Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Luis Bahamondes, University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01392157
First received: June 16, 2011
Last updated: June 12, 2012
Last verified: June 2012

June 16, 2011
June 12, 2012
June 2011
June 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01392157 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector
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.

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

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Contraceptive Usage
  • Bleeding Due to Intrauterine Contraceptive 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: copper intrauterine device
    100 women will be allocated to receive a TCu380A intrauterine device
    Interventions:
    • Device: copper-releasing intrauterine device
    • Device: ENG-releasing implant
    • Device: LNG-releasing intrauterine system
    • Device: LNG-IUS
  • Active Comparator: LNG-releasing intrauterine system
    100 women were allocated to receive a LNG-IUS
    Interventions:
    • Device: ENG-releasing implant
    • Device: LNG-releasing intrauterine system
    • Device: LNG-IUS
  • Active Comparator: ENG-releasing implant
    100 women will receive an LNG-IUS
    Interventions:
    • Device: ENG-releasing implant
    • Device: LNG-releasing intrauterine system
    • Device: LNG-IUS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
March 2013
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindications to contraceptive methods
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01392157
07/2011/PC
No
Luis Bahamondes, University of Campinas, Brazil
University of Campinas, Brazil
Not Provided
Principal Investigator: Luis Bahamondes, MD University of Campinas, Brazil
University of Campinas, Brazil
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP