Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector

University of Campinas, Brazil

Status and phase: Completed; Phase 4

Conditions: Bleeding Due to Intrauterine Contraceptive Device; Contraceptive Usage

Treatments: Device: ENG-releasing implant; Device: copper-releasing intrauterine device; Device: LNG-IUS; Device: LNG-releasing intrauterine system

Study type: Interventional

Funder types: Other

Identifiers

NCT01392157

07/2011/PC

Details and patient eligibility

About

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.

Full 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

Enrollment: 300 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women 18 to 40 years
• New users of Implanon, IUDs and the LNG-IUS TCu380A

Exclusion criteria

• Contraindications to contraceptive methods

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

copper intrauterine device

Active Comparator group

Description:

100 women will be allocated to receive a TCu380A intrauterine device

Treatment:

Device: LNG-releasing intrauterine system

Device: LNG-IUS

Device: copper-releasing intrauterine device

Device: ENG-releasing implant

LNG-releasing intrauterine system

Active Comparator group

Description:

100 women were allocated to receive a LNG-IUS

Treatment:

Device: LNG-releasing intrauterine system

Device: LNG-IUS

Device: ENG-releasing implant

ENG-releasing implant

Active Comparator group

Description:

100 women will receive an LNG-IUS

Treatment:

Device: LNG-releasing intrauterine system

Device: LNG-IUS

Device: ENG-releasing implant