Phase 3 N=150 Treatment

Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism

Hypogonadism

Bottom Line

View on ClinicalTrials.gov: NCT02159469 ↗

Enrolled (actual)

150

Serious AEs

2.0%

Results posted

Jan 2018

Primary outcome: Primary: Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL) — 139 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Testosterone enanthate auto-injector (Combination_product)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Antares Pharma Inc.
Primary completion: Feb 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL)	139	—
SECONDARY Safety and Tolerability	125; 66; 3; 30; 1; 1	—

Summary

Evaluation of efficacy and safety of testosterone enanthate administered subcutaneously using an auto-injector

Eligibility Criteria

Inclusion Criteria

Adult males aged ≥ 18 year of age with a documented diagnosis of hypogonadism
Total testosterone levels 50 mL of blood or plasma within 3 months of screening.
Donation of plasma or blood during study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02159469). 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.