Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
39 participants
INTERVENTIONAL
2013-09-30
2014-01-31
Brief Summary
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Detailed Description
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Safety comparisons were based upon the occurrence, severity and rate of treatment emergent adverse events.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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QuickShot™ - 100 mg Treatment A
QuickShot™Testosterone - Auto-injector device for SC use
QuickShot™ - 100 mg Treatment A
QuickShot™ for the delivery of testosterone
QuickShot™ - 50 mg Treatment B
QuickShot™Testosterone- Auto-injector device for SC use
QuickShot™ - 50 mg Treatment B
QuickShot™ for the delivery of testosterone
Delatestryl 200 mg IM Treatment C
Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference
Delatestryl 200 mg IM Treatment C
Standard of care
Interventions
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QuickShot™ - 50 mg Treatment B
QuickShot™ for the delivery of testosterone
QuickShot™ - 100 mg Treatment A
QuickShot™ for the delivery of testosterone
Delatestryl 200 mg IM Treatment C
Standard of care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
75 Years
MALE
No
Sponsors
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Antares Pharma Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Gary Bedel, MD
Role: PRINCIPAL_INVESTIGATOR
Prestige Clinical Research
Locations
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Mens Health Boston
Brookline, Massachusetts, United States
Countries
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Other Identifiers
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QST-13-002
Identifier Type: -
Identifier Source: org_study_id
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