Condition category
Pregnancy and Childbirth
Date applied
19/03/2004
Date assigned
01/04/2004
Last edited
09/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr D Chikamata

ORCID ID

Contact details

World Health Organization
20 Avenue Appia
Geneva
CH-1211
Switzerland
chikamatad@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WHO/HRP ID: A15062

Study information

Scientific title

Acronym

Study hypothesis

Compare two regimens of levonorgestrel for emergency contraception in seven centres in Nigeria.

Ethics approval

Not provided at time of registration.

Study design

Multicentre controlled randomised double-blind two-arm clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

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 names

Levonorgestrel

Primary outcome measures

Efficacy, side-effects and timing of next menstrual period at six weeks.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/08/2002

Overall trial end date

01/08/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

3150 total, 450 per centre, 1575 per group

Participant exclusion criteria

Does not comply with the above inclusion criteria.

Recruitment start date

01/08/2002

Recruitment end date

01/08/2004

Locations

Countries of recruitment

Nigeria

Trial participating centre

World Health Organization
Geneva
CH-1211
Switzerland

Sponsor information

Organisation

World Health Organization (WHO) (Switzerland)

Sponsor details

20 Avenue Appia
Geneva
CH-1211
Switzerland

Sponsor type

Research organisation

Website

http://www.who.int/en/

Funders

Funder type

Research organisation

Funder name

World Health Organization (WHO) (Switzerland)

Alternative name(s)

WHO

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

Switzerland

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12413624
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20851232

Publication citations

  1. Results

    Arowojolu AO, Okewole IA, Adekunle AO, Comparative evaluation of the effectiveness and safety of two regimens of levonorgestrel for emergency contraception in Nigerians., Contraception, 2002, 66, 4, 269-273.

  2. Results

    Dada OA, Godfrey EM, Piaggio G, von Hertzen H, , A randomized, double-blind, noninferiority study to compare two regimens of levonorgestrel for emergency contraception in Nigeria., Contraception, 2010, 82, 4, 373-378, doi: 10.1016/j.contraception.2010.06.004.

Additional files

Editorial Notes