Transfer of transdermally applied testosterone to clothing: A comparison of a testosterone patch versus a testosterone gel

Journal of Sexual Medicine

Volumn 2, Issue 2, 2005, Pages 227-234

  Mazer, Norman ^a,e,f   Fisher, Daniel ^b   Fischer, Jerome ^c   Cosgrove, Michael ^c   Bell, Damon ^a   Eilers, Barbara ^d  

^a Watson Pharmaceuticals Inc   (United States)

^b AAI Development Services   (United States)

^c Diabet/Glandular Dis Res Assoc   (United States)

^d Clinical Research Services   (United States)

^e UNIVERSITY OF UTAH   (United States)

^f Department of Pharmaceuticals ^*  (United States)

Author keywords

Male design methodology of clinical trials; Male sex steroid replacement; Male topical treatment

Indexed keywords

TESTOSTERONE;

ABDOMEN; ADULT; AGED; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CLOTHING; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORRELATION ANALYSIS; DRUG ABSORPTION; DRUG DELIVERY SYSTEM; GEL; HORMONE DETERMINATION; HORMONE SUBSTITUTION; HUMAN; HYPOGONADISM; MALE; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; RADIOIMMUNOASSAY; RANDOMIZED CONTROLLED TRIAL; SKIN EXFOLIATION; STRATUM CORNEUM; SWEAT; TRANSDERMAL PATCH;

EID: 16344391388     PISSN: 17436095     EISSN: 17436109     Source Type: Journal    
DOI: 10.1111/j.1743-6109.2005.20232.x     Document Type: Article

References (22)

1. Androderm® Testosterone Transdermal System CIII, Prescribing Information, Physicians Desk Reference. 57th edition. Montvale, NJ: Thomson PDR; 2003:3280-2.
2. Wang C, Berman N, Longstreth JA, Chuapoco B, Hull L, Steiner B, Faulkner S, Dudley RE, Swerdloff RS. Pharmacokinetics of transdermal testosterone gel in hypogonadal men: Application of gel at one site versus four sites: A General Clinical Research Center Study. J Clin Endocrinol Metab 2000;85:964-9.
3. Delanoe D, Fougeyrollas B, Meyer L, Thonneau P. Androgenisation of female partners of men on medroxyprogesterone acetate/percutaneous testosterone contraception. Lancet 1984;1:276.
4. Moore N, Paux G, Nobler C, Andrejak M. Spouse-related drug side-effects. Lancet 1988;1:468.
5. Yu YM, Punyasavatsu N, Elder D, D'Ercole AJ. Sexual development in a two-year-old boy induced by topical exposure to testosterone. Pediatrics 1999;104:e23.
6. AndroGel® 1% Testosterone Gel CIII, Prescribing Information, Physicians Desk Reference. 57th edition. Montvale, NJ: Thomson PDR; 2001:3230-2.
7. Testim® 1% Testosterone Gel CIII, Prescribing Information. Norristown, PA: Auxilium Pharmaceuticals Inc; 2003.
8. Summary Basis of Approval, Application 21-015, Medical Review (http://www.fda.gov/cder/foi/nda/2000/21-015_AndroGel_Medr.pdf) and Clinical Pharmacology and Biopharmaceutics Reviews (http://www.fda.gov/cder/foi/nda/2000/21-015-AndroGel_BioPharmr.pdf.).
9. Mazer NA, Bell D, Wu J, Fischer JS, Cosgrove MF, Eilers B. Comparison of the steady-state pharmacokinetics, metabolism and variability of a transdermal testosterone patch versus a transdermal testosterone gel in hypogonadal men. J Sex Med 2005;2:213-26.
10. National Weather Service Forecast Office, Austin/San Antonio, Texas. Monthly/Annual/Average Temperature San Antonio, Texas (1885-August 2004). http://www.srh.noaa.gov/ewx/html/cli/sat/satmontemp.htm.
11. Patterson MJ, Galloway SD, Nimmo MA. Variations in regional sweat composition in normal human males. Exp Physiol 2000;85:869-75.
12. Kurata S, Itami S, Komada S, Takayasu S. Intranuclear androgen and cytosolic receptor concentrations in the axillary skin of osmidrosis. Arch Dermatol Res 1990;282:33-7.
13. Stoeckelhuber M, Stoeckelhuber BM, Welsch U. Human glands of Moll: Histochemical and ultrastructural characterization of the glands of Moll in the human eyelid. J Invest Dermatol 2003;121:28-36.
14. Downing DT, Stewart ME, Strauss JS. Estimation of sebum production rates in man by measurement of the squalene content of skin biopsies. J Invest Dermatol 1981;77:358-60.
15. Schwartz JI, Tanaka WK, Wang DZ, Ebel DL, Geissler LA, Dallob A, Hafkin B, Gertz BJ. MK-386, an inhibitor of 5alpha-reductase type 1, reduces dihydrotestosterone concentrations in serum and sebum without affecting dihydrotestosterone concentrations in semen. J Clin Endocrinol Metab 1997;82:1373-7.
16. Sandby-Moller J, Poulsen T, Wulf HC. Epidermal thickness at different body sites: Relationship to age, gender, pigmentation, blood content, skin type and smoking habits. Acta Derm Venereol 2003;83:410-3.
17. Hoath SB, Leahy DG. The organization of human epidermis: Functional epidermal units and phi proportionality. J Invest Dermatol 2003;121:1440-6.
18. Surber C, Wilhelm KP, Hori M, Maibach HI, Guy RH. Optimization of topical therapy: Partitioning of drugs into stratum corneum. Pharm Res 1990;7:1320-4.
19. Roberts MS, Cross SE, Anissimov YG. Factors affecting the formation of a skin reservoir for topically applied solutes. Skin Pharmacol Physiol 2004;17:3-16.
20. Swerdloff RS, Wang C, Cunningham G, Dobs A, Iranmanesh A, Matsumoto AM, Snyder PJ, Weber T, Longstreth J, Berman N. Long-term pharmacokinetics of transdermal testosterone gel in hypogonadal men. J Clin Endocrinol Metab 2000;85:4500-10.
21. Mazer NA. Testosterone deficiency in women: Etiologies, diagnosis, and emerging treatments. Int J Fertil Womens Med 2002;47:77-86.
22. Redmond G. Risks of testosterone replacement. N Engl J Med 2004;350:2004-6.