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
Department of Urology, University of Florida Jacksonville, Jacksonville, FL 32209, United States.
Department of Urology, Hospital Veredas, Maceió 57050, Brazil.
Sex Med. 2023 Mar 17;11(2):qfad007. doi: 10.1093/sexmed/qfad007. eCollection 2023 Apr.
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 <300 ng/dL by the end of the trial. Adverse events were also similar, such as elevations in prostate-specific antigen, estradiol, and hematocrit. Most dropouts were related to persistent TD symptoms and serum testosterone <300 ng/dL, with similar rates between the groups in the study.
Men treated with Testopel and E100 pellets had comparable serum testosterone levels and similar adverse event rates, providing an effective choice of long-term TTh among men with TD.
Strengths include the prospective, randomized, single-blinded study design and adequate follow-up. Limitations include the lack of external validity and the single-institution cohort.
E100 compounded testosterone pellets are a noninferior option of TTh as compared with Testopel for men presenting with TD.
睾酮缺乏（TD）是一种普遍存在的情况，尤其是在45岁及以上的男性中，而睾酮治疗（TTh）可以改善这些患者的生活质量。
评估复方皮下注射睾酮丸剂的安全性，并比较复方睾酮丸剂与市售品牌睾酮丸剂（分别为E100（Empower药房）和Testopel（美国食品药品监督管理局批准））在TTh方面的疗效。
这是一项前瞻性、3期、随机、非劣效性临床试验。我们招募了75名被诊断为TD的男性，并将他们按1:1随机分为市售品牌组和复方丸剂组。患者分别植入各自的睾酮丸剂：Testopel（10粒75毫克）和E100（8粒100毫克）。
随机分组后，Testopel组有33名参与者，E100组有42名。两组在2个月、4个月和6个月时的血清睾酮水平相似，到试验结束时，大多数男性（82%）降至<300 ng/dL。不良事件也相似，如前列腺特异性抗原、雌二醇和血细胞比容升高。大多数退出研究的情况与持续的TD症状和血清睾酮<300 ng/dL有关，研究中两组的发生率相似。
接受Testopel和E100丸剂治疗的男性血清睾酮水平相当，不良事件发生率相似，为TD男性提供了一种有效的长期TTh选择。
优点包括前瞻性、随机、单盲研究设计和充分的随访。局限性包括缺乏外部有效性和单机构队列。
对于患有TD的男性，与Testopel相比，E100复方睾酮丸剂是TTh的非劣效选择。
