Efficacy and safety outcomes of a compounded testosterone pellet versus a branded testosterone pellet in men with testosterone deficiency: a single-center, open-label, randomized trial

• Published in: Sexual medicine 2023-04, Vol.11 (2), p.qfad007-qfad007
• Main Authors: Kresch, Eliyahu, Lima, Thiago Fernandes Negris, Molina, Manuel, Deebel, Nicholas A, Reddy, Rohit, Patel, Mehul, Loloi, Justin, Carto, Chase, Nackeeran, Sirpi, Gonzalez, Daniel C, Ory, Jesse, Ramasamy, Ranjith
• Format: Article
• Language: English
• Subjects: Pharmacotherapy
• ISSN: 2050-1161; 2050-1161
• DOI: 10.1093/sexmed/qfad007

Testosterone deficiency (TD) is a prevalent condition, especially in men ≥45 years old, and testosterone therapy (TTh) can improve the quality of life in these patients. To evaluate the safety profile of compounded subcutaneous testosterone pellets and to compare the efficacy between compounded and market brand testosterone pellets for TTh: E100 (Empower Pharmacy) and Testopel (Food and Drug Administration approved), respectively. This was a prospective, phase 3, randomized, noninferiority clinical trial. We enrolled 75 men diagnosed with TD and randomized them 1:1 to a market brand group and a compounded pellet group. The patients were implanted with their respective testosterone pellets: Testopel (10 pellets of 75 mg) and E100 (8 pellets of 100 mg). We evaluated adverse events after implantation and followed men at 2, 4, and 6 months for morning laboratory levels (prior to 10 am): serum testosterone, estradiol, hematocrit, and prostate-specific antigen. After randomization, 33 participants were enrolled in the Testopel arm and 42 in the E100 arm. Serum testosterone levels were similar between the groups at 2, 4, and 6 months, with most men (82%) dropping to