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 |
| Protocol serial number | WHO/HRP ID 97137 |
| Sponsor | World Health Organisation (WHO) (Switzerland) |
| Funder | Hong Kong Research Grant Council (Hong Kong) (ref: HKU7286/98M) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre controlled randomised two-arm clinical trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Levonorgestrel |
| Primary outcome measure(s) |
Pregnancy rate |
| Key secondary outcome measure(s) |
1. Delay in onset of next menses |
| Completion date | 01/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 2071 |
| 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
