PMID- 24035132
OWN - NLM
STAT- MEDLINE
DCOM- 20140807
LR  - 20131223
IS  - 1879-1972 (Electronic)
IS  - 1054-139X (Linking)
VI  - 54
IP  - 1
DP  - 2014 Jan
TI  - A multicenter, open-label, observational study of testosterone gel (1%) in the 
      treatment of adolescent boys with klinefelter syndrome or anorchia.
PG  - 20-5
LID - S1054-139X(13)00403-5 [pii]
LID - 10.1016/j.jadohealth.2013.07.021 [doi]
AB  - PURPOSE: 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.
CI  - Copyright (c) 2014 Society for Adolescent Health and Medicine. Published by 
      Elsevier Inc. All rights reserved.
FAU - Rogol, Alan D
AU  - Rogol AD
AD  - Department of Pediatrics, University of Virginia School of Medicine, 
      Charlottesville, Virginia. Electronic address: adrogol@comcast.net.
FAU - Swerdloff, Ronald S
AU  - Swerdloff RS
AD  - Division of Endocrinology, Department of Medicine, David Geffen School of 
      Medicine, Harbor-UCLA Medical Center and Los Angeles Biomedical Research 
      Institute, Torrance, California.
FAU - Reiter, Edward O
AU  - Reiter EO
AD  - Department of Pediatrics, Baystate Children's Hospital/Tufts University School of 
      Medicine, Springfield, Massachusetts.
FAU - Ross, Judith L
AU  - Ross JL
AD  - Department of Pediatrics, Thomas Jefferson University, DuPont Hospital for 
      Children, Philadelphia, Pennsylvania.
FAU - ZumBrunnen, Troy L
AU  - ZumBrunnen TL
AD  - AbbVie, North Chicago, Illinois.
FAU - Pratt, Gregg A
AU  - Pratt GA
AD  - AbbVie, North Chicago, Illinois.
FAU - Brennan, John J
AU  - Brennan JJ
AD  - AbbVie, North Chicago, Illinois.
FAU - Benesh, Janet
AU  - Benesh J
AD  - AbbVie, North Chicago, Illinois.
FAU - Kan-Dobrosky, Natalia
AU  - Kan-Dobrosky N
AD  - AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.
FAU - Miller, Michael G
AU  - Miller MG
AD  - AbbVie, North Chicago, Illinois.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20130913
PL  - United States
TA  - J Adolesc Health
JT  - The Journal of adolescent health : official publication of the Society for 
      Adolescent Medicine
JID - 9102136
RN  - 0 (Gels)
RN  - 3XMK78S47O (Testosterone)
RN  - Anorchia
SB  - IM
MH  - Adolescent
MH  - Child
MH  - Gels
MH  - Gonadal Dysgenesis, 46,XY/complications/*drug therapy
MH  - Humans
MH  - Klinefelter Syndrome/complications/*drug therapy
MH  - Male
MH  - Puberty, Delayed/*drug therapy/etiology
MH  - Testis/*abnormalities
MH  - Testosterone/*administration & dosage/adverse effects/blood
OTO - NOTNLM
OT  - Androgens
OT  - Anorchia
OT  - Delayed puberty
OT  - Hypogonadism
OT  - Klinefelter syndrome
OT  - Testosterone gel
EDAT- 2013/09/17 06:00
MHDA- 2014/08/08 06:00
CRDT- 2013/09/17 06:00
PHST- 2012/12/18 00:00 [received]
PHST- 2013/07/19 00:00 [revised]
PHST- 2013/07/22 00:00 [accepted]
PHST- 2013/09/17 06:00 [entrez]
PHST- 2013/09/17 06:00 [pubmed]
PHST- 2014/08/08 06:00 [medline]
AID - S1054-139X(13)00403-5 [pii]
AID - 10.1016/j.jadohealth.2013.07.021 [doi]
PST - ppublish
SO  - J Adolesc Health. 2014 Jan;54(1):20-5. doi: 10.1016/j.jadohealth.2013.07.021. 
      Epub 2013 Sep 13.