Pharmacokinetic Study of Testosterone Enanthate

Antares Pharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hypogonadism

Treatments: Drug: QuickShot™ - 100 mg Treatment A; Drug: QuickShot™ - 50 mg Treatment B; Drug: Delatestryl 200 mg IM Treatment C

Study type: Interventional

Funder types: Industry

Identifiers

NCT01887418

QST-13-002

Details and patient eligibility

About

Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.

Full 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.

Enrollment: 39 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult males aged 18 to 75 with a documented diagnosis of hypogonadism

Exclusion criteria

• Normal testosterone levels
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 3 patient groups

QuickShot™ - 100 mg Treatment A

Experimental group

Description:

QuickShot™Testosterone - Auto-injector device for SC use

Treatment:

Drug: QuickShot™ - 100 mg Treatment A

QuickShot™ - 50 mg Treatment B

Experimental group

Description:

QuickShot™Testosterone- Auto-injector device for SC use

Treatment:

Drug: QuickShot™ - 50 mg Treatment B

Delatestryl 200 mg IM Treatment C

Active Comparator group

Description:

Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference

Treatment:

Drug: Delatestryl 200 mg IM Treatment C