title: 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: BACKGROUND
  The clinical significance of low to low-normal testosterone (T) levels in men remains debated.
  
  
  OBJECTIVE
  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: Center for Reproductive Medicine and Andrology of the University, Halle, Germany. hermann.behre@medizin.uni-halle.de
authors: Hermann M
authors: HM
authors: Behre
authors: Teuvo L J
authors: TL
authors: Tammela
authors: Stefan
authors: S
authors: Arver
authors: Josep R
authors: JR
authors: Tolrá
authors: Vincenzo
authors: V
authors: Bonifacio
authors: Michael
authors: M
authors: Lamche
authors: Judy
authors: J
authors: Kelly
authors: Florian
authors: F
authors: Hiemeyer
authors: Erik J
authors: EJ
authors: Giltay
authors: Louis J
authors: LJ
authors: Gooren
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001823:Body Composition / Q000187:drug effects*; D004311:Double-Blind Method; D005500:Follow-Up Studies; D005782:Gels; D006304:Health Status; D006801:Humans; D007006:Hypogonadism / Q000188:drug therapy / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D057566:Self Report; D013739:Testosterone / Q000097:blood / Q000494:pharmacology*
chemical_list: D005782:Gels; D013739:Testosterone