Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: copper intrauterine device 100 women will be allocated to receive a TCu380A intrauterine device |
Device: copper-releasing intrauterine device
100 women received a 380 mm2 of copper releasing intrauterine device
Other Names:
Device: ENG-releasing implant
60 mcg/day releasing etonogestrel implant
Other Names:
Device: LNG-releasing intrauterine system
a LNG-IUS releasing 20 mcd/day of LNG
Other Names:
Device: LNG-IUS
100 women will receive an LNG-IUS
Other Names:
|
| Active Comparator: LNG-releasing intrauterine system 100 women were allocated to receive a LNG-IUS |
Device: ENG-releasing implant
60 mcg/day releasing etonogestrel implant
Other Names:
Device: LNG-releasing intrauterine system
a LNG-IUS releasing 20 mcd/day of LNG
Other Names:
Device: LNG-IUS
100 women will receive an LNG-IUS
Other Names:
|
| Active Comparator: ENG-releasing implant 100 women will receive an LNG-IUS |
Device: ENG-releasing implant
60 mcg/day releasing etonogestrel implant
Other Names:
Device: LNG-releasing intrauterine system
a LNG-IUS releasing 20 mcd/day of LNG
Other Names:
Device: LNG-IUS
100 women will receive an LNG-IUS
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Assessment of acceptability of Implanon in comparison to the TCu380A IUD and the LNG-IUS [Participants will receive counseling before admission and at 12 months after]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Women 18 to 40 years
-
New users of Implanon, IUDs and the LNG-IUS TCu380A
Exclusion Criteria:
- Contraindications to contraceptive methods
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Campinas | Campinas | SP | Brazil | 6181 |
Sponsors and Collaborators
- University of Campinas, Brazil
Investigators
- Principal Investigator: Luis Bahamondes, MD, University of Campinas, Brazil
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 07/2011/PC