MedDataX Logo

Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector

NCT ID: NCT01392157

Last Updated: 2013-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Contraceptive Usage Bleeding Due to Intrauterine Contraceptive Device

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

copper intrauterine device

100 women will be allocated to receive a TCu380A intrauterine device

Group Type ACTIVE_COMPARATOR

copper-releasing intrauterine device

Intervention Type DEVICE

100 women received a 380 mm2 of copper releasing intrauterine device

ENG-releasing implant

Intervention Type DEVICE

60 mcg/day releasing etonogestrel implant

LNG-releasing intrauterine system

Intervention Type DEVICE

a LNG-IUS releasing 20 mcd/day of LNG

LNG-IUS

Intervention Type DEVICE

100 women will receive an LNG-IUS

LNG-releasing intrauterine system

100 women were allocated to receive a LNG-IUS

Group Type ACTIVE_COMPARATOR

ENG-releasing implant

Intervention Type DEVICE

60 mcg/day releasing etonogestrel implant

LNG-releasing intrauterine system

Intervention Type DEVICE

a LNG-IUS releasing 20 mcd/day of LNG

LNG-IUS

Intervention Type DEVICE

100 women will receive an LNG-IUS

ENG-releasing implant

100 women will receive an LNG-IUS

Group Type ACTIVE_COMPARATOR

ENG-releasing implant

Intervention Type DEVICE

60 mcg/day releasing etonogestrel implant

LNG-releasing intrauterine system

Intervention Type DEVICE

a LNG-IUS releasing 20 mcd/day of LNG

LNG-IUS

Intervention Type DEVICE

100 women will receive an LNG-IUS

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

copper-releasing intrauterine device

100 women received a 380 mm2 of copper releasing intrauterine device

Intervention Type DEVICE

ENG-releasing implant

60 mcg/day releasing etonogestrel implant

Intervention Type DEVICE

LNG-releasing intrauterine system

a LNG-IUS releasing 20 mcd/day of LNG

Intervention Type DEVICE

LNG-IUS

100 women will receive an LNG-IUS

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Optima, Injeflex, Brazil Implanion, MSD, Os, The Nedherland Mirena, Bayer Oy, Turku, Finland Mirena, Bayer Oy, Turku, Finland

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Contraindications to contraceptive methods
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Luis Bahamondes

MD Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Luis Bahamondes, MD

Role: PRINCIPAL_INVESTIGATOR

University of Campinas, Brazil

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Campinas

Campinas, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 24812309 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

07/2011/PC

Identifier Type: -

Identifier Source: org_study_id