|
ISRCTN
|
ISRCTN06428555
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
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
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
WHO/HRP ID 97137
|
|
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.
|
|
Countries of recruitment
|
China (five centres: Hong Kong, Shanghai, Nanjing, Shenzhen and Beijing)
|
|
Disease/condition/study domain
|
Contraception
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
01/10/1998
|
|
Anticipated end date
|
01/06/2003
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
2071
|
|
Interventions
|
1. Levonorgestrel two doses of 0.75 mg 12 hours apart
2. Levonorgestrel two doses of 0.75 mg 24 hours apart
|
|
Primary outcome measure(s)
|
Pregnancy rate
|
|
Secondary outcome measure(s)
|
1. Delay in onset of next menses
2. Incidence of side-effects
|
|
Sources of funding
|
Hong Kong Research Grant Council (Hong Kong) (ref: HKU7286/98M)
|
|
Trial website
|
|
|
Publications
|
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=15567882
|
|
Contact name
|
Prof
Pak
Chung Ho
|
|
Address
|
Department of Obstetrics and Gynaecology
Queen Mary Hospital
6F Professorial Block
Pokfulam Road
|
|
City/town
|
-
|
|
Zip/Postcode
|
-
|
|
Country
|
Hong Kong
|
|
Email
|
pcho@hkusub.hku.hk
|
|
Sponsor
|
World Health Organisation (WHO) (Switzerland)
|
|
Address
|
20 Avenue Appia
|
|
City/town
|
Geneva
|
|
Zip/Postcode
|
CH-1211
|
|
Country
|
Switzerland
|
|
Sponsor website:
|
http://www.who.int/en/
|
|
Date applied
|
23/03/2004
|
|
Last edited
|
11/09/2007
|
|
Date ISRCTN assigned
|
01/04/2004
|
