A New Oral Testosterone Undecanoate Formulation Restores Testosterone to Normal Concentrations in Hypogonadal Men.
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Swerdloff RS, Wang C, White WB, Kaminetsky J, Gittelman MC, Longstreth JA, Dudley RE, Danoff TM
A New Oral Testosterone Undecanoate Formulation Restores Testosterone to Normal Concentrations in Hypogonadal Men.
J Clin Endocrinol Metab. 2020 Aug 1;105(8). pii: 5834353. doi: 10.1210/clinem/dgaa238.
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- 32382745 [ View in PubMed]
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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(R); n = 166) or a topical T product once daily (Axiron(R); 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.
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