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 withtransdermal 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. TotalHRQoL 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.
RCT Entities:
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.
Authors: Tom E Nightingale; Pamela Moore; Joshua Harman; Refka Khalil; Ranjodh S Gill; Teodoro Castillo; Robert A Adler; Ashraf S Gorgey Journal: J Spinal Cord Med Date: 2017-08-03 Impact factor: 1.985
Authors: Jemma Hudson; Moira Cruickshank; Richard Quinton; Lorna Aucott; Magaly Aceves-Martins; Katie Gillies; Shalender Bhasin; Peter J Snyder; Susan S Ellenberg; Mathis Grossmann; Thomas G Travison; Emily J Gianatti; Yvonne T van der Schouw; Marielle H Emmelot-Vonk; Erik J Giltay; Geoff Hackett; Sudarshan Ramachandran; Johan Svartberg; Kerry L Hildreth; Kristina Groti Antonic; Gerald B Brock; J Lisa Tenover; Hui Meng Tan; Christopher Ho Chee Kong; Wei Shen Tan; Leonard S Marks; Richard J Ross; Robert S Schwartz; Paul Manson; Stephen Roberts; Marianne Skovsager Andersen; Line Velling Magnussen; Rodolfo Hernández; Nick Oliver; Frederick Wu; Waljit S Dhillo; Siladitya Bhattacharya; Miriam Brazzelli; Channa N Jayasena Journal: Lancet Healthy Longev Date: 2022-06
Authors: Heather L Gelhorn; Margaret K Vernon; Katie D Stewart; Michael G Miller; Meryl Brod; Stanley E Althof; Leonard R DeRogatis; Adrian Dobs; Allen D Seftel; Dennis A Revicki Journal: Patient Date: 2016-04 Impact factor: 3.883
Authors: G Corona; W Vena; A Pizzocaro; V A Giagulli; D Francomano; G Rastrelli; G Mazziotti; A Aversa; A M Isidori; R Pivonello; L Vignozzi; E Mannucci; M Maggi; A Ferlin Journal: J Endocrinol Invest Date: 2022-01-18 Impact factor: 4.256
Authors: Claire Pexman-Fieth; Hermann M Behre; Alvaro Morales; Natalia Kan-Dobrosky; Michael G Miller Journal: Aging Male Date: 2013-11-25 Impact factor: 5.892