Objective: The objective of this study was to document the efficacy and tolerability of the new formulation of Andriol Testocaps in the treatment of late-onset hypogonadism in a clinical practice setting.
Methods: The primary inclusion criterion was symptomatic testosterone deficiency, as confirmed by laboratory testing (morning total testosterone <12 nmol/L) on two separate occasions. The study was performed in 43 centres in Austria and a dosage of oral testosterone undecanoate of 2 x 80 mg/day was used for three months. The ADAM questionnaire, the AMS scale and the SF-36 questionnaire were administered by the patients and specific questions were asked to the prescribers.
Results: A total of 189 patient report forms and 185 doctor report forms were completed. The average age of the participants was 54.7 +/- 12.3 years and average treatment duration was 13.9 +/- 2.2 weeks. Serum testosterone level increased by more than 50% from 8.7 +/- 4.3 nmol/L to 13.2 +/- 6.7 nmol/L (p < 0.001). Treatment improved symptoms on the ADAM and AMS scales, whereas no changes were observed on the SF-36. There were no significant effects on serum PSA levels.
Conclusion: Short-term treatment with oral testosterone undecanoate in a clinical practice setting improved late-onset hypogonadism symptoms in aging men with low testosterone levels.