A randomised double-blind study to compare two regimens of Levonorgestrel in emergency contraception in Nigeria
| ISRCTN | ISRCTN69287540 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69287540 |
| Protocol serial number | WHO/HRP ID: A15062 |
| Sponsor | World Health Organization (WHO) (Switzerland) |
| Funder | World Health Organization (WHO) (Switzerland) |
- Submission date
- 19/03/2004
- Registration date
- 01/04/2004
- Last edited
- 09/02/2011
- 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
Dr D Chikamata
Scientific
Scientific
World Health Organization
20 Avenue Appia
Geneva
CH-1211
Switzerland
| chikamatad@who.int |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre controlled randomised double-blind two-arm clinical trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Compare two regimens of levonorgestrel for emergency contraception in seven centres in Nigeria. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Contraception |
| Intervention | 1. Levonorgestrel two doses of 0.75 mg 12 hours apart 2. Levonorgestrel one dose of 1.5 mg |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Levonorgestrel |
| Primary outcome measure(s) |
Efficacy, side-effects and timing of next menstrual period at six weeks. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/08/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 3150 |
| 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 | Does not comply with the above inclusion criteria. |
| Date of first enrolment | 01/08/2002 |
| Date of final enrolment | 01/08/2004 |
Locations
Countries of recruitment
- Nigeria
- Switzerland
Study participating centre
World Health Organization
Geneva
CH-1211
Switzerland
CH-1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2002 | Yes | No | |
| Results article | results | 01/10/2010 | Yes | No |
