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

World Health Organization (WHO)
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Phone +41 (0)22 791 3376
Email vonhertzenh@who.int

Study information

Study designRandomised single-blind study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesThe 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) studiedPregnancy
InterventionTo 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Mifepristone, misoprostol
Primary outcome measureThe 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 measuresThe 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 date19/10/2007
Completion date19/10/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants60
Key inclusion criteriaSubjects 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 criteriaSubjects 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 enrolment19/10/2007
Date of final enrolment19/10/2008

Locations

Countries of recruitment

  • Finland
  • Switzerland

Study participating centre

World Health Organization (WHO)
Geneva-27
CH-1211
Switzerland

Sponsor information

World Health Organization (WHO) (Switzerland)
Research organisation

20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Phone +41 (0)22 791 3376
Email vonhertzenh@who.int
Website http://www.who.int
ROR logo "ROR" https://ror.org/01f80g185

Funders

Funder type

Research organisation

World Health Organization (WHO) (Switzerland) (ref: A65037)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan