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ISRCTN
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ISRCTN33378571
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial of two implantable contraceptives: Jadelle and Implanon
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Scientific title
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Acronym
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N/A
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Serial number at source
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WHO/HRP ID A15229
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Study hypothesis
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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.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Brazil, Chile, China, Dominican Republic, Hungary, Thailand, Turkey, Slovenia, Zimbabwe.
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Disease/condition/study domain
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Contraception
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Participants - inclusion criteria
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1. General good health
2. Age between18 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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/05/2003
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Anticipated end date
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31/12/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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3000
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Interventions
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Jadelle, Implanon, TCu380A (for the observational cohort).
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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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)
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Trial website
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Publications
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Contact name
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Dr
Tim
Farley
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Address
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World Health Organization
20 Avenue Appia
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City/town
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Geneva-27
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Zip/Postcode
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CH-1211
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Country
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Switzerland
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Email
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farleyt@who.int
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Sponsor
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UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
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Address
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World Health Organisation
20 Avenue Appia
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City/town
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Geneva-27
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Zip/Postcode
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CH-1211
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Country
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Switzerland
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Sponsor website:
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http://www.who.int/reproductive-health/hrp/
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Date applied
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22/03/2004
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Last edited
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26/03/2008
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Date ISRCTN assigned
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01/04/2004
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