Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-02-20 @ 6:39 PM
Study NCT ID:
NCT02159469
Status:
COMPLETED
Last Update Posted:
2018-02-07
First Post:
2014-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism
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': '609-359-3020', 'title': 'Jonathan Jaffe, MD', 'organization': 'Antares Pharma, Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Incidence of Adverse Events Throughout the Study, During the 12-Week Titration Phase, and During the Extended Treatment Phase up to 52 weeks', 'description': 'Treatment-emergent adverse events were defined as any event that started in the study on or after the first dosing of IP, or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.\n\nIn total, 125 (83.3%) patients had TEAEs during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Testosterone Enanthate Auto-injector', 'description': 'Testosterone enanthate administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.\n\nTestosterone enanthate auto-injector Dose Adjustment 50 mg / 75 mg / 100 mg', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 125, 'seriousNumAtRisk': 150, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Hematocrit increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Prostatic specific antigen increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood testosterone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sleep apnea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Polycythemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Depression', 'notes': 'Worsening depressive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Suicide', 'notes': 'SUICIDE, METHOD UNKNOWN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vertigo', 'notes': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Testosterone Enanthate Auto-injector', 'description': 'Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.'}], 'classes': [{'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'The primary objective of this study was to demonstrate the efficacy of QST (QuickShot Testosterone) administered subcutaneously once each week to adult males with hypogonadism.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Population consisted of all patients who received at least 1 dose of the investigational product. Percentage was calculated using the number of patients in the column heading as the denominator.'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Testosterone Enanthate Auto-injector', 'description': 'Testosterone enanthate administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.\n\nTestosterone enanthate auto-injector Dose Adjustment 50 mg / 75 mg / 100 mg'}], 'classes': [{'title': 'Patients with any TEAE', 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}]}]}, {'title': 'Patients with any TEAE related to IP', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}, {'title': 'Patients with any SAE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Patients with TEAE leading to discontinuation', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Patients discontinued due to IP related TEAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Patients with any adverse event leading to death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '52 weeks', 'description': '* Incidence of adverse events throughout the study\n* Incidence and severity of injection site reactions throughout the study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TEAE (Treatment-emergent adverse event)s were defined as any event that started on or after the first dosing of IP (Investigational Product), or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. The Population consisted of all patients who received at least 1 dose of the investigational product.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'QST 50 mg / 75 mg / 100 mg', 'description': 'Testosterone enanthate 50 mg / 75 mg / 100 mg dose administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}]}, {'type': 'Completed 12 Week', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}], 'dropWithdraws': [{'type': 'Missing Completion status', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': "Sponsor's request", 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Met Stopping Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Multiple', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}]}]}], 'recruitmentDetails': 'Approximately 150 patients were enrolled in this study. 128 patients completed through at least Week 26, 98 patients completed through Week 52, and 97 patients completed the full study (through the Follow-up Visit).', 'preAssignmentDetails': 'The study was designed to ensure a minimum of 100 patients completed a collection of 26 weeks of safety data, and a minimum of 50 patients completed a collection of 52 weeks of safety data. Minimum enrollment goals were exceeded.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Testosterone Enanthate Auto-injector', 'description': 'Testosterone enanthate administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.\n\nTestosterone enanthate auto-injector Dose Adjustment: 50 mg / 75 mg / 100 mg'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.4', 'spread': '12.04', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '150', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '142', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '133', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Masked dose assignment based upon Testosterone levels; Individual patients may receive all three dose levels.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'dispFirstSubmitDate': '2017-08-01', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-11', 'studyFirstSubmitDate': '2014-06-06', 'dispFirstSubmitQcDate': '2017-08-01', 'resultsFirstSubmitDate': '2017-12-12', 'studyFirstSubmitQcDate': '2014-06-06', 'dispFirstPostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-12', 'studyFirstPostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL)', 'timeFrame': '12 weeks', 'description': 'The primary objective of this study was to demonstrate the efficacy of QST (QuickShot Testosterone) administered subcutaneously once each week to adult males with hypogonadism.'}], 'secondaryOutcomes': [{'measure': 'Safety and Tolerability', 'timeFrame': '52 weeks', 'description': '* Incidence of adverse events throughout the study\n* Incidence and severity of injection site reactions throughout the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypogonadism', 'Testosterone enanthate'], 'conditions': ['Hypogonadism']}, 'descriptionModule': {'briefSummary': 'Evaluation of efficacy and safety of testosterone enanthate administered subcutaneously using an auto-injector', 'detailedDescription': "This study will evaluate, if testosterone enanthate administered subcutaneously once each week by an auto-injector to men with low testosterone, can raise their levels into the normal range.\n\nThe study will investigate the ability to adjust testosterone enanthate dose levels using single point blood concentrations.\n\nSafety and tolerability of testosterone administration will be evaluated along with the patient's ability to use the auto-injector and follow the instructions for auto-injector use."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult males aged ≥ 18 year of age with a documented diagnosis of hypogonadism\n* Total testosterone levels \\< 300 ng/dL at two qualification visits\n* Patients in good general health\n\nExclusion Criteria:\n\n* Allergy to sesame or testosterone products\n* BMI ≥ 40 kg/m2\n* Hematocrit ≥ 52%\n* History or current evidence of breast or prostate cancer\n* Elevated PSA (Prostate-Specific Antigen) for age.\n* Abnormal DRE (digital rectal examination)\n* Obstructive uropathy of prostatic origin\n* Poorly controlled diabetes\n* Congestive heart failure\n* Within 6 months of screening, MI (myocardial ischemia), unstable angina leading to hospitalization, percutaneous coronary intervention, coronary artery bypass graft, uncontrolled cardiac arrhythmia, stroke transient ischemia attack, ceratoid revascularization, endovascular procedure, or surgical intervention for peripheral vascular disease.\n* History or current treatment of thromboembolic disease.\n* Use of ACTH (adrenocorticotropic hormone) or oral/depot corticosteroids within 6 weeks of screening.\n* History of severe, untreated sleep apnea\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\n* Positive serology for HIV, hepatitis B or hepatitis C\n* Current evidence of drug or alcohol abuse.\n* Skin conditions in injection site that could confound injection site assessments.\n* Administration of other investigational compounds within one month of screening or 5 half-lives of the investigational compound, whichever is longer).\n* Use of estrogen, GnRH (gonadotropin-releasing hormone) or growth hormone within 12 months of screening.\n* Use of other androgens (DHEA(Dehydroepiandrosterone), anabolic steroids, other sex hormones) or other substances/supplements know to affect the PK (pharmacokinetics) of testosterone enanthate\n* Considered or scheduled surgical or dental procedures associated with blood loss ≥500 mL during study.\n* Donation of plasma or blood within 56 days of screening or history of donation of \\> 50 mL of blood or plasma within 3 months of screening.\n* Donation of plasma or blood during study'}, 'identificationModule': {'nctId': 'NCT02159469', 'acronym': 'STEADY', 'briefTitle': 'Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism', 'organization': {'class': 'INDUSTRY', 'fullName': 'Antares Pharma Inc.'}, 'officialTitle': 'A Multiple-dose, 52-week Study to Evaluate the Efficacy and Safety of Testosterone Enanthate Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism', 'orgStudyIdInfo': {'id': 'QST-13-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Testosterone enanthate auto-injector', 'description': 'Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.', 'interventionNames': ['Combination Product: Testosterone enanthate auto-injector']}], 'interventions': [{'name': 'Testosterone enanthate auto-injector', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Testosterone', 'Testosterone enanthate', 'QuickShot® Testosterone (QST)'], 'description': 'Dose Adjustment to 50 mg or 75 mg or 100 mg based upon Testosterone levels', 'armGroupLabels': ['Testosterone enanthate auto-injector']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Burbank', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'city': 'Torrance', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'city': 'Upland', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Oviedo', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.67, 'lon': -81.20812}}, {'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'city': 'Brookline', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.33176, 'lon': -71.12116}}, {'city': 'Methuen', 'state': 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