title: Effects of long-term oral testosterone undecanoate therapy on urinary symptoms: data from a 1-year, placebo-controlled, dose-ranging trial in aging men with symptomatic hypogonadism.
abstract: BACKGROUND
  There has been a longstanding question as to whether testosterone therapy could precipitate or worsen urinary symptoms in aging men. We investigated the effects of 1-year oral testosterone undecanoate (TU) therapy on urinary symptoms in aging, hypogonadal men.
  
  
  METHODS
  A total of 322 men ≥50 years with symptomatic testosterone deficiency participated in a 1-year, randomized, multicenter, double-blind trial. Patients received placebo or oral TU 80 mg/day, 160 mg/day, or 240 mg/day.
  
  
  CONCLUSIONS
  Compared with placebo, treatment with oral TU at doses of 80 mg/day and 160 mg/day resulted in no significant change in IPSS urinary symptoms or quality of life (QoL) scores. Treatment with oral TU 240 mg/day led to a statistically significant, but clinically insignificant, improvement in IPSS total score and a significant improvement in IPSS QoL score. None of the TU doses tested had a significant effect on PSA or PV.
  
  
  CONCLUSIONS
  Long-term oral TU therapy had no deleterious effects on IPSS total score and did not change PV and PSA in aging, hypogonadal men. Oral TU therapy at a dose of 240 mg/day may even improve IPSS QoL score.
authors.affiliation: a Department of Urology , VU University Medical Center , Amsterdam , The Netherlands .
authors.forename: Eric J H
authors.initials: EJ
authors.lastname: Meuleman
authors.affiliation: b Department of Endocrinology , University of Liege , Liege , Belgium .
authors.forename: Jean-Jacques
authors.initials: JJ
authors.lastname: Legros
authors.affiliation: c Centre for Neuroendocrinology, Royal Free and University College School of Medicine , London , UK .
authors.forename: Pierre M G
authors.initials: PM
authors.lastname: Bouloux
authors.affiliation: d Merck & Co., Inc., Whitehouse Station , New Jersey , NJ , USA , and.
authors.forename: Amy O
authors.initials: AO
authors.lastname: Johnson-Levonas
authors.affiliation: e MSD Oss , Oss , The Netherlands.
authors.forename: Marion J G H
authors.initials: MJ
authors.lastname: Kaspers
authors.affiliation: e MSD Oss , Oss , The Netherlands.
authors.forename: Jolanda M H
authors.initials: JM
authors.lastname: Elbers
authors.affiliation: e MSD Oss , Oss , The Netherlands.
authors.forename: T B Paul
authors.initials: TB
authors.lastname: Geurts
authors.affiliation: d Merck & Co., Inc., Whitehouse Station , New Jersey , NJ , USA , and.
authors.forename: Alan G
authors.initials: AG
authors.lastname: Meehan
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000375:Aging; D000728:Androgens / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D006801:Humans; D007006:Hypogonadism / Q000188:drug therapy* / Q000503:physiopathology; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011470:Prostatic Hyperplasia / Q000150:complications; D013739:Testosterone / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000097:blood
chemical_list: D000728:Androgens; D013739:Testosterone; C010792:testosterone undecanoate
keywords: International prostatic symptoms score; oral testosterone undecanoate; placebo; prostate volume; prostate-specific antigen; symptomatic hypogonadism