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Testosterone and Aging: Clinical Research Directions (2004)

Chapter: Appendix D: Testosterone Levels in Clinical Studies

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Suggested Citation:"Appendix D: Testosterone Levels in Clinical Studies." Institute of Medicine. 2004. Testosterone and Aging: Clinical Research Directions. Washington, DC: The National Academies Press. doi: 10.17226/10852.
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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.

Suggested Citation:"Appendix D: Testosterone Levels in Clinical Studies." Institute of Medicine. 2004. Testosterone and Aging: Clinical Research Directions. Washington, DC: The National Academies Press. doi: 10.17226/10852.
×

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.

Suggested Citation:"Appendix D: Testosterone Levels in Clinical Studies." Institute of Medicine. 2004. Testosterone and Aging: Clinical Research Directions. Washington, DC: The National Academies Press. doi: 10.17226/10852.
×

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

Suggested Citation:"Appendix D: Testosterone Levels in Clinical Studies." Institute of Medicine. 2004. Testosterone and Aging: Clinical Research Directions. Washington, DC: The National Academies Press. doi: 10.17226/10852.
×

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.

Suggested Citation:"Appendix D: Testosterone Levels in Clinical Studies." Institute of Medicine. 2004. Testosterone and Aging: Clinical Research Directions. Washington, DC: The National Academies Press. doi: 10.17226/10852.
×
Page 198
Suggested Citation:"Appendix D: Testosterone Levels in Clinical Studies." Institute of Medicine. 2004. Testosterone and Aging: Clinical Research Directions. Washington, DC: The National Academies Press. doi: 10.17226/10852.
×
Page 199
Suggested Citation:"Appendix D: Testosterone Levels in Clinical Studies." Institute of Medicine. 2004. Testosterone and Aging: Clinical Research Directions. Washington, DC: The National Academies Press. doi: 10.17226/10852.
×
Page 200
Suggested Citation:"Appendix D: Testosterone Levels in Clinical Studies." Institute of Medicine. 2004. Testosterone and Aging: Clinical Research Directions. Washington, DC: The National Academies Press. doi: 10.17226/10852.
×
Page 201
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Popular culture often equates testosterone with virility, strength, and the macho male physique. Viewed by some as an “antiaging tonic,” testosterone’s reputation and increased use by men of all ages in the United States have outpaced the scientific evidence about its potential benefits and risks. In particular there has been growing concern about an increase in the number of middle-aged and older men using testosterone and the lack of scientific data on the effect it may have on aging males. Studies of testosterone replacement therapy in older men have generally been of short duration, involving small numbers of participants and often lacking adequate controls. Testosterone and Aging weighs the options of future research directions, examines the risks and benefits of testosterone replacement therapy, assesses the potential public health impact of such therapy in the United States, and considers ethical issues related to the conduct of clinical trials. Testosterone therapy remains an attractive option to many men even as speculation abounds regarding its potential.

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