A 52-Week Study of Dose Adjusted Subcutaneous Testosterone Enanthate in Oil Self-Administered via Disposable...

Area of Science:

• Endocrinology
• Pharmacology

Background:

• Hypogonadism is a condition characterized by the testes' inability to produce sufficient testosterone.
• Testosterone replacement therapy (TRT) is a common treatment for hypogonadism.
• Current TRT methods include injections, gels, and patches, each with varying efficacy and patient adherence.

Purpose of the Study:

• To evaluate the efficacy and safety of a novel subcutaneous testosterone enanthate auto-injector administered weekly.
• To assess the pharmacokinetic profile and patient-reported outcomes of the auto-injector in men with hypogonadism.

Main Methods:

• An open-label, single-arm, dose-blinded, 52-week study.
• 150 men with hypogonadism received weekly subcutaneous testosterone enanthate via an auto-injector.
• Dose adjustments were based on week 6 total testosterone trough concentrations.

Main Results:

• 92.7% of patients achieved target testosterone levels (300-1,100 ng/dl) by week 12.
• Mean testosterone trough concentration at week 52 was 487.2 ± 153.33 ng/dl.
• Over 95% reported no injection-related pain; common adverse events included increased hematocrit and hypertension.

Conclusions:

• The subcutaneous testosterone enanthate auto-injector provides a steady pharmacokinetic profile with minimal fluctuations.
• The device is safe, well-tolerated, and virtually painless.
• This auto-injector offers a convenient and effective weekly option for testosterone deficiency treatment.