Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-02-20 @ 8:14 PM
Study NCT ID:
NCT01963403
Status:
TERMINATED
Last Update Posted:
2017-05-12
First Post:
2013-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With an Oral Contraceptive
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008796', 'term': 'Metrorrhagia'}], 'ancestors': [{'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019304', 'term': 'Ethinyl Estradiol-Norgestrel Combination'}], 'ancestors': [{'id': 'D004997', 'term': 'Ethinyl Estradiol'}, {'id': 'D009651', 'term': 'Norpregnatrienes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D009644', 'term': 'Norgestrel'}, {'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D042782', 'term': 'Estrogenic Steroids, Alkylated'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mdcreinin@ucdavis.edu', 'phone': '916-734-6670', 'title': 'Dr. Mitchell Creinin', 'organization': 'UC Davis'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 84 days on either medication or placebo.', 'description': 'Adverse events for the drug arms reported combined arms. Placebo adverse events are reported for the single arm.', 'eventGroups': [{'id': 'EG000', 'title': 'EE 30mcg/LNG 150mcg', 'description': 'Combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)\n\nEE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo: 1 pill per day; daily during study participation (up to 84 days)', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 8, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea/vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cramping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mood change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Bleeding Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EE 30mcg/LNG 150mcg', 'description': 'combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)\n\nEE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: 1 pill per day; daily during study participation (up to 84 days)'}], 'classes': [{'categories': [{'title': 'Significant improvement', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Slight improvement', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'No change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Slightly worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Significantly worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Bleeding improvement will be evaluated during first cycle of study treatment (28 days)', 'description': 'Bleeding improvement will be measured by participant response to the question of whether she feels her bleeding is improved and she is satisfied with the treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '1 person in each group LTFU at one month, which was the primary outcome'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EE 30mcg/LNG 150mcg', 'description': 'combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)\n\nEE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: 1 pill per day; daily during study participation (up to 84 days)'}], 'classes': [{'categories': [{'title': 'Headache', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Nausea/vomiting', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Cramping', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Mood change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'None of above', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Adverse events will be evaluated at each contact (visits at 1 and 3 months, phone contact at 2 months) with the participant', 'description': 'Participants will be evaluated for adverse events while using a combined oral contraceptive with ETG implant.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcomes at one month; 1 person LTFU at one month in each group'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants withTreatment Success or Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EE 30mcg/LNG 150mcg', 'description': 'combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)\n\nEE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: 1 pill per day; daily during study participation (up to 84 days)'}], 'classes': [{'categories': [{'title': 'Continued assigned treatment', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Desired COC prescription', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Desired no treatment', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Implant removal', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Evaluated at follow up visits at 1 month and, if subject continues after 1st month, again at 3 months', 'description': 'Treatment success will be measured by desire to continue treatment because the initial treatment made the bleeding better.\n\nPartial failure of the study treatment will be measured by the desire to continue treatment because the initial treatment did not work\n\nComplete failure of treatment will be measured by the desire to:\n\n* discontinue treatment because it did not work; no further treatment requested\n* ETG implant removal\n* Desire to use non-study treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'one month evaluation; 1 subject LTFU at one month in each group'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Bleeding Patterns and Number of Participants With Bleeding Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Used COC at Any Time During 3 Months'}, {'id': 'OG001', 'title': 'No Use of COC at Any Time During 3 Months'}], 'classes': [{'categories': [{'title': 'Bleeding improvement', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'No bleeding improvement', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Evaluated at follow up visits at 1 month and, if subject continues after 1st month, again at 3 months', 'description': '* Bleeding improvement in women who received placebo but opted for open-label treatment after first cycle\n* Bleeding improvement over the 84 days of study participation\n* Bleeding patterns in placebo vs. combined oral contraceptive users', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'EE 30mcg/LNG 150mcg', 'description': 'combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)\n\nEE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: 1 pill per day; daily during study participation (up to 84 days)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Follow-up over three months', 'groupId': 'FG000', 'numSubjects': '11'}, {'comment': 'Follow-up over three months', 'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Implant removal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'EE 30mcg/LNG 150mcg', 'description': 'combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)\n\nEE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: 1 pill per day; daily during study participation (up to 84 days)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.4', 'spread': '3.8', 'groupId': 'BG000'}, {'value': '25.8', 'spread': '5.0', 'groupId': 'BG001'}, {'value': '25.6', 'spread': '4.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Primary reason for implant', 'classes': [{'categories': [{'title': 'Contraception', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Bleeding Problem', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Dysmenorrhea', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of implant use', 'classes': [{'categories': [{'measurements': [{'value': '343', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '764'}, {'value': '109', 'groupId': 'BG001', 'lowerLimit': '41', 'upperLimit': '518'}, {'value': '144.5', 'groupId': 'BG002', 'lowerLimit': '25', 'upperLimit': '764'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}, {'title': 'intervention requested before enrollment', 'classes': [{'categories': [{'title': 'implant removal', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Hormonal treatment', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': "'Some treatment'", 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'whyStopped': 'Futility of recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-04', 'studyFirstSubmitDate': '2013-10-10', 'resultsFirstSubmitDate': '2016-12-19', 'studyFirstSubmitQcDate': '2013-10-11', 'lastUpdatePostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-04', 'studyFirstPostDateStruct': {'date': '2013-10-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants withTreatment Success or Failure', 'timeFrame': 'Evaluated at follow up visits at 1 month and, if subject continues after 1st month, again at 3 months', 'description': 'Treatment success will be measured by desire to continue treatment because the initial treatment made the bleeding better.\n\nPartial failure of the study treatment will be measured by the desire to continue treatment because the initial treatment did not work\n\nComplete failure of treatment will be measured by the desire to:\n\n* discontinue treatment because it did not work; no further treatment requested\n* ETG implant removal\n* Desire to use non-study treatment'}, {'measure': 'Bleeding Patterns and Number of Participants With Bleeding Improvement', 'timeFrame': 'Evaluated at follow up visits at 1 month and, if subject continues after 1st month, again at 3 months', 'description': '* Bleeding improvement in women who received placebo but opted for open-label treatment after first cycle\n* Bleeding improvement over the 84 days of study participation\n* Bleeding patterns in placebo vs. combined oral contraceptive users'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Bleeding Improvement', 'timeFrame': 'Bleeding improvement will be evaluated during first cycle of study treatment (28 days)', 'description': 'Bleeding improvement will be measured by participant response to the question of whether she feels her bleeding is improved and she is satisfied with the treatment.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Adverse events will be evaluated at each contact (visits at 1 and 3 months, phone contact at 2 months) with the participant', 'description': 'Participants will be evaluated for adverse events while using a combined oral contraceptive with ETG implant.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['etonogestrel implant', 'birth control', 'irregular bleeding', 'heavy bleeding'], 'conditions': ['Abnormal Uterine Bleeding, Unspecified', 'Uterine Bleeding Heavy']}, 'referencesModule': {'references': [{'pmid': '27419258', 'type': 'RESULT', 'citation': 'Hou MY, McNicholas C, Creinin MD. Combined oral contraceptive treatment for bleeding complaints with the etonogestrel contraceptive implant: a randomised controlled trial. Eur J Contracept Reprod Health Care. 2016 Oct;21(5):361-6. doi: 10.1080/13625187.2016.1210122. Epub 2016 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'This double-blinded, placebo-controlled, randomized trial will compare the effects of the use of a combined oral contraceptive pill to a placebo pill for women who are experiencing irregular and/or heavy bleeding associated with the use of an etonogestrel (ETG) implant.\n\nThe hypothesis of the study is:\n\n* Use of combined oral contraceptive will significantly improve bleeding patterns for users of ETG implant\n* Continuation rate of ETG implant users will be increased by use of combined oral contraceptive in women desiring ETG implant removal because of the undesirable bleeding\n* Adverse events will be uncommon and acceptable to women who use a combined oral contraceptive with the ETG implant', 'detailedDescription': 'Women who are experiencing irregular and/or heavy bleeding associated with the use of an etonogestrel (ETG) implant will be recruited for this study. Women who have bothersome bleeding will be randomized to use either a combined oral contraceptive pill or a placebo pill.\n\nParticipants will take one pill every day and record their bleeding patterns on a daily diary.\n\nParticipants will have one screening/enrollment visit, two in-person follow up visits, and one telephone follow up contact. Subjects will be enrolled for a total of 84 days (three months).\n\nParticipants will be assigned to a treatment group at her screening/enrollment visit. Her first follow up visit will occur 22-28 days after her enrollment. Participants can choose to:\n\n* Continue use of assigned treatment medication\n* Discontinue use of assigned treatment medication, but use an open-label combined oral contraceptive pill\n* Discontinue the use of assigned treatment medication, decline use of an open-label combined oral contraceptive pill\n* Discontinue use of ETG implant.\n\nParticipants who choose to continue use of ETG implant will have a follow up telephone contact 50-56 days after her enrollment visit. A final in-person visit will occur 78-84 days after enrollment. Bleeding patterns will be assessed by daily bleeding diaries completed by the participant.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women who have an ETG implant in place\n* Women who subjectively experience the side effect of an undesirable bleeding profile such as bleeding irregularity or heavy flow after ETG implant was placed and who desire intervention for this side effect by either treatment of bleeding or removal of the implant\n* Age 14 years an older, inclusive\n\nExclusion Criteria:\n\n* Irregular or heavy bleeding from an etiology other than ETG use (e.g. fibroids, cervical polyp, or other organic cause of bleeding)\n* Has attempted prescription treatment for menstrual side effects while using ETG implant\n* Has one or more of the conditions considered Category 3 (risks outweigh benefits) or Category 4 (unacceptable health risk) for estrogen-containing oral contraceptives by the Center for Disease Control Medical Eligibility Criteria for Contraceptive Use:\n\n * Current or history of heart or vascular diseases, including deep venous thrombosis, pulmonary embolism, known thrombogenic mutations, peripartum cardiomyopathy, and complicated valvular heart disease\n * Hypertension, even if adequately controlled\n * Diabetes with vascular involvement\n * Headaches with focal aura, or migraines in women age 35 and older even without focal aura\n * Major surgery with prolonged immobilization\n * Breast cancer (current or past)\n * Severe (decompensated) cirrhosis\n * Acute or flare viral hepatitis\n * Breastfeeding less than 1 month postpartum\n * Post-partum less than 3 weeks\n * 35 years of age and older and smoking\n * Multiple risk factors for arterial cardiovascular disease\n * Systemic Lupus Erythematosus with positive or unknown antiphospholipid antibodies\n * Current symptomatic gallbladder disease or history of cholestasis related to past combined oral contraceptive use\n * On certain anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine, lamotrigine)\n * On Ritonavir-boosted protease inhibitors for antiretroviral therapy\n* Issues or concerns, in the judgment of the investigator, that may compromise the safety of the subject, impact the subject's adherence to the protocol requirements, or confound the reliability of the data acquired in this study"}, 'identificationModule': {'nctId': 'NCT01963403', 'acronym': 'ROBI', 'briefTitle': 'Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With an Oral Contraceptive', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Relief of Bleeding on the Implant: Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With a Combined Oral Contraceptive: A Placebo-Controlled Randomized Trial', 'orgStudyIdInfo': {'id': '478388'}, 'secondaryIdInfos': [{'id': 'MISP 50618', 'type': 'OTHER_GRANT', 'domain': 'Merck Sharp & Dohme Corp.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'EE 30mcg/LNG 150mcg', 'description': 'combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)', 'interventionNames': ['Drug: EE 30mcg/LNG 150mcg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'EE 30mcg/LNG 150mcg', 'type': 'DRUG', 'otherNames': ['Levlen28', 'Levora', 'Portia 28', 'Altavera'], 'description': '1 pill per day; daily during study participation (up to 84 days)', 'armGroupLabels': ['EE 30mcg/LNG 150mcg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '1 pill per day; daily during study participation (up to 84 days)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine, Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Mitchell Creinin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}, {'name': 'Melody Hou, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of California, Davis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Washington University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Director of Family Planning', 'investigatorFullName': 'Mitchell Creinin, MD', 'investigatorAffiliation': 'University of California, Davis'}}}}