Pharmacokinetics of a new testosterone transdermal delivery system, TDS

Results The mean AUC(0,12 h) was higher following application of TDS ® -testosterone (61.8 ng ml − 1 h), compared with Androgel ® (57.7 ng ml − 1 h) and TDS ® -placebo (50.7 ng ml − 1 h. The mean C max (0,12 h) was similar for TDS ® -testosterone (6.6 ng ml −1 ) and Androgel ® (6.5 ng ml − 1 ) and these values were higher than those for TDS ® -placebo (5.7 ng ml − 1 ). Analysis of variance showed that the 90% confidence intervals on the relative difference of the ratio for the AUC(0,12 h) and the C max (0,12 h) between TDS ® -testosterone and Androgel ® , were contained within the bioequivalence limit (80, 125%) ( C max 89.2, 112.3% and AUC 93.5, 120.5%). Serum testosterone concentrations were lower following TDS ® -Placebo and were not bioequivalent either to the gel or spray.