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

No AccessJournal of UrologyAdult Urology1 Mar 2019A 52-Week Study of Dose Adjusted Subcutaneous Testosterone Enanthate in Oil Self-Administered via Disposable Auto-Injector Jed C. Kaminetsky, Andrew McCullough, Kathleen Hwang, Jonathan S. Jaffe, Christina Wang, and Ronald S. Swerdloff Jed C. KaminetskyJed C. Kaminetsky Manhattan Medical Research, New York, New York More articles by this author , Andrew McCulloughAndrew McCullough Lahey Hospital and Medical Center, Burlington, Massachusetts More articles by this author , Kathleen HwangKathleen Hwang Division of Urology, Department of Surgery, Brown University, Providence, Rhode Island More articles by this author , Jonathan S. JaffeJonathan S. Jaffe *Correspondence: Antares Pharma, Inc., 100 Princeton South Corporate Center, Suite 300, Ewing, New Jersey 08628 (telephone: 609-359-3020, extension 324; FAX: 609-359-3015; e-mail: E-mail Address: [email protected]). Antares Pharma, Inc., Ewing, New Jersey Financial interest and/or other relationship with Antares Pharma. More articles by this author , Christina WangChristina Wang Division of Endocrinology, Department of Medicine, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, California Financial interest and/or other relationship with Antares Pharma. More articles by this author , and Ronald S. SwerdloffRonald S. Swerdloff Division of Endocrinology, Department of Medicine, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, California More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.09.057AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: In this open label, single arm, dose blinded, 52-week registration phase study we evaluated the efficacy and safety of a subcutaneous testosterone enanthate auto-injector administered weekly to men with hypogonadism. Materials and Methods: A total of 150 patients were initiated on a 75 mg subcutaneous testosterone enanthate auto-injector self-administered weekly. Dose adjustments were made at week 7 to 50, 75 or 100 mg testosterone enanthate based on the week 6 total testosterone trough concentration. If required, dose adjustments continued through the extended treatment phase. Pharmacokinetic and clinical laboratory parameters, treatment emergent adverse events and injection site reactions were captured. Results: The primary end point was met since 92.7% of patients achieved an average total testosterone concentration of 300 to 1,100 ng/dl (mean ± SD 553.3 ± 127.29) at week 12. A maximum concentration of less than 1,500 ng/dl was achieved by 91.3% of patients and no patient had a level greater than 1,800 ng/dl at week 12. The mean total testosterone trough concentration was 487.2 ± 153.33 ng/dl at week 52. Of the patients more than 95% reported no injection related pain. The most frequently reported treatment emergent adverse events were increased hematocrit, hypertension and increased prostate specific antigen, which led to discontinuation in 30 men. There were no study drug related serious adverse events. Conclusions: The dose adjusted subcutaneous testosterone enanthate auto-injector demonstrated a steady serum total testosterone pharmacokinetic profile with small peak and trough fluctuations. The device was safe, well tolerated and virtually painless, indicating that this subcutaneous testosterone enanthate auto-injector offers a testosterone delivery system that is a convenient weekly option to treat testosterone deficiency. References 1. : Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2010; 95: 2536. Google Scholar 2. : Prevalence of symptomatic androgen deficiency in men. J Clin Endocrinol Metab 2007; 92: 4241. Google Scholar 3. : Low testosterone associated with obesity and the metabolic syndrome contributes to sexual dysfunction and cardiovascular disease risk in men with type 2 diabetes. Diabetes Care 2011; 34: 1669. 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No direct or indirect commercial, personal, academic, political, religious or ethical incentive is associated with publishing this article. © 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byChoi E, Xu P, Barham D, El-Khatib F, Yafi F and Kavoussi P (2021) Comparison of Outcomes for Hypogonadal Men Treated with Intramuscular Testosterone Cypionate versus Subcutaneous Testosterone EnanthateJournal of Urology, VOL. 207, NO. 3, (677-683), Online publication date: 1-Mar-2022.Seftel A (2019) Re: Testosterone Imposters: An Analysis of Popular Online Testosterone Boosting SupplementsJournal of Urology, VOL. 202, NO. 4, (645-645), Online publication date: 1-Oct-2019. Volume 201Issue 3March 2019Page: 587-594Supplementary Materials Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.Keywordsdisposable equipmenthypogonadismtestisinjectionssubcutaneoustestosterone enanthateMetricsAuthor Information Jed C. Kaminetsky Manhattan Medical Research, New York, New York More articles by this author Andrew McCullough Lahey Hospital and Medical Center, Burlington, Massachusetts More articles by this author Kathleen Hwang Division of Urology, Department of Surgery, Brown University, Providence, Rhode Island More articles by this author Jonathan S. Jaffe Antares Pharma, Inc., Ewing, New Jersey *Correspondence: Antares Pharma, Inc., 100 Princeton South Corporate Center, Suite 300, Ewing, New Jersey 08628 (telephone: 609-359-3020, extension 324; FAX: 609-359-3015; e-mail: E-mail Address: [email protected]). Financial interest and/or other relationship with Antares Pharma. More articles by this author Christina Wang Division of Endocrinology, Department of Medicine, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, California Financial interest and/or other relationship with Antares Pharma. More articles by this author Ronald S. Swerdloff Division of Endocrinology, Department of Medicine, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, California More articles by this author Expand All The corresponding author certifies that, when applicable, a statement(s) has been included in the manuscript documenting institutional review board, ethics committee or ethical review board study approval; principles of Helsinki Declaration were followed in lieu of formal ethics committee approval; institutional animal care and use committee approval; all human subjects provided written informed consent with guarantees of confidentiality; IRB approved protocol number; animal approved project number. Supported by Antares Pharma. No direct or indirect commercial, personal, academic, political, religious or ethical incentive is associated with publishing this article. Advertisement PDF downloadLoading ...