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Pharmacokinetics and Acute Safety of Inhaled Testosterone in Postmenopausal Women

From the Jean Hailes Foundation, Clayton, Australia (Dr Davison, Ms Adams, Dr Davis); Aradigm Corp, Hayward, California (Dr Thipphawong, Dr Blanchard, Dr Liu, Mr. Morishige, Dr Gonda, Mr Okikawa, Dr Otulana); Centre for Pharmaceutical Research, University of South Australia (Dr Evans); Department of Biochemistry, Monash University, Melbourne, Australia (Dr Davison); and Department of Obstetrics and Gynaecology, Monash University, Melbourne, Australia (Dr Davis).

This was a preliminary feasibility study to assess the pharmacokinetics and acute safety of a single dose of orally inhaled testosterone via the AERx system, a novel handheld aerosol delivery system in postmenopausal women. Twelve postmenopausal women stabilized on oral estrogen therapy were treated with a single dose of testosterone (0.1, 0.2, or 0.3 mg) by inhalation. Plasma concentrations of sex steroids were measured between 1 and 360 minutes. Pulmonary and cardiovascular adverse events were monitored. Inhaled testosterone produced a dose-dependent increase in plasma total and free testosterone. At the highest dose (0.3 mg), total and free testosterone increased from baseline (mean ± SD, 0.6 ± 0.3 nmol/L, 2.5 ± 1.0 pmol/L) to maximum levels of 62.6 ± 20.4 nmol/L (total) and 168.2 ± 50.2pmol/L(free), occurring 1 to 2 minutes after dosing. A 2-compartment model best described the free and total testosterone pharmacokinetic profile. Dihydrotestosterone levels were higher than baseline at 60 minutes (P < .0002). Estradiol did not vary, but sex hormone binding globulin and albumin fell. There were no adverse events related to the treatment. Administration of inhaled testosterone is safe and achieves a supraphysiologic "pulse" kinetic profile of total and free testosterone with a rapid return to pretreatment levels.

Key Words: Inhaled testosterone • AERx • drug safety • pharmacokinetics • pharmacodynamics

Address for reprints: Sonia Davison, Jean Hailes Foundation, 173 Carinish Road, Clayton, Victoria, Australia.

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