D
Testosterone Levels in Clinical Studies

The table that follows provides examples of the testosterone level entry criteria used in several studies of testosterone therapy that included older men in the study populations. The table also provides information on baseline testosterone levels and the levels attained during the study.

REFERENCES

Blackman MR, Sorkin JD, Munzer T, Bellantoni MF, Busby-Whitehead J, Stevens TE, Jayme J, O’Connor KG, Christmas C, Tobin JD, Stewart KJ, Cottrell E, St Clair C, Pabst KM, Harman SM. 2002. Growth hormone and sex steroid administration in healthy aged women and men: a randomized controlled trial. Journal of the American Medical Association 288(18):2282–2292.


Christmas C, O’Connor KG, Harman SM, Tobin JD, Munzer T, Bellantoni MF, St Clair CS, Pabst KM, Sorkin JD, Blackman MR. 2002. Growth hormone and sex steroid effects on bone metabolism and bone mineral density in healthy aged women and men. Journals of Gerontology. Series A, Biological Sciences & Medical Sciences 57(1):M12–M18.


JAMA (Journal of the American Medical Association). 2001. Systeme International (SI) Conversion Factors for Selected Laboratory Components. [Online]. Available: http://jama.ama-assn.org/content/vol290/issue1/images/data/125/DC6/auinst_si.dtl [accessed July 2003].


Katznelson L, Finkelstein JS, Schoenfeld DA, Rosenthal DI, Anderson EJ, Klibanski A. 1996. Increase in bone density and lean body mass during testosterone administration in men with acquired hypogonadism. Journal of Clinical Endocrinology and Metabolism 81(12):4358–4365.



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Testosterone and Aging: Clinical Research Directions D Testosterone Levels in Clinical Studies The table that follows provides examples of the testosterone level entry criteria used in several studies of testosterone therapy that included older men in the study populations. The table also provides information on baseline testosterone levels and the levels attained during the study. REFERENCES Blackman MR, Sorkin JD, Munzer T, Bellantoni MF, Busby-Whitehead J, Stevens TE, Jayme J, O’Connor KG, Christmas C, Tobin JD, Stewart KJ, Cottrell E, St Clair C, Pabst KM, Harman SM. 2002. Growth hormone and sex steroid administration in healthy aged women and men: a randomized controlled trial. Journal of the American Medical Association 288(18):2282–2292. Christmas C, O’Connor KG, Harman SM, Tobin JD, Munzer T, Bellantoni MF, St Clair CS, Pabst KM, Sorkin JD, Blackman MR. 2002. Growth hormone and sex steroid effects on bone metabolism and bone mineral density in healthy aged women and men. Journals of Gerontology. Series A, Biological Sciences & Medical Sciences 57(1):M12–M18. JAMA (Journal of the American Medical Association). 2001. Systeme International (SI) Conversion Factors for Selected Laboratory Components. [Online]. Available: http://jama.ama-assn.org/content/vol290/issue1/images/data/125/DC6/auinst_si.dtl [accessed July 2003]. Katznelson L, Finkelstein JS, Schoenfeld DA, Rosenthal DI, Anderson EJ, Klibanski A. 1996. Increase in bone density and lean body mass during testosterone administration in men with acquired hypogonadism. Journal of Clinical Endocrinology and Metabolism 81(12):4358–4365.

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Testosterone and Aging: Clinical Research Directions Kenny AM, Prestwood KM, Gruman CA, Marcello KM, Raisz LG. 2001. Effects of transdermal testosterone on bone and muscle in older men with low bioavailable testosterone levels. Journals of Gerontology. Series A, Biological Sciences & Medical Sciences 56(5):M266–M272. Kenny AM, Bellantonio S, Gruman CA, Acosta RD, Prestwood KM. 2002a. Effects of transdermal testosterone on cognitive function and health perception in older men with low bioavailable testosterone levels. Journals of Gerontology. Series A, Biological Sciences & Medical Sciences 57(5):M321–M325. Kenny AM, Prestwood KM, Gruman CA, Fabregas G, Biskup B, Mansoor G. 2002b. Effects of transdermal testosterone on lipids and vascular reactivity in older men with low bioavailable testosterone levels. Journals of Gerontology. Series A, Biological Sciences & Medical Sciences 57(7):M460–M465. Morley JE, Perry HM 3rd, Kaiser FE, Kraenzle D, Jensen J, Houston K, Mattammal M, Perry HM Jr. 1993. Effects of testosterone replacement therapy in old hypogonadal males: a preliminary study. Journal of the American Geriatrics Society 41(2):149–152. Münzer T, Harman SM, Hees P, Shapiro E, Christmas C, Bellantoni MF, Stevens TE, O’Connor KG, Pabst KM, St. Clair C, Sorkin JD, Blackman MR. 2001. Effects of GH and/or sex steroid administration on abdominal subcutaneous and visceral fat in healthy aged women and men. Journal of Clinical Endocrinology and Metabolism 86(8):3604–3610. Pope HG Jr, Cohane GH, Kanayama G, Siegel AJ, Hudson JI. 2003. Testosterone gel supplementation for men with refractory depression: a randomized, placebo-controlled trial. American Journal of Psychiatry 160(1):105–111. Sih R, Morley JE, Kaiser FE, Perry HM 3rd, Patrick P, Ross C. 1997. Testosterone replacement in older hypogonadal men: a 12-month randomized controlled trial. Journal of Clinical Endocrinology and Metabolism 82(6):1661–1667. Snyder PJ, Peachey H, Hannoush P, Berlin JA, Loh L, Holmes JH, Dlewati A, Staley J, Santanna J, Kapoor SC, Attie MF, Haddad JG Jr, Strom BL. 1999a. Effect of testosterone treatment on bone mineral density in men over 65 years of age. Journal of Clinical Endocrinology and Metabolism 84(6):1966–1972. Snyder PJ, Peachey H, Hannoush P, Berlin JA, Loh L, Lenrow DA, Holmes JH, Dlewati A, Santanna J, Rosen CJ, Strom BL. 1999b. Effect of testosterone treatment on body composition and muscle strength in men over 65 years of age. Journal of Clinical Endocrinology and Metabolism 84(8):2647–2653. Snyder PJ, Peachey H, Berlin JA, Rader D, Usher D, Loh L, Hannoush P, Dlewati A, Holmes JH, Santanna J, Strom BL. 2001. Effect of transdermal testosterone treatment on serum lipid and apolipoprotein levels in men more than 65 years of age. American Journal of Medicine 111(4):255–260. Tenover JS. 1992. Effects of testosterone supplementation in the aging male. Journal of Clinical Endocrinology and Metabolism 75(4):1092–1098. Wang C, Swedloff RS, Iranmanesh A, Dobs A, Snyder PJ, Cunningham G, Matsumoto AM, Weber T, Berman N. 2000. Transdermal testosterone gel improves sexual function, mood, muscle strength, and body composition parameters in hypogonadal men. Testosterone Gel Study Group. Journal of Clinical Endocrinology and Metabolism 85(8):2839–2853.

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Testosterone and Aging: Clinical Research Directions TABLE D-1 Testosterone Levels in Clinical Studies Reference Treatment Duration, Preparation, Dose T Level Entry Criteria (ng/dL) Baseline Level in T-Treated Group (ng/dL) Mean Level Attained During Study in T-Treated Group (ng/dL) Randomized Placebo Controlled Trials Tenover, 1992 3 months 100 mg TE, IM weekly None TT: 334 ng/dL* TT: 568 ng/dL* Sih et al., 1997 12 months 200 mg TC, IM every 14-17 days BT ≤ 60 ng/dL BT: 42 ng/dL TT: 294 ng/dL BT: 73 ng/dL TT: 370 ng/dL Blackman et al., 2002; Christmas et al., 2002; Münzer et al., 2001 26 weeks 100 mg TE, IM biweekly TT ≤ 470 ng/dL TT: 409 ng/dL Not available Kenny et al., 2001, 2002a,b 12 months Two 2.5 mg patches daily BT < 128 ng/dL* TT: 389 ng/dL* BT: 92 ng/dL* TT: 640 ng/dL* BT: 161 ng/dL* Snyder et al., 1999a,b, 2001 36 months 6 mg scrotal patch daily TT < 475 ng/dL TT: 367 ng/dL TT: 625 ng/dL

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Testosterone and Aging: Clinical Research Directions Pope et al., 2003 8 weeks 10 g 1% T gel daily TT of 100-350 ng/dL TT: 293 ng/dL TT: 789 ng/dLa Additional Studies Morley et al., 1993 3 months 200 mg TE, IM every 2 weeks BT < 70 ng/dL BT: 37 ng/dL BT: 323 ng/dL Katznelson et al., 1996 18 months 100 mg IM, TE, or TC weekly TT < 300 ng/dL* TT: 184 ng/dL* Not available Wang et al., 2000 180 days 50 mg gel, 100 m gel, or 5 mg patch daily TT < 300 ng/dL TT: 237 ng/dL*b patch: 407 ng/dL* 50 mg gel: 450-554 ng/dL* 100 mg gel: 712-743 ng/dL* a Mean level after 1 week of testosterone therapy. b Baseline level for participants receiving T patch or T gel (50 mg/day). Average baseline level of serum testosterone for the pa rticipants receiving 100 mg/day T gel was 248 ng/dL. NOTE: *Converted from nmol/L. The conversion factor from conventional units (ng/dL) to Système International (SI) units (nmol/L) is 0.0347. To convert ng/dL to nmol/L multiply by 0.0347 (JAMA, 2001). BT = bioavailable testosterone; IM = intramuscular; T = testosterone; TE = testosterone enanthate; TC = testosterone cypionate; TT = total testosterone.