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 |
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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
Scientific
Department of Obstetrics and Gynaecology
Queen Mary Hospital
6F Professorial Block
Pokfulam Road
-
-
Hong Kong
pcho@hkusub.hku.hk |
Study information
Study design | Multicentre controlled randomised two-arm clinical trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | 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(s) | The Institutional Review Board (IRB) approved the study at each participating centre |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Levonorgestrel |
Primary outcome measure | Pregnancy rate |
Secondary outcome measures | 1. Delay in onset of next menses 2. Incidence of side-effects |
Overall study start date | 01/10/1998 |
Completion date | 01/06/2003 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 2071 at five centres (Hong Kong, Shanghai, Nanjing, Shenzhen and Beijing) |
Key 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 |
Key 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 |
Date of first enrolment | 01/10/1998 |
Date of final enrolment | 01/06/2003 |
Locations
Countries of recruitment
- China
- Hong Kong
Study participating centre
Department of Obstetrics and Gynaecology
-
-
Hong Kong
-
Hong Kong
Sponsor information
World Health Organisation (WHO) (Switzerland)
Research organisation
Research organisation
20 Avenue Appia
Geneva
CH-1211
Switzerland
Website | http://www.who.int/en/ |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/01/2005 | Yes | No |