Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector

November 26, 2013 updated by: Luis Bahamondes, University of Campinas, Brazil

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Campinas, SP, Brazil, 6181
        • University of Campinas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindications to contraceptive methods

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Optima, Injeflex, Brazil
Device: ENG-releasing implant
60 mcg/day releasing etonogestrel implant
Other Names:
  • Implanion, MSD, Os, The Nedherland
Device: LNG-releasing intrauterine system
a LNG-IUS releasing 20 mcd/day of LNG
Other Names:
  • Mirena, Bayer Oy, Turku, Finland
Device: LNG-IUS
100 women will receive an LNG-IUS
Other Names:
  • Mirena, Bayer Oy, Turku, Finland
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:
  • Implanion, MSD, Os, The Nedherland
Device: LNG-releasing intrauterine system
a LNG-IUS releasing 20 mcd/day of LNG
Other Names:
  • Mirena, Bayer Oy, Turku, Finland
Device: LNG-IUS
100 women will receive an LNG-IUS
Other Names:
  • Mirena, Bayer Oy, Turku, Finland
Active Comparator: ENG-releasing implant
100 women will receive an LNG-IUS
Device: ENG-releasing implant
60 mcg/day releasing etonogestrel implant
Other Names:
  • Implanion, MSD, Os, The Nedherland
Device: LNG-releasing intrauterine system
a LNG-IUS releasing 20 mcd/day of LNG
Other Names:
  • Mirena, Bayer Oy, Turku, Finland
Device: LNG-IUS
100 women will receive an LNG-IUS
Other Names:
  • Mirena, Bayer Oy, Turku, Finland

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Participants will receive counseling before admission and at 12 months after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Investigators

  • Principal Investigator: Luis Bahamondes, MD, University of Campinas, Brazil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 16, 2011

First Submitted That Met QC Criteria

July 11, 2011

First Posted (Estimate)

July 12, 2011

Study Record Updates

Last Update Posted (Estimate)

November 27, 2013

Last Update Submitted That Met QC Criteria

November 26, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07/2011/PC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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