Contraceptive UsagePhase 4NCT01392157
Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector
A Phase 4 study testing copper-releasing intrauterine device, ENG-releasing implant and LNG-releasing intrauterine system in people with Contraceptive Usage and Bleeding Due to Intrauterine Contraceptive Device, run by University of Campinas, Brazil at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Usage, Bleeding Due to Intrauterine Contraceptive Device
- What is being tested?
- copper-releasing intrauterine device, ENG-releasing implant and LNG-releasing intrauterine system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2011to Jul 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women 18 to 40 years
- New users of Implanon, IUDs and the LNG-IUS TCu380A
Who cannot join
- Contraindications to contraceptive methods
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- copper-releasing intrauterine device, ENG-releasing implant, LNG-releasing intrauterine system, LNG-IUS
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
copper-releasing intrauterine deviceDevice
Also called Optima, Injeflex, Brazil
100 women received a 380 mm2 of copper releasing intrauterine device
ENG-releasing implantDevice
Also called Implanion, MSD, Os, The Nedherland
60 mcg/day releasing etonogestrel implant
LNG-releasing intrauterine systemDevice
Also called Mirena, Bayer Oy, Turku, Finland
a LNG-IUS releasing 20 mcd/day of LNG
LNG-IUSDevice
Also called Mirena, Bayer Oy, Turku, Finland
100 women will receive an LNG-IUS
| Study group | Role | What they receive |
|---|---|---|
| copper intrauterine device | Active comparator | 100 women will be allocated to receive a TCu380A intrauterine device Receives: Device: copper-releasing intrauterine device; Device: ENG-releasing implant; Device: LNG-releasing intrauterine system; Device: LNG-IUS |
| LNG-releasing intrauterine system | Active comparator | 100 women were allocated to receive a LNG-IUS Receives: Device: ENG-releasing implant; Device: LNG-releasing intrauterine system; Device: LNG-IUS |
| ENG-releasing implant | Active comparator | 100 women will receive an LNG-IUS Receives: Device: ENG-releasing implant; Device: LNG-releasing intrauterine system; Device: LNG-IUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will receive counseling before admission and at 12 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contraceptive UsageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Bahamondes, University of Campinas, Brazil
- Investigators
- Luis Bahamondes, MD, Principal investigator, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392157
- Sponsor's protocol ID
- 07/2011/PC
- Status last verified
- Nov 2013
- First submitted
- 16 Jun 2011
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24812309
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector
- ClinicalTrials.gov ID
- NCT01392157
- Acronym / sponsor ID
- 07/2011/PC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 12 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| copper intrauterine device | Active comparator | Device: copper-releasing intrauterine device, Device: ENG-releasing implant, Device: LNG-releasing intrauterine system, Device: LNG-IUS100 women will be allocated to receive a TCu380A intrauterine device |
| LNG-releasing intrauterine system | Active comparator | Device: ENG-releasing implant, Device: LNG-releasing intrauterine system, Device: LNG-IUS100 women were allocated to receive a LNG-IUS |
| ENG-releasing implant | Active comparator | Device: ENG-releasing implant, Device: LNG-releasing intrauterine system, Device: LNG-IUS100 women will receive an LNG-IUS |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women 18 to 40 years
- New users of Implanon, IUDs and the LNG-IUS TCu380A
Key exclusion criteria (1 listed)
- Contraindications to contraceptive methods
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| copper-releasing intrauterine deviceAlso: Optima, Injeflex, Brazil100 women received a 380 mm2 of copper releasing intrauterine device | Device | copper intrauterine device |
| ENG-releasing implantAlso: Implanion, MSD, Os, The Nedherland60 mcg/day releasing etonogestrel implant | Device | ENG-releasing implant, LNG-releasing intrauterine system, copper intrauterine device |
| LNG-releasing intrauterine systemAlso: Mirena, Bayer Oy, Turku, Finlanda LNG-IUS releasing 20 mcd/day of LNG | Device | ENG-releasing implant, LNG-releasing intrauterine system, copper intrauterine device |
| LNG-IUSAlso: Mirena, Bayer Oy, Turku, Finland100 women will receive an LNG-IUS | Device | ENG-releasing implant, LNG-releasing intrauterine system, copper intrauterine device |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
- Derived from this study: PubMed 24812309Modesto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Bahamondes, MD principal investigator
University of Campinas, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing copper-releasing intrauterine device, ENG-releasing implant and LNG-releasing intrauterine system in people with Contraceptive Usage and Bleeding Due to Intrauterine Contraceptive Device, run by University of Campinas, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01392157, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2013.