Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector
| Tracking Information | |||||
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| First Received Date ICMJE | June 16, 2011 | ||||
| Last Updated Date | June 12, 2012 | ||||
| Start Date ICMJE | June 2011 | ||||
| Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Assessment of acceptability of Implanon in comparison to the TCu380A IUD and the LNG-IUS [ Time Frame: Participants will receive counseling before admission and at 12 months after ] [ Designated as safety issue: No ] All the acceptors (contraceptive implants, the LNG-IUS and the copper IUD) will be follow for up to one year and we will record all the adverse events and mainly all the discontinuations due to bleeding irregularities, to compare one group to other and the half of the women who will receive intense counseling in comparison to the women with regular counseling at the clinic. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01392157 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector | ||||
| Official Title ICMJE | Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector | ||||
| Brief Summary | The main side-effect of Implanon is the changes induces in bleeding patterns including amenorrhea, infrequent to irregular bleeding and frequent and prolonged bleeding; without any previous symptom and it was characterized as "breakthrough bleeding" (BTB). BTB is the main causes of early discontinuations. Unfortunately, there is no indication to predict prior to insertion what sort of bleeding pattern any individual woman may have after insertion and the proposed treatments were disappointed. Nevertheless, previous studies with other progestin-only contraceptives (including Implanon) provide evidence that the provision of adequate and intensive counseling to potential users and new acceptors about bleeding changes can help to improve method continuation. The availability of Implanon in the public sector could help in the development of strategies to introduce the method in the public sector network and the training of medical residents. |
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| Detailed Description | 100 women were either allocated to received Implanon contraceptive implant, the LNG-IUS or TCu380A copper-IUD. The women were allocated according to their preference on each of the contraceptive methods. half of the women will receive the common counseling at the clinic and the other 50% will receive intense counselling about menstrual changes induced by these three contraceptive methods. The continuation rate up to one year will be evaluated through life-table analysis |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 300 | ||||
| Estimated Completion Date | March 2013 | ||||
| Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 40 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01392157 | ||||
| Other Study ID Numbers ICMJE | 07/2011/PC | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Luis Bahamondes, University of Campinas, Brazil | ||||
| Study Sponsor ICMJE | University of Campinas, Brazil | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Campinas, Brazil | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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