Conditions: Hypogonadism
Keywords: Hypogonadism Testosterone enanthate
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 39
Healthy volunteers: no

Brief summary:
Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.

Detailed description:
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.

Safety comparisons were based upon the occurrence, severity and rate of treatment emergent adverse events.

Arms:
arm 1: QuickShot™Testosterone - Auto-injector device for SC use arm 2: QuickShot™Testosterone- Auto-injector device for SC use arm 3: Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference

Interventions: intervention 1: QuickShot™ - 50 mg Treatment B intervention 2: QuickShot™ - 100 mg Treatment A intervention 3: Delatestryl 200 mg IM Treatment C
Intervention descriptions: intervention 1: QuickShot™ for the delivery of testosterone intervention 2: QuickShot™ for the delivery of testosterone intervention 3: Standard of care

Protocol document: