title: EFFICACY AND SAFETY OF A NEW TOPICAL TESTOSTERONE REPLACEMENT GEL THERAPY FOR THE TREATMENT OF MALE HYPOGONADISM.
abstract: OBJECTIVE
  Testosterone replacement therapy is indicated for male hypogonadism. This study aimed to evaluate the efficacy and safety of testosterone gel 2% (Tgel) over 90 days.
  
  
  METHODS
  This phase 3, open-label, noncomparator study was conducted in adult hypogonadal men (2 consecutive fasting serum testosterone values <300 ng/dL and >86% subjects with symptoms consistent with testosterone deficiency). Subjects applied Tgel 23 mg/day (single pump-actuation using a hands-free cap applicator). The dose was uptitrated to 46 mg/day after 2 weeks if the 4-hour serum total testosterone level was <500 ng/dL. The dose could be further up- or downtitrated to 23, 46, and 69 mg on Days 21, 42, and 63. The primary endpoint included the percentage of subjects with average testosterone concentration (Cave (0-24)) between 300 and 1,050 ng/dL on Day 90. Safety endpoints were adverse events (AEs), laboratory parameters, and vital signs.
  
  
  RESULTS
  Of the 159 who enrolled, 139 men completed the study. Approximately three-quarters (76.1%) of subjects met Cavecriteria on Day 90. Most AEs were mild to moderate. There were 5 serious AEs, and 1 (myocardial infarction) was judged as possibly related to Tgel. Confirmed excessive increases in prostate-specific antigen or hematocrit levels were rare. Tgel had a favorable local skin tolerability profile.
  
  
  CONCLUSIONS
  Overall, 76% of subjects achieved Cavebetween 300 and 1,050 ng/dL with Tgel. Symptoms of testosterone deficiency improved with few safety concerns.
  
  
  BACKGROUND
  AE = adverse event Cave(0-24)= average testosterone concentration CI = confidence interval Cmax= maximum concentration IIEF = International Index of Erectile Function MAF = Multidimensional Assessment of Fatigue PK = pharmacokinetic PSA = prostate-specific antigen SAE = serious adverse event SF-12 = Short Form 12 Health Survey Tgel = testosterone gel 2% Tmax= time to achieve maximum concentration TRT = testosterone replacement therapy.
authors.forename: Glenn
authors.initials: G
authors.lastname: Cunningham
authors.forename: Laurence
authors.initials: L
authors.lastname: Belkoff
authors.forename: Gerald
authors.initials: G
authors.lastname: Brock
authors.forename: Mitchell
authors.initials: M
authors.lastname: Efros
authors.forename: Marc
authors.initials: M
authors.lastname: Gittelman
authors.forename: Dario
authors.initials: D
authors.lastname: Carrara
authors.forename: Anders
authors.initials: A
authors.lastname: Neijber
authors.forename: Masakazu
authors.initials: M
authors.lastname: Ando
authors.forename: Jules
authors.initials: J
authors.lastname: Mitchel
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D005782:Gels; D020249:Hormone Replacement Therapy / Q000009:adverse effects / Q000379:methods; D006801:Humans; D007006:Hypogonadism / Q000188:drug therapy* / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D013739:Testosterone / Q000008:administration & dosage* / Q000009:adverse effects* / Q000493:pharmacokinetics; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005782:Gels; D013739:Testosterone