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Transdermal Testosterone Application: Pharmacokinetics and Effects on Pubertal Status, Short-Term Growth, and Bone Turnover

Department of Paediatrics (A.M.), Royal Aberdeen Children’s Hospital, Aberdeen AB25 2ZG, Scotland, United Kingdom; Department of Clinical Biochemistry (H.M., A.M.W.), Glasgow Royal Infirmary, Glasgow G4 0SF, Scotland, United Kingdom; and Bone and Endocrine Research Group, Department of Child Health (S.F.A.), Royal Hospital for Sick Children, Glasgow G3 8SJ, Scotland, United Kingdom

Address all correspondence and requests for reprints to: Dr. S. F. Ahmed, Department of Child Health, Royal Hospital for Sick Children, Yorkhill, Glasgow G3 8SJ, Scotland, United Kingdom. E-mail: gcl328{at}clinmed.gla.ac.uk.

The aim of the study was to assess the effect of transdermal testosterone on free testosterone concentrations in saliva and on short-term growth and bone turnover in boys with growth or pubertal delay.

A prospective, randomized, crossover study was conducted over 26 wk with 4 wk of run-in, 8 wk of treatment I (8 or 12 h), 4 wk of washout, 8 wk of treatment II (8 or 12 h), and 4 wk of final washout.

The main outcome measures were salivary testosterone profiles during the different study periods; weekly change in lower leg length (LLL) as measured by knemometry, i.e. LLL velocity; absolute and percentage change in bone alkaline phosphatase (bALP) levels; and deoxypyridinoline cross-links measured in urine.

Eight boys who took part in the study had a median age of 13.5 yr (range, 12.4–14.9 yr), testicular volume of 3 ml (range, 2–6 ml), height SD score of -2.4 (range, -1.44 to -3.35), and bone age delay of 2 yr (range, 1–3.2 yr).

Median salivary testosterone during 8- and 12-h treatments [179 pg/ml (range, 7–3579 pg/ml) and 150 pg/ml (range, 12–3472 pg/ml) (not significant)] was significantly higher than during the run-in and washout blocks (P < 0.0001) [9 pg/ml (range, <7 to 122 pg/ml) and 13 pg/ml (range, <7 to 285 pg/ml) (not significant)]. LLL velocity in the treatment blocks (median, 0.64 mm/wk; range, 0.1–1.08 mm/wk) was significantly higher than during the run-in and washout periods (median, 0.48 mm/wk; range, -0.06 to 0.92 mm/wk) (P < 0.001). The main rise in bALP occurred during the first treatment block with a median percentage change in bALP of 44.2% (range, -4 to 87%) and a smaller percentage change in bALP at the end of the second treatment block of 9.8% (range, -4 to 55%). The increases in bALP were not significantly different between the 8- and 12-h treatment periods, and there was no significant decline during the washout periods.

Overnight transdermal testosterone application, as Virormone (5 mg), may be a potentially acceptable method of induction of puberty and stimulates short-term growth and bone turnover.

Abbreviations: BA, Bone age; bALP, bone alkaline phosphatase; DPD, deoxypyridinoline cross-links; LLL, lower leg length; LLLV, LLL velocity; NS, not significant; SalT, salivary testosterone; TT, transdermal testosterone; TU, testosterone undecanoate.

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