Condition category
Pregnancy and Childbirth
Date applied
15/05/2008
Date assigned
15/05/2008
Last edited
15/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Mifepristone, misoprostol

Primary outcome measures

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 trial start date

19/10/2007

Overall trial end date

19/10/2008

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

http://www.who.int

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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes