Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-28 @ 7:59 PM
Study NCT ID:
NCT01392157
Status:
COMPLETED
Last Update Posted:
2013-11-27
First Post:
2011-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003268', 'term': 'Contraception Behavior'}], 'ancestors': [{'id': 'D043762', 'term': 'Reproductive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007435', 'term': 'Intrauterine Devices, Copper'}], 'ancestors': [{'id': 'D007436', 'term': 'Intrauterine Devices, Medicated'}, {'id': 'D007434', 'term': 'Intrauterine Devices'}, {'id': 'D003274', 'term': 'Contraceptive Devices, Female'}, {'id': 'D003273', 'term': 'Contraceptive Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-26', 'studyFirstSubmitDate': '2011-06-16', 'studyFirstSubmitQcDate': '2011-07-11', 'lastUpdatePostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of acceptability of Implanon in comparison to the TCu380A IUD and the LNG-IUS', 'timeFrame': 'Participants will receive counseling before admission and at 12 months after', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Contraceptive Usage', 'Bleeding Due to Intrauterine Contraceptive Device']}, 'referencesModule': {'references': [{'pmid': '24812309', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nhalf 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'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women 18 to 40 years\n* New users of Implanon, IUDs and the LNG-IUS TCu380A\n\nExclusion Criteria:\n\n* Contraindications to contraceptive methods'}, 'identificationModule': {'nctId': 'NCT01392157', 'briefTitle': 'Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector', 'organization': {'class': 'OTHER', 'fullName': 'University of Campinas, Brazil'}, 'officialTitle': 'Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector', 'orgStudyIdInfo': {'id': '07/2011/PC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'copper intrauterine device', 'description': '100 women will be allocated to receive a TCu380A intrauterine device', 'interventionNames': ['Device: copper-releasing intrauterine device', 'Device: ENG-releasing implant', 'Device: LNG-releasing intrauterine system', 'Device: LNG-IUS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LNG-releasing intrauterine system', 'description': '100 women were allocated to receive a LNG-IUS', 'interventionNames': ['Device: ENG-releasing implant', 'Device: LNG-releasing intrauterine system', 'Device: LNG-IUS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ENG-releasing implant', 'description': '100 women will receive an LNG-IUS', 'interventionNames': ['Device: ENG-releasing implant', 'Device: LNG-releasing intrauterine system', 'Device: LNG-IUS']}], 'interventions': [{'name': 'copper-releasing intrauterine device', 'type': 'DEVICE', 'otherNames': ['Optima, Injeflex, Brazil'], 'description': '100 women received a 380 mm2 of copper releasing intrauterine device', 'armGroupLabels': ['copper intrauterine device']}, {'name': 'ENG-releasing implant', 'type': 'DEVICE', 'otherNames': ['Implanion, MSD, Os, The Nedherland'], 'description': '60 mcg/day releasing etonogestrel implant', 'armGroupLabels': ['ENG-releasing implant', 'LNG-releasing intrauterine system', 'copper intrauterine device']}, {'name': 'LNG-releasing intrauterine system', 'type': 'DEVICE', 'otherNames': ['Mirena, Bayer Oy, Turku, Finland'], 'description': 'a LNG-IUS releasing 20 mcd/day of LNG', 'armGroupLabels': ['ENG-releasing implant', 'LNG-releasing intrauterine system', 'copper intrauterine device']}, {'name': 'LNG-IUS', 'type': 'DEVICE', 'otherNames': ['Mirena, Bayer Oy, Turku, Finland'], 'description': '100 women will receive an LNG-IUS', 'armGroupLabels': ['ENG-releasing implant', 'LNG-releasing intrauterine system', 'copper intrauterine device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6181', 'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'University of Campinas', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}], 'overallOfficials': [{'name': 'Luis Bahamondes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Campinas, Brazil'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campinas, Brazil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Medical Doctor', 'investigatorFullName': 'Luis Bahamondes', 'investigatorAffiliation': 'University of Campinas, Brazil'}}}}