NCT01392157

Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: University of Campinas, Brazil · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

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

Conditions

• Contraceptive Usage
• Bleeding Due to Intrauterine Contraceptive Device

Interventions

Type	Name	Description
DEVICE	copper-releasing intrauterine device	100 women received a 380 mm2 of copper releasing intrauterine device
DEVICE	ENG-releasing implant	60 mcg/day releasing etonogestrel implant
DEVICE	LNG-releasing intrauterine system	a LNG-IUS releasing 20 mcd/day of LNG
DEVICE	LNG-IUS	100 women will receive an LNG-IUS

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-06-01
• Completion: 2013-07-01
• First posted: 2011-07-12
• Last updated: 2013-11-27

Locations

1 site across 1 country: Brazil