Contact information
Type
Scientific
Primary contact
Prof Pak Chung Ho
ORCID ID
Contact details
Department of Obstetrics and Gynaecology
Queen Mary Hospital
6F Professorial Block
Pokfulam Road
-
-
Hong Kong
pcho@hkusub.hku.hk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
WHO/HRP ID 97137
Study information
Scientific title
Acronym
Study hypothesis
To 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
The Institutional Review Board (IRB) approved the study at each participating centre
Study design
Multicentre controlled randomised two-arm clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Contraception
Intervention
1. Levonorgestrel two doses of 0.75 mg 12 hours apart
2. Levonorgestrel two doses of 0.75 mg 24 hours apart
Intervention type
Drug
Phase
Not Specified
Drug names
Levonorgestrel
Primary outcome measures
Pregnancy rate
Secondary outcome measures
1. Delay in onset of next menses
2. Incidence of side-effects
Overall trial start date
01/10/1998
Overall trial end date
01/06/2003
Reason abandoned
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
2071 at five centres (Hong Kong, Shanghai, Nanjing, Shenzhen and Beijing)
Participant exclusion criteria
1. 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
Recruitment start date
01/10/1998
Recruitment end date
01/06/2003
Locations
Countries of recruitment
China
Trial participating centre
Department of Obstetrics and Gynaecology
-
-
Hong Kong
Sponsor information
Organisation
World Health Organisation (WHO) (Switzerland)
Sponsor details
20 Avenue Appia
Geneva
CH-1211
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Research council
Funder name
Hong Kong Research Grant Council (Hong Kong) (ref: HKU7286/98M)
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
2005 results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=15567882
Publication citations
-
Results
Ngai SW, Fan S, Li S, Cheng L, Ding J, Jing X, Ng EH, Ho PC, A randomized trial to compare 24 h versus 12 h double dose regimen of levonorgestrel for emergency contraception., Hum. Reprod., 2005, 20, 1, 307-311, doi: 10.1093/humrep/deh583.