title: Improved sexual function with testosterone replacement therapy in hypogonadal men: real-world data from the Testim Registry in the United States (TRiUS).
abstract: BACKGROUND
  Up to 30% of erectile dysfunction (ED) patients treated with phosphodiesterase type 5 (PDE5) inhibitors do not show improved sexual function, which may be due in part to low serum testosterone. Hypogonadal patients already receiving testosterone replacement therapy (TRT) likewise can still suffer from symptoms of sexual dysfunction. In these patient populations, augmenting with, or switching, TRT treatment may improve sexual function.
  
  
  OBJECTIVE
  To determine if 12-month treatment with a testosterone gel improves sexual function in hypogonadal men, as measured by the Brief Male Sexual Function Inventory (BMSFI), and in subgroups defined by low testosterone, PDE5 inhibitor use, and prior TRT.
  
  
  METHODS
  The Testim Registry in the United States (TRiUS) was a large (N = 849) multicenter registry of hypogonadal men treated with Testim (testosterone 1%) topical gel and followed for 12 months.
  
  
  METHODS
  Data collected at suggested visits (baseline; 1, 3, 6, and 12 months) included total testosterone (TT), free testosterone (FT), BMSFI scores, physical exam, and body measurements.
  
  
  RESULTS
  TRiUS had 271 patients with baseline testosterone and BMSFI measurements. At 12 months of TRT, TT and FT levels significantly increased from baseline (P < 0.001), with mean ± standard deviation final TT = 17.37 ± 8.61 nmol/L (500.6 ± 248.2 ng/dL) and FT = 240.1 ± 296.0 pmol/L (69.2 ± 85.3 pg/mL). The mean total BMSFI score significantly increased from baseline at 12 months (27.4 ± 10.3 to 33.8 ± 9.8, P < 0.001) and at each visit in all domains (sex drive/libido, erectile function, ejaculatory function, level of bother), overall and for all subgroups. Regression analysis indicated that increased total BMSFI score was significantly associated with increased TT levels at 6 months.
  
  
  CONCLUSIONS
  In hypogonadal patients, 12-month administration of topical testosterone gel resulted in increased TT and FT levels and significantly improved sexual function. All subgroups studied, including men taking PDE5 inhibitors for ED and those previously on TRT, demonstrated significant improvement in sexual function from baseline scores.
authors.affiliation: Scott Department of Urology, Baylor College of Medicine, Houston, TX 77030, USA. mkhera@bcm.edu
authors.forename: Mohit
authors.initials: M
authors.lastname: Khera
authors.forename: Rajib K
authors.initials: RK
authors.lastname: Bhattacharya
authors.forename: Gary
authors.initials: G
authors.lastname: Blick
authors.forename: Harvey
authors.initials: H
authors.lastname: Kushner
authors.forename: Dat
authors.initials: D
authors.lastname: Nguyen
authors.forename: Martin M
authors.initials: MM
authors.lastname: Miner
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000209:etiology; D020249:Hormone Replacement Therapy; D006801:Humans; D007006:Hypogonadism / Q000150:complications* / Q000188:drug therapy; D007989:Libido / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D012042:Registries; D011795:Surveys and Questionnaires; D013739:Testosterone / Q000097:blood / Q000627:therapeutic use*; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
chemical_list: D013739:Testosterone