A New Oral Testosterone Undecanoate Formulation Restores Testosterone to Normal Concentrations in Hypogonadal Men
| Autor: | Theodore Danoff, Ronald S. Swerdloff, Jed Kaminetsky, James Longstreth, Marc Gittelman, Robert E Dudley, Christina Wang, William B. White |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Male medicine.medical_specialty Ambulatory blood pressure Adolescent Hormone Replacement Therapy Endocrinology Diabetes and Metabolism Clinical Biochemistry Urology Administration Oral Phases of clinical research Blood Pressure 030209 endocrinology & metabolism Context (language use) 030204 cardiovascular system & hematology Administration Cutaneous Biochemistry Drug Administration Schedule law.invention Young Adult 03 medical and health sciences 0302 clinical medicine Endocrinology Randomized controlled trial Pharmacokinetics law Internal medicine medicine Humans Testosterone Aged Oral testosterone business.industry Hypogonadism Biochemistry (medical) Middle Aged United States Solutions Clinical trial Treatment Outcome Corrigendum business AcademicSubjects/MED00250 |
| Zdroj: | The Journal of Clinical Endocrinology and Metabolism |
| ISSN: | 1945-7197 0021-972X |
| DOI: | 10.1210/clinem/dgaa238 |
| Popis: | Context A novel formulation of oral testosterone (T) undecanoate (TU) was evaluated in a phase 3 clinical trial. Objective Determine efficacy, short-term safety, and alignment of new oral TU formulation with current US approval standards for T replacement therapy. Design Randomized, active-controlled, open-label study. Setting and Patients Academic and private clinical practice sites; enrolled patients were clinically hypogonadal men 18 to 65 years old. Methods Patients were randomized 3:1 to oral TU, as prescribed (JATENZO®; n = 166) or a topical T product once daily (Axiron®; n = 56) for 3 to 4 months. Dose titration was based on average T levels (Cavg) calculated from serial pharmacokinetic (PK) samples. T was assayed by liquid chromatography–mass spectrometry/mass spectrometry. Patients had 2 dose adjustment opportunities prior to final PK visit. Safety was assessed by standard clinical measures, including ambulatory blood pressure (BP). Results 87% of patients in both groups achieved mean T Cavg in the eugonadal range. Sodium fluoride-ethylenediamine tetra-acetate plasma T Cavg (mean ± standard deviation) for the oral TU group was 403 ± 128 ng/dL (~14 ± 4 nmol/L); serum T equivalent, ~489 ± 155 ng/dL (17 ± 5 nmol/L); and topical T, 391 ± 140 ng/dL (~14 ± 5 nmol/L). Modeling/simulation of T PK data demonstrated that dose titration based on a single blood sample 4 to 6 h after oral TU dose yielded efficacy (93%) equivalent to Cavg-based titration (87%). Safety profiles were similar in both groups, but oral TU was associated with a mean increase in systolic BP of 3 to 5 mm Hg. Conclusion A new oral TU formulation effectively restored T to mid-eugonadal levels in hypogonadal patients. |
| Databáze: | OpenAIRE |
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