Which Androgen Replacement Therapy for Women?

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Abstract
Although,the postmenopausal,ovary remains,an important,source of testosterone (T) production, there is nevertheless a decline in total circulating androgen,levels with age. A role for androgen,replacement in addition to estrogens in some postmenopausal, particularly ovari- ectomized, women is increasingly gaining acceptance. We have com- pared,the pharmacokinetics,of two,existing,testosterone,prepara- tions, oral testosterone undecanoate (TU) and sc testosterone implants, with a new matrix transdermal delivery system for T. In study 1, three different doses of TU (40 mg, two 20-mg doses 6 h apart and two 10-mg doses 6 h apart, orally) were investigated in 10 post- menopausal women. Median peak levels of 18 nmol/L (range, 5.8 ‐ 64.0 nmol/L; 40 mg), 12.3 nmol/L (range, 5.7‐29.2 nmol/L; 20 mg), and 9.7 nmol/L (range, 7.8 ‐28.7 nmol/L; 10 mg) were observed, but T levels varied considerably,within and between,subjects regardless,of the dose used. In study 2, 30 women receiving sc estradiol therapy were,randomized,to receive either a 100-mg T implant,or placebo. In the T-treated group, levels peaked at 8.9 6 1.7 nmol/L 1 month after insertion and then declined gradually,to 2.9 6 0.4 nmol/L at 6 months. In study 3, a novel matrix transdermal delivery system for T was investigated in 6 females. Estimated daily delivery rates of 840 (TD1), 1100 (TD2), and 3000 mg (TD3) T/24 h were investigated. T rose rapidly after a single application,of TD1 and TD2 and were,relatively constant for the next 18 h, at which time peaks of 2.3 6 1.0 and 4.1 6 1.6 nmol/L, respectively, at 24 h were seen. T concentrations fell to baseline levels within 6 h after patch removal. When TD2 was applied for 7 days, a T level of 4.3 6 0.7 nmol was seen 24 h after application, falling gradually,to 2.8 6 0.7 nmol/L by day 7. During twice weekly application of TD2, stable T concentrations were maintained, and all peak levels were similar (peak level, 4.2 6 0.3 nmol/L 24 h post-TD application) as were,predose,troughs,(3.2 6 0.3 nmol). Twice weekly

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