Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-05 @ 6:58 PM
Study NCT ID:
NCT01798394
Status:
COMPLETED
Last Update Posted:
2017-01-09
First Post:
2013-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Progesterone & Postpartum Relapse to Smoking
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020340', 'term': 'Tobacco Use Cessation'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011374', 'term': 'Progesterone'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tosun004@umn.edu', 'phone': '612-624-5439', 'title': 'Nicole Tosun', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': 'Progesterone', 'description': 'Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.\n\nProgesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.', 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.\n\nPlacebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Hospitalization for post-cesarean section infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Relapsed by Week 4 Postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Progesterone', 'description': 'Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.\n\nProgesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.\n\nPlacebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 Postpartum', 'description': 'Determined by seven-day point prevalence, a binary smoking relapse outcome - defined as a single puff of a cigarette during the seven days prior to a pre-specified time point of interest.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Relapsed by Week 12 Postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Progesterone', 'description': 'Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.\n\nProgesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.\n\nPlacebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12 Postpartum', 'description': 'Determined by seven-day point prevalence, a binary smoking relapse outcome - defined as a single puff of a cigarette during the seven days prior to a pre-specified time point of interest.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Relapsed at All During Postpartum (up to Day 84)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Progesterone', 'description': 'Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.\n\nProgesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.\n\nPlacebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Postpartum Day 0 to 84', 'description': 'Defined by continuous abstinence (CA) defined as a single puff of a cigarette as a relapse.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Protocol Compliance - Number of Visits Attended', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Progesterone', 'description': 'Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.\n\nProgesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.\n\nPlacebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Gestational Week 36 - Postpartum Week 12', 'description': 'Compliance was measured as the number of visits attended (maximum of 5).', 'unitOfMeasure': 'Number of visits attended', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Compliance Determinants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Progesterone', 'description': 'Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.\n\nProgesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.\n\nPlacebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Postpartum Week 12', 'description': 'This was determined by the Feasibility Questionnaire; a 10-item measure used to assess participant expectations, satisfaction of study protocol, study medication and electronic data capture. All questions were answered on a four-point Likert-type scale (1=low acceptability and 4=high acceptability). The total score was determined by adding up all the scores and dividing by 10.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Protocol Compliance - Doses of Medication Taken', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Progesterone', 'description': 'Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.\n\nProgesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.\n\nPlacebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.9', 'spread': '22.3', 'groupId': 'OG000'}, {'value': '37.5', 'spread': '18.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Postpartum Week 0 - Week 12', 'description': 'Compliance was measured by doses of medication taken (maximum of 56).', 'unitOfMeasure': 'Doses of medication taken', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Protocol Compliance - EDC's Completed", 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Progesterone', 'description': 'Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.\n\nProgesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.\n\nPlacebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.9', 'spread': '21.8', 'groupId': 'OG000'}, {'value': '61.8', 'spread': '24.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Gestational Week 36 - Postpartum Week 12', 'description': 'Compliance was measured as the number by number of EDCs completed (maximum of 84).', 'unitOfMeasure': "EDC's completed", 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Progesterone', 'description': 'Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.\n\nProgesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.\n\nPlacebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Progesterone', 'description': 'Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.\n\nProgesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.\n\nPlacebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.2', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '26.7', 'spread': '5.0', 'groupId': 'BG001'}, {'value': '26.5', 'spread': '5.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-10', 'studyFirstSubmitDate': '2013-02-21', 'resultsFirstSubmitDate': '2016-07-26', 'studyFirstSubmitQcDate': '2013-02-21', 'lastUpdatePostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-10', 'studyFirstPostDateStruct': {'date': '2013-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Relapsed by Week 4 Postpartum', 'timeFrame': 'Week 4 Postpartum', 'description': 'Determined by seven-day point prevalence, a binary smoking relapse outcome - defined as a single puff of a cigarette during the seven days prior to a pre-specified time point of interest.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Relapsed by Week 12 Postpartum', 'timeFrame': 'Week 12 Postpartum', 'description': 'Determined by seven-day point prevalence, a binary smoking relapse outcome - defined as a single puff of a cigarette during the seven days prior to a pre-specified time point of interest.'}, {'measure': 'Number of Participants Who Relapsed at All During Postpartum (up to Day 84)', 'timeFrame': 'Postpartum Day 0 to 84', 'description': 'Defined by continuous abstinence (CA) defined as a single puff of a cigarette as a relapse.'}, {'measure': 'Protocol Compliance - Number of Visits Attended', 'timeFrame': 'Gestational Week 36 - Postpartum Week 12', 'description': 'Compliance was measured as the number of visits attended (maximum of 5).'}, {'measure': 'Compliance Determinants', 'timeFrame': 'Postpartum Week 12', 'description': 'This was determined by the Feasibility Questionnaire; a 10-item measure used to assess participant expectations, satisfaction of study protocol, study medication and electronic data capture. All questions were answered on a four-point Likert-type scale (1=low acceptability and 4=high acceptability). The total score was determined by adding up all the scores and dividing by 10.'}, {'measure': 'Protocol Compliance - Doses of Medication Taken', 'timeFrame': 'Postpartum Week 0 - Week 12', 'description': 'Compliance was measured by doses of medication taken (maximum of 56).'}, {'measure': "Protocol Compliance - EDC's Completed", 'timeFrame': 'Gestational Week 36 - Postpartum Week 12', 'description': 'Compliance was measured as the number by number of EDCs completed (maximum of 84).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pregnant', 'smoker', 'cigarette', 'tobacco'], 'conditions': ['Tobacco Use Cessation', 'Tobacco Use Disorder']}, 'descriptionModule': {'briefSummary': 'The primary goal of this project is to investigate the potential efficacy of exogenous progesterone (with supplemental relapse prevention counseling) on postpartum relapse in new mothers. Also to determine the feasibility of enhanced compliance monitoring and identification of collateral factors effecting outcomes.', 'detailedDescription': 'Pregnant women will be recruited at gestational weeks 33-36 who have quit smoking during pregnancy and are motivated to maintain abstinence after delivery. At the time of delivery, women will be randomly assigned to receive 4 weeks of active or placebo exogenous progesterone starting on the 4th day postpartum. Participants will be in contact with study staff either by phone or clinic visits until 12 weeks postpartum to collect data on smoking status and protocol compliance, measure serum progesterone levels and receive behavioral counseling.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Woman\n* 18-35 years old\n* Zero CPD for past 4 weeks\n* 5 or more CPD for at least 6 out of past 12 months\n* Motivated to remain abstinent (7 or higher out of 10)\n* Stable physical/mental health\n* Established prenatal care\n* Stable physical/mental health\n* Willing to take Progesterone\n* Willing to use double-barrier protection if sexually active\n* English fluency\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Psychotropic medications\n* Illicit drugs\n* Other types of tobacco, NRT, smoking cessation medications\n* Pregnancy complications (Diabetes, Anomaly, Fetal growth restriction, HTN, Hx of \\>2 miscarriages)\n* Current use of: Finasteroid (propecia), Efavirenz, Red Clover, Ketoconazole, CYP3A4 Inhibitors\n* History of: Thrombophelitis, Deep vein thrombosis, Pulmonary embolus, Clotting disorder, Bleeding disorder, Heart disease, Diabetes, Stroke, Peanut allergy, Liver dysfunction, Hypersensitivity to progesterone'}, 'identificationModule': {'nctId': 'NCT01798394', 'briefTitle': 'Progesterone & Postpartum Relapse to Smoking', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Progesterone & Postpartum Relapse to Smoking', 'orgStudyIdInfo': {'id': '2012NTLS059'}, 'secondaryIdInfos': [{'id': 'R21DA034840', 'link': 'https://reporter.nih.gov/quickSearch/R21DA034840', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Progesterone', 'description': 'Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.', 'interventionNames': ['Drug: Progesterone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Progesterone', 'type': 'DRUG', 'otherNames': ['Prometrium'], 'description': 'Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.', 'armGroupLabels': ['Progesterone']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55414', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota, 717 Delaware Street SE', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Sharon S. Allen, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Masonic Cancer Center, University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}