A prospective, randomised study to compare the effectiveness of the 24 hour versus 12 hour double doses regimen of levonorgestrel for emergency post-coital contraception

ISRCTN ISRCTN06428555
DOI https://doi.org/10.1186/ISRCTN06428555
Secondary identifying numbers WHO/HRP ID 97137
Submission date
23/03/2004
Registration date
01/04/2004
Last edited
31/05/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Pak Chung Ho
Scientific

Department of Obstetrics and Gynaecology
Queen Mary Hospital
6F Professorial Block
Pokfulam Road
-
-
Hong Kong

Email pcho@hkusub.hku.hk

Study information

Study designMulticentre controlled randomised two-arm clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo compare the effectiveness of two double dose regimens of levonorgestrel (given at either 12 or 24 hour intervals) for emergency contraception. In addition, we studied the efficacy of both regimens when the coitus-treatment period was extended to 120 hours.
Ethics approval(s)The Institutional Review Board (IRB) approved the study at each participating centre
Health condition(s) or problem(s) studiedContraception
Intervention1. Levonorgestrel two doses of 0.75 mg 12 hours apart
2. Levonorgestrel two doses of 0.75 mg 24 hours apart
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Levonorgestrel
Primary outcome measurePregnancy rate
Secondary outcome measures1. Delay in onset of next menses
2. Incidence of side-effects
Overall study start date01/10/1998
Completion date01/06/2003

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants2071 at five centres (Hong Kong, Shanghai, Nanjing, Shenzhen and Beijing)
Key inclusion criteria1. Requesting emergency contraception within 120 hours 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)
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. Not breastfeeding
10. No use of hormonal contraceptives or of rhythm or natural family planning method of contraception during current cycle
11. Not unsure about the date of last menstrual period
Key exclusion criteria1. Post-abortion or post-partum patients whose period had not yet returned
2. Regular use of prescription drugs before admission to the study
3. Intercourse during the treatment cycle greater than 120 hours before admission into the study
Date of first enrolment01/10/1998
Date of final enrolment01/06/2003

Locations

Countries of recruitment

  • China
  • Hong Kong

Study participating centre

Department of Obstetrics and Gynaecology
-
-
Hong Kong

Sponsor information

World Health Organisation (WHO) (Switzerland)
Research organisation

20 Avenue Appia
Geneva
CH-1211
Switzerland

Website http://www.who.int/en/
ROR logo "ROR" https://ror.org/01f80g185

Funders

Funder type

Research council

Hong Kong Research Grant Council (Hong Kong) (ref: HKU7286/98M)

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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2005 Yes No