Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luis Bahamondes, University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01392157
First received: June 16, 2011
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Contraceptive Usage
Bleeding Due to Intrauterine Contraceptive Device
Device: copper-releasing intrauterine device
Device: ENG-releasing implant
Device: LNG-releasing intrauterine system
Device: LNG-IUS
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector

Resource links provided by NLM:


Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 300
Study Start Date: June 2011
Study Completion Date: July 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Optima, Injeflex, Brazil
Device: ENG-releasing implant
60 mcg/day releasing etonogestrel implant
Other Name: Implanion, MSD, Os, The Nedherland
Device: LNG-releasing intrauterine system
a LNG-IUS releasing 20 mcd/day of LNG
Other Name: Mirena, Bayer Oy, Turku, Finland
Device: LNG-IUS
100 women will receive an LNG-IUS
Other Name: 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 Name: Implanion, MSD, Os, The Nedherland
Device: LNG-releasing intrauterine system
a LNG-IUS releasing 20 mcd/day of LNG
Other Name: Mirena, Bayer Oy, Turku, Finland
Device: LNG-IUS
100 women will receive an LNG-IUS
Other Name: 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 Name: Implanion, MSD, Os, The Nedherland
Device: LNG-releasing intrauterine system
a LNG-IUS releasing 20 mcd/day of LNG
Other Name: Mirena, Bayer Oy, Turku, Finland
Device: LNG-IUS
100 women will receive an LNG-IUS
Other Name: Mirena, Bayer Oy, Turku, Finland

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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindications to contraceptive methods
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392157

Locations
Brazil
University of Campinas
Campinas, SP, Brazil, 6181
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
Principal Investigator: Luis Bahamondes, MD University of Campinas, Brazil
  More Information

No publications provided

Responsible Party: Luis Bahamondes, MD Medical Doctor, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01392157     History of Changes
Other Study ID Numbers: 07/2011/PC
Study First Received: June 16, 2011
Last Updated: November 26, 2013
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Copper
3-keto-desogestrel
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014