Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-03-03 @ 9:16 PM
Study NCT ID:
NCT02233751
Status:
COMPLETED
Last Update Posted:
2019-04-19
First Post:
2014-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetic Study of Subcutaneous 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jjaffe@antarespharma.com', 'phone': '609-359-3020', 'title': 'Jonathan Jaffe, MD', 'organization': 'Antares Pharma, Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '14 days', 'description': 'Safety assessments included adverse events and injection site assessments.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment A', 'description': 'Testosterone enanthate auto-injector (SC injection) Treatment A', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment B', 'description': 'Testosterone enanthate auto-injector (SC injections) Treatment B', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Concentration (Cmax) for Serum Testosterone and Testosterone Enanthate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Testosterone Enanthate 50 mg', 'description': 'Testosterone enanthate auto-injector 50 mg'}, {'id': 'OG001', 'title': 'Testosterone Enanthate 200 mg', 'description': 'Testosterone enanthate auto-injector 200 mg'}], 'classes': [{'title': 'Serum testosterone', 'categories': [{'measurements': [{'value': '773.7', 'spread': '121.26', 'groupId': 'OG000'}, {'value': '1487.0', 'spread': '405.34', 'groupId': 'OG001'}]}]}, {'title': 'Serum testosterone enanthate', 'categories': [{'measurements': [{'value': '49.25', 'spread': '6.90', 'groupId': 'OG000'}, {'value': '267.33', 'spread': '75.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Maximum serum concentrations occurring during an 8 days study window', 'description': 'Cmax = Maximum blood concentration (ng/dL) of TT=Total Testosterone and TE=Testosterone Enanthate', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Healthy normal male volunteers'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve From Time Zero to Time t', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Testosterone Enanthate 50 mg', 'description': 'Testosterone enanthate auto-injector 50 mg'}, {'id': 'OG001', 'title': 'Testosterone Enanthate 200 mg', 'description': 'Testosterone enanthate auto-injector 200 mg'}], 'classes': [{'title': 'TT', 'categories': [{'measurements': [{'value': '103731.5', 'spread': '12591.81', 'groupId': 'OG000'}, {'value': '176112.8', 'spread': '47349.64', 'groupId': 'OG001'}]}]}, {'title': 'TE', 'categories': [{'measurements': [{'value': '6122.2', 'spread': '929.12', 'groupId': 'OG000'}, {'value': '33535.5', 'spread': '9977.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '168 hrs', 'description': 'AUC(0-168h) (ng⋅hr/dL) = area under the concentration-time curve from time zero to Day 8 (1 week);', 'unitOfMeasure': '(ng⋅hr/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve From Time Zero to Infinity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Testosterone Enanthate 50 mg', 'description': 'Testosterone enanthate auto-injector 50 mg'}, {'id': 'OG001', 'title': 'Testosterone Enanthate 200 mg', 'description': 'Testosterone enanthate auto-injector 200 mg'}], 'classes': [{'title': 'TT', 'categories': [{'measurements': [{'value': '279062.2', 'spread': '35973.32', 'groupId': 'OG000'}, {'value': '362627.4', 'spread': '138773.09', 'groupId': 'OG001'}]}]}, {'title': 'TE', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'AUC(0-inf) is not calculated when the constant lambda z is not assigned, which occurs if the terminal elimination phase is not linear, if the tmax is one of the 3 last data points, or if the regression coefficient is \\<0.8.', 'groupId': 'OG000'}, {'value': '62497.5', 'spread': '24618.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'time zero to infinity', 'description': 'AUC(0-inf) (ng⋅hr/dL) = area under the concentration-time curve from time zero to infinity', 'unitOfMeasure': '(ng⋅hr/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Concentration (Tmax)(hr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Testosterone Enanthate 50 mg', 'description': 'Testosterone enanthate auto-injector 50 mg'}, {'id': 'OG001', 'title': 'Testosterone Enanthate 200 mg', 'description': 'Testosterone enanthate auto-injector 200 mg'}], 'classes': [{'title': 'TT', 'categories': [{'measurements': [{'value': '40.51', 'spread': '52.95', 'groupId': 'OG000'}, {'value': '19.00', 'spread': '7.75', 'groupId': 'OG001'}]}]}, {'title': 'TE', 'categories': [{'measurements': [{'value': '82.01', 'spread': '53.88', 'groupId': 'OG000'}, {'value': '74.00', 'spread': '57.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The sample time of Cmax during a 168 hour sampling interval', 'description': 'tmax = Time to reach maximum concentration', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Half-life (t 1/2)(hr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Testosterone Enanthate 50 mg', 'description': 'Testosterone enanthate auto-injector 50 mg'}, {'id': 'OG001', 'title': 'Testosterone Enanthate 200 mg', 'description': 'Testosterone enanthate auto-injector 200 mg'}], 'classes': [{'title': 'TT', 'categories': [{'measurements': [{'value': '261.73', 'spread': '99.04', 'groupId': 'OG000'}, {'value': '131.75', 'spread': '28.05', 'groupId': 'OG001'}]}]}, {'title': 'TE', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Half-life (t 1/2) is not calculated when the constant lambda z is not assigned, which occurs if the terminal elimination phase is not linear, if the tmax is one of the 3 last data points, or if the regression coefficient is \\<0.8.', 'groupId': 'OG000'}, {'value': '133.00', 'spread': '67.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '168 hours', 'description': 't 1/2 = Half-life is the time required for a concentration to reduce to half its initial value', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clearance CL/F (L/hr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Testosterone Enanthate 50 mg', 'description': 'Testosterone enanthate auto-injector 50 mg'}, {'id': 'OG001', 'title': 'Testosterone Enanthate 200 mg', 'description': 'Testosterone enanthate auto-injector 200 mg'}], 'classes': [{'title': 'TT', 'categories': [{'measurements': [{'value': '18.07', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '60.46', 'spread': '21.21', 'groupId': 'OG001'}]}]}, {'title': 'TE', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Clearance - CL/F is not calculated when the constant lambda z is not assigned, which occurs if the terminal elimination phase is not linear, if the tmax is one of the 3 last data points, or if the regression coefficient is \\<0.8.', 'groupId': 'OG000'}, {'value': '352.84', 'spread': '127.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '168 hours', 'description': 'Clearance - volume of plasma from which TT/TE is completely removed per unit time', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vd/F (L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Testosterone Enanthate 50 mg', 'description': 'Testosterone enanthate auto-injector 50 mg'}, {'id': 'OG001', 'title': 'Testosterone Enanthate 200 mg', 'description': 'Testosterone enanthate auto-injector 200 mg'}], 'classes': [{'title': 'TT', 'categories': [{'measurements': [{'value': '6655.8', 'spread': '1702.04', 'groupId': 'OG000'}, {'value': '10959.5', 'spread': '2040.99', 'groupId': 'OG001'}]}]}, {'title': 'TE', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Vd/F is not calculated when the constant lambda z is not assigned, which occurs if the terminal elimination phase is not linear, if the tmax is one of the 3 last data points, or if the regression coefficient is \\<0.8.', 'groupId': 'OG000'}, {'value': '62366.4', 'spread': '23950.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '168 hours', 'description': 'Vd/F (L) = Apparent volume of distribution', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Testosterone Enanthate 50 mg', 'description': 'Testosterone enanthate auto-injector\n\n* 50 mg SC injection'}, {'id': 'FG001', 'title': 'Testosterone Enanthate 200 mg', 'description': 'Testosterone enanthate auto-injector\n\n* 200 mg SC injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Pharmacokinetics of single doses of Testosterone Enanthate administered via a drug-auto injector combination product in Healthy Male Subjects', 'preAssignmentDetails': 'Two dose groups, Testosterone Enanthate 50 mg and Testosterone Enanthate 200 mg , were evaluated in parallel with 6 subjects in each dose group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Testosterone Enanthate 50 mg', 'description': 'Testosterone enanthate auto-injector 50 mg'}, {'id': 'BG001', 'title': 'Testosterone Enanthate 200 mg', 'description': 'Testosterone enanthate auto-injector 200 mg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.0', 'spread': '11.54', 'groupId': 'BG000'}, {'value': '37.5', 'spread': '10.84', 'groupId': 'BG001'}, {'value': '37.8', 'spread': '10.68', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'In total, 12 subjects were administered study drug: 6 subjects received 50 mg SC QST and 6 subjects received 200 mg SC QST. There were no discontinuations in the study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The dose assignment was random among the enrolled participants.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-18', 'studyFirstSubmitDate': '2014-09-02', 'resultsFirstSubmitDate': '2017-12-19', 'studyFirstSubmitQcDate': '2014-09-04', 'lastUpdatePostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-18', 'studyFirstPostDateStruct': {'date': '2014-09-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Concentration (Cmax) for Serum Testosterone and Testosterone Enanthate', 'timeFrame': 'Maximum serum concentrations occurring during an 8 days study window', 'description': 'Cmax = Maximum blood concentration (ng/dL) of TT=Total Testosterone and TE=Testosterone Enanthate'}, {'measure': 'Area Under the Concentration-time Curve From Time Zero to Time t', 'timeFrame': '168 hrs', 'description': 'AUC(0-168h) (ng⋅hr/dL) = area under the concentration-time curve from time zero to Day 8 (1 week);'}, {'measure': 'Area Under the Concentration-time Curve From Time Zero to Infinity', 'timeFrame': 'time zero to infinity', 'description': 'AUC(0-inf) (ng⋅hr/dL) = area under the concentration-time curve from time zero to infinity'}], 'secondaryOutcomes': [{'measure': 'Time to Maximum Concentration (Tmax)(hr)', 'timeFrame': 'The sample time of Cmax during a 168 hour sampling interval', 'description': 'tmax = Time to reach maximum concentration'}, {'measure': 'Half-life (t 1/2)(hr)', 'timeFrame': '168 hours', 'description': 't 1/2 = Half-life is the time required for a concentration to reduce to half its initial value'}, {'measure': 'Clearance CL/F (L/hr)', 'timeFrame': '168 hours', 'description': 'Clearance - volume of plasma from which TT/TE is completely removed per unit time'}, {'measure': 'Vd/F (L)', 'timeFrame': '168 hours', 'description': 'Vd/F (L) = Apparent volume of distribution'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Healthy Adult Males'], 'conditions': ['Hypogonadism']}, 'descriptionModule': {'briefSummary': 'Evaluation of pharmacokinetics of subcutaneous testosterone enanthate', 'detailedDescription': 'Evaluation of pharmacokinetics and safety profile of testosterone enanthate injected subcutaneously via auto-injector in healthy male volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Male', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult male subjects, 18-55 years of age, inclusive, at the time of signing the informed consent;\n* Body weight ≥50 kg and body mass index within the range 19-30 kg/m2, inclusive, at screening;\n* Medically healthy subjects with clinically insignificant screening and check-in results (medical history, 12-lead electrocardiogram \\[ECG\\], physical examination, and laboratory tests); and\n* Subjects who are able to understand and are willing and able to give their signed informed consent before any trial-related procedures are performed.\n\nExclusion Criteria:\n\n* Currently diagnosed or a history of asthma, urticarial, angioedema, anaphylaxis, atopic dermatitis, clinically significant abnormality of skin of the abdomen, cancer, diabetes, or any other clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, hematological, dermatological, venereal, neurological, psychiatric, or other major disorders;\n* History of benign prostate hypertrophy (BPH), prostate cancer, or abnormal prostate specific antigen (PSA) values;\n* PSA level \\> 3 ng/ml at screening;\n* Presence or history of gastrointestinal, hepatic or renal disease, or any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines;\n* Systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 40 to 90 mmHg, and/or pulse rate outside the range of 40 to 100 beats per minute after one repeat at screening or check-in;\n* Abnormal ECG at screening as judged by the Investigator;\n* History of clinically significant drug and/or food allergies as determined by the Investigator;\n* Allergy to sesame, sesame oil, or a history of hypersensitivity or idiosyncratic reaction to compounds related to the study drug\n* Subjects undergoing current treatment with other androgens (i.e. dehydroepiandrosterone \\[DHEA\\]), anabolic steroids, other sex hormones, or drugs that interfere with the metabolism of testosterone (i.e. opioids, anastrozole, clomiphene, dutasteride, finasteride, flutamide, ketoconazole, spironolactone, and testolactone);\n* Subjects treated within the past 12 months with estrogens, gonadotropin releasing hormone (GnRH) agonists, or growth hormone;\n* Prescription, over the counter medications, vitamins, herbal and dietary supplements taken within 7 days or 5 half-lives (whichever is longer) prior to the dose of study medication and duration of the study;\n* Positive screen for human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C at screening;\n* Positive urine screen for drugs of abuse (amphetamine, barbiturates, benzodiazepines, cocaine, marijuana, methadone, methamphetamines, oxycodone, and opiates) or positive breath alcohol test at screening and check-in'}, 'identificationModule': {'nctId': 'NCT02233751', 'briefTitle': 'Pharmacokinetic Study of Subcutaneous Testosterone Enanthate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Antares Pharma Inc.'}, 'officialTitle': 'An Open-Label Study to Evaluate the Pharmacokinetics of Testosterone Enanthate After Single-Dose Injection Via QuickShot® Testosterone in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'QST-14-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Testosterone enanthate auto-injector - 50 mg', 'description': 'Testosterone enanthate auto-injector - 50 mg (SC injection)', 'interventionNames': ['Combination Product: Testosterone enanthate auto-injector']}, {'type': 'EXPERIMENTAL', 'label': 'Testosterone enanthate auto-injector - 200 mg', 'description': 'Testosterone enanthate auto-injector- 200 mg (SC injection)', 'interventionNames': ['Combination Product: Testosterone enanthate auto-injector']}], 'interventions': [{'name': 'Testosterone enanthate auto-injector', 'type': 'COMBINATION_PRODUCT', 'description': 'Randomization then administration of combination product study medication according to group assignment', 'armGroupLabels': ['Testosterone enanthate auto-injector - 200 mg', 'Testosterone enanthate auto-injector - 50 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45227', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Medpace Clinical Pharmacology Unit', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Jonathan Jaffe, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Antares Pharma Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Antares Pharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}