Login to Access Video or Poster Abstract: MP91-16
Sources of Funding: This study was supported by Antares Pharma Inc. Editorial assistance for this abstract was provided by Axon Communications, funded by Antares Pharma Inc.

Introduction

Phase 3, double-blind, multicenter Subcutaneous Testosterone Efficacy and Safety in Adult Men Diagnosed with Hypogonadism (STEADY) trial results of a novel, pre-filled auto-injector are presented.

Methods

This 1-year study enrolled 150 men with hypogonadism with 2 baseline testosterone (T) levels of <300 ng/dL. Starting doses of 75 mg of T enanthate (TE) were administered subcutaneously weekly for 6 weeks. At Week 7, blinded dose adjustments were based on Week-6 pre-dose levels. PK was obtained at Week 12. Success required ≥75% of patients to achieve Cavg of 300 to 1100 ng/dL with a lower limit of a 95% 2-sided confidence interval ≥65%, ≥85% of Week 12 Cmax values of <1500 ng/dL, and ≤5% of Cmax values of >1800 ng/dL. Patients without Cmax determination at Week 12 were treated as ≥1500 ng/dL for analysis.

Results

137 patients had complete Week 12 PK profiles; 98 were still receiving treatment at Week 52. At Week 12, 92.7% of patients had total T Cavg 0-168h within the range of 300 to 1100 ng/dL (100% of 50 mg; 90.4% of the 75 mg, and 95.2% of the 100 mg patients). Week 12 Cavg was 553.3 (SD 127.3) ng/dL. All Week 12 total T Cmax was <1500 ng/dL. Concentration was within range on days 1, 2, 3, 4, and 8. Daily mean total T ranged from 483.2 to 741.4 ng/dL. In Week 12, total T concentrations <300 ng/dL were observed in <3% of patients. Treatment was well tolerated. Thirty (20%) patients had treatment-emergent adverse events that led to discontinuation; most frequently reported were elevated PSA and/or hematocrit. Three (2.0%) treatment-emergent serious adverse events (SAEs) were not considered drug-related by investigators. One SAE of death was the result of suicide. Fifteen hundred and ten of 1519 injections were reported as painless. Median compliance was 100%.

Conclusions

Starting dose of 75 mg TE via the auto-injector achieved T levels within a clinically desirable, pre-defined, physiologically normal range. The TE auto-injector was safe, well tolerated, and pain-free.

Funding

This study was supported by Antares Pharma Inc. Editorial assistance for this abstract was provided by Axon Communications, funded by Antares Pharma Inc.