Condition category
Pregnancy and Childbirth
Date applied
18/12/2009
Date assigned
04/01/2010
Last edited
29/03/2010
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 Shungchun Wu

ORCID ID

Contact details

National Research Institute for Family Planning
12 Da Hui Si
Hai Dian Qu
Beijing
100081
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WHO/HRP ID: A15022

Study information

Scientific title

Gestrienone (R2323) in emergency contraception: a multicentre double blind randomised controlled trial

Acronym

Study hypothesis

Compare two different types of antiprogesterone for emergency contraception in four provinces in China.

Ethics approval

1. China: Institutional Review Board of National Research Institute for Family Planning approved on the 20th September 2005 (ref: A15022; Protocol: 95063)
2. WHO Secretariat Committee on Research Involving Human Subjects

All other centres will seek ethics approval before recruiting participants.

Study design

Multicentre controlled randomised double-blind two-arm clinical trial

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

Contraception

Intervention

1. 10 mg of gestrienone (R2323)
2. 10 mg of mifepristone (RU486)

Women were to receive a single dose of gestrienone or mifepristone within 72 hours after unprotected intercourse (initial visit). They were followed to 7 days after the expected first day of the participants' next menstrual period.

Intervention type

Drug

Phase

Phase III

Drug names

Gestrienone (R2323), mifepristone

Primary outcome measures

Pregnancy rates, measured at the follow up visit (7 days after expected next menstrual period) using urine pregnancy test and ultrasonography, if indicated.

Secondary outcome measures

1. Side effects, measured using daily diary cards which were given at the initial visit, and reviewed and recorded at the follow up visit
2. Timing of next menstrual period, measured using daily diary cards which were given at the initial visit and reviewed and recorded at the follow up visit

Overall trial start date

01/11/2002

Overall trial end date

28/02/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Requesting emergency contraception within 72 hour of unprotected intercourse
2. Only one act of unprotected intercourse during current cycle
3. Willing to abstain from further acts during current cycle
4. Regular menstrual cycles (24 to 42 days with no more than 5 days variation)
5. Having at least one spontaneous cycle before current cycle
6. Available for follow up in the next six weeks
7. Negative pregnancy test
8. Willing to participate
9. Aged 18 - 44 years

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

800

Participant exclusion criteria

1. Pregnancy
2. Contraindication to mifepristone
3. Presence of chronic medical condition
4. Subfertility

Recruitment start date

01/11/2002

Recruitment end date

28/02/2003

Locations

Countries of recruitment

China

Trial participating centre

National Research Institute for Family Planning
Beijing
100081
China

Sponsor information

Organisation

World Health Organization (WHO) (Switzerland)

Sponsor details

20 Avenue Appia
Geneva
CH-1211
Switzerland

Sponsor type

Research organisation

Website

http://www.who.int/en/

Funders

Funder type

Research organisation

Funder name

World Health Organization (WHO) (Switzerland)

Alternative name(s)

WHO

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

Switzerland

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20308833

Publication citations

  1. Results

    Wu S, Dong J, Cong J, Wang C, VonHertzen H, Godfrey EM, Gestrinone compared with mifepristone for emergency contraception: a randomized controlled trial., Obstet Gynecol, 2010, 115, 4, 740-744, doi: 10.1097/AOG.0b013e3181d43ae4.

Additional files

Editorial Notes