Clinical TrialID 5534
Pharmacokinetic Study of Subcutaneous Testosterone Enanthate
NCT02233751
Hypogonadism
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5534
- Evidence Id
- 5534
- Core Evidence Id
- 5534
- Source Clinical Trial Id
- 5576
- Herb2 Clinical Trial Id
- HBCT005576
- Nct Id
- NCT02233751
- Title
- Pharmacokinetic Study of Subcutaneous Testosterone Enanthate
- Status
- Completed
- Phase
- Phase 1
- Study Result
- Yes
- Study Condition
- Hypogonadism
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- COMBINATION_PRODUCT: Testosterone enanthate auto-injector
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- Male
- Age
- Adult
- Enrollment
- 12
- Outcome Measure
- Maximum Concentration (Cmax) for Serum Testosterone and Testosterone Enanthate, Cmax = Maximum blood concentration (ng/dL) of TT=Total Testosterone and TE=Testosterone Enanthate, Maximum serum concentrations occurring during an 8 days study window|Area Under the Concentration-time Curve From Time Zero to Time t, AUC(0-168h) (ng⋅hr/dL) = area under the concentration-time curve from time zero to Day 8 (1 week);, 168 hrs|Area Under the Concentration-time Curve From Time Zero to Infinity, AUC(0-inf) (ng⋅hr/dL) = area under the concentration-time curve from time zero to infinity, time zero to infinity
- Sponsor Collaborator
- Antares Pharma Inc.
- Funded By
- INDUSTRY
- Location
- Medpace Clinical Pharmacology Unit, Cincinnati, Ohio, 45227, United States
- Other Id
- QST-14-004
- Start Date
- 2014-09
- Primary Completion Date
- 2014-10
- Completion Date
- 2014-10
- First Posted
- 2014-09-08
- Results First Posted
- 2019-04-19
- Last Update Posted
- 2019-04-19
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT02233751
- Title Cn
- Title En
- Pharmacokinetic Study of Subcutaneous Testosterone Enanthate
- Bilingual Status
- semi_complete