Phase 2 N=39 Randomized Treatment

Pharmacokinetic Study of Testosterone Enanthate

Hypogonadism

Bottom Line

View on ClinicalTrials.gov: NCT01887418 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2015

Primary outcome: Primary: The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks — 150445.2; 70955.7; 278657.9 ng*hr/dL

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: QuickShot™ - 50 mg Treatment B (Drug); QuickShot™ - 100 mg Treatment A (Drug); Delatestryl 200 mg IM Treatment C (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Antares Pharma Inc.
Primary completion: Jan 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks	150445.2; 70955.7; 278657.9	—
PRIMARY The Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks	1345.6; 622.4; 261.9	—
PRIMARY The Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks	895.5; 422.4; 1658.7	—
SECONDARY Number of Patients in the PK Parameter Category	10; 12; 3	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01887418). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.