| Autor: |
Davison, Sonia, Thipphawong, John, Blanchard, Jim, Liu, Kui, Morishige, Richard, Gonda, Igor, Okikawa, Jerry, Adams, Jennifer, Evans, Allan, Otulana, Babatunde, Davis, Susan |
| Zdroj: |
Journal of Clinical Pharmacology; Feb2005, Vol. 45 Issue 2, p177-184, 8p |
| Abstrakt: |
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 steroidswere 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) tomaximumlevels of 62.6 ± 20.4 nmol/L (total) and 168.2 ± 50.2 pmol/L (free), occurring 1 to 2 minutes after dosing. A2-compartmentmodel 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. [ABSTRACT FROM PUBLISHER] |
| Databáze: |
Complementary Index |
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