edited
- 15/05/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Helena von Hertzen
Scientific
Scientific
World Health Organization (WHO)
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| Phone | +41 (0)22 791 3376 |
|---|---|
| vonhertzenh@who.int |
Study information
| Study design | Randomised single-blind study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | The present study aims at comparing the pharmacokinetics of the original formulations of mifepristone and misoprostol and a new generic co-packaged product. This is necessary to demonstrate bioequivalence to regulatory authorities. |
| Ethics approval(s) | Ethics approval received from: 1. World Health Organization (WHO) Scientific and Ethical Review Group, Department of Reproductive Health and Research on the 27th April 2006 (ref: A65037) 2. Ethics Committee of Gynaecology and Obstetrics, Otology, Ophtalmology, Neurology and Neurosurgery of the Hospital District of Helsinki and Uusimaa on the 17th August 2006 (ref: 297/E9/06) 3. WHO Ethics Review Committee on the 13th September 2007 (ref: A65037) |
| Health condition(s) or problem(s) studied | Pregnancy |
| Intervention | 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 (one tablet x 200 mg [Exelgyn, France]) and misoprostol (four tablets x 0.2 mg [Pfizer, USA]). Contact details for Principal Investigator: Dr Oskari Heikinheimo Department of Obstetrics and Gynaecology Helsinki University Central Hospital Helsinki 00029-HUS Finland Tel: +358 (0)40 587 1070 Fax: +358 (0)94 717 4801 Email: oskari.heikinheimo@helsinki.fi Details of joint sponsor: Concept Foundation (Thailand) 111 Paholyothin Rd Thailand Science Park Pathumthani 12120 Thailand Tel: +66 (0)2 564 8021 Fax: +66 (0)2 564 8024 Email: phall@rhalliance.org Website: http://www.conceptfoundation.org |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Mifepristone, misoprostol |
| Primary outcome measure | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 19/10/2007 |
| Completion date | 19/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 19/10/2007 |
| Date of final enrolment | 19/10/2008 |
Locations
Countries of recruitment
- Finland
- Switzerland
Study participating centre
World Health Organization (WHO)
Geneva-27
CH-1211
Switzerland
CH-1211
Switzerland
Sponsor information
World Health Organization (WHO) (Switzerland)
Research organisation
Research organisation
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| Phone | +41 (0)22 791 3376 |
|---|---|
| vonhertzenh@who.int | |
| Website | http://www.who.int |
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
World Health Organization (WHO) (Switzerland) (ref: A65037)
Private sector organisation / International organizations
Private sector organisation / International organizations
- Alternative name(s)
- منظمة الصحة العالمية, 世界卫生组织, Всемирная организация здравоохранения, Organisation mondiale de la Santé, Organización Mundial de la Salud, WHO, 世卫组织, ВОЗ, OMS
- Location
- Switzerland
Concept Foundation (Thailand) (ref: BE0101)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
