Testosterone supplementation for hypogonadal men by the nasal route

Aging Male

Volumn 11, Issue 4, 2008, Pages 171-178

  Mattern, Claudia ^a   Hoffmann, Claudia ^b   Morley, John E ^c   Badiu, Corin ^d  

^a M et P Pharma AG   (Switzerland)

^b Buro der Facharzte Dr W Muhle Dr C Hoffmann Partner   (Germany)

^c SAINT LOUIS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d C I PARHON NATIONAL INSTITUTE OF ENDOCRINOLOGY   (Romania)

Author keywords

Circadian rhythm; DHT; Hypogonadism; MPP 10; Nasal; Testosterone

Indexed keywords

STROMELYSIN 2; TESTOSTERONE;

ADULT; ANDROGEN THERAPY; AREA UNDER THE CURVE; ARTICLE; BONE DISEASE; CIRCADIAN RHYTHM; CLINICAL ARTICLE; CLINICAL EVALUATION; CLINICAL TRIAL; COMPARATIVE STUDY; CONNECTIVE TISSUE DISEASE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; FEVER; GASTROINTESTINAL DISEASE; HUMAN; HYPOGONADISM; IDIOPATHIC HYPOGONADOTROPIC HYPOGONADISM; INJECTION SITE REACTION; KALLMANN SYNDROME; KIDNEY DISEASE; KLINEFELTER SYNDROME; MALE; MAXIMUM PLASMA CONCENTRATION; MEDIASTINUM DISEASE; MENTAL DISEASE; NAUSEA; NONFUNCTIONING PITUITARY ADENOMA; OPEN STUDY; OPTIMAL DRUG DOSE; PRIORITY JOURNAL; PROLACTINOMA; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; SINGLE DRUG DOSE; SKIN DISEASE; STEADY STATE; TESTOSTERONE BLOOD LEVEL; THORAX DISEASE; TREATMENT DURATION; TREATMENT OUTCOME; URINARY TRACT DISEASE; VISUAL ANALOG SCALE; ANALYSIS OF VARIANCE; GEL; INTRANASAL DRUG ADMINISTRATION; MIDDLE AGED; NONPARAMETRIC TEST; QUESTIONNAIRE;

ADMINISTRATION, INTRANASAL; ADULT; ANALYSIS OF VARIANCE; AREA UNDER CURVE; GELS; HUMANS; HYPOGONADISM; MALE; MIDDLE AGED; QUESTIONNAIRES; STATISTICS, NONPARAMETRIC; TESTOSTERONE; TREATMENT OUTCOME;

EID: 63249093111     PISSN: 13685538     EISSN: 14730790     Source Type: Journal    
DOI: 10.1080/13685530802351974     Document Type: Article

References (46)

1. Wang C, Swerdloff RS. Androgen replacement therapy. Ann Med 1997;29:365-370.
2. Matsumoto AM. Andropause: clinical implications of the decline in serum testosterone levels with aging in men. J Gerontol A Med Sci 2002;57:M76-M99.
3. Haren MT, Kim MJ, Tariq SH, Wittert GA, Morley JE. Andropause: a quality-of-life issue in older males. Med Clin North Am 2006;90:1005-1023.
4. Nieschlag E. Testosterone treatment comes of age: new options for hypogonadal men. Clin Endocrinol (Oxf) 2006;65:275-281.
5. Tenover JL. The androgen-deficient aging male: current treatment options. Rev Urol 2003;5 (Suppl 1):S22-S28.
6. Jockenhovel F. Testosterone therapy - what, when and to whom? Aging Male 2004;7:319-324.
7. Wang C, Swerdloff RS, Irnamanesh A, Dobs A, Snyder PJ, Cunningham G, Matsumoto AM, Weber T, Berman N, Testosterone Gel Study Group. Transdermal testosterone gel improves sexual function, mood, muscle strength, and body composition parameters in hypogonadal men. J Clin Endocrinol Metab 2000;85:3020-3023.
8. 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;85:4500-4510.
9. Kunz GJ, Klein KO, Clemons RD, Gottschalk ME, Jones KL. Virilization of young children after topical androgen use by their parents. Pediatrics 2004;114:282-284.
10. Brachet C, Vermeulen J, Heinrichs C. Children's virilization and the use of a testosterone gel by their fathers. Eur J Pediatr. 2005;164:646-647.
11. Spielberg TE. Abnormal testosterone levels in partners of patients using testosterone gels. J Sex Med. 2005;2:278.
12. Merhi ZO, Santoro N. Postmenopausal virilization after spousal use of topical androgens. Fertil Steril 2007;87:976.e13-e15.
13. Bhowmick SK, Ricke T, Rettig KR. Sexual precocity in a 16- month-old boy induced by indirect topical exposure to testosterone. Clin Pediatr 2007;46:540-543.
14. Morley JE. Androgens and aging. Maturitas 2001;38:61-71; discussion 71-73.
15. Gooren LJ, Bunch MC. Androgen replacement therapy: present and future. Drugs 2004;64:1861-1891.
16. GheorghiuM, Badiu C, Caragheorgheopol A. Clinical efficacy of the long-acting intramuscular compared to oral testosterone undecanoate in adult men with central hypogonadism. Acta Endocrinol 2008;4:59-73.
17. Bagchus WM, Hust R, Maris F, Schnabel PG, Houwing NS. Important effect of food on the bioavailability of oral testosterone undecanoate. Pharmacotherapy 2003;23:319- 325.
18. Haren M, Chapman I, Coates P, Morley J, Wittert G. Effect of 12 month oral testosterone on testosterone deficiency symptoms in symptomatic elderly males with low-normal gonadal status. Age Ageing 2005;34:123-130.
19. Wittert GA, Chapman IM, Haren MT, MacKintosh S, Coates P, Morley JE. Oral testosterone supplementation increases muscle and decreases fat mass in healthy elderly males with low-normal gonadal status. J Gerontol A Biol Sci Med Sci 2003;58:618-625.
20. Houwing NS, Maris F, Schnabel PG, Bagchus WM. Pharmacokinetic study in women of three different doses of a new formulation of oral testosterone undecanoate, Andriol Testocaps. Pharmacotherapy 2003;23:1257-1265.
21. Illum L. Nasal drug delivery: new developments and strategies. Drug Discov Today 2002:7:1184-1189.
22. Hussain A. Intranasal drug administration delivery. Adv Drug Del Rev 1998;29:39-49.
23. Wattanakumtornkul S, Pinto AB, Williams DB. Intranasal hormone replacement therapy. Menopause 2003;10:88-98.
24. Danner CH, Frick J. Androgen substitution with testosterone containing nasal drops. Int J Androl 1980;3:429-435.
25. Hussain AA, Kimura R, Hunag CH. Nasal absorption of testosterone in rats. J Pharmaceut Sci 1984;73:1300-1301.
26. Hussain AA, Al-Bayatti AA, Dakkuri A, OkochI K, Hussain MA. Testosterone 17b-N,N-dimethylglycinate hydrochloride: a prodrug with a potential for nasal delivery of testosterone. J Pharmaceut Sci 2002;91:785-789.
27. Arora P, Sharma S, Garg S. Permeability issues in nasal drug delivery. Drug Discov Today 2002;7:967-975.
28. Meikle AW, Mazer NA, Moellmer JF, Stringham JD, Tolman KG, Sanders SW, Odell WD. Enhanced transdermal delivery of testosterone across non-scrotal skin produces physiological concentrations of testosterone and its metabolites in hypogonadal men. J Clin Endocrinol Metab 1992;74:623-628.
29. Ohdo S. Chronopharmacology focused on biological clock. Drug Metab Pharmacokinet 2007;22:3-14.
30. Meikle AW, Arver S, Dobs AS, Sanders SW, Rajaram L, Mazer NA. Pharmacokinetics and metabolism of a permeation- enhanced testosterone transdermal system in hypogonadal men: influence of application site - a clinical research center study. J Clin Endocrinol Metab 1996;81:1832-1840.
31. Veldhuis JD, Iranmanesh A, Keenan DM. Erosion of endogenous testosterone-driven negative feedback on pulsatile luteinizing hormone secretion in healthy aging men. J Clin Endocrinol Metab 2004;89:5753-5761.
32. Winters SJ. Diurnal rhythm of testosterone and luteinizing hormone in hypogonadal men. Androl 1991;12: 185-190.
33. Liu PY, Takahashi PY, Roebuck PD, Iranmanesh A, Veldhuis JD. Age-specific changes in the regulation of LH-dependent testosterone secretion: assessing responsiveness to varying endogenous gonadotropin output in normal men. Am J Physiol Regul Integr Comp Physiol 2005;289:R721-R728.
34. Karatsoreos IN, Silver, R. Minireview: the neuroendocrinology of the suprachiasmatic nucleus as a conductor of body time in mammals. Endocrinology 2007;148:5640-5647.
35. Kriegsfeld LJ, Silver R. The regulation of neuroendocrine function: timing is everything (Review). Horm Behav 2006;49:557-574.
36. Diver MJ, Imtiaz KE, Ahmad AM, Vora JP, Fraser WD. Diurnal rhythms of serum total, free and bioavailable testosterone and of SHBG in middle-aged men compared with those in young men. Clin Endocrinol (Oxf) 2003;58:710- 717.
37. Diver MJ. Analytical and physiological factors affecting the interpretation of serum testosterone concentration in men. Ann Clin Biochem 2006;43:3-12.
38. Spratt DI, O'Dea LS, Schoenfeld D, Butler J, Rao PN, Crowley WF Jr. Neuroendocrine-gonadal axis in men: frequent sampling of LH, FSH, and testosterone. Am J Physiol 1988;254:E658-E666.
39. Robinson JA, Spelsberg TC. Mode of action at the cellular level with specific reference to bone cells. In: Lindsay R, Dempster DW, Jordan VC, editors. Estrogens and antiestrogens. Philadelphia: Lippincott-Raven; 1997. pp 43-62.
40. Tarter TH, Vaughan ED, Jr. Inhibitors of 5-alpha-reductase in the treatment of benign prostatic hyperplasia. Curr Pharm Des 2006;12:775-783.
41. Bartsch G, Rittmaster RS, Klocker H. Dihydrotestosterone and the concept of 5-alpha-reductase inhibition in human benign prostatic hyperplasia. World J Urol 2002;19:413-425.
42. Mooradian AD, Morley JE, Korenman SG. Biological actions of androgens. Endocrinol Rev 1987;8:1-28.
43. Zhu Y, Zheng T, Stevens RG, Zhang Y, Boyle P. Does 'clock' matter in prostate cancer? Cancer Epidemiol Biomarkers Prev 2006;15:3-5.
44. Alvarez JD, Hansen A, Ord T, Bebas P, Chappell PE, Giebultowicz JM, Williams C, Moss S, Sehgal A. The circadian clock protein BMAL1 is necessary for fertility and proper testosterone production in mice. J Biol Rhythms 2008;23:26-36.
45. Hertoghe T. The 'Multiple Hormone Deficiency' theory of aging: is human senescence caused mainly by multiple hormone deficiencies? Ann NY Acad Sci 2005;1057:448-465.
46. Chakraborty A, Krzyzanski W, Jusko WJ. Mathematical modeling of circadian cortisol concentrations using indirect response models: comparison of several methods. J Pharmacokinet Biopharm 1999;27:23-43.