NCT01392157

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2011

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

November 27, 2013

Status Verified

November 1, 2013

Enrollment Period

1 year

First QC Date

June 16, 2011

Last Update Submit

November 26, 2013

Conditions

Contraceptive UsageBleeding Due to Intrauterine Contraceptive Device

Outcome Measures

Primary Outcomes (1)

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

    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

Study Arms (3)

copper intrauterine device

ACTIVE COMPARATOR

100 women will be allocated to receive a TCu380A intrauterine device

Device: copper-releasing intrauterine deviceDevice: ENG-releasing implantDevice: LNG-releasing intrauterine systemDevice: LNG-IUS

LNG-releasing intrauterine system

ACTIVE COMPARATOR

100 women were allocated to receive a LNG-IUS

Device: ENG-releasing implantDevice: LNG-releasing intrauterine systemDevice: LNG-IUS

ENG-releasing implant

ACTIVE COMPARATOR

100 women will receive an LNG-IUS

Device: ENG-releasing implantDevice: LNG-releasing intrauterine systemDevice: LNG-IUS

Interventions

copper-releasing intrauterine deviceDEVICE

100 women received a 380 mm2 of copper releasing intrauterine device

Also known as: Optima, Injeflex, Brazil
copper intrauterine device
ENG-releasing implantDEVICE

60 mcg/day releasing etonogestrel implant

Also known as: Implanion, MSD, Os, The Nedherland
ENG-releasing implantLNG-releasing intrauterine systemcopper intrauterine device
LNG-releasing intrauterine systemDEVICE

a LNG-IUS releasing 20 mcd/day of LNG

Also known as: Mirena, Bayer Oy, Turku, Finland
ENG-releasing implantLNG-releasing intrauterine systemcopper intrauterine device
LNG-IUSDEVICE

100 women will receive an LNG-IUS

Also known as: Mirena, Bayer Oy, Turku, Finland
ENG-releasing implantLNG-releasing intrauterine systemcopper intrauterine device

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Contraindications to contraceptive methods

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Campinas

Campinas, São Paulo, 6181, Brazil

Location

Related Publications (1)

  • Modesto W, Bahamondes MV, Bahamondes L. A randomized clinical trial of the effect of intensive versus non-intensive counselling on discontinuation rates due to bleeding disturbances of three long-acting reversible contraceptives. Hum Reprod. 2014 Jul;29(7):1393-9. doi: 10.1093/humrep/deu089. Epub 2014 May 8.

    PMID: 24812309DERIVED

MeSH Terms

Conditions

Contraception Behavior

Interventions

Intrauterine Devices, Copper

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Intrauterine Devices, MedicatedIntrauterine DevicesContraceptive Devices, FemaleContraceptive DevicesEquipment and Supplies

Study Officials

  • Luis Bahamondes, MD

    University of Campinas, Brazil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Medical Doctor

Study Record Dates

First Submitted

June 16, 2011

First Posted

July 12, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2012

Study Completion

July 1, 2013

Last Updated

November 27, 2013

Record last verified: 2013-11

Locations

BR(1)