Pharmacokinetics of 2 novel formulations of modified-release oral testosterone alone and with finasteride in normal men with experimental hypogonadism

Journal of Andrology

Volumn 31, Issue 6, 2010, Pages 527-535

  Snyder, Christin N ^a   Clark, Richard V ^b   Caricofe, Ralph B ^b   Bush, Mark A ^b   Roth, Mara Y ^a   Page, Stephanie T ^a   Bremner, William J ^a   Amory, John K ^a  

^a UNIVERSITY OF WASHINGTON   (United States)

^b GLAXOSMITHKLINE   (United States)

Author keywords

5 reductase; Androgen; Dihydrotestosterone (DHT); Drug delivery; Estradiol

Indexed keywords

ACYLINE; ANDROSTANOLONE; ANTIRETROVIRUS AGENT; ESTRADIOL; FINASTERIDE; GONADORELIN ANTAGONIST; TESTOSTERONE; UNCLASSIFIED DRUG;

ADULT; ANDROGEN DEFICIENCY; ANDROGEN THERAPY; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED RELEASE FORMULATION; CONTROLLED STUDY; DRUG DOSAGE FORM COMPARISON; DRUG DOSE COMPARISON; ESTRADIOL BLOOD LEVEL; GASTROINTESTINAL SYMPTOM; HEADACHE; HOT FLUSH; HUMAN; HYPOGONADISM; MALE; OPEN STUDY; PRIORITY JOURNAL; SIDE EFFECT; SLOW RELEASE FORMULATION; TESTOSTERONE BLOOD LEVEL;

5-ALPHA REDUCTASE INHIBITORS; ADOLESCENT; ADULT; DELAYED-ACTION PREPARATIONS; DIHYDROTESTOSTERONE; DRUG COMBINATIONS; ESTRADIOL; FINASTERIDE; HUMANS; HYPOGONADISM; MALE; MIDDLE AGED; OLIGOPEPTIDES; TESTOSTERONE; YOUNG ADULT;

EID: 78649438203     PISSN: 01963635     EISSN: 19394640     Source Type: Journal    
DOI: 10.2164/jandrol.109.009746     Document Type: Article

References (29)

1. Amory JK, Bremner WJ. Oral testosterone in oil plus dutasteride: a pharmacokinetic study in men. J Clin Endocrinol Metab. 2005;90:2610-2617.
2. Amory JK, Page ST, Bremner WJ. Oral testosterone in oil: pharmacokinetic effects of 5α-reduction with finasteride or dutasteride and food intake in men. J Androl. 2006;27:72-78.
3. Amory JK, Wang C, Swerdloff RS, Anawalt BD, Matsumoto AM, Bremner WJ, Walker SE, Haberer LJ, Clark RV. The effect of 5alpha-reductase inhibition with dutasteride and finasteride on semen parameters and serum hormones in healthy men. J Clin Endocrinol Metab. 2007;92:1659-1665. (Pubitemid 46997168)
4. Araujo AB, Esche GR, Kupelian V, O'Donnell AB, Travison TG, Williams RE, Clark RV, McKinlay JB. Prevalence of symptomatic androgen deficiency in men. J Clin Endocrinol Metab. 2007;92:4241-4247. (Pubitemid 350074738)
5. 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. (Pubitemid 36259335)
6. 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. (Pubitemid 41428253)
7. Daggett PR, Wheeler MJ, Nabarro JD. Oral testosterone, a reappraisal. Horm Res. 1978;9:121-129.
8. de Ronde W. Hyperandrogenism after transfer of topical testosterone gel: case report and review of published and unpublished studies. Hum Reprod. 2009;24:425-428.
9. Dobs AS, Meikle AW, Arver S, Sanders SW, Caramelli KE, Mazer MA. Pharmacokinetics, efficacy and safety of a permeation-enhanced testosterone transdermal system in comparison with biweekly injections of testosterone enanthate for the treatment of hypogonadal men. J Clin Endocrinol Metab. 1999;84:3469-3478. (Pubitemid 30645193)
10. Foss GL. Clinical administration of androgens. Lancet. 1939;1:502-504.
11. Fossa SD, Opjordsmoen S, Haug E. Androgen replacement and quality of life in patients treated for bilateral testicular cancer. Eur J Cancer. 1999;35:1220-1225. (Pubitemid 29359182)
12. Franchimont P, Kicovic PM, Mattei A, Roulier R. Effects of oral testosterone undecanoate in hypogonadal male patients. Clin Endocrinol (Oxf). 1978;9:313-320. (Pubitemid 9037303)
13. Herbst KL, Coviello AD, Page ST, Amory JK, Anawalt BD, Bremner WJ. A single dose of the potent gonadotropin-releasing hormone antagonist acyline suppresses gonadotropins and testosterone for 2 weeks in healthy young men. J Clin Endocrinol Metab. 2004;89:5959-5965.
14. Johnsen SG. Long-term oral testosterone and liver function. Lancet. 1978;1:50.
15. Johnsen SG, Bennett EP, Jensen VG. Therapeutic effectiveness of oral testosterone. Lancet. 1974;2:1473-1475.
16. Kalhorn TF, Page ST, Howald WN, Mostaghel EA, Nelson PS. Analysis of testosterone and dihydrotestosterone from biological fluids as the oxime derivatives using high-performance liquid chromatography/tandem mass spectroscopy. Rapid Commun Mass Spectrom. 2007;21:3200-3206.
17. Katznelson L, Finkelstein JS, Schoenfeld DA, Rosenthal DI, Anderson EJ, Klibanski A. Increase in bone density and lean body mass during testosterone administration in men with acquired hypogonadism. J Clin Endocrinol Metab. 1996;81:4358-4365. (Pubitemid 26412044)
18. Lowdell CP, Murray-Lyon IM. Reversal of liver damage due to long term methyltestosterone and safety of 17-alpha alkylated androgens. Br Med J. 1985;291:637-645.
19. Nieschlag E, Mauss J, Coert A, Kicovic P. Plasma androgen levels in men after oral administration of testosterone and testosterone undecanoate. Acta Endocrinol (Copenh). 1975;79:366-374.
20. Page ST, Bremner WJ, Clark RV, Bush MA, Zhi H, Caricofe RB, Smith PM, Amory JK. Nanomilled oral testosterone plus dutasteride effectively normalizes serum testosterone in normal men with induced hypogonadism. J Androl. 2008;29:222-227. (Pubitemid 351345720)
21. Pavlatos AM, Fultz O, Monberg MJ, Vootkur A. Review of oxymetholone: a 17alpha-alkylated anabolic-androgenic steroid. Clin Ther. 2001;23:789-801. (Pubitemid 32554565)
22. Schnabel PG, Bagchus W, Lass H, Thomsen T, Geurts TB. The effect of food composition on serum testosterone levels after oral administration of Andriol Testocaps. Clin Endocrinol (Oxf). 2007;66:579-585. (Pubitemid 46434947)
23. Snyder PJ, Peachey H, Berlin JA, Hannoush P, Haddad G, Dlewati A, Santanna J, Loh L, Lenrow DA, Holmes JH, Kapoor SC, Atkinson LE, Strom BL. Effects of testosterone replacement in hypogonadal men. J Clin Endocrinol Metab. 2000;85:2670-2677. (Pubitemid 32269134)
24. 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. (Pubitemid 32157624)
25. Thompson IM, Goodman PJ, Tangen CM, Lucia MS, Miller GJ, Ford LG, Lieber MM, Cespedes RD, Atkins JN, Lippman SM, Carlin SM, Ryan A, Szczepanek CM, Crowley JJ, Coltman CA Jr. The influence of finasteride on the development of prostate cancer. New Engl J Med. 2003;349:215-224.
26. Turani H, Levi J, Zevin D, Kessler E. Hepatic lesions in patients on anabolic androgenic therapy. Isr J Med Sci. 1983;19:332-337. (Pubitemid 13042620)
27. Wang C, Alexander G, Berman N, Salehian B, Davidson T, McDonald V, Steiner B, Hull L, Callegari C, Swerdloff RS. Testosterone replacement therapy improves mood in hypogonadal men - a clinical research center study. J Clin Endocrinol Metab. 1996;81:3578-3583. (Pubitemid 26339918)
28. Wang C, Swerdloff RS, Iranmanesh 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;85:2839-2853. (Pubitemid 32269162)
29. Westaby D, Ogle SJ, Paradinas FJ, Randell JB, Murray-Lyon IM. Liver damage from long-term methyltestosterone. Lancet. 1977;2:262-263.