Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2026-01-04 @ 2:06 PM
Study NCT ID:
NCT02524561
Status:
COMPLETED
Last Update Posted:
2017-03-08
First Post:
2015-08-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
KEEPS Mammographic Density And Breast Health Ancillary Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C031278', 'term': '2-chloroethyl ethyl sulfide'}, {'id': 'D004966', 'term': 'Estrogens, Conjugated (USP)'}, {'id': 'C511292', 'term': 'Ortho Evra'}, {'id': 'D004958', 'term': 'Estradiol'}], 'ancestors': [{'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'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rulla.tamimi@channing.harvard.edu', 'phone': '617-525-0862', 'title': 'Dr. Rulla Tamimi', 'organization': "Brigham and Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'baseline through 4 years.', 'description': 'There were no adverse events related to the ancillary mammographic density study.', 'eventGroups': [{'id': 'EG000', 'title': 'CEE Pill, Active Progesterone', 'description': 'Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nCEE pill: Conjugated equine estrogens 0.45 mg/day\n\nActive Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nPlacebo patch: placebo patch', 'otherNumAtRisk': 168, 'otherNumAffected': 0, 'seriousNumAtRisk': 168, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Estradiol Patch, Active Progesterone', 'description': 'Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nEstradiol patch: Climara 50 mcg/day\n\nActive Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nPlacebo tablet: Placebo tablet', 'otherNumAtRisk': 162, 'otherNumAffected': 0, 'seriousNumAtRisk': 162, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo tablet, placebo patch, placebo progesterone\n\nPlacebo tablet: Placebo tablet\n\nPlacebo patch: placebo patch\n\nPlacebo progesterone: placebo progesterone', 'otherNumAtRisk': 187, 'otherNumAffected': 0, 'seriousNumAtRisk': 187, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'BIRADS Breast Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CEE Pill, Active Progesterone', 'description': 'Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nCEE pill: Conjugated equine estrogens 0.45 mg/day\n\nActive Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nPlacebo patch: placebo patch'}, {'id': 'OG001', 'title': 'Estradiol Patch, Active Progesterone', 'description': 'Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nEstradiol patch: Climara 50 mcg/day\n\nActive Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nPlacebo tablet: Placebo tablet'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet, placebo patch, placebo progesterone\n\nPlacebo tablet: Placebo tablet\n\nPlacebo patch: placebo patch\n\nPlacebo progesterone: placebo progesterone'}], 'classes': [{'title': 'BIRADS 1', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'BIRADS 2', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}]}, {'title': 'BIRADS 3', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}]}, {'title': 'BIRADS 4', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Prior to Randomization)', 'description': 'Breast density prior to randomization. Frequency of the BIRADS category according to randomization status. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with mammograms are included.'}, {'type': 'PRIMARY', 'title': 'BIRADS Breast Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CEE Pill, Active Progesterone', 'description': 'Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nCEE pill: Conjugated equine estrogens 0.45 mg/day\n\nActive Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nPlacebo patch: placebo patch'}, {'id': 'OG001', 'title': 'Estradiol Patch, Active Progesterone', 'description': 'Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nEstradiol patch: Climara 50 mcg/day\n\nActive Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nPlacebo tablet: Placebo tablet'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet, placebo patch, placebo progesterone\n\nPlacebo tablet: Placebo tablet\n\nPlacebo patch: placebo patch\n\nPlacebo progesterone: placebo progesterone'}], 'classes': [{'title': 'BIRADS 1', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'BIRADS 2', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}]}, {'title': 'BIRADS 3', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}]}, {'title': 'BIRADS 4', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 1', 'description': 'Frequency of the BIRADS category 1 year after randomization. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with mammograms 1 year after randomization'}, {'type': 'PRIMARY', 'title': 'BIRADS Breast Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CEE Pill, Active Progesterone', 'description': 'Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nCEE pill: Conjugated equine estrogens 0.45 mg/day\n\nActive Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nPlacebo patch: placebo patch'}, {'id': 'OG001', 'title': 'Estradiol Patch, Active Progesterone', 'description': 'Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nEstradiol patch: Climara 50 mcg/day\n\nActive Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nPlacebo tablet: Placebo tablet'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet, placebo patch, placebo progesterone\n\nPlacebo tablet: Placebo tablet\n\nPlacebo patch: placebo patch\n\nPlacebo progesterone: placebo progesterone'}], 'classes': [{'title': 'BIRADS 1', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'BIRADS 2', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}]}, {'title': 'BIRADS 3', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}]}, {'title': 'BIRADS 4', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Latest (Year 3 of 4)', 'description': 'Frequency of the BIRADS category 3-4 years after randomization. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with mammograms 3-4 years after randomization'}, {'type': 'SECONDARY', 'title': 'Abnormal Mammogram/Biopsy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CEE Pill, Active Progesterone', 'description': 'Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nCEE pill: Conjugated equine estrogens 0.45 mg/day\n\nActive Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nPlacebo patch: placebo patch'}, {'id': 'OG001', 'title': 'Estradiol Patch, Active Progesterone', 'description': 'Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nEstradiol patch: Climara 50 mcg/day\n\nActive Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nPlacebo tablet: Placebo tablet'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet, placebo patch, placebo progesterone\n\nPlacebo tablet: Placebo tablet\n\nPlacebo patch: placebo patch\n\nPlacebo progesterone: placebo progesterone'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline to 3 years', 'description': 'Abnormal mammogram requiring additional imaging modality such as MRI or ultrasound, or a breast biopsy. Information obtained from mammography reports.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Women with mammography reports'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CEE Pill, Active Progesterone', 'description': 'Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nCEE pill: Conjugated equine estrogens 0.45 mg/day\n\nActive Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nPlacebo patch: placebo patch'}, {'id': 'FG001', 'title': 'Estradiol Patch, Active Progesterone', 'description': 'Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nEstradiol patch: Climara 50 mcg/day\n\nActive Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nPlacebo tablet: Placebo tablet'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo tablet, placebo patch, placebo progesterone\n\nPlacebo tablet: Placebo tablet\n\nPlacebo patch: placebo patch\n\nPlacebo progesterone: placebo progesterone'}], 'periods': [{'title': 'Baseline: Pre-randomization Mammogram', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Consented to MDBHAS', 'groupId': 'FG000', 'numSubjects': '168'}, {'comment': 'Consented to MDBHAS', 'groupId': 'FG001', 'numSubjects': '162'}, {'comment': 'Consented to MDBHAS.', 'groupId': 'FG002', 'numSubjects': '187'}]}, {'type': 'Obtained Baseline Mammogram', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '133'}, {'groupId': 'FG002', 'numSubjects': '151'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '168'}, {'groupId': 'FG001', 'numSubjects': '162'}, {'groupId': 'FG002', 'numSubjects': '187'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Year 1: Post Randomization Mammograms', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Consented to MDBHAS', 'groupId': 'FG000', 'numSubjects': '168'}, {'comment': 'Consented to MDBHAS', 'groupId': 'FG001', 'numSubjects': '162'}, {'comment': 'Consented to MDBHAS', 'groupId': 'FG002', 'numSubjects': '187'}]}, {'type': 'Obtained Mammogam', 'achievements': [{'comment': 'Obtained post-randomization mammogram', 'groupId': 'FG000', 'numSubjects': '136'}, {'comment': 'Obtained post randomization mammogram', 'groupId': 'FG001', 'numSubjects': '123'}, {'comment': 'Obtained post randomization mammogram', 'groupId': 'FG002', 'numSubjects': '148'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '168'}, {'groupId': 'FG001', 'numSubjects': '162'}, {'groupId': 'FG002', 'numSubjects': '187'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Final: Year 3 or 4 Post-randomization', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Consented to MDBHAS', 'groupId': 'FG000', 'numSubjects': '168'}, {'comment': 'Consented to MDBHAS', 'groupId': 'FG001', 'numSubjects': '162'}, {'comment': 'Consented to MDBHAS', 'groupId': 'FG002', 'numSubjects': '187'}]}, {'type': 'Obtained Year 3 or 4 Mammogram', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '139'}, {'groupId': 'FG002', 'numSubjects': '151'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '168'}, {'groupId': 'FG001', 'numSubjects': '162'}, {'groupId': 'FG002', 'numSubjects': '187'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Women in the parent study were approached to be part of this ancillary study (MDBHAS). For women who consented we attempted to collect their mammograms. Our collection took place after they started and were randomized in the parent study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}, {'value': '488', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'CEE Pill, Active Progesterone', 'description': 'Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nCEE pill: Conjugated equine estrogens 0.45 mg/day\n\nActive Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nPlacebo patch: placebo patch'}, {'id': 'BG001', 'title': 'Estradiol Patch, Active Progesterone', 'description': 'Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nEstradiol patch: Climara 50 mcg/day\n\nActive Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime\n\nPlacebo tablet: Placebo tablet'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo tablet, placebo patch, placebo progesterone\n\nPlacebo tablet: Placebo tablet\n\nPlacebo patch: placebo patch\n\nPlacebo progesterone: placebo progesterone'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.7', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '52.8', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '52.6', 'spread': '2.4', 'groupId': 'BG002'}, {'value': '52.7', 'spread': '2.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}, {'value': '488', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Population with mammographic density data from at least one time point during study.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 517}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-18', 'studyFirstSubmitDate': '2015-08-13', 'resultsFirstSubmitDate': '2016-09-20', 'studyFirstSubmitQcDate': '2015-08-14', 'lastUpdatePostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-18', 'studyFirstPostDateStruct': {'date': '2015-08-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BIRADS Breast Density', 'timeFrame': 'Baseline (Prior to Randomization)', 'description': 'Breast density prior to randomization. Frequency of the BIRADS category according to randomization status. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense.'}, {'measure': 'BIRADS Breast Density', 'timeFrame': 'Year 1', 'description': 'Frequency of the BIRADS category 1 year after randomization. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense.'}, {'measure': 'BIRADS Breast Density', 'timeFrame': 'Latest (Year 3 of 4)', 'description': 'Frequency of the BIRADS category 3-4 years after randomization. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense.'}], 'secondaryOutcomes': [{'measure': 'Abnormal Mammogram/Biopsy', 'timeFrame': 'baseline to 3 years', 'description': 'Abnormal mammogram requiring additional imaging modality such as MRI or ultrasound, or a breast biopsy. Information obtained from mammography reports.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['mammographic density', 'abnormal mammogram', 'biopsy'], 'conditions': ['Mammographic Density', 'Abnormal Mammogram']}, 'descriptionModule': {'briefSummary': 'Combined estrogen and progestin therapy has been shown to increase mammographic density and incidence of breast cancer in randomized trials. The investigators propose to examine the effects of now commonly used low-dose combined hormone therapy (HT) regimens on breast density, rates of abnormal mammogram, and circulating estrogens in the ongoing, already-funded Kronos Early Estrogen Prevention Study (KEEPS). KEEPS is a randomized clinical trial with a primary goal of examining the effects of low-dose transdermal versus oral estrogen combined with cyclic micronized progesterone on progression of subclinical atherosclerosis in recently menopausal women. Prior studies of low-dose HT have been of short duration and small size. By determining the effects of low-dose hormone therapy on the breast, the proposed ancillary study will add important information about the estimated balance of risks and benefits associated with low-dose HT and will help guide future research trials.', 'detailedDescription': 'Despite data from clinical trials showing an increased risk of breast cancer and lack of overall benefit for primary prevention with hormone therapy (HT), there is still significant usage of HT by clinicians and women for treatment of moderate-to-severe systemic menopausal symptoms. Due to the possible increased risks with these preparations, current clinical recommendations advocate utilizing the lowest dose for the shortest possible duration, but average duration is often for 2-4 years. However, the effects of commonly used low-dose HT regimens on breast density and breast cancer risk are unknown. Recent data from intervention trials support the long standing hypothesis that hormonal effects on breast cancer risk are mediated through breast density. The Kronos Early Estrogen Prevention Study (KEEPS) is an ongoing, already- funded randomized clinical trial with a primary goal of examining the effects of 4 years of low- dose transdermal versus oral estrogen combined with cyclic micronized progesterone on progression of subclinical atherosclerosis in recently menopausal women. The proposed ancillary study will efficiently examine the effects of randomized low-dose HT on key breast cancer surrogate endpoints: mammographic density and rates of abnormal mammograms. In the parent KEEPS study, a total of 720 women were randomized to oral conjugated equine estrogens (0.45 mg/d), transdermal 17-beta estradiol (50 mcg/d), or placebo, with cyclic micronized progesterone (200 mg for 12 days) for active hormonal therapy groups. All participants were required to have mammography prior to study entry as well as yearly during follow-up; blood samples also were collected at these time points. Randomization was completed in 2008. In this ancillary study, we aimed to collect mammograms from eligible women consenting to be part of the ancillary study(n=517) from baseline, year 1 and year 3 will be obtained and processed centrally to calculate mammographic density. The investigators will determine if these two low-dose HT regimens are associated with change in mammographic density. The investigators will also examine if baseline mammographic density or circulating biomarkers including estradiol, estrone, and estrone sulfate, modify or mediate changes in breast density with HT. In addition, the effects of hormonal regimens on the rates of abnormal mammogram and biopsy will be determined. By determining the effects of low-dose combined HT on the breast, the proposed study will add timely and important information about the estimated balance of risks and benefits associated with low-dose HT and will help guide future research.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '58 Years', 'minimumAge': '42 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women were 42-58 years of age, have had cessation of menses at or after age 40 and no menses for a minimum of 6 and a maximum of 36 months at screening.\n* Subjects may or may not have had current vasomotor estrogen deficiency symptoms, had not taken estrogen- or progestogen-containing medication (oral contraceptive or hormone replacement) within 3 months of randomization, and had plasma FSH levels measured at ≥35 ng/ml and plasma E2 levels of \\<40 pg/ml.\n\nExclusion Criteria:\n\n* Subjects were excluded for increased endometrial thickness on ultrasound \\>5 mm, unless endometrial biopsy was negative; for LDL ≥ 190 mg/dl or triglycerides ≥ 400 at screening, or use of lipid lowering drugs.'}, 'identificationModule': {'nctId': 'NCT02524561', 'acronym': 'KEEPS MDBHAS', 'briefTitle': 'KEEPS Mammographic Density And Breast Health Ancillary Study', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'KEEPS Mammographic Density And Breast Health Ancillary Study', 'orgStudyIdInfo': {'id': '2009P002326'}, 'secondaryIdInfos': [{'id': 'R01CA136918', 'link': 'https://reporter.nih.gov/quickSearch/R01CA136918', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CEE pill, active progesterone', 'description': 'Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime', 'interventionNames': ['Drug: CEE pill', 'Drug: Active Progesterone', 'Other: Placebo patch']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'estradiol patch, active progesterone', 'description': 'Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime', 'interventionNames': ['Drug: Estradiol patch', 'Drug: Active Progesterone', 'Other: Placebo tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Placebo tablet, placebo patch, placebo progesterone', 'interventionNames': ['Other: Placebo tablet', 'Other: Placebo patch', 'Other: Placebo progesterone']}], 'interventions': [{'name': 'CEE pill', 'type': 'DRUG', 'otherNames': ['premarin'], 'description': 'Conjugated equine estrogens 0.45 mg/day', 'armGroupLabels': ['CEE pill, active progesterone']}, {'name': 'Estradiol patch', 'type': 'DRUG', 'otherNames': ['Climara 50 mcg/day'], 'description': 'Climara 50 mcg/day', 'armGroupLabels': ['estradiol patch, active progesterone']}, {'name': 'Active Progesterone', 'type': 'DRUG', 'description': 'Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime', 'armGroupLabels': ['CEE pill, active progesterone', 'estradiol patch, active progesterone']}, {'name': 'Placebo tablet', 'type': 'OTHER', 'description': 'Placebo tablet', 'armGroupLabels': ['estradiol patch, active progesterone', 'placebo']}, {'name': 'Placebo patch', 'type': 'OTHER', 'description': 'placebo patch', 'armGroupLabels': ['CEE pill, active progesterone', 'placebo']}, {'name': 'Placebo progesterone', 'type': 'OTHER', 'description': 'placebo progesterone', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Kathy Rexrode, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We are willing to share data with collaborators if analyses are approved by the investigative team and approved by our IRB.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Kronos Longevity Research Institute', 'class': 'OTHER'}, {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, {'name': 'Columbia University', 'class': 'OTHER'}, {'name': 'Mayo Clinic', 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}, {'name': 'University of Utah', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}, {'name': 'Yale University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Rulla Tamimi', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}