title: A multicenter, open-label, observational study of testosterone gel (1%) in the treatment of adolescent boys with klinefelter syndrome or anorchia.
abstract: OBJECTIVE
  To assess the safety and clinical outcomes of 6-month treatment with testosterone gel 1% therapy in adolescent boys with primary hypogonadism resulting from Klinefelter syndrome (KS) or anorchia.
  
  
  METHODS
  This was a subgroup analysis of a multicenter, open-label study of adolescent boys (N = 86) with delayed puberty who received .5-5.0 g testosterone gel 1% daily for ≤6 months. Adolescent boys 12-17 years of age with KS (n = 21) or anorchia (n = 8), bone age ≥10.5 years, and baseline growth data ≥6 months were included in this analysis. Serum hormone levels (total/free testosterone, luteinizing hormone, dihydrotestosterone, follicle-stimulating hormone, and estradiol) were measured using validated assays. Safety was assessed through adverse events (AEs).
  
  
  RESULTS
  At baseline, patients with KS were taller, weighed more, and had higher total testosterone levels (mean 174 vs. 19 ng/dL) than patients with anorchia. At 6 months, total and free testosterone and dihydrotestosterone levels increased 1.8- to 2.3-fold in the KS group and eight- to 10-fold in anorchia patients. Estradiol levels increased 1.9-fold in the anorchia group and 1.4-fold in the KS group after treatment. No clinically significant changes were noted for luteinizing hormone, follicle-stimulating hormone, and sex hormone-binding globulin concentrations in either group. Cough was the most common AE (eight of 29), followed by acne and headache (both four of 29). One anorchia and two KS patients discontinued prematurely.
  
  
  CONCLUSIONS
  Once-daily testosterone gel application increased serum testosterone levels into the pubertal range and maintained pubertal testosterone levels during 6-month treatment. In this study, testosterone gel 1% raised testosterone levels and was associated with cough as the most common AE.
authors.affiliation: Department of Pediatrics, University of Virginia School of Medicine, Charlottesville, Virginia. Electronic address: adrogol@comcast.net.
authors.forename: Alan D
authors.initials: AD
authors.lastname: Rogol
authors.affiliation: Division of Endocrinology, Department of Medicine, David Geffen School of Medicine, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, California.
authors.forename: Ronald S
authors.initials: RS
authors.lastname: Swerdloff
authors.affiliation: Department of Pediatrics, Baystate Children's Hospital/Tufts University School of Medicine, Springfield, Massachusetts.
authors.forename: Edward O
authors.initials: EO
authors.lastname: Reiter
authors.affiliation: Department of Pediatrics, Thomas Jefferson University, DuPont Hospital for Children, Philadelphia, Pennsylvania.
authors.forename: Judith L
authors.initials: JL
authors.lastname: Ross
authors.affiliation: AbbVie, North Chicago, Illinois.
authors.forename: Troy L
authors.initials: TL
authors.lastname: ZumBrunnen
authors.affiliation: AbbVie, North Chicago, Illinois.
authors.forename: Gregg A
authors.initials: GA
authors.lastname: Pratt
authors.affiliation: AbbVie, North Chicago, Illinois.
authors.forename: John J
authors.initials: JJ
authors.lastname: Brennan
authors.affiliation: AbbVie, North Chicago, Illinois.
authors.forename: Janet
authors.initials: J
authors.lastname: Benesh
authors.affiliation: AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.
authors.forename: Natalia
authors.initials: N
authors.lastname: Kan-Dobrosky
authors.affiliation: AbbVie, North Chicago, Illinois.
authors.forename: Michael G
authors.initials: MG
authors.lastname: Miller
mesh_terms: D000293:Adolescent; D002648:Child; D005782:Gels; D006061:Gonadal Dysgenesis, 46,XY / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D007713:Klinefelter Syndrome / Q000150:complications / Q000188:drug therapy*; D008297:Male; D011628:Puberty, Delayed / Q000188:drug therapy* / Q000209:etiology; D013737:Testis / Q000002:abnormalities*; D013739:Testosterone / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood
chemical_list: D005782:Gels; D013739:Testosterone
keywords: Androgens; Anorchia; Delayed puberty; Hypogonadism; Klinefelter syndrome; Testosterone gel