Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT00931827
Status:
COMPLETED
Last Update Posted:
2013-12-24
First Post:
2009-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acceptability of Long-term Progestin-only Contraception in Europe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016912', 'term': 'Levonorgestrel'}, {'id': 'C044815', 'term': 'etonogestrel'}], 'ancestors': [{'id': 'D009644', 'term': 'Norgestrel'}, {'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 436}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-22', 'studyFirstSubmitDate': '2009-06-30', 'studyFirstSubmitQcDate': '2009-06-30', 'lastUpdatePostDateStruct': {'date': '2013-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Continuation rate', 'timeFrame': 'At 24 months'}], 'secondaryOutcomes': [{'measure': 'Continuation rate', 'timeFrame': 'At 12 months'}, {'measure': 'Bleeding intensity, dysmenorrhea, and user satisfaction (questionnaires completed by patient)', 'timeFrame': 'Initial and after 3, 6, 12 and 24 months'}, {'measure': 'Cumulative discontinuation rate for unintended pregnancy, bleeding problems, other medical reasons, for non-medical reasons', 'timeFrame': 'At 24 months'}, {'measure': 'Incidence of Adverse Events, Serious Adverse Events', 'timeFrame': 'During 24 months'}, {'measure': 'The return to fertility of women discontinuing the method for wish for pregnancy', 'timeFrame': '12 months after discontinuation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contraception'], 'conditions': ['Contraception']}, 'descriptionModule': {'briefSummary': 'The study examines the use of Mirena or Implanon for long-term contraception in women. The duration of therapy use is the key focus of the study. Also, any reasons for discontinuation and the safety profile will be examined. In addition, patients are asked to fill out a short questionnaire about their menstrual bleeding before and during therapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women aged 20-35 years switching from short-acting hormonal contraception', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 20-35 in good general health requesting contraception\n* Women who have used short-acting hormonal contraception (combined or progestogen-only pills, vaginal ring or contraceptive patch) for at least 3 cycles immediately before entering the study and opting to change to either Mirena or Implanon for contraception\n* Women who have given a written informed consent to participate in the study (if applicable)\n\nExclusion Criteria:\n\n* The contraindications and warnings of the respective Summary of Product Characteristics (Mirena or Implanon) must be followed. The decision to start Mirena or Implanon has to be made clearly before the decision to include patients in the study\n* Patients who are breast-feeding at time of inclusion for the study will also be excluded since breast-feeding affects the bleeding pattern'}, 'identificationModule': {'nctId': 'NCT00931827', 'briefTitle': 'Acceptability of Long-term Progestin-only Contraception in Europe', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Acceptability of Long-term Progestin-only Contraception in Europe', 'orgStudyIdInfo': {'id': '14688'}, 'secondaryIdInfos': [{'id': 'MA0801', 'type': 'OTHER', 'domain': 'company internal'}, {'id': '14239', 'type': 'OTHER', 'domain': 'company internal'}, {'id': '14177', 'type': 'OTHER', 'domain': 'company internal'}, {'id': '14176', 'type': 'OTHER', 'domain': 'company internal'}, {'id': '14016', 'type': 'OTHER', 'domain': 'company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'interventionNames': ['Drug: Levonorgestrel IUS (Mirena, BAY86-5028)']}, {'label': 'Group 2', 'interventionNames': ['Drug: Implanon (Etonogestrel)']}], 'interventions': [{'name': 'Levonorgestrel IUS (Mirena, BAY86-5028)', 'type': 'DRUG', 'description': 'Patients under daily life treatment receiving Mirena according to local drug information.', 'armGroupLabels': ['Group 1']}, {'name': 'Implanon (Etonogestrel)', 'type': 'DRUG', 'description': 'Patients under daily life treatment receiving Implanon according to local drug information.', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Many Locations', 'country': 'France'}, {'city': 'Many Locations', 'country': 'Ireland'}, {'city': 'Many Locations', 'country': 'Slovakia'}, {'city': 'Many Locations', 'country': 'United Kingdom'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}