Clinical experience using the Androderm (R) testosterone transdermal system in hypogonadal adolescents and young men with beta-thalassemia major

beta-Thalassemia major is associated with a high prevalence of hypogonadotr opic hypogonadism affecting adolescents and young men with this disease. Th e pharmacokinetics of Androderm(R), a non-scrotal permeation-enhanced testo sterone transdermal system, was previously studied in this population using three application regimens designed to mimic the nocturnal secretion and c ircadian patterns of testosterone production characteristic of puberty and young adulthood. In regimen I, designed for prepubertal 14 to 16 year-olds, a single Androderm(R) patch (2.5 mg/day nominal delivery rate) is applied at night and removed 12 hours later in the morning. In regimen II, designed for partially virilized 17 to 19 year-olds, a single Androderm(R) patch is applied nightly for 24 hours. In regimen III, intended for virilized men a ged 20 years and older, two Androderm(R) patches (total dose of 5 mg/day) a re applied nightly for 24 hours. This report presents the results of a 12-m onth open label study using these three Androderm(R) regimens to treat nine hypogonadal males with beta-thalassemia (ages 16.8 to 31.8 yr), Our data s how that Androderm(R) produced physiologically appropriate testosterone lev els, lowered SHBG levels, promoted growth and virilization, increased bone mineral density, and was generally well tolerated in this population of hyp ogonadal adolescents and young men with beta-thalassemia.