A novel formulation of oral TU was studied in a long- and short-term phase III trial to evaluate safety and efficacy.
Hypogonadal men were recruited into a 365 day or 105 days, randomized, multicenter trial. Patients were randomized 1:1 to oral TU or T-gel in practice I, and 3:1 to oral TU, BID JATENZO®, or a topical T product in trial II.
Oral TU efficacy was 84% and 87% in trials I and II, respectively. Oral TU significantly improved all Psychosexual Daily Questionnaire parameters in trials I and II. In test I, the lean mass increased 3.2 ± 2.7 kg and fat decreased by 2.4 ± 3.6 kilograms, and bone density improved in the hip and spine after 365 days. Oral TU subjects in both studies exhibited an increase in mean systolic blood pressure of about 3–5 mmHg. Oral TU was not associated with liver toxicity, nor did it cause an elevation in high-sensitivity C-reactive protein or lipoprotein-associated phospholipase A2 after 365 days of therapy.
A new oral TU formulation was safe and effective and represented a significant therapeutic advance for treating appropriate hypogonadal men.
Reference: https://journals.sagepub.com/doi/full/10.1177/1756287220937232
