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A New Oral Testosterone Undecanoate Formulation Restores Testosterone to Normal Concentrations in Hypogonadal Men.
- Source :
-
The Journal of clinical endocrinology and metabolism [J Clin Endocrinol Metab] 2020 Aug 01; Vol. 105 (8). - Publication Year :
- 2020
-
Abstract
- Context: A novel formulation of oral testosterone (T) undecanoate (TU) was evaluated in a phase 3 clinical trial.<br />Objective: Determine efficacy, short-term safety, and alignment of new oral TU formulation with current US approval standards for T replacement therapy.<br />Design: Randomized, active-controlled, open-label study.<br />Setting and Patients: Academic and private clinical practice sites; enrolled patients were clinically hypogonadal men 18 to 65 years old.<br />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).<br />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.<br />Conclusion: A new oral TU formulation effectively restored T to mid-eugonadal levels in hypogonadal patients.<br /> (© Endocrine Society 2020.)
- Subjects :
- Administration, Cutaneous
Administration, Oral
Adolescent
Adult
Aged
Blood Pressure drug effects
Drug Administration Schedule
Hormone Replacement Therapy adverse effects
Humans
Hypogonadism blood
Hypogonadism diagnosis
Male
Middle Aged
Solutions
Testosterone adverse effects
Testosterone analysis
Treatment Outcome
United States
Young Adult
Hormone Replacement Therapy methods
Hypogonadism drug therapy
Testosterone administration & dosage
Testosterone analogs & derivatives
Subjects
Details
- Language :
- English
- ISSN :
- 1945-7197
- Volume :
- 105
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- The Journal of clinical endocrinology and metabolism
- Publication Type :
- Academic Journal
- Accession number :
- 32382745
- Full Text :
- https://doi.org/10.1210/clinem/dgaa238