Dr. John K. Amory is applying for this Mentored Patient-Oriented Research Career Development Award (K23). Dr. Amory's career goal is to become an independent clinician-investigator proficient in the design and conduct of research evaluating the use of existing and novel androgens in: 1) the treatment of testosterone deficiency in young men; 2) the development of hormonal contraceptives for men; and 3) in male aging. Having gained considerable experience in designing and conducting clinical research relating to the uses of androgens, he now proposes mentored research and didactic training to facilitate the development and evaluation of novel means of oral androgen delivery for men with testosterone deficiency. He proposes a comprehensive assessment of the potential utility of high-dose oral testosterone administration. In his initial study, normal men will be rendered transiently testosterone deficient, and then administered increasing doses of high-dose testosterone by mouth, something not previously tested. Careful pharmacokinetic analysis will allow Dr. Amory to determine the optimal dosages for further study. In subsequent studies of oral testosterone therapy, testosterone deficient (hypogonadal) men currently receiving testosterone therapy will be treated with either oral testosterone or currently available testosterone therapy and followed both short and long-term to assess the ability of oral testosterone to serve as androgen replacement therapy. Validated tools for the assessment of mood, energy and sexual function for the assessment of short-term androgen endpoints will be used to compare the effects of the oral testosterone to currently used testosterone therapy. Long-term androgen-responsive endpoints such as bone mineral density, body composition and prostate volume will be followed to ascertain the impact of oral androgen therapy on men with testosterone deficiency. Data from these studies will eventually guide the design of larger, more definitive trials of oral androgen replacement, which could eventually lead to the clinical use of oral testosterone in the treatment of testosterone deficiency, and potentially in the treatment of age-related conditions and in the development of a male hormonal contraceptive. William J. Bremner, M.D., Ph.D., Chairman of the Department of Medicine, and Director of the Center for Research in Human Reproduction and Center for Contraceptive Development and Alvin M. Matsumoto M.D., Director, Clinical Research Unit VA-Puget Sound and Professor of Medicine, University of Washington School of Medicine will co-mentor this award. ? ?

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
5K23HD045386-04
Application #
7282066
Study Section
Pediatrics Subcommittee (CHHD)
Program Officer
Rankin, Tracy L
Project Start
2004-09-30
Project End
2009-09-29
Budget Start
2007-09-30
Budget End
2008-09-29
Support Year
4
Fiscal Year
2007
Total Cost
$126,044
Indirect Cost
Name
University of Washington
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
605799469
City
Seattle
State
WA
Country
United States
Zip Code
98195
Roth, Mara Y; Lin, K; Amory, J K et al. (2010) Serum LH correlates highly with intratesticular steroid levels in normal men. J Androl 31:138-45
Amory, John Kenneth; Leonard, Thomas W; Page, Stephanie T et al. (2009) Oral administration of the GnRH antagonist acyline, in a GIPET-enhanced tablet form, acutely suppresses serum testosterone in normal men: single-dose pharmacokinetics and pharmacodynamics. Cancer Chemother Pharmacol 64:641-5
Amory, John K (2008) Progress and prospects in male hormonal contraception. Curr Opin Endocrinol Diabetes Obes 15:255-60
Page, Stephanie T; Bremner, William J; Clark, Richard V et al. (2008) Nanomilled oral testosterone plus dutasteride effectively normalizes serum testosterone in normal men with induced hypogonadism. J Androl 29:222-7
Amory, John K; Anawalt, Bradley D; Matsumoto, Alvin M et al. (2008) The effect of 5alpha-reductase inhibition with dutasteride and finasteride on bone mineral density, serum lipoproteins, hemoglobin, prostate specific antigen and sexual function in healthy young men. J Urol 179:2333-8
Amory, John K; Kalhorn, Thomas F; Page, Stephanie T (2008) Pharmacokinetics and pharmacodynamics of oral testosterone enanthate plus dutasteride for 4 weeks in normal men: implications for male hormonal contraception. J Androl 29:260-71
Page, Stephanie T; Amory, John K; Bremner, William J (2008) Advances in male contraception. Endocr Rev 29:465-93
Roth, Mara Y; Amory, John K; Page, Stephanie T (2008) Treatment of male infertility secondary to morbid obesity. Nat Clin Pract Endocrinol Metab 4:415-9
Amory, John K; Coviello, Andrea D; Page, Stephanie T et al. (2008) Serum 17-hydroxyprogesterone strongly correlates with intratesticular testosterone in gonadotropin-suppressed normal men receiving various dosages of human chorionic gonadotropin. Fertil Steril 89:380-6
Page, Stephanie T; Kalhorn, Thomas F; Bremner, William J et al. (2007) Intratesticular androgens and spermatogenesis during severe gonadotropin suppression induced by male hormonal contraceptive treatment. J Androl 28:734-41

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