Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector

Phase 4

Completed

• Conditions: Contraceptive Usage; Bleeding Due to Intrauterine Contraceptive Device

• Registration Number: NCT01392157
• Lead Sponsor: University of Campinas, Brazil

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.

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 Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-07-11
• Study First Posted: 2011-07-12
• Primary Completion: 2012-06
• Study Completion: 2013-07
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-26
• Last Update Posted: 2013-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

• Contraindications to contraceptive methods

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Campinas; 🇧🇷 Campinas, SP, Brazil