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- W2015348574 abstract "No AccessJournal of UrologyAdult Urology1 Feb 2011Oral Testosterone With and Without Concomitant Inhibition of 5α-Reductase by Dutasteride in Hypogonadal Men for 28 Days John K. Amory, Mark A. Bush, Hui Zhi, Ralph B. Caricofe, Alvin M. Matsumoto, Ronald S. Swerdloff, Christina Wang, and Richard V. Clark John K. AmoryJohn K. Amory University of Washington, Seattle, Washington More articles by this author , Mark A. BushMark A. Bush GlaxoSmithKline Research and Development, Research Triangle Park, North Carolina Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author , Hui ZhiHui Zhi GlaxoSmithKline Research and Development, Research Triangle Park, North Carolina Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author , Ralph B. CaricofeRalph B. Caricofe GlaxoSmithKline Research and Development, Research Triangle Park, North Carolina Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author , Alvin M. MatsumotoAlvin M. Matsumoto Geriatric Research Education and Clinical Center, Veterans Affairs-Puget Sound Health Care System, Seattle, Washington Financial interest and/or other relationship with GlaxoSmithKline, Solvay, USADA, Merck, PCC and Up to Date. More articles by this author , Ronald S. SwerdloffRonald S. Swerdloff Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, California More articles by this author , Christina WangChristina Wang Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, California Financial interest and/or other relationship with Clarus Therapeutics. More articles by this author , and Richard V. ClarkRichard V. Clark GlaxoSmithKline Research and Development, Research Triangle Park, North Carolina Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2010.09.089AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: Co-administration of the 5α-reductase inhibitor dutasteride increases the oral testosterone bioavailability in men with experimentally induced hypogonadism. We examined oral testosterone with and without dutasteride administration in hypogonadal men for 28 days. Materials and Methods: We randomly assigned 43 hypogonadal men to twice daily oral doses of 150, 250 or 400 mg testosterone with 0.25 mg dutasteride, 400 mg testosterone alone or 0.25 mg dutasteride alone for 28 days in a multicenter study. Subjects underwent pharmacokinetic profiling of serum hormones on days 1 and 28. A total of 32 men completed all study procedures. Results: Serum testosterone increased in all groups on testosterone compared with that in the dutasteride only group. At the 400 mg dose the combination of testosterone and dutasteride resulted in average testosterone concentrations that were 2.7 and 4.6 times higher than in the testosterone only group on days 1 and 28, respectively (p <0.01). On day 28 average testosterone was 20% to 30% lower in all groups on testosterone and dutasteride, and 50% lower in the testosterone only group compared with day 1. Serum dihydrotestosterone was suppressed in all groups on dutasteride and increased in the testosterone only group. Conclusions: Oral testosterone administration resulted in a therapeutic serum testosterone concentration in hypogonadal men. Dutasteride improved the oral bioavailability of testosterone while suppressing dihydrotestosterone. Compared with day 1, testosterone was decreased after 28 days of administration. 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Link, Google Scholar © 2011 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 185Issue 2February 2011Page: 626-632 Advertisement Copyright & Permissions© 2011 by American Urological Association Education and Research, Inc.KeywordstestosteronetestishypogonadismdutasterideadministrationoralAcknowledgmentsMarilyn Busher, Kathy Winter and Kathryn Torrez Duncan assisted with study clinical aspects. Part of the study was done at the Clinical Research Center, University of Washington and the General Clinical Research Center, Harbor-UCLA Medical Center. Crystalline T as a hard gelatin capsule and D were provided by GlaxoSmithKline Research and Development.MetricsAuthor Information John K. Amory University of Washington, Seattle, Washington More articles by this author Mark A. Bush GlaxoSmithKline Research and Development, Research Triangle Park, North Carolina Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author Hui Zhi GlaxoSmithKline Research and Development, Research Triangle Park, North Carolina Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author Ralph B. Caricofe GlaxoSmithKline Research and Development, Research Triangle Park, North Carolina Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author Alvin M. Matsumoto Geriatric Research Education and Clinical Center, Veterans Affairs-Puget Sound Health Care System, Seattle, Washington Financial interest and/or other relationship with GlaxoSmithKline, Solvay, USADA, Merck, PCC and Up to Date. More articles by this author Ronald S. Swerdloff Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, California More articles by this author Christina Wang Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, California Financial interest and/or other relationship with Clarus Therapeutics. More articles by this author Richard V. Clark GlaxoSmithKline Research and Development, Research Triangle Park, North Carolina Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author Expand All Advertisement PDF downloadLoading ..." @default.
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