Randomised controlled trial of two implantable contraceptives: Jadelle and Implanon
| ISRCTN | ISRCTN33378571 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33378571 |
| Protocol serial number | WHO/HRP ID A15229 |
| Sponsor | UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction |
| Funder | 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) |
- 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 of protocol
Not provided at time of registration
Contact information
Dr Tim Farley
Scientific
Scientific
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| farleyt@who.int |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Randomised controlled trial of two implantable contraceptives: Jadelle and Implanon |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | Contraception |
| Intervention | Jadelle, Implanon, TCu380A (for the observational cohort). |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Pregnancies |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 3000 |
| Total final enrolment | 2963 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2003 |
| Date of final enrolment | 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
CH-1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
