Contact information
Type
Scientific
Contact name
Dr Helena von Hertzen
ORCID ID
Contact details
World Health Organization (WHO)
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 3376
vonhertzenh@who.int
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
A65037
Study information
Scientific title
Acronym
Study hypothesis
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)
Study design
Randomised single-blind study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Overall study end date
19/10/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Sex
Female
Target number of participants
60
Participant 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
Recruitment start date
19/10/2007
Recruitment end date
19/10/2008
Locations
Countries of recruitment
Finland, Switzerland
Study participating centre
World Health Organization (WHO)
Geneva-27
CH-1211
Switzerland
Sponsor information
Organisation
World Health Organization (WHO) (Switzerland)
Sponsor details
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 3376
vonhertzenh@who.int
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Research organisation
Funder name
World Health Organization (WHO) (Switzerland) (ref: A65037)
Alternative name(s)
WHO
Funding Body Type
private sector organisation
Funding Body Subtype
International organizations
Location
Switzerland
Funder name
Concept Foundation (Thailand) (ref: BE0101)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|