Pharmacokinetics of a transdermal testosterone cream in healthy postmenopausal women

Menopause

Volumn 22, Issue 1, 2015, Pages 44-49

  Fooladi, Ensieh ^a   Reuter, Stephanie E ^b   Bell, Robin J ^a   Robinson, Penelope J ^a   Davis, Susan R ^a  

^a MONASH UNIVERSITY   (Australia)

^b UNIVERSITY OF SOUTH AUSTRALIA   (Australia)

Author keywords

Postmenopausal androgen therapy; Testosterone replacement

Indexed keywords

ANDROSTANEDIOL; ANDROSTANOLONE; EPIANDROSTERONE; ESTRADIOL; ESTRONE; FOLLITROPIN; SEX HORMONE BINDING GLOBULIN; TESTOSTERONE;

ADULT; ANDROGEN THERAPY; APPLICATION SITE REACTION; AREA UNDER THE CURVE; ARTICLE; BLOATING; BODY MASS; CLINICAL ARTICLE; CONSTIPATION; CONTROLLED STUDY; CROSS REACTION; CROSSOVER PROCEDURE; DRUG INDUCED HEADACHE; DRUG TOLERABILITY; ESTRADIOL BLOOD LEVEL; ESTRONE BLOOD LEVEL; FEMALE; FOLLITROPIN BLOOD LEVEL; GLOBULIN BLOOD LEVEL; HORMONE BLOOD LEVEL; HUMAN; LIMIT OF DETECTION; LIMIT OF QUANTITATION; MAXIMUM PLASMA CONCENTRATION; MEDICATION COMPLIANCE; MIDDLE AGED; MORNING DOSAGE; NORMAL HUMAN; OPEN STUDY; PATIENT COMPLIANCE; PLASMA CONCENTRATION-TIME CURVE; POSTMENOPAUSE; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; STEADY STATE; TESTOSTERONE BLOOD LEVEL; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION; TREATMENT OUTCOME; BLOOD; INTRADERMAL DRUG ADMINISTRATION; PHYSIOLOGY;

ADMINISTRATION, CUTANEOUS; ANDROSTANE-3,17-DIOL; CROSS-OVER STUDIES; DIHYDROTESTOSTERONE; ESTRONE; FEMALE; HUMANS; MIDDLE AGED; POSTMENOPAUSE; SEX HORMONE-BINDING GLOBULIN; TESTOSTERONE;

EID: 84920286664     PISSN: 10723714     EISSN: 15300374     Source Type: Journal    
DOI: 10.1097/GME.0000000000000259     Document Type: Article

References (28)

1. Braunstein GD, Sundwall DA, Katz M, et al. Safety and efficacy of a testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women: a randomized, placebo-controlled trial. Arch Intern Med 2005;165:1582-1589.
2. Buster JE, Kingsberg SA, Aguirre O, et al. Testosterone patch for low sexual desire in surgically menopausal women: a randomized trial. Obstet Gynecol 2005;105:944-952.
3. Simon J, Braunstein G, Nachtigall L, et al. Testosterone patch increases sexual activity and desire in surgically menopausal women with hypoactive sexual desire disorder. J Clin Endocrinol Metab 2005;90:5226-5233.
4. Shifren JL, Davis SR, Moreau M, et al. Testosterone patch for the treatment of hypoactive sexual desire disorder in naturally menopausal women: results from the INTIMATE NM1 study. Menopause 2006;13: 770-779.
5. Davis SR, van der Mooren MJ, van Lunsen RHW, et al. The efficacy and safety of a testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women: a randomized, placebocontrolled trial. Menopause 2006;13:387-396.
6. Davis SR, Moreau M, Kroll R, et al. Testosterone for low libido in menopausal women not taking estrogen therapy. N Engl J Med 2008;359: 2005-2017.
7. Davis SR, Papalia MA, Norman RJ, et al. Safety and efficacy of a testosterone metered-dose transdermal spray for treatment of decreased sexual satisfaction in premenopausal women: a placebo-controlled randomized, dose-ranging study. Ann Intern Med 2008;148:569-577.
8. Goldstat R, Briganti E, Tran J, Wolfe R, Davis SR. Transdermal testosterone therapy improves well-being, mood, and sexual function in premenopausal women. Menopause 2003;10:390-398.
9. Shifren JL, Braunstein G, Simon J, et al. Transdermal testosterone treatment in women with impaired sexual function after oophorectomy. N Engl J Med 2000;343:682-688.
10. Dobs AS, Nguyen T, Pace C, Roberts C. Differential effects of oral estrogen versus estrogen-androgen replacement therapy on body composition in postmenopausal women. J Clin Endocrinol Metab 2002;87:1509-1516.
11. Watts NB, Notelovitz M, Chrystie Timmons M, Allen Addison W, Wiita B, Downey LJ. Comparison of oral estrogens and estrogens plus androgen on bone mineral density, menopausal symptoms, and lipid-lipoprotein profiles in surgical menopause. Obstet Gynecol 1995;85:529-537.
12. Iellamo F, Volterrani M, Caminiti G, et al. Testosterone therapy in women with chronic heart failure: a pilot double-blind, randomized, placebo-controlled study. J Am Coll Cardiol 2010;56:1310-1316.
13. Davison SL, Bell RJ, Gavrilescu M, et al. Testosterone improves verbal learning and memory in postmenopausal women: results from a pilot study. Maturitas 2011;70:307-311.
14. Mazer N, Shifren J. Transdermal testosterone for women: a new physiological approach for androgen therapy. Obstet Gynecol Surv 2003;58:489-500.
15. Mazer N. Enhanced transdermal delivery of testosterone using the TheraDerm TDS. In: Crommelin DJA, Midha KK, eds. Topics in Pharmaceutical Sciences: Proceedings of the 51st International Congress of Pharmaceutical Sciences of FIP, Washington, DC, September 1-6. Stuttgart, Germany: Medpharm Scientific Publishers; 1991:149-170.
16. Snabes MC, Simes SM. Approved hormonal treatments for HSDD: an unmet medical need. J Sex Med 2009;6:1846-1849.
17. Eden JA, ed. A pilot study of Andro-Feme cream (1% testosterone). Proceeding of the 4th Annual Congress of the Australasian Menopause Society, Adelaide, SA, Australia; 2000.
18. Harwood DT, Handelsman DJ. Development and validation of a sensitive liquid chromatographyYtandem mass spectrometry assay to simultaneously measure androgens and estrogens in serum without derivatization. Clin Chim Acta 2009;409:78-84.
19. Vermeulen A, Verdonck L, Kaufman M. A critical evaluation of simple methods for the estimation of free testosterone in serum. J Clin Endocrinol Metab 1999;84:3666-3672.
20. Haring R, Hannemann A, John U, et al. Age-specific reference ranges for serum testosterone and androstenedione concentrations in women measured by liquid chromatographyYtandem mass spectrometry. J Clin Endocrinol Metab 2012;97:408-415.
21. Dunn JF, Nisula BC, Rodboard D. Transport of steroid hormones. Binding of 21 endogenous steroids to both testosterone-binding globulin and cortico-steroidYbinding globulin in human plasma. J Clin Endocrinol Metab 1981;53:58-68.
22. Labrie F, Martel C, Balser J. Wide distribution of the serum dehydroepiandrosterone and sex steroid levels in postmenopausal women: role of the ovary? Menopause 2011;18:30-43.
23. Horton R, Hawks D, Lobo R. 3>,17A-Androstanediol glucuronide in plasma. A marker of androgen action in idiopathic hirsutism. J Clin Invest 1982;69:1203-1206.
24. El-Hage G, Eden JA, Zoa Manga R. 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;10:335-343.
25. Vesper HW, Botelho JC. Standardization of testosterone measurements in humans. J Steroid Biochem Mol Biol 2010;121:513-519.
26. Taieb J, Mathian B, Millot F, et al. Testosterone measured by 10 immunoassays and by isotope-dilution gas chromatographyYmass spectrometry in sera from 116 men, women, and children. Clin Chem 2003;49:1381-1395.
27. Moal V, Mathieu E, Reynier P, Malthièry Y, Gallois Y. Low serum testosterone assayed by liquid chromatographyYtandem mass spectrometry. Comparison with five immunoassay techniques. Clin Chim Acta 2007;386:12-19.
28. Slater CC, Zhang C, Hodis HN, et al. Comparison of estrogen and androgen levels after oral estrogen replacement therapy. J Reprod Med 2001;46:1052-1056.