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Objective

The steady-state pharmacokinetics of two doses of a transdermal testosterone cream (TTC) was investigated after daily application for 21 days.

Methods

This was a two-way cross-over study conducted for 6 weeks. Seven healthy postmenopausal women (mean age, 59.3 y) were randomly allocated to 5 or 10 mg of TTC applied daily to the upper arm. Serum total testosterone (TT), free testosterone (fT), sex hormone–binding globulin, and metabolite concentrations were measured. Baseline-corrected and uncorrected serum TT and fT pharmacokinetic parameters (AUC 0-24, C avg, C max, and T max) were calculated using a standard model-independent approach.

Results

After the single-dose application of 5 mg of TTC on day 22, the median uncorrected TT C avg was found to be 0.54 ng/mL (range, 0.43-1.31), and the median uncorrected fT C avg was found to be 4.14 pg/mL (range, 2.41-9.72). Doubling of …