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ISRCTN
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ISRCTN87842530
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ClinicalTrials.gov identifier
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Public title
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A clinical study of gestrienone (R2323) in emergency contraception
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Scientific title
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Gestrienone (R2323) in emergency contraception: a multicentre double blind randomised controlled trial
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Acronym
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N/A
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Serial number at source
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WHO/HRP ID: A15022
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Study hypothesis
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Compare two different types of antiprogesterone for emergency contraception in four provinces in China.
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Lay summary
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Ethics approval
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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.
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Study design
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Multicentre controlled randomised double-blind two-arm clinical trial
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Countries of recruitment
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China
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Disease/condition/study domain
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Contraception
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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1. Pregnancy
2. Contraindication to mifepristone
3. Presence of chronic medical condition
4. Subfertility
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Anticipated start date
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01/11/2002
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Anticipated end date
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28/02/2003
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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800
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Interventions
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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.
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Primary outcome measure(s)
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Pregnancy rates, measured at the follow up visit (7 days after expected next menstrual period) using urine pregnancy test and ultrasonography, if indicated.
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Secondary outcome measure(s)
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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
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Sources of funding
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World Health Organization (WHO) (Switzerland)
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Trial website
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Publications
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2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20308833
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Contact name
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Dr
Shungchun
Wu
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Address
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National Research Institute for Family Planning
12 Da Hui Si, Hai Dian Qu
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City/town
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Beijing
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Zip/Postcode
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100081
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Country
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China
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Sponsor
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World Health Organization (WHO) (Switzerland)
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Address
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20 Avenue Appia
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City/town
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Geneva
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Zip/Postcode
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CH-1211
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Country
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Switzerland
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Sponsor website:
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http://www.who.int/en/
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Date applied
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18/12/2009
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Last edited
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29/03/2010
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Date ISRCTN assigned
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04/01/2010
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