title: Efficacy and safety of the 2% formulation of testosterone topical solution applied to the axillae in androgen-deficient men.
abstract: OBJECTIVE
  Testosterone replacement therapy in hypogonadal men relieves symptoms and restores serum testosterone levels to the physiological range. In this study, we assessed the safety, pharmacokinetics, and efficacy of the 2% formulation of testosterone topical solution applied daily to the axillae.
  
  
  METHODS
  An open-label trial was conducted in testosterone-deficient men who started on a daily dose of 60 mg of testosterone. Dose was adjusted on Days 45 and 90 when necessary to maintain serum testosterone levels within the physiological range (10·41-36·44 nmol/l) based on average serum testosterone levels on Days 15 and 60, respectively. Sexual function and mood changes were assessed by the Psychosexual Daily Questionnaire (PDQ) for the 7 days preceding visits at Days 1, 15, 60, and 120; and quality of life by SF-36 questionnaire on Days 1, 60, and 120. Safety parameters, laboratory tests, and adverse events were collected at each visit.
  
  
  RESULTS
  Among the Completer Set (135 study completers and 3 patients who discontinued due to adverse events), 76·1% (Days 15/16), 84·8% (Days 60/61), and 84·1% (Days 120/121) had an average total testosterone level between 10·41-36·44 nmol/l. PDQ scores increased significantly from baseline to 120 days of treatment (p < 0·0001). Significant improvement was observed in the physical (p < 0·05) and mental (p < 0·0001) components of the SF-36 after 120 days of treatment. Adverse events reported in >2% of the 155 subjects who received ≥ 1 dose were application site irritation (7·1%), application site erythema (5·2%), headache (5·2%), increased hematocrit (3.9%), nasopharyngitis (3·9%), diarrhea (2·6%), and vomiting (2·6%).
  
  
  CONCLUSIONS
  These results indicate that once-daily application of the testosterone topical solution 2% to the axillae is a safe and effective treatment for androgen replacement in hypogonadal men.
authors.affiliation: Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA 90509, USA. wang@labiomed.org
authors.forename: Christina
authors.initials: C
authors.lastname: Wang
authors.forename: Niloufar
authors.initials: N
authors.lastname: Ilani
authors.forename: Stefan
authors.initials: S
authors.lastname: Arver
authors.forename: Robert I
authors.initials: RI
authors.lastname: McLachlan
authors.forename: Tina
authors.initials: T
authors.lastname: Soulis
authors.forename: Adam
authors.initials: A
authors.lastname: Watkinson
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000339:Affect / Q000187:drug effects; D000368:Aged; D000728:Androgens / Q000172:deficiency*; D001365:Axilla; D002626:Chemistry, Pharmaceutical; D020249:Hormone Replacement Therapy / Q000009:adverse effects / Q000379:methods; D006801:Humans; D007006:Hypogonadism / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009994:Osmolar Concentration; D013739:Testosterone / Q000008:administration & dosage* / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D000728:Androgens; D013739:Testosterone