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The steady-state pharmacokinetics of two doses of a transdermal testosterone cream: 5 and 10 mg was investigated after daily application for 21 days by Fooladi and colleagues in a two-way, cross-over study conducted for 6 weeks [1]. Seven healthy postmenopausal women (mean age 59.3 years) were randomly allocated to 5 or 10 mg of transdermal testosterone cream 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. After the single-dose application of 5 mg of the transdermal testosterone cream on day 22, the median uncorrected TT C[-]avg[/-] was found to be 0.54 ng/ml (range 0.43–1.31 ng/ml), and the median uncorrected fT C[-]avg[/-] was found to be 4.14 pg/ml (range 2.41–9.72 pg/ml). Doubling of the dose only resulted in a 30% increase in baseline-corrected TT C[-]avg[/-] (0.52 vs. 0.69 ng/ml for 5 and 10 mg, respectively) and a 31% increase in baseline-corrected fT C[-]avg[/-] (4.75 vs. 6.24 pg/ml for 5 and 10 mg, respectively). Neither dose resulted in any meaningful variation in dihydrotestosterone, estrone, estradiol, or sex hormone binding globulin across the post-dose sampling period. It was concluded that the 5-mg dose of transdermal testosterone cream restores TT and fT levels to levels above and within the reference range, respectively, for premenopausal women.

Author(s)

  • Frits Riphagen
    Brussels, Belgium

Citations

  1. Fooladi E, Reuter SE, Bell RJ, et al. Pharmacokinetics of a transdermal testosterone cream in healthy postmenopausal women. Menopause 2014, May 19. Epub ahead of print
    http://www.ncbi.nlm.nih.gov/pubmed/24845394
  2. Davis SR. Androgen therapy in women, beyond libido. Climacteric 2013;16(Suppl l):18-24.
    http://www.ncbi.nlm.nih.gov/pubmed/23647457
  3. El Hage G, Eden JA, Manga RZ. A double-blind, randomized, placebo-controlled trial of the effect of testosterone cream on the sexual motivation of menopausal hysterectomized women with hypoactive sexual desire disorder. Climacteric 2007;10:335-43
    http://www.ncbi.nlm.nih.gov/pubmed/17653960
  4. Shifren JL, Braunstein GD, Simon JA, et al. Transdermal testosterone treatment in women with impaired sexual function after oophorectomy. N Engl J Med 2000;343:682-8.
    http://www.ncbi.nlm.nih.gov/pubmed/10974131
  5. Tamimi RM, Hankinson SE, Chen WY, et al. Combined estrogen and testosterone use and risk of breast cancer in postmenopausal women. Arch Intern Med 2006;166:1483-9.
    http://www.ncbi.nlm.nih.gov/pubmed/16864758
  6. Haring R, Hannemann A, Ulrich J, et al. Age-specific reference ranges for serum testosterone and androstenedione concentration in women measured by liquid chromatography-tandem mass spectrometry. J Clin Endocrinol Metab 2012;97;408-15.
    http://www.ncbi.nlm.nih.gov/pubmed/22162468
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