Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-06 @ 2:36 AM
Study NCT ID:
NCT01887418
Status:
COMPLETED
Last Update Posted:
2018-01-11
First Post:
2013-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetic Study of Testosterone Enanthate
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007006', 'term': 'Hypogonadism'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013739', 'term': 'Testosterone'}, {'id': 'C004648', 'term': 'testosterone enanthate'}], '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': 'jjaffe@antarespharma.com', 'phone': '609-329-3020', 'title': 'Jonathan Jaffe, MD; Vice President Clinical Development', 'phoneExt': '324', 'organization': 'Antares Pharma Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were classified as any adverse events that occurred from Day1 (after screening) to a given treatment period until the subject completed the study. The duration of the study participation for subjects was approximately 19 weeks.', 'description': 'The Safety Population was defined as all randomized subjects who received at least 1 dose of investigational product. The safety population was 39 subjects.', 'eventGroups': [{'id': 'EG000', 'title': 'QuickShot™ - 100 mg Treatment A', 'description': 'QuickShot™ - Auto-injector device for SC use\n\nQuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone once a week', 'otherNumAtRisk': 15, 'otherNumAffected': 7, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'QuickShot™ - 50 mg Treatment B', 'description': 'QuickShot™ - Auto-injector device for SC use\n\nQuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone once a week.', 'otherNumAtRisk': 14, 'otherNumAffected': 6, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Delatestryl 200 mg IM Treatment C', 'description': "Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference\n\nDelatestryl 200 mg IM Treatment C: injected once only", 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vessel puncture site hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site hemorrhage*', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Prostatic specific antigen increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Paranasal sinus hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Number of Patients in the PK Parameter Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'QuickShot™ - 100 mg Treatment A', 'description': 'QuickShot™ - Auto-injector device for SC use\n\nQuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone'}, {'id': 'OG001', 'title': 'QuickShot™ - 50 mg Treatment B', 'description': 'QuickShot™ - Auto-injector device for SC use\n\nQuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone'}, {'id': 'OG002', 'title': 'Delatestryl 200 mg IM Treatment C', 'description': "Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference\n\nDelatestryl 200 mg IM Treatment C: Standard of care"}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'The number of TT Cavg (0-168h) values within the normal range (300-1100 ng/dL) following treatment with SC TE administered via QST or IM TE', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'QuickShot™ - 100 mg Treatment A', 'description': 'QuickShot™ - Auto-injector device for SC use\n\nQuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone'}, {'id': 'OG001', 'title': 'QuickShot™ - 50 mg Treatment B', 'description': 'QuickShot™ - Auto-injector device for SC use\n\nQuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone'}, {'id': 'OG002', 'title': 'Delatestryl 200 mg IM Treatment C', 'description': "Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference\n\nDelatestryl 200 mg IM Treatment C: Standard of care"}], 'classes': [{'categories': [{'measurements': [{'value': '150445.2', 'spread': '46998.76', 'groupId': 'OG000'}, {'value': '70955.7', 'spread': '20815.18', 'groupId': 'OG001'}, {'value': '278657.9', 'spread': '168295.52', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks', 'description': 'The area under the curve from time zero to last quantifiable concentration \\[AUC (0-t)\\] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST', 'unitOfMeasure': 'ng*hr/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK profile of TT obtained at Week 6 of treatment by QST'}, {'type': 'PRIMARY', 'title': 'The Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'QuickShot™ - 100 mg Treatment A', 'description': 'QuickShot™ - Auto-injector device for SC use\n\nQuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone'}, {'id': 'OG001', 'title': 'QuickShot™ - 50 mg Treatment B', 'description': 'QuickShot™ - Auto-injector device for SC use\n\nQuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone'}, {'id': 'OG002', 'title': 'Delatestryl 200 mg IM Treatment C', 'description': "Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference\n\nDelatestryl 200 mg IM Treatment C: Standard of care"}], 'classes': [{'categories': [{'measurements': [{'value': '1345.6', 'spread': '435.63', 'groupId': 'OG000'}, {'value': '622.4', 'spread': '129.51', 'groupId': 'OG001'}, {'value': '261.9', 'spread': '1310.34', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks', 'description': 'The maximum observed plasma concentration \\[Cmax\\] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK profile of TT obtained at Week 6 of treatment by QST'}, {'type': 'PRIMARY', 'title': 'The Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'QuickShot™ - 100 mg Treatment A', 'description': 'QuickShot™ - Auto-injector device for SC use\n\nQuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone'}, {'id': 'OG001', 'title': 'QuickShot™ - 50 mg Treatment B', 'description': 'QuickShot™ - Auto-injector device for SC use\n\nQuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone'}, {'id': 'OG002', 'title': 'Delatestryl 200 mg IM Treatment C', 'description': "Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference\n\nDelatestryl 200 mg IM Treatment C: Standard of care"}], 'classes': [{'categories': [{'measurements': [{'value': '895.5', 'spread': '279.75', 'groupId': 'OG000'}, {'value': '422.4', 'spread': '123.90', 'groupId': 'OG001'}, {'value': '1658.7', 'spread': '1001.76', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks', 'description': 'The average concentration \\[Cavg\\] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK profile of TT obtained at Week 6 of treatment by QST'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'QuickShot™ - 100 mg Treatment A', 'description': 'QuickShot™ - Auto-injector device for SC use\n\nQuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone once a week'}, {'id': 'FG001', 'title': 'QuickShot™ - 50 mg Treatment B', 'description': 'QuickShot™ - Auto-injector device for SC use\n\nQuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone once a week.'}, {'id': 'FG002', 'title': 'Delatestryl 200 mg IM Treatment C', 'description': "Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference\n\nDelatestryl 200 mg IM Treatment C: injected once only"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Travelling difficulties', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were screened at 10 sites in USA. In total, 39 eligible subjects were enrolled and received study medication (investigational SC QST or IM RLD): 14 subjects in 50 mg SC QST arm, 15 subjects in 100 mg SC QST arm and 10 subjects in 200 mg IM RLD arm.', 'preAssignmentDetails': 'Eligible patients were randomized to receive SC 50mg (Treatment B) or SC 100mg (Treatment A) QST and the subject who were on IM testosterone replacement therapy, received IM TE RLD (Treatment C).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'QuickShot™ - 100 mg Treatment A', 'description': 'QuickShot™ - Auto-injector device for SC use\n\nQuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone once a week for 6 weeks'}, {'id': 'BG001', 'title': 'QuickShot™ - 50 mg Treatment B', 'description': 'QuickShot™ - Auto-injector device for SC use\n\nQuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone once a week for 6 weeks'}, {'id': 'BG002', 'title': 'Delatestryl 200 mg IM Treatment C', 'description': "Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference\n\nDelatestryl 200 mg IM Treatment C: injected once only"}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.7', 'spread': '12.80', 'groupId': 'BG000'}, {'value': '54.0', 'spread': '12.42', 'groupId': 'BG001'}, {'value': '48.9', 'spread': '10.94', 'groupId': 'BG002'}, {'value': '52.9', 'spread': '12.14', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI) at screening (kg/m^2)', 'classes': [{'categories': [{'measurements': [{'value': '29.19', 'spread': '2.87', 'groupId': 'BG000'}, {'value': '28.51', 'spread': '2.17', 'groupId': 'BG001'}, {'value': '29.05', 'spread': '2.21', 'groupId': 'BG002'}, {'value': '28.91', 'spread': '2.43', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Total Testosterone (TT) (ng/dL)', 'classes': [{'categories': [{'measurements': [{'value': '201.50', 'spread': '71.53', 'groupId': 'BG000'}, {'value': '214.64', 'spread': '59.05', 'groupId': 'BG001'}, {'value': '735.10', 'spread': '187.96', 'groupId': 'BG002'}, {'value': '343.04', 'spread': '256.67', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The Safety Population (39 subjects) was all randomized subjects who received at least 1 dose of investigational product.\n\nThe PK Population (39 subjects) was all subjects from Safety Population who did not have a major protocol deviation that impacted the integrity of PK data and had at least 1 valid post-dose plasma concentration value.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-13', 'studyFirstSubmitDate': '2013-06-17', 'resultsFirstSubmitDate': '2015-07-20', 'studyFirstSubmitQcDate': '2013-06-24', 'lastUpdatePostDateStruct': {'date': '2018-01-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-09-23', 'studyFirstPostDateStruct': {'date': '2013-06-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks', 'description': 'The area under the curve from time zero to last quantifiable concentration \\[AUC (0-t)\\] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST'}, {'measure': 'The Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks', 'description': 'The maximum observed plasma concentration \\[Cmax\\] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST'}, {'measure': 'The Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks', 'description': 'The average concentration \\[Cavg\\] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST'}], 'secondaryOutcomes': [{'measure': 'Number of Patients in the PK Parameter Category', 'timeFrame': '6 weeks', 'description': 'The number of TT Cavg (0-168h) values within the normal range (300-1100 ng/dL) following treatment with SC TE administered via QST or IM TE'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypogonadism', 'Testosterone enanthate'], 'conditions': ['Hypogonadism']}, 'descriptionModule': {'briefSummary': 'Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.', 'detailedDescription': 'Standard Pharmacokinetic (PK) analyses of data for serum testosterone were done. Cmax, Area Under Curve (AUC), and Cavg were used for the comparison of relative bioavailability of the treatments and reference arm.\n\nSafety comparisons were based upon the occurrence, severity and rate of treatment emergent adverse events.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult males aged 18 to 75 with a documented diagnosis of hypogonadism\n\nExclusion Criteria:\n\n* Normal testosterone levels\n* Subjects with any clinically significant medical condition which, in the opinion of the Investigator, would make the subject an unsuitable candidate for enrollment in the study'}, 'identificationModule': {'nctId': 'NCT01887418', 'briefTitle': 'Pharmacokinetic Study of Testosterone Enanthate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Antares Pharma Inc.'}, 'officialTitle': '3 Arm Open-label Randomized Multidose Study of Pharmacokinetics, Safety & Tolerability of Testosterone Enanthate Administered Subcutaneously Via an Auto-injector Device or Intramuscular Testosterone Enanthate in Hypogonadal Adult Males', 'orgStudyIdInfo': {'id': 'QST-13-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QuickShot™ - 100 mg Treatment A', 'description': 'QuickShot™Testosterone - Auto-injector device for SC use', 'interventionNames': ['Drug: QuickShot™ - 100 mg Treatment A']}, {'type': 'EXPERIMENTAL', 'label': 'QuickShot™ - 50 mg Treatment B', 'description': 'QuickShot™Testosterone- Auto-injector device for SC use', 'interventionNames': ['Drug: QuickShot™ - 50 mg Treatment B']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delatestryl 200 mg IM Treatment C', 'description': "Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference", 'interventionNames': ['Drug: Delatestryl 200 mg IM Treatment C']}], 'interventions': [{'name': 'QuickShot™ - 50 mg Treatment B', 'type': 'DRUG', 'otherNames': ['Testosterone', 'Testosterone enanthate'], 'description': 'QuickShot™ for the delivery of testosterone', 'armGroupLabels': ['QuickShot™ - 50 mg Treatment B']}, {'name': 'QuickShot™ - 100 mg Treatment A', 'type': 'DRUG', 'otherNames': ['Testosterone', 'Testosterone enanthate'], 'description': 'QuickShot™ for the delivery of testosterone', 'armGroupLabels': ['QuickShot™ - 100 mg Treatment A']}, {'name': 'Delatestryl 200 mg IM Treatment C', 'type': 'DRUG', 'otherNames': ['Testosterone', 'Testosterone enanthate'], 'description': 'Standard of care', 'armGroupLabels': ['Delatestryl 200 mg IM Treatment C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02445', 'city': 'Brookline', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Mens Health Boston', 'geoPoint': {'lat': 42.33176, 'lon': -71.12116}}], 'overallOfficials': [{'name': 'Gary Bedel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prestige Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Antares Pharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}