Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector

Conditions
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Contraceptive Usage, Bleeding Due to Intrauterine Contraceptive Device

Intervention / Treatment
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* Device: copper-releasing intrauterine device
* Device: ENG-releasing implant
* Device: LNG-releasing intrauterine system
* Device: LNG-IUS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 18 to 40 years New users of Implanon, IUDs and the LNG-IUS TCu380A Exclusion Criteria: Contraindications to contraceptive methods

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: copper intrauterine device<br>100 women will be allocated to receive a TCu380A intrauterine device | Device: copper-releasing intrauterine device<br>* 100 women received a 380 mm2 of copper releasing intrauterine device<br>* Other names: Optima, Injeflex, Brazil;Device: ENG-releasing implant<br>* 60 mcg/day releasing etonogestrel implant<br>* Other names: Implanion, MSD, Os, The Nedherland;Device: LNG-releasing intrauterine system<br>* a LNG-IUS releasing 20 mcd/day of LNG<br>* Other names: Mirena, Bayer Oy, Turku, Finland;Device: LNG-IUS<br>* 100 women will receive an LNG-IUS<br>* Other names: Mirena, Bayer Oy, Turku, Finland;|
| Active Comparator: LNG-releasing intrauterine system<br>100 women were allocated to receive a LNG-IUS | Device: ENG-releasing implant<br>* 60 mcg/day releasing etonogestrel implant<br>* Other names: Implanion, MSD, Os, The Nedherland;Device: LNG-releasing intrauterine system<br>* a LNG-IUS releasing 20 mcd/day of LNG<br>* Other names: Mirena, Bayer Oy, Turku, Finland;Device: LNG-IUS<br>* 100 women will receive an LNG-IUS<br>* Other names: Mirena, Bayer Oy, Turku, Finland;|
| Active Comparator: ENG-releasing implant<br>100 women will receive an LNG-IUS | Device: ENG-releasing implant<br>* 60 mcg/day releasing etonogestrel implant<br>* Other names: Implanion, MSD, Os, The Nedherland;Device: LNG-releasing intrauterine system<br>* a LNG-IUS releasing 20 mcd/day of LNG<br>* Other names: Mirena, Bayer Oy, Turku, Finland;Device: LNG-IUS<br>* 100 women will receive an LNG-IUS<br>* Other names: Mirena, Bayer Oy, Turku, Finland;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of acceptability of Implanon in comparison to the TCu380A IUD and the LNG-IUS | 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. | Participants will receive counseling before admission and at 12 months after |