title: Retrospective investigation of testosterone undecanoate depot for the long-term treatment of male hypogonadism in clinical practice.
abstract: BACKGROUND
  Testosterone undecanoate depot (TUD) administered intramuscularly is an effective form of testosterone replacement therapy (TRT) for male hypogonadism. Because of the ease of administration, TUD therapy may be preferable to subcutaneously implanted extended release T pellet implants (TI).
  
  
  OBJECTIVE
  The primary objective was to retrospectively assess the efficacy and safety of long-term (≥ 2 years therapy) TUD therapy in the clinical setting. The secondary objective was to retrospectively compare TUD with TI therapy.
  
  
  METHODS
  Retrospective data were collected from the Waikato Hospital Endocrine Database for 179 hypogonadal men treated with TUD for ≥ 2 years from 1998-2011, with 124 of these men receiving previous TI therapy.
  
  
  METHODS
  The main outcome measure for efficacy was serum trough total testosterone (TT), and for safety an increase in hemoglobin (Hb) and/or hematocrit (Hct), rise in prostate-specific antigen (PSA) and/or prostatic biopsy and alteration in body mass index and lipid profile. Additional outcome measures were changes in the dosing and/or interval regimens for TUD therapy.
  
  
  RESULTS
  Overall, 72% of trough TT levels were in the normal range for TUD therapy compared with 53% of trough TT levels during TI therapy. TUD therapy was well tolerated with 162 men (90.5%) completing 2 years of treatment, and only seven men (3.9%) stopping TUD because of adverse effects. A rise in Hb and/or Hct occurred in 25 men (14%), and a significant rise in PSA in 20 men (13%) at some stage during TUD therapy. At 2 years, 91% of men received the standard 1,000 mg TUD dose with 66% at the standard dosing interval of 10-14 weekly.
  
  
  CONCLUSIONS
  TUD is an efficacious, safe, and well tolerated form of TRT, and individual optimisation of the dose and/or interval is only required in the minority of men. Particularly given the ease of administration, TUD was the preferred TRT for both patients and clinicians.
authors.affiliation: Department of Medicine, Waikato Clinical School, University of Auckland, Faculty of Medical & Health Sciences, Hamilton, New Zealand.
authors.forename: Helen M
authors.initials: HM
authors.lastname: Conaglen
authors.forename: Ryan G
authors.initials: RG
authors.lastname: Paul
authors.forename: Tania
authors.initials: T
authors.lastname: Yarndley
authors.forename: Jozef
authors.initials: J
authors.lastname: Kamp
authors.forename: Marianne S
authors.initials: MS
authors.lastname: Elston
authors.forename: John V
authors.initials: JV
authors.lastname: Conaglen
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003692:Delayed-Action Preparations; D004343:Drug Implants / Q000627:therapeutic use; D020249:Hormone Replacement Therapy / Q000009:adverse effects; D006801:Humans; D007006:Hypogonadism / Q000097:blood / Q000188:drug therapy*; D007273:Injections, Intramuscular; D008134:Long-Term Care; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000097:blood; D012016:Reference Values; D012189:Retrospective Studies; D013739:Testosterone / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D003692:Delayed-Action Preparations; D004343:Drug Implants; D013739:Testosterone; D017430:Prostate-Specific Antigen; C010792:testosterone undecanoate
keywords: Hypogonadism; Testosterone Deficiency Syndrome; Testosterone Replacement; Testosterone Undecanoate Depot