A randomized, double-blind, placebo-controlled trial of testosterone gel on body composition and health-related quality-of-life in men with hypogonadal to low-normal levels of serum testosterone and symptoms of androgen deficiency over 6 months with 12 months open-label follow-up

Abstract

Introduction: The clinical significance of low to low-normal testosterone (T) levels in men remains debated. Aim: To analyze the effects of raising serum T on lean body mass (LBM), fat mass (FM), total body mass, and health-related quality-of-life (HRQoL). Methods: Randomized, double-blind, placebo-controlled study. Men, aged 50–80 years, with serum total T<15 nmol/L and bioavailable T < 6.68 nmol/L, and a Aging Males’ Symptoms (AMS) total score >36, received 6 months treatment with transdermal 1% T gel (5–7.5 mg/day; n =183) or placebo gel (n =179), followed by 12 months open-label with T in all. Results: After 6 months, LBM increased in T- treated patients by 1.28 ± 0.15 kg (mean ± SE) and FM decreased by 1.16 ± 0.16 kg, with minor changes with placebo (LBM +0.02 ± 0.10 kg and FM −0.14 ± 0.12 kg; all p < 0.001, T group vs. placebo). Changes were largely similar across subgroups of age, baseline total testosterone, and baseline BMI. Total HRQoL improved compared with placebo (p < 0.05, T group vs. placebo). Conclusions: Six months 1% T gel improved body composition and HRQoL in symptomatic men with low to low-normal T, with further improvements over the following 12 months.

Keywords::

• Late-onset hypogonadism
• testosterone
• testosterone gel
• aging
• body composition
• quality-of-life
• prostate safety

Acknowledgements

The European Testogel® Study Team: Austria: R Herwig, Innsbruck; A Jungwirth, Salzburg; M Lamche, Vienna; G Nell, Vienna; G Pinggera, Innsbruck; N Schmeller, Salzburg; P Schramek, Vienna; H Trummer, Graz; Finland: O Lukkarinen, Oulu; V Nurmenniemi, Helsinki; T Tammela, Tampere. Germany: H M Behre, Halle; G Haidl, Bonn; B Lochmann, Dresden; G Meissner, Magdeburg; H Stahl, Leipzig; Italy: V Bonifacio, Rome; F Colombo, Milan; C Imbimbo, Napoli; C Moretti, Rome; A Fabbri, Rome; Ireland: M Byrne, Dublin; J Nolan, Dublin; Spain: J M Cuadrado, Barcelona; I Moncada, Madrid; E Ruiz Castañé, Barcelona; J R Tolrá, Barcelona; Sweden: S Arver, Stockholm; A Giwercman, Malmö; G Johannsson, Göteborg; UK: P-M Bouloux, London; J Fraser, Wigan; A Grossman, London; R Pawa, Wigan; R Ross, Sheffield; H Shaw, Reading; H Thomas, Cardiff; study management: J Kelly, Berlin, Germany; statistical analyses: F Hiemeyer, Berlin, Germany.

Declaration of Interest: Josep R. Tolrá, Vincenzo Bonifacio and Michael Lamche have nothing to declare. Teuvo L. J. Tammela has received grant support from Bayer Pharma. Stefan Arver, Hermann M. Behre and Erik J. Giltay have received grant support and/or lecture fees from Bayer Pharma. Judy Kelly and Florian Hiemeyer are employed by Bayer Pharma. This study was sponsored by Bayer Pharma AG, Berlin, Germany.