Condition category
Pregnancy and Childbirth
Date applied
23/03/2004
Date assigned
01/04/2004
Last edited
31/05/2011
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

Prof Pak Chung Ho

ORCID ID

Contact details

Department of Obstetrics and Gynaecology
Queen Mary Hospital
6F Professorial Block
Pokfulam Road
-
-
Hong Kong
pcho@hkusub.hku.hk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WHO/HRP ID 97137

Study information

Scientific title

Acronym

Study hypothesis

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

The Institutional Review Board (IRB) approved the study at each participating centre

Study design

Multicentre controlled randomised two-arm clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Levonorgestrel

Primary outcome measures

Pregnancy rate

Secondary outcome measures

1. Delay in onset of next menses
2. Incidence of side-effects

Overall trial start date

01/10/1998

Overall trial end date

01/06/2003

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

2071 at five centres (Hong Kong, Shanghai, Nanjing, Shenzhen and Beijing)

Participant 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

Recruitment start date

01/10/1998

Recruitment end date

01/06/2003

Locations

Countries of recruitment

China

Trial participating centre

Department of Obstetrics and Gynaecology
-
-
Hong Kong

Sponsor information

Organisation

World Health Organisation (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 council

Funder name

Hong Kong Research Grant Council (Hong Kong) (ref: HKU7286/98M)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2005 results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=15567882

Publication citations

  1. Results

    Ngai SW, Fan S, Li S, Cheng L, Ding J, Jing X, Ng EH, Ho PC, A randomized trial to compare 24 h versus 12 h double dose regimen of levonorgestrel for emergency contraception., Hum. Reprod., 2005, 20, 1, 307-311, doi: 10.1093/humrep/deh583.

Additional files

Editorial Notes