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Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector

NCT01392157 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2013-11-27

No results posted yet for this study

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.

Conditions

  • Contraceptive Usage
  • Bleeding Due to Intrauterine Contraceptive Device

Interventions

DEVICE

copper-releasing intrauterine device

100 women received a 380 mm2 of copper releasing intrauterine device

DEVICE

ENG-releasing implant

60 mcg/day releasing etonogestrel implant

DEVICE

LNG-releasing intrauterine system

a LNG-IUS releasing 20 mcd/day of LNG

DEVICE

LNG-IUS

100 women will receive an LNG-IUS

Sponsors & Collaborators

  • University of Campinas, Brazil

    lead OTHER

Principal Investigators

  • Luis Bahamondes, MD · University of Campinas, Brazil

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-06-30
Completion
2013-07-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01392157 on ClinicalTrials.gov