A multi-institutional observational study of testosterone levels after testosterone pellet (Testopel(®)) insertion

Area of Science:

• Endocrinology
• Urology
• Pharmacology

Background:

• Implantable testosterone pellets, approved in 1972, offer a treatment for testosterone deficiency syndrome (TDS).
• Recent reintroduction of Testopel® has increased clinical interest in this testosterone delivery method.
• Six academic institutions collaborated to analyze real-world data on serum testosterone levels post-pellet implantation.

Purpose of the Study:

• To evaluate the time-dependent serum testosterone profiles following subcutaneous testosterone pellet implantation in clinical practice.
• To assess the efficacy and safety of testosterone pellets for treating TDS.

Main Methods:

• Retrospective analysis of pooled data from 380 men undergoing 702 testosterone pellet insertions across six institutions.
• Variables included patient demographics, pre- and post-implantation testosterone levels, number of pellets, and time to measurement.
• Statistical analysis assessed testosterone levels in relation to pellet number and time.

Main Results:

• Implanting six to ten or more testosterone pellets (450-750 mg) achieved therapeutic testosterone levels within one month, sustained for 4-6 months.
• Higher pellet counts (10-12) correlated with higher, more consistent, and prolonged therapeutic testosterone levels.
• Adverse events, including four extrusions and three hematomas, were infrequent and generally mild to moderate and transient.

Conclusions:

• Testosterone pellets (Testopel®) effectively provide sustained testosterone levels for 4-6 months in men with TDS.
• Implantation of eight or more pellets yielded optimal peak levels and duration of effect.
• Testosterone pellet therapy was generally well-tolerated by patients.