Clinical experience with Andriol® Testocaps®- The first Austrian surveillance study on the treatment of late-onset hypogonadism

• Published in: The aging male Vol. 10; no. 4; pp. 183 - 187
• Main Authors: Jungwirth, Andreas, Plas, Eugen, Geurts, Paul
• Format: Journal Article
• Language: English
• Published: England Informa UK Ltd 01.12.2007; Taylor & Francis; Taylor & Francis Ltd
• Subjects: Age; Age of Onset; Aged; Aging; aging males; Androgens; Austria; Clinical medicine; Clinical trials; Humans; hypogonadism; Hypogonadism - blood; Hypogonadism - drug therapy; Hypogonadism - epidemiology; Lymphatic system; Male; Marketing; Middle Aged; Prostate-Specific Antigen - blood; PSA; Small intestine; Surveillance; Testosterone; Testosterone - administration & dosage; Testosterone - analogs & derivatives; Testosterone - blood; Testosterone Congeners - administration & dosage; testosterone undecanoate; Austria
• ISSN: 1368-5538; 1473-0790
• DOI: 10.1080/13685530701495088

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 2×80 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.