Randomised controlled trial of two implantable contraceptives: Jadelle and Implanon

ISRCTN	ISRCTN33378571
DOI	https://doi.org/10.1186/ISRCTN33378571
Secondary identifying numbers	WHO/HRP ID A15229

Submission date: 22/03/2004
Registration date: 01/04/2004
Last edited: 18/10/2019

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

Not provided at time of registration

Contact information

Dr Tim Farley
Scientific

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

Email	farleyt@who.int

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Randomised controlled trial of two implantable contraceptives: Jadelle and Implanon
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(s)	Not provided at time of registration
Condition	Contraception
Intervention	Jadelle, Implanon, TCu380A (for the observational cohort).
Intervention type	Other
Primary outcome measure	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 study start date	01/05/2003
Overall study end date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	3000
Total final enrolment	2963
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 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
Switzerland
Thailand
Türkiye
Zimbabwe

Study participating centre

World Health Organization

Geneva-27
CH-1211
Switzerland

Sponsor information

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

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

Website	http://www.who.int/reproductive-health/hrp/
"ROR"	https://ror.org/01f80g185

Funders

Funder type

Research organisation

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)

No information available

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	01/11/2015		Yes	No
Results article	results	01/09/2018	18/10/2019	Yes	No

Editorial Notes

18/10/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.