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Completed

NCT Number: NCT01392157

Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector

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.

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Key information

Conditions

Contraceptive Usage Behavior Bleeding Due to Intrauterine Contraceptive Device Contraception Behavior Reproductive Behavior

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Campinas

Campinas, São Paulo, 6181, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Contraindications to contraceptive methods

Treatment and study plan

copper-releasing intrauterine device

Device

100 women received a 380 mm2 of copper releasing intrauterine device

Other names: Optima, Injeflex, Brazil

ENG-releasing implant

Device

60 mcg/day releasing etonogestrel implant

Other names: Implanion, MSD, Os, The Nedherland

LNG-releasing intrauterine system

Device

a LNG-IUS releasing 20 mcd/day of LNG

Other names: Mirena, Bayer Oy, Turku, Finland

LNG-IUS

Device

100 women will receive an LNG-IUS

Other names: Mirena, Bayer Oy, Turku, Finland

Primary outcomes

  1. Assessment of acceptability of Implanon in comparison to the TCu380A IUD and the LNG-IUS

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jul 12, 2011
Registry last updated
Nov 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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