Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2025-12-28 @ 6:26 AM
Study NCT ID:
NCT01717768
Status:
COMPLETED
Last Update Posted:
2015-12-15
First Post:
2012-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oral Testosterone for the Treatment of Hypogonadism
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007006', 'term': 'Hypogonadism'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013739', 'term': 'Testosterone'}], 'ancestors': [{'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'karl@tesorx.com', 'phone': '909-595-0500', 'title': 'Michael Oefelein, MD, Chief Medical Officer', 'phoneExt': '104', 'organization': 'TesoRx Pharma LLC'}, 'certainAgreement': {'otherDetails': 'Restriction Description: At 60 days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Site shall provide to Sponsor a copy and allow Sponsor 60 days to review and comment and provide written permission prior to publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: 120 mg BID', 'description': 'Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.', 'otherNumAtRisk': 17, 'otherNumAffected': 6, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part 1: 240 mg BID', 'description': 'Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.', 'otherNumAtRisk': 17, 'otherNumAffected': 8, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part 2: 120 mg BID', 'description': 'Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.', 'otherNumAtRisk': 17, 'otherNumAffected': 6, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part 3: A-B-C 120 mg QD', 'description': 'Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.\n\n* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part 3: B-C-A 120 mg QD', 'description': 'Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.\n\n* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.', 'otherNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part 3: C-A-B 120 mg QD', 'description': 'Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.\n\n* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.', 'otherNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part 4 Cohort 1: 60 mg BID', 'description': 'Oral TSX-002 60 mg BID for 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.', 'otherNumAtRisk': 17, 'otherNumAffected': 3, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part 4 Cohort 1: 60 mg TID', 'description': 'Oral TSX-002 60 mg TID for 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.', 'otherNumAtRisk': 17, 'otherNumAffected': 3, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Part 4 Cohort 2: 90 mg BID', 'description': 'Oral TSX-002 90 mg BID for 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Part 4 Cohort 2: 90 mg TID', 'description': 'Oral TSX-002 90 mg TID for 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.', 'otherNumAtRisk': 16, 'otherNumAffected': 2, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'Part 4 Cohort 3: 180 mg QD', 'description': 'Oral TSX-002 180 mg once daily (QD) for 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.', 'otherNumAtRisk': 16, 'otherNumAffected': 6, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'Part 4 Cohort 4: 120 mg BID', 'description': 'Oral TSX-002 120 mg BID for 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.', 'otherNumAtRisk': 16, 'otherNumAffected': 3, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Sinus Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Catheter site phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 0, 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{'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 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'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 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'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Achieving a 24 Hour Average Total Serum Testosterone Concentration (Cavg,0-24h) in the Range 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testosterone as the active ingredient.'}, {'id': 'OG008', 'title': 'Part 4 Cohort 4: 120 mg BID', 'description': 'Oral TSX-002 120 mg BID for 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '31', 'groupId': 'OG007'}, {'value': '27', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 days', 'description': 'Percentage of subjects achieving a 24-hour average total serum testosterone concentration (Cavg,0-24h) in the range of 300 to 1050 ng/dL after 15 days of treatment with TSX-002. PK samples taken at 0 ,2 ,4, 5 ,6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8 ,12, 13, 14, 15, 16, 17, 18, 20, 24 hours post-dose after 15 days of treatment for Part 4.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy analyses were conducted based on the modified intent-to-treat (MITT) analysis population, comprised of all randomized subjects who receive at least 1 dose of study drug and have at least 1 post-baseline measurement of total serum testosterone.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Cmax ≤ 1500 ng/dL After 15 Days of Treatment 2. Percentage of Subjects With Cmax ≥ 1800 and ≤ 2500 ng/dL After 15 Days of BID Treatment 3. Percentage of Subjects With Cmax > 2500 ng/dL After 15 Days of BID Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 120 mg BID', 'description': 'Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'OG001', 'title': 'Part 1: 240 mg BID', 'description': 'Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'OG002', 'title': 'Part 2: 120 mg BID', 'description': 'Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'OG003', 'title': 'Part 4 Cohort 1: 60 mg BID', 'description': 'Oral TSX-002 60 mg BID for 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'OG004', 'title': 'Part 4 Cohort 1: 60 mg TID', 'description': 'Oral TSX-002 60 mg three times daily (TID) for 15 days'}, {'id': 'OG005', 'title': 'Part 4 Cohort 2: 90 mg BID', 'description': 'Oral TSX-002 90 mg BID for 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'OG006', 'title': 'Part 4 Cohort 2: 90 mg TID', 'description': 'Oral TSX-002 90 mg TID for 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'OG007', 'title': 'Part 4 Cohort 3: 180 mg QD', 'description': 'Oral TSX-002 180 mg once daily (QD) for 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'OG008', 'title': 'Part 4 Cohort 4: 120 mg BID', 'description': 'Oral TSX-002 120 mg BID for 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}], 'classes': [{'title': 'Percentage of subjects with Cmax ≤ 1500 ng/dL afte', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '94.1', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '100', 'groupId': 'OG005'}, {'value': '100', 'groupId': 'OG006'}, {'value': '100', 'groupId': 'OG007'}, {'value': '93.75', 'groupId': 'OG008'}]}]}, {'title': 'Percentage of subjects with Cmax ≥ 1800 and ≤ 2500', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '6.25', 'groupId': 'OG008'}]}]}, {'title': 'Percentage of subjects with Cmax > 2500 ng/dL afte', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 days', 'description': 'Cmax. PK samples taken at 0, 2, 4, 5, 6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 13, 14, 15, 16, 17,18, 20, 24 hours post-dose after 15 days of treatment for Part 4.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'All efficacy analyses were conducted based on the modified intent-to-treat (MITT) analysis population, comprised of all randomized subjects who receive at least 1 dose of study drug and have at least 1 post-baseline measurement of total serum testosterone.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cavg 0-24 Hrs (ng/dL) After 120 mg Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3:120 mg QD Treatment A', 'description': 'Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.'}, {'id': 'OG001', 'title': 'Part 3:120 mg QD Treatment B', 'description': 'Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.'}, {'id': 'OG002', 'title': 'Part 3:120 mg QD Treatment C', 'description': 'Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.'}], 'classes': [{'categories': [{'measurements': [{'value': '296', 'spread': '108', 'groupId': 'OG000'}, {'value': '297', 'spread': '75', 'groupId': 'OG001'}, {'value': '273', 'spread': '109', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 hrs', 'description': 'PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3. Mean of Cavg values from all time points for 14 subjects.', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects that received 120 mg TSX-002 under defined Treatment conditions (timing of high-calorie, high-fat meal).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'AUC 0-24 Hrs After 120 mg Dose of TSX-002', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3:120 mg QD Treatment A', 'description': 'Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.'}, {'id': 'OG001', 'title': 'Part 3:120 mg QD Treatment B', 'description': 'Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.'}, {'id': 'OG002', 'title': 'Part 3:120 mg QD Treatment C', 'description': 'Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.'}], 'classes': [{'categories': [{'measurements': [{'value': '1941', 'spread': '1198', 'groupId': 'OG000'}, {'value': '2117', 'spread': '1351', 'groupId': 'OG001'}, {'value': '1516', 'spread': '1217', 'groupId': 'OG002'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hrs', 'description': 'AUC 0-24 hrs with PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3.', 'unitOfMeasure': 'hr×ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects that received 120 mg TSX-002 under defined Treatment conditions (timing of high-calorie, high-fat meal).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: 120 mg BID', 'description': 'Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'FG001', 'title': 'Part 1: 240 mg BID', 'description': 'Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'FG002', 'title': 'Part 2: 120 mg BID', 'description': 'Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'FG003', 'title': 'Part 3: A-B-C 120 mg QD', 'description': 'Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.\n\n* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'FG004', 'title': 'Part 3: B-C-A 120 mg QD', 'description': 'Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.\n\n* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.'}, {'id': 'FG005', 'title': 'Part 3: C-A-B 120 mg QD', 'description': 'Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.\n\n* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.'}, {'id': 'FG006', 'title': 'Part 4 Cohort 1: 60 mg BID', 'description': 'Oral TSX-002 60 mg BID for 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'FG007', 'title': 'Part 4 Cohort 1: 60 mg TID', 'description': 'Oral TSX-002 60 mg TID for 15 days\n\nTSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'FG008', 'title': 'Part 4 Cohort 2: 90 mg BID', 'description': 'Oral TSX-002 90 mg BID for 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'FG009', 'title': 'Part 4 Cohort 2: 90 mg TID', 'description': 'Oral TSX-002 90 mg TID for 15 days'}, {'id': 'FG010', 'title': 'Part 4 Cohort 3: 180 mg QD', 'description': 'Oral TSX-002 180 mg once daily (QD) for 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'FG011', 'title': 'Part 4 Cohort 4: 120 mg BID', 'description': 'Oral TSX-002 120 mg BID for 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}], 'periods': [{'title': 'Part 1 (Duration of 15 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}, {'title': 'Part 2 (Duration of 15 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}, {'title': 'Part 3 - Treatment 1 (Duration of 1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}, {'title': 'Part 3 - Treatment 2 (Duration of 1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}, {'title': 'Part 3 - Treatment 3 (Duration of 1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}, {'title': 'Part 4-Treatment 1 (Duration of 15 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '17'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '16'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '16'}, {'groupId': 'FG011', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '17'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '16'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '16'}, {'groupId': 'FG011', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}]}]}, {'title': 'Part 4-Treatment 2 (Duration of 15 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '17'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '16'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '15'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '15'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '130 subjects were recruited at 1 center in the US from October 2012 to May 2014. The study was designed with 4 parts, including 9 different dosages of the investigational drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}, {'value': '16', 'groupId': 'BG008'}, {'value': '16', 'groupId': 'BG009'}, {'value': '130', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: 120 mg BID', 'description': 'Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'BG001', 'title': 'Part 1: 240 mg BID', 'description': 'Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'BG002', 'title': 'Part 2: 120 mg BID', 'description': 'Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'BG003', 'title': 'Part 3: A-B-C 120 mg QD', 'description': 'Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.\n\n* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'BG004', 'title': 'Part 3: B-C-A 120 mg QD', 'description': 'Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.\n\n* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'BG005', 'title': 'Part 3: C-A-B 120 mg QD', 'description': 'Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.\n\n* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'BG006', 'title': 'Part 4 Cohort 1: 60 mg BID/ 60 mg TID', 'description': 'Oral TSX-002 60 mg BID for 15 days then 60 mg TID for 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'BG007', 'title': 'Part 4 Cohort 2: 90 mg BID/ 90 mg TID', 'description': 'Oral TSX-002 90 mg BID for 15 days then 90 mg TID for 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'BG008', 'title': 'Part 4 Cohort 3: 180 mg QD', 'description': 'Oral TSX-002 180 mg once daily (QD) for 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'BG009', 'title': 'Part 4 Cohort 4: 120 mg BID', 'description': 'Oral TSX-002 120 mg BID for 15 days\n\nTSX-002: TSX-002 are capsules with testosterone as the active ingredient.'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<50 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '38', 'groupId': 'BG010'}]}]}, {'title': '50-64 years', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '9', 'groupId': 'BG009'}, {'value': '69', 'groupId': 'BG010'}]}]}, {'title': '65-74 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '19', 'groupId': 'BG010'}]}]}, {'title': '75 years or older', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}, {'value': '16', 'groupId': 'BG008'}, {'value': '16', 'groupId': 'BG009'}, {'value': '130', 'groupId': 'BG010'}]}]}], 'paramType': 'NUMBER', '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'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '27', 'groupId': 'BG010'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '13', 'groupId': 'BG008'}, {'value': '12', 'groupId': 'BG009'}, {'value': '96', 'groupId': 'BG010'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}, {'value': '16', 'groupId': 'BG008'}, {'value': '16', 'groupId': 'BG009'}, {'value': '130', 'groupId': 'BG010'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-14', 'studyFirstSubmitDate': '2012-10-25', 'resultsFirstSubmitDate': '2015-08-14', 'studyFirstSubmitQcDate': '2012-10-26', 'lastUpdatePostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-14', 'studyFirstPostDateStruct': {'date': '2012-10-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cavg 0-24 Hrs (ng/dL) After 120 mg Dose', 'timeFrame': '24 hrs', 'description': 'PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3. Mean of Cavg values from all time points for 14 subjects.'}, {'measure': 'AUC 0-24 Hrs After 120 mg Dose of TSX-002', 'timeFrame': '24 hrs', 'description': 'AUC 0-24 hrs with PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3.'}], 'primaryOutcomes': [{'measure': 'Percentage of Subjects Achieving a 24 Hour Average Total Serum Testosterone Concentration (Cavg,0-24h) in the Range of 300 to 1050 ng/dL After 15 Days of Treatment With TSX-002', 'timeFrame': '15 days', 'description': 'Percentage of subjects achieving a 24-hour average total serum testosterone concentration (Cavg,0-24h) in the range of 300 to 1050 ng/dL after 15 days of treatment with TSX-002. PK samples taken at 0 ,2 ,4, 5 ,6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8 ,12, 13, 14, 15, 16, 17, 18, 20, 24 hours post-dose after 15 days of treatment for Part 4.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects With Cmax ≤ 1500 ng/dL After 15 Days of Treatment 2. Percentage of Subjects With Cmax ≥ 1800 and ≤ 2500 ng/dL After 15 Days of BID Treatment 3. Percentage of Subjects With Cmax > 2500 ng/dL After 15 Days of BID Treatment', 'timeFrame': '15 days', 'description': 'Cmax. PK samples taken at 0, 2, 4, 5, 6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 13, 14, 15, 16, 17,18, 20, 24 hours post-dose after 15 days of treatment for Part 4.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hypogonadism', 'Gonadal Disorders', 'Endocrine System Diseases', 'Testosterone', 'Testosterone enanthate', 'Testosterone undecanoate', 'Testosterone 17 beta-cypionate', 'Methyltestosterone', 'Androgens', 'Hormones', 'Hormones, Hormone Substitutes, and Hormone Antagonists', 'Physiological Effects of Drugs', 'Pharmacologic Actions', 'Therapeutic Uses', 'Anabolic Agents'], 'conditions': ['Hypogonadism']}, 'descriptionModule': {'briefSummary': 'Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms.\n\nThe purpose of this study is to evaluate the ability of TSX-002, which is testosterone provided in easy to swallow capsules, to maintain serum (blood) testosterone levels within the normal range in hypogonadal men. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the tolerability of TSX-002, which will be taken orally twice per day for 15 days. In addition, the study is intended to determine a dosing regimen(s) that achieves testosterone levels within the normal range. Related Outcome Measures will be reported for Parts 1, 2, and 4.\n\nA portion of the study (Part 3) to also assess the effect of a high-calorie, high-fat meal on the single dose pharmacokinetic exposure of TSX-002. Related outcome measures to be reported for Part 3.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prior documentation of a diagnosis of hypogonadism as evidenced by a screening serum testosterone \\< 300 ng/dL (based on the average of 2 morning samples taken at least 1 week apart)\n* Men over the age of 18 years with a body mass index (BMI) \\< 39.0 kg/m2 and weighing ≥ 55 kg\n* Hemoglobin levels at screening and baseline \\> 12.5 g/dL\n* Testosterone treatment not contraindicated\n* No evidence of suspected reversible hypogonadism\n* Willing to abstain from current treatment for hypogonadism in accordance with approved labeling to facilitate an appropriate washout period before study participation (for nondepot formulations of testosterone only)\n* Understands the requirements of the study and voluntarily consents to participate in the study\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01717768', 'briefTitle': 'Oral Testosterone for the Treatment of Hypogonadism', 'organization': {'class': 'INDUSTRY', 'fullName': 'TesoRx Pharma, LLC'}, 'officialTitle': 'A Phase 2, Randomized, Double-blind, Dose Response Study of Oral Testosterone in Subjects With Hypogonadism', 'orgStudyIdInfo': {'id': 'TT-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: 120 mg BID', 'description': 'Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days', 'interventionNames': ['Drug: TSX-002']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: 240 mg BID', 'description': 'Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days', 'interventionNames': ['Drug: TSX-002']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: 120 mg BID', 'description': 'Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days', 'interventionNames': ['Drug: TSX-002']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3: A-B-C 120 mg QD', 'description': 'Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.\n\n* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.', 'interventionNames': ['Drug: TSX-002']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3: B-C-A 120 mg QD', 'description': 'Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.\n\n* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.', 'interventionNames': ['Drug: TSX-002']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3: C-A-B 120 mg QD', 'description': 'Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.\n\n* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.\n* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.', 'interventionNames': ['Drug: TSX-002']}, {'type': 'EXPERIMENTAL', 'label': 'Part 4 Cohort 1: 60 mg BID/ 60 mg TID', 'description': 'Oral TSX-002 60 mg BID for 15 days then 60 mg TID for 15 days', 'interventionNames': ['Drug: TSX-002']}, {'type': 'EXPERIMENTAL', 'label': 'Part 4 Cohort 2: 90 mg BID/ 90 mg TID', 'description': 'Oral TSX-002 90 mg BID for 15 days then 90 mg TID for 15 days', 'interventionNames': ['Drug: TSX-002']}, {'type': 'EXPERIMENTAL', 'label': 'Part 4 Cohort 3: 180 mg QD', 'description': 'Oral TSX-002 180 mg once daily (QD) for 15 days', 'interventionNames': ['Drug: TSX-002']}, {'type': 'EXPERIMENTAL', 'label': 'Part 4 Cohort 4: 120 mg BID', 'description': 'Oral TSX-002 120 mg BID for 15 days', 'interventionNames': ['Drug: TSX-002']}], 'interventions': [{'name': 'TSX-002', 'type': 'DRUG', 'otherNames': ['Testosterone'], 'description': 'TSX-002 are capsules with testosterone as the active ingredient.', 'armGroupLabels': ['Part 1: 120 mg BID', 'Part 1: 240 mg BID', 'Part 2: 120 mg BID', 'Part 3: A-B-C 120 mg QD', 'Part 3: B-C-A 120 mg QD', 'Part 3: C-A-B 120 mg QD', 'Part 4 Cohort 1: 60 mg BID/ 60 mg TID', 'Part 4 Cohort 2: 90 mg BID/ 90 mg TID', 'Part 4 Cohort 3: 180 mg QD', 'Part 4 Cohort 4: 120 mg BID']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Urology Group of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'John Kowalczyk, DO, FACOS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urology Group of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TesoRx Pharma, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}