Topical testosterone supplementation for the treatment of male hypogonadism

Drugs

Volumn 72, Issue 12, 2012, Pages 1591-1603

  Abadilla, Katrina A ^a   Dobs, Adrian S ^b  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

Buccal; Hypogonadism; Oral; Subdermal; Testosterone; Testosterone cipionate; Testosterone enantate; Testosterone undecanoate; Topical; Transdermal

Indexed keywords

ITNOGEN; PLACEBO; PROSTATE SPECIFIC ANTIGEN; TESTOSTERONE; TESTOSTERONE CIPIONATE; TESTOSTERONE ENANTATE; TESTOSTERONE ESTER; TESTOSTERONE PROPIONATE; TESTOSTERONE UNDECANOATE; TOSTRAN; UNCLASSIFIED DRUG;

ALZHEIMER DISEASE; AREA UNDER THE CURVE; BLEEDING; CANCER SCREENING; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; COMORBIDITY; DIABETES MELLITUS; DRUG ABSORPTION; DRUG EFFICACY; DRUG ERUPTION; GEL; HEMATOCRIT; HORMONAL THERAPY; HUMAN; HYPOGONADISM; INFECTION; MALE INFERTILITY; MAXIMUM PLASMA CONCENTRATION; METABOLIC SYNDROME X; MOOD; PATIENT COMPLIANCE; PRACTICE GUIDELINE; PROSTATE CANCER; REVIEW; TESTOSTERONE BLOOD LEVEL; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT OUTCOME;

ADMINISTRATION, CUTANEOUS; ANIMALS; HORMONE REPLACEMENT THERAPY; HUMANS; HYPOGONADISM; MALE; TESTOSTERONE;

EID: 84864708706     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.2165/11635620-000000000-00000     Document Type: Review

References (58)

1. Diver MJ, Imtiaz KE, Ahmad AM, et al. Diurnal rhythms of serum total, free and bioavailable testosterone and of SHBG in middle-aged men compared with those in young men. Clin Endocrinol 2003; 58 (6): 710-7 (Pubitemid 36702730)
2. Andersson AM, Carlsen E, Petersen JH, et al. Variation in levels ofserum inhibin b, testosterone, estradiol, luteinizing hormone, follicle-stimulating hormone, and sex hormone-binding globulin in monthly samples from healthy men during a 17-month period: possible effects ofseasons. J Clin Endocrinol Metab 2003; 88 (2): 932-7 (Pubitemid 36207844)
3. Harman SM, Metter EJ, Tobin JD, et al. Longitudinal effects ofaging on serum total and free testosterone levels in healthy men: Baltimore longitudinal study ofaging. J Clin Endocrinol Metab 2001; 86 (2): 724-31 (Pubitemid 32207487)
4. Kaufman JM, Vermeulen A. Declining gonadal function in elderlymen. Baillieres Clin Endocrinol Metab 1997; 11 (2): 289-309
5. Snyder PJ. Effects of age on testicular function and con- sequences of testosterone treatment. J Clin Endocrinol Metab 2001; 86 (6): 2369-72 (Pubitemid 32545679)
6. Faiman C. Male hypogonadism. Cleveland (OH): Cleveland Clinic Foundation, 2011: 157-70
7. Edelstein D, Sivanandy M, Shahani S, et al. The latest options and future agents for treating male hypogonadism. Expert Opin Pharmacother 2007; 8 (17): 2991-3008 (Pubitemid 350285013)
8. Pfeil E, Dobs A. Current and future testosterone delivery systems for treatment of the hypogonadal male. Expert Opin Durg Deliv 2008; 5 (4): 471-81 (Pubitemid 351721725)
9. Nieschlag E, Behre HM, Bouchard P, et al. Testosterone replacement therapy: current trends and future directions. Hum Reprod Update 2004; 10 (5): 409-19 (Pubitemid 39232796)
10. American Association ofClinical Endocrinologists: American Association ofClinical Endocrinologists Medical Guidelines for clinical practice for the evaluation and treatment of hy-pogonadism in adult patients: 2002 update. Endocr Pract 2002; 8: 440-56
11. Bassil N, Alkaade S, Morley J. The benefits and risks of testosterone replacement therapy: a review. Ther Clin Risk Manag 2009; 5 (3): 427-48
12. Pike CJ, Rosario ER, Nguyen TV. Androgens, aging, and Alzheimer's disease. Endocrine 2006; 29 (2): 233-41 (Pubitemid 44097366)
13. Jones TH, Arver S, Behre HM, et al. Testosterone replace- ment in hypogonadal men with type 2 diabetes and/or metabolic syndrome (the TIMES2 study). Diabetes Care 2011; 34 (4): 828-37
14. Wang C, Nieschlag E, Swerdloff R, et al. ISA, ISSAM, EAU, EAA and ASA recommendations: investigation, treatment, and monitoring of late-onset hypogonadism in males. Aging Male 2009; 12: 5-12
15. Bhasin S, Cunningham GR, Hayes FJ, et al. Testosterone therapy in adult men with androgen deficiency syndromes: an endocrine society clinical practice guidelines. J Clin Endocrinol Metab 2010; 95 (6): 2536-59
16. Brown-Sequard CE. The effects produced on man by sub- cutaneous injections of liquid obtained from the testicles of animals. Lancet 1889; 137: 105-7
17. Freeman ER, Bloom DA, McGuire EJ. A briefhistory of testosterone. J Urol 2001; 165 (2): 371-3
18. Giagulli VA, Triggiani V, Corona GD, et al. Evidence-based medicine update on testosterone replacement therapy in male hypogonadism: focus on new formulations. Curr PharmDes2011; 17: 1500-11
19. Handelsman DJ, Mackey MA, Howe C, et al. An analysis of testosterone implants for androgen replacement therapy. Clin Endocrinol 1997; 47: 311-6 (Pubitemid 27395962)
20. Dobs AS, Matsumoto AM, Wang C, et al. Short-term pharmacokinetic comparison of a novel testosterone buc-cal system and a testosterone gel in testosterone deficient men. Curr Med Res Opin 2004; 20: 729-38 (Pubitemid 38685019)
21. IMS Health Pharmaceutical Information. Testosterone therapy marketing online. Available from URL: http:// www.imshealth.com/ims/Global/Content/ Solutions/Solu tions%20by%20Sector/Small%20and%20Emerging/ASK/IMS/Offering/ Template3.pdfAccessed 2012 Feb 14
22. Dobs AS, Meikle AW, Arver S, et al. Pharmacokinetics, efficacy, and safety of a permeation-enhanced testosterone transdermal system in comparison with bi-weekly injec-tions of testosterone enanthate for the treatment of hypo-gonadal men. J Clin Endocrinol Metab 1999; 84: 3469-78 (Pubitemid 30645193)
23. Rhoden EL, Morgentaler A. Risks oftestosterone-replacement therapy and recommendations for monitoring. N Engl J Med 2004; 350 (5): 482-92 (Pubitemid 38133769)
24. Bagatell CJ, Bremner WJ. Androgens in men: uses and abuses. N Engl J Med 1996; 334: 707-14
25. Behre HM, von Eckardstein S, Kliesch S, et al. Long-term substitution therapy ofhypogonadal men with transscrotal testosterone over 7-10 years. Clin Endocrinol (Oxf) 1999; 50 (5): 629-35 (Pubitemid 29236340)
26. Wang C, Swerdloff RS, Iranmanesh A, et al. Transdermal testosterone gel improves sexual function, mood, muscle strength, and body composition parameters in hypogona-dal men. J Clin Endocrinol Metab 2000; 85: 2839-53 (Pubitemid 32269162)
27. Wilson DE, Kaidbey K, Boike SC, et al. Use of topical corticosteroid pretreatment to reduce the incidence and severity of skin reactions associated with testosterone transdermal therapy. Clin Ther 1998; 20: 299-306 (Pubitemid 28241750)
28. Brocks DR, Meikle AW, Boike SC, et al. Pharmacokinetics of testosterone in hypogonadal men after transdermal de-livery: influence ofdose. J Clin Pharmacol 1996; 36: 732-9 (Pubitemid 26295778)
29. Meikle AW, Mazer NA, Moellmer JF, et al. Enhanced transdermal delivery oftestosterone across nonscrotal skin produces physiological concentrations of testosterone and its metabolites in hypogonadal men. J Clin Endocrinol Metab 1992; 74: 623-8
30. Meikle AW, Arver S, Dobs AS, et al. Pharmacokinetics and metabolism of a permeation-enhanced testosterone trans-dermal system in hypogonadal men: influence of applica-tion site- a clinical research center study. J Clin Endocrinol Metab 1996; 81: 1832-40 (Pubitemid 26152472)
31. Bhowmick SK, Ricke T, Rettig KR. Sexual precocity in a 16-month-old boy induced by indirect topical exposure to testosterone. Clin Pediatr (Phila) 2007; 46 (6): 540-3 (Pubitemid 46920335)
32. US Department of Health and Human Services. US Food and Drug Administration. Testosterone gel safety con-cerns prompt FDA to require label changes, medication guide media release. 2009 May 7 online. Available from URL: http://www.fda.gov/NewsEvents/Newsroom/Press Announcements/2009/ucm149580.htm/ Accessed 2012 Feb 10
33. McNicholas TA, Dean JD, Mulder H, et al. A novel tes- tosterone gel formulation normalizes androgen levels in hypogonadal men, with improvements in body composi-tion and sexual function. BJU Int 2003; 91 (1): 69-74
34. Steidle C, Schwartz S, Jacoby K, et al. AA2500 testosterone gel normalizes androgen levels in aging males with im- provements in body composition and sexual function. J Clin Endocrinol Metab 2003; 88 (6): 2673-81 (Pubitemid 36724441)
35. Marbury T, Hamill E, Bachand R, et al. Evaluation of the pharmacokinetic profiles of the new testosterone topical gel formulation, Testim, compared to AndroGel. Bio-pharm Drug Dispos 2003; 24 (3): 115-20 (Pubitemid 36526938)
36. McNicholas T, Ong T. Review of Testim gel. Expert Opin Pharmacother 2006; 7 (4): 477-84
37. Loizides E, Swierzewski MJ, O'Neill C, et al. Early response time in sexual activity and mood following testosterone gel replacement in hypogonadal males from the Testim® START study. Rev Urol 2004; 6: 16S-21S
38. Dean JD, Carnegie C, Rodzvilla J, et al. Long-term effects of Testim® 1% testosterone gel in hypogonadal men. Rev Urol 2004; 6: 22S-9S
39. Swerdloff RS, Wang C, Cunningham G, et al. Long-term pharmacokinetics of transdermal testosterone gel in hypo-gonadal men. J Clin Endocrinol Metab 2000; 85 (12): 4500-10 (Pubitemid 32157624)
40. Wang C, Berman N, Longstreth JA, et al. Pharmacokinetics of transdermal testosterone gel in hypogonadal men: appli-cation of gel at one site versus four sites. J Clin Endocrinol Metab 2000; 85 (3): 964-9 (Pubitemid 32269334)
41. Kaufman JM, Miller MG, Garwin JL, et al. Efficacy and safety study of 1.62% testosterone gel for the treatment of hypogonadal men. J Sex Med 2011; 8: 2079-89
42. Kaufman JM, Miller MG, Fitzpatrick S, et al. One-year efficacy and safety study of a 1.62% testosterone gel in hypogonadal men: results of a 182-day open-label exten-sion of a 6-monthdouble-blind study. J SexMed 2012Apr; 9 (4): 1149-61
43. Miller J, Britto M, Fitzpatrick S, et al. Pharmacokinetics and relative bioavailability of absorbed testosterone after administration of a 1.62% testosterone gel to different application sites in men with hypogonadism. Endocr Pract 2011; 17: 574-83
44. Stahlman J, Britto M, Fitzpatrick S, et al. Effects of skin washing on systemic absorption of testosterone in hypo-gonadal males after administration of 1.62% testosterone gel. Curr Med Res Opin 2012; 28 (2): 271-9
45. Dobs AS, McGettigan J, Norwood P, et al. A novel testos- terone 2% gel for the treatment of hypogonadal males. J Androl 2012 Jul; 33 (4): 601-7
46. Wang C, Ilani N, Arver S, et al. Efficacy and safety of the 2% formulation of testosterone topical solution applied to the axillae in androgen-deficient men. Clin Endocrinol (Oxf) 2011; 75 (6): 836-43
47. Marjason J, Watkinson A, Soulis T. Evaluation of the amount of residual testosterone topical solution 2% remain-ing on the underarm in healthy males who undergo post-dose washing procedures. J Androl 2011; 32 Suppl.: 77S
48. Theodoraki A, Bouloux PM. Testosterone therapy in men. Menopause Int 2009; 15 (2): 87-92
49. Ding EL, Song Y, Malik VS, et al. Sex differences ofendo- genous sex hormones and risk oftype 2 diabetes: a systematic review and meta-analysis. JAMA 2006; 295 (11): 1288-99
50. Behre HM, Bohmeyer J, Nieschlag E. Prostate volume in testosterone-treated and untreated hypogonadal men in com-parison to age-matched normal controls. Clin Endocrinol (Oxf) 1994; 40 (3): 341-9 (Pubitemid 24194627)
51. Coward RM, Simhan J, Carson CC. Prostate-specific anti- gen changes and prostate cancer in hypogonadal men treated with testosterone replacement therapy. BJU Int 2008; 103 (9): 1179-83
52. Dickerman RD, Pertusi R, Zachariah NY. Androgen- induced erythrocytosis: is it erythropoietin? Am J Hematol 1999; 61 (2): 154-5
53. Bachman E, Feng R, Travison T, et al. Testosterone sup- presses hepcidin in men: a potential mechanism for testos-terone-induced erythrocytosis. J Clin Endocrinol Metab 2010; 95 (10): 4743-7
54. Lee KK, Berman N, Alexander GM, et al. A simple self- report diary for assessing psychosexual function in men. J Androl 2003; 24: 688-98 (Pubitemid 38133070)
55. Jackson JA, Riggs MW, Spiekerman AM. Testosterone de- ficiency as a risk factor for hip fractures in men: a case-control study. Am J Med Sci 1992; 304: 4-8
56. Behre HM, Kliesch S, Leifke E, et al. Long-term effect of testosterone therapy on bone mineral density in hypogo-nadal men. J Clin Endocrinol Metab 1997; 82: 2386-90 (Pubitemid 27337844)
57. De Rosa M, Paesano L, Nuzzo V, et al. Bonemineraldensity and bone markers in hypogonadotropic and hypergona-dotropic hypogonadal men after prolonged testosterone treatment. J Endocrinol Invest 2001; 24 (4): 246-52 (Pubitemid 32435504)
58. Wang C, Swerdloff RS, Iranmanesh A, et al. Effects of transdermal testosterone gel on bone turnover markers and bone mineral density in hypogonadal men. Clin Endocrinol (Oxf) 2001; 54 (6): 739-50 (Pubitemid 34208885)