Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-02-25 @ 9:49 PM
Study NCT ID:
NCT04177693
Status:
COMPLETED
Last Update Posted:
2023-06-05
First Post:
2019-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetics and Hepatic Safety of EGCG
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C045651', 'term': 'epigallocatechin gallate'}, {'id': 'D002996', 'term': 'Clomiphene'}, {'id': 'D000077289', 'term': 'Letrozole'}], 'ancestors': [{'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'heping.zhang@yale.edu', 'phone': '2037855185', 'title': 'Dr. Heping Zhang', 'organization': 'Yale University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 60 days', 'eventGroups': [{'id': 'EG000', 'title': 'EGCG Daily Alone.', 'description': 'EGCG daily alone. 800mg\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 2, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'EGCG With Clomiphene Citrate', 'description': 'EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months\n\nClomiphene Citrate: 100 mg for 5 days', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 4, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'EGCG With Letrozole', 'description': 'EGCG 800mg daily with letrozole 5mg for 5 days.\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months\n\nLetrozole: 5 mg for 5 days', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal discomfort and loose stool', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Facial flushing, muscle ache, and diarrhea after letrozole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Greenish discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headaches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Loose stool', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Low mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine after vaccine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea with EGCG', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pelvic cramps, dull and intermittent aching after letrozole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting and diarrhea after clomid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Epigallocatechin Gallate (EGCG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EGCG Daily Alone.', 'description': 'EGCG daily alone. 800mg\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months'}, {'id': 'OG001', 'title': 'EGCG With Clomiphene Citrate', 'description': 'EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months\n\nClomiphene Citrate: 100 mg for 5 days'}, {'id': 'OG002', 'title': 'EGCG With Letrozole', 'description': 'EGCG 800mg daily with letrozole 5mg for 5 days.\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months\n\nLetrozole: 5 mg for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '-418.2', 'upperLimit': '263.1'}, {'value': '256.3', 'groupId': 'OG001', 'lowerLimit': '37.9', 'upperLimit': '770.1'}, {'value': '86.4', 'groupId': 'OG002', 'lowerLimit': '-130.6', 'upperLimit': '788.1'}]}]}], 'analyses': [{'pValue': '0.112', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, and Visit 4 (end of study, up to 40 days)', 'description': 'Changes in epigallocatechin gallate (EGCG) from Visit 1 to Visit 4 (end of study). EGCG levels measured at 1 hour after taking study medication were used for both visits.', 'unitOfMeasure': 'nM', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes in Epigallocatechin (EGC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EGCG Daily Alone.', 'description': 'EGCG daily alone. 800mg\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months'}, {'id': 'OG001', 'title': 'EGCG With Clomiphene Citrate', 'description': 'EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months\n\nClomiphene Citrate: 100 mg for 5 days'}, {'id': 'OG002', 'title': 'EGCG With Letrozole', 'description': 'EGCG 800mg daily with letrozole 5mg for 5 days.\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months\n\nLetrozole: 5 mg for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-58.9', 'groupId': 'OG000', 'lowerLimit': '-66.2', 'upperLimit': '62.2'}, {'value': '8.9', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '17.3'}, {'value': '35.4', 'groupId': 'OG002', 'lowerLimit': '-19.7', 'upperLimit': '193.6'}]}]}], 'analyses': [{'pValue': '0.613', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, and Visit 4 (end of study, up to 40 days)', 'description': 'Changes in epigallocatechin (EGC) from Visit 1 to Visit 4 (end of study). EGC levels measured at 1 hour after taking study medication were used for both visits.', 'unitOfMeasure': 'nM', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes in Epicatechin Gallate(ECG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EGCG Daily Alone.', 'description': 'EGCG daily alone. 800mg\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months'}, {'id': 'OG001', 'title': 'EGCG With Clomiphene Citrate', 'description': 'EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months\n\nClomiphene Citrate: 100 mg for 5 days'}, {'id': 'OG002', 'title': 'EGCG With Letrozole', 'description': 'EGCG 800mg daily with letrozole 5mg for 5 days.\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months\n\nLetrozole: 5 mg for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '-121.7', 'upperLimit': '63.0'}, {'value': '64.1', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '248.0'}, {'value': '60.3', 'groupId': 'OG002', 'lowerLimit': '-20.2', 'upperLimit': '127.7'}]}]}], 'analyses': [{'pValue': '0.202', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, and Visit 4 (end of study, up to 40 days)', 'description': 'Changes in epicatechin gallate(ECG) from Visit 1 to Visit 4 (end of study). ECG levels measured at 1 hour after taking study medication were used for both visits.', 'unitOfMeasure': 'nM', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EGCG Daily Alone.', 'description': 'EGCG daily alone. 800mg\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months'}, {'id': 'OG001', 'title': 'EGCG With Clomiphene Citrate', 'description': 'EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months\n\nClomiphene Citrate: 100 mg for 5 days'}, {'id': 'OG002', 'title': 'EGCG With Letrozole', 'description': 'EGCG 800mg daily with letrozole 5mg for 5 days.\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months\n\nLetrozole: 5 mg for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.508', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Visit 4 (end of study, up to 40 days)', 'description': 'Changes in total bilirubin between the 3 groups.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in ALT/SGPT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EGCG Daily Alone.', 'description': 'EGCG daily alone. 800mg\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months'}, {'id': 'OG001', 'title': 'EGCG With Clomiphene Citrate', 'description': 'EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months\n\nClomiphene Citrate: 100 mg for 5 days'}, {'id': 'OG002', 'title': 'EGCG With Letrozole', 'description': 'EGCG 800mg daily with letrozole 5mg for 5 days.\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months\n\nLetrozole: 5 mg for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '11.7', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '7.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.237', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Visit 4 (end of study, up to 40 days)', 'description': 'Changes in alanine aminotransferase /SGPT between the 3 groups.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Alkaline Phosphatase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EGCG Daily Alone.', 'description': 'EGCG daily alone. 800mg\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months'}, {'id': 'OG001', 'title': 'EGCG With Clomiphene Citrate', 'description': 'EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months\n\nClomiphene Citrate: 100 mg for 5 days'}, {'id': 'OG002', 'title': 'EGCG With Letrozole', 'description': 'EGCG 800mg daily with letrozole 5mg for 5 days.\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months\n\nLetrozole: 5 mg for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '-5.6', 'spread': '10.2', 'groupId': 'OG001'}, {'value': '-6.0', 'spread': '9.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.327', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Visit 4 (end of study, up to 40 days)', 'description': 'Changes in Alkaline Phosphatase between the 3 groups.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Estrogen (E2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EGCG Daily Alone.', 'description': 'EGCG daily alone. 800mg\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months'}, {'id': 'OG001', 'title': 'EGCG With Clomiphene Citrate', 'description': 'EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months\n\nClomiphene Citrate: 100 mg for 5 days'}, {'id': 'OG002', 'title': 'EGCG With Letrozole', 'description': 'EGCG 800mg daily with letrozole 5mg for 5 days.\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months\n\nLetrozole: 5 mg for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-50.9', 'spread': '122.4', 'groupId': 'OG000'}, {'value': '-49.4', 'spread': '76.6', 'groupId': 'OG001'}, {'value': '-50.2', 'spread': '127.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.633', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Visit 4 (end of study, up to 40 days)', 'description': 'Changes in Estrogen (E2) between the 3 groups.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Endometrial Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EGCG Daily Alone.', 'description': 'EGCG daily alone. 800mg\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months'}, {'id': 'OG001', 'title': 'EGCG With Clomiphene Citrate', 'description': 'EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months\n\nClomiphene Citrate: 100 mg for 5 days'}, {'id': 'OG002', 'title': 'EGCG With Letrozole', 'description': 'EGCG 800mg daily with letrozole 5mg for 5 days.\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months\n\nLetrozole: 5 mg for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '2.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.146', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Visit 4 (end of study, up to 40 days)', 'description': 'Changes in endometrial thickness between the 3 groups.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Serum Folate Level Between MTHFR677-Wild Type (WT) Group and MTHFR677-Hetero Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MTHFR677-Wild Type (WT) Group', 'description': 'MTHFR677-Wild Type (WT) group'}, {'id': 'OG001', 'title': 'MTHFR677-Hetero Group', 'description': 'MTHFR677-Hetero group'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.2', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.372', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Visit 4 (end of study, up to 40 days)', 'description': 'Change in serum folate levels between MTHFR677-Wild Type (WT) group and MTHFR677-Hetero group', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Serum Folate Level Between MTHFR1298-Wild Type (WT) Group and MTHFR1298-Hetero Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MTHFR1298-Wild Type (WT) Group', 'description': 'MTHFR1298-Wild Type (WT) group'}, {'id': 'OG001', 'title': 'MTHFR1298-Hetero Group', 'description': 'MTHFR1298-Hetero group'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '3.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Visit 4 (end of study, up to 40 days)', 'description': 'Change in serum folate levels between MTHFR1298-Wild Type (WT) group and MTHFR1298-Hetero group', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Serum Folate Level Between DHFR-Wild Type (WT) Group and DHFR-Hetero or Homo Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DHFR-Wild Type (WT) Group', 'description': 'DHFR-Wild Type (WT) group'}, {'id': 'OG001', 'title': 'DHFR-Hetero or Homo Group.', 'description': 'DHFR-Hetero or homo group.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.9', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '3.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.24', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Visit 4 (end of study, up to 40 days)', 'description': 'Change in serum folate levels between DHFR-Wild Type (WT) group and DHFR-Hetero or homo group.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'EGCG Daily Alone.', 'description': 'EGCG daily alone. 800mg\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months'}, {'id': 'FG001', 'title': 'EGCG With Clomiphene Citrate', 'description': 'EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months\n\nClomiphene Citrate: 100 mg for 5 days'}, {'id': 'FG002', 'title': 'EGCG With Letrozole', 'description': 'EGCG 800mg daily with letrozole 5mg for 5 days.\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months\n\nLetrozole: 5 mg for 5 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'EGCG Daily Alone.', 'description': 'EGCG daily alone. 800mg\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months'}, {'id': 'BG001', 'title': 'EGCG With Clomiphene Citrate', 'description': 'EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months\n\nClomiphene Citrate: 100 mg for 5 days'}, {'id': 'BG002', 'title': 'EGCG With Letrozole', 'description': 'EGCG 800mg daily with letrozole 5mg for 5 days.\n\nEpigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months\n\nLetrozole: 5 mg for 5 days'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.6', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '27.2', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '29.3', 'spread': '6.3', 'groupId': 'BG002'}, {'value': '28.8', 'spread': '6.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '39', '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', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-29', 'size': 752379, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-27T10:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The 36 women will be randomized to one of the following groups:\n\n1. EGCG daily alone.\n2. EGCG daily with clomiphene citrate 100mg for 5 days.\n3. EGCG daily with letrozole 5mg for 5 days.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2019-11-20', 'resultsFirstSubmitDate': '2023-01-27', 'studyFirstSubmitQcDate': '2019-11-22', 'lastUpdatePostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-08', 'studyFirstPostDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Epigallocatechin Gallate (EGCG)', 'timeFrame': 'Baseline, and Visit 4 (end of study, up to 40 days)', 'description': 'Changes in epigallocatechin gallate (EGCG) from Visit 1 to Visit 4 (end of study). EGCG levels measured at 1 hour after taking study medication were used for both visits.'}, {'measure': 'Changes in Epigallocatechin (EGC)', 'timeFrame': 'Baseline, and Visit 4 (end of study, up to 40 days)', 'description': 'Changes in epigallocatechin (EGC) from Visit 1 to Visit 4 (end of study). EGC levels measured at 1 hour after taking study medication were used for both visits.'}, {'measure': 'Changes in Epicatechin Gallate(ECG)', 'timeFrame': 'Baseline, and Visit 4 (end of study, up to 40 days)', 'description': 'Changes in epicatechin gallate(ECG) from Visit 1 to Visit 4 (end of study). ECG levels measured at 1 hour after taking study medication were used for both visits.'}], 'secondaryOutcomes': [{'measure': 'Changes in Total Bilirubin', 'timeFrame': 'Baseline, and Visit 4 (end of study, up to 40 days)', 'description': 'Changes in total bilirubin between the 3 groups.'}, {'measure': 'Changes in ALT/SGPT', 'timeFrame': 'Baseline, and Visit 4 (end of study, up to 40 days)', 'description': 'Changes in alanine aminotransferase /SGPT between the 3 groups.'}, {'measure': 'Changes in Alkaline Phosphatase', 'timeFrame': 'Baseline, and Visit 4 (end of study, up to 40 days)', 'description': 'Changes in Alkaline Phosphatase between the 3 groups.'}, {'measure': 'Changes in Estrogen (E2)', 'timeFrame': 'Baseline, and Visit 4 (end of study, up to 40 days)', 'description': 'Changes in Estrogen (E2) between the 3 groups.'}, {'measure': 'Changes in Endometrial Thickness', 'timeFrame': 'Baseline, and Visit 4 (end of study, up to 40 days)', 'description': 'Changes in endometrial thickness between the 3 groups.'}, {'measure': 'Change in Serum Folate Level Between MTHFR677-Wild Type (WT) Group and MTHFR677-Hetero Group', 'timeFrame': 'Baseline, and Visit 4 (end of study, up to 40 days)', 'description': 'Change in serum folate levels between MTHFR677-Wild Type (WT) group and MTHFR677-Hetero group'}, {'measure': 'Change in Serum Folate Level Between MTHFR1298-Wild Type (WT) Group and MTHFR1298-Hetero Group', 'timeFrame': 'Baseline, and Visit 4 (end of study, up to 40 days)', 'description': 'Change in serum folate levels between MTHFR1298-Wild Type (WT) group and MTHFR1298-Hetero group'}, {'measure': 'Change in Serum Folate Level Between DHFR-Wild Type (WT) Group and DHFR-Hetero or Homo Group.', 'timeFrame': 'Baseline, and Visit 4 (end of study, up to 40 days)', 'description': 'Change in serum folate levels between DHFR-Wild Type (WT) group and DHFR-Hetero or homo group.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Uterine Fibroids']}, 'descriptionModule': {'briefSummary': 'A trial to assess the pharmacokinetics and hepatic safety of EGCG in women with and without uterine fibroids.', 'detailedDescription': 'This will be a randomized, multi-center, pharmacokinetics and hepatic safety trial of EGCG with 36 total patients in 3 treatment arms. 36 women will be randomized to one of the following groups: EGCG daily alone, EGCG daily with clomiphene citrate and EGCG daily with letrozole. The randomization scheme will be stratified for age groups 18-29 and 30-40 and presence of uterine fibroids. The pharmacokinetics and hepatic safety of EGCG with clomiphene citrate and letrozole are unknown. The trial conducted in women with and without fibroids will allow comparisons between these groups. The results of this study will be used to confirm hepatic safety for the larger multi-center FRIEND study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy women ≥18 to ≤40 years of age with or without uterine fibroids\n2. Must use a double-barrier method for contraception\n\nExclusion Criteria:\n\n1. Subjects using green tea/EGCG within 2 weeks prior to study enrollment\n2. Known liver disease (defined as AST or ALT\\>2 times normal, or total bilirubin \\>2.5 mg/dL).\n3. History of alcohol abuse (defined as \\>14 drinks/week) or binge drinking of ≥ 6 drinks at one time).\n4. Subject using hormonal contraceptives\n5. Subjects who are pregnant or breastfeeding\n6. Known hypersensitivity to the study drugs\n7. Any chronic disease'}, 'identificationModule': {'nctId': 'NCT04177693', 'briefTitle': 'Pharmacokinetics and Hepatic Safety of EGCG', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Pharmacokinetics and Hepatic Safety of EGCG', 'orgStudyIdInfo': {'id': '2000028370'}, 'secondaryIdInfos': [{'id': '1R01HD100369-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01HD100369-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EGCG daily alone.', 'description': 'EGCG daily alone. 800mg', 'interventionNames': ['Dietary Supplement: Epigallocatechin gallate (EGCG)']}, {'type': 'EXPERIMENTAL', 'label': 'EGCG with clomiphene citrate', 'description': 'EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.', 'interventionNames': ['Dietary Supplement: Epigallocatechin gallate (EGCG)', 'Drug: Clomiphene Citrate']}, {'type': 'EXPERIMENTAL', 'label': 'EGCG with letrozole', 'description': 'EGCG 800mg daily with letrozole 5mg for 5 days.', 'interventionNames': ['Dietary Supplement: Epigallocatechin gallate (EGCG)', 'Drug: Letrozole']}], 'interventions': [{'name': 'Epigallocatechin gallate (EGCG)', 'type': 'DIETARY_SUPPLEMENT', 'description': '800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months', 'armGroupLabels': ['EGCG daily alone.', 'EGCG with clomiphene citrate', 'EGCG with letrozole']}, {'name': 'Clomiphene Citrate', 'type': 'DRUG', 'otherNames': ['Clomid', 'Serophene'], 'description': '100 mg for 5 days', 'armGroupLabels': ['EGCG with clomiphene citrate']}, {'name': 'Letrozole', 'type': 'DRUG', 'otherNames': ['Femara'], 'description': '5 mg for 5 days', 'armGroupLabels': ['EGCG with letrozole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Esther Eisenberg, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)'}, {'name': 'Ayman Al-Hendy, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}, {'name': 'Heping Zhang, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Yale University'}, {'name': 'James Segars, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johns Hopkins University'}, {'name': 'Hugh Taylor, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Yale University'}, {'name': 'Frank Gonzales, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Illinois Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'University of Chicago', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair of Obstetrics, Gynecology and Reproductive Sciences', 'investigatorFullName': 'Hugh Taylor', 'investigatorAffiliation': 'Yale University'}}}}