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 |
| Secondary identifying numbers | WHO/HRP ID: A15062 |
- 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
| Study design | Multicentre controlled randomised double-blind two-arm clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Levonorgestrel |
| Primary outcome measure | Efficacy, side-effects and timing of next menstrual period at six weeks. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/08/2002 |
| Completion date | 01/08/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 3150 total, 450 per centre, 1575 per group |
| 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
Sponsor information
World Health Organization (WHO) (Switzerland)
Research organisation
Research organisation
20 Avenue Appia
Geneva
CH-1211
Switzerland
| Website | http://www.who.int/en/ |
|---|---|
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
World Health Organization (WHO) (Switzerland)
Private sector organisation / International organizations
Private sector organisation / International organizations
- Alternative name(s)
- منظمة الصحة العالمية, 世界卫生组织, Всемирная организация здравоохранения, Organisation mondiale de la Santé, Organización Mundial de la Salud, WHO, 世卫组织, ВОЗ, OMS
- Location
- Switzerland
Results and Publications
| Intention to publish date | |
|---|---|
| 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? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2002 | Yes | No | |
| Results article | results | 01/10/2010 | Yes | No |
