Condition category
Pregnancy and Childbirth
Date applied
22/03/2004
Date assigned
01/04/2004
Last edited
28/09/2015
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 Tim Farley

ORCID ID

Contact details

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
-
farleyt@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WHO/HRP ID A15229

Study information

Scientific title

Randomised controlled trial of two implantable contraceptives: Jadelle and Implanon

Acronym

Study hypothesis

Prospective randomised trial to compare efficacy and acceptability of sub-dermal two contraceptive implants (Implanon and Jadelle) in women aged 18 to 44 year requesting long-term reversible contraception, plus a non-randomised comparison group of women using the TCu 380A copper intrauterine device. Women followed at six-monthly intervals up to three years since insertion.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Contraception

Intervention

Jadelle, Implanon, TCu380A (for the observational cohort).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Pregnancies
2. Adverse events
3. Method continuation rates
4. Incidence of complaints reportedly associated with implant contraception
5. Vaginal bleeding patterns
Follow-up duration for primary endpoints: three years.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/05/2003

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. General good health
2. Age between 18 and 44 years
3. Not pregnant
4. Requesting long-term reversible contraception
5. Able to keep a menstrual diary
6. Willing to return for follow-up

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

3000

Participant exclusion criteria

1. Breastfeeding an infant less than six weeks
2. High blood pressure
3. Current venous thromboembolism
4. Ischaemic heart disease
5. Vaginal bleeding
6. History of breast cancer

Recruitment start date

01/05/2003

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Brazil, Chile, China, Dominican Republic, Hungary, Slovenia, Thailand, Turkey, Zimbabwe

Trial participating centre

World Health Organization
Geneva-27
CH-1211
Switzerland

Sponsor information

Organisation

UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction

Sponsor details

World Health Organisation
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Sponsor type

Research organisation

Website

http://www.who.int/reproductive-health/hrp/

Funders

Funder type

Research organisation

Funder name

United Nations Development Programme (UNDP)/United Nations Population Fund (UNFPA)/World Health Organization (WHO)/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP)

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26409014

Publication citations

Additional files

Editorial Notes