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*CHOLESTEROL
*TESTOSTERONE
The Journal of Clinical Endocrinology & Metabolism Vol. 85, No. 8 2839-2853
Copyright © 2000 by The Endocrine Society

Original Studies

Transdermal Testosterone Gel Improves Sexual Function, Mood, Muscle Strength, and Body Composition Parameters in Hypogonadal Men1

Christina Wang, Ronald S. Swerdloff, Ali Iranmanesh, Adrian Dobs, Peter J. Snyder, Glenn Cunningham, Alvin M. Matsumoto, Thomas Weber and Nancy Berman the Testosterone Gel Study Group2

Divisions of Endocrinology, Departments of Medicine/Pediatrics, Harbor-University of California-Los Angeles Medical Center and Research and Education Institute (C.W., R.S.S., N.B.), Torrance, California 90509; Veterans Affairs Medical Center (A.I.), Salem, Virginia 24153; The Johns Hopkins University (A.D.), Baltimore, Maryland 21287; University of Pennsylvania Medical Center (P.J.S.), Philadelphia, Pennsylvania 19104; Veterans Affairs Medical Center, Baylor College of Medicine (G.C.), Houston, Texas 77030; Veterans Affairs Puget Sound Health Care System, University of Washington (A.M.M.), Seattle, Washington 98108; and Duke University Medical Center (T.W.), Durham, North Carolina 27705

Address all correspondence and requests for reprints to: Dr. Christina Wang, Division of Endocrinology, Department of Medicine, Harbor-University of California-Los Angeles Medical Center, 1000 West Carson Street, Torrance, California 90509.

Testosterone (T) therapy for hypogonadal men should correct the clinical abnormalities of T deficiency, including improvement of sexual function, increase in muscle mass and strength, and decrease in fat mass, with minimal adverse effects. We have shown that administration of a new transdermal T gel formulation to hypogonadal men provided dose proportional increases in serum T levels to the normal adult male range. We now report the effects of 180 days of treatment with this 1% T gel preparation (50 or 100 mg/day, contained in 5 or 10 g gel, respectively) compared to those of a permeation-enhanced T patch (5 mg/day) on defined efficacy parameters in 227 hypogonadal men. In the T gel groups, the T dose was adjusted up or down to 75 mg/day (contained in 7.5 g gel) on day 90 if serum T concentrations were below or above the normal male range. No dose adjustment was made with the T patch group. Sexual function and mood changes were monitored by questionnaire, body composition was determined by dual energy x-ray absorptiometry, and muscle strength was measured by the one repetitive maximum technique on bench and leg press exercises. Sexual function and mood improved maximally on day 30 of treatment, without differences across groups, and showed no further improvement with continuation of treatment. Mean muscle strength in the leg press exercise increased by 11 to 13 kg in all treatment groups by 90 days and did not improve further at 180 days of treatment. Moderate increases were also observed in arm/chest muscle strength. At 90 days of treatment, lean body mass increased more in the 100 mg/day T gel group (2.74 ± 0.28 kg; P = 0.0002) than in the 50 mg/day T gel (1.28 ± 0.32 kg) and T patch groups (1.20 ± 0.26 kg). Fat mass and percent fat were not significantly decreased in the T patch group, but showed decreases in the T gel groups (50 mg/day, -0.90 ± 0.32 kg; 100 mg/day, -1.05 ± 0.22 kg). The increase in lean mass and the decrease in fat mass were correlated with the changes in average serum T levels attained after transdermal T replacement. These beneficial effects of T replacement were accompanied by the anticipated increases in hematocrit and hemoglobin but without significant changes in the lipid profile. The increase in mean serum prostate-specific antigen levels (within the normal range) was correlated with serum levels of T. The greatest increases were noted in the 100 mg/day T gel group. Skin irritation was reported in 5.5% of subjects treated with T gel and in 66% of subjects in the permeation-enhanced T patch group.

We conclude that T gel replacement improved sexual function and mood, increased lean mass and muscle strength (principally in the legs), and decreased fat mass in hypogonadal men with less skin irritation and discontinuation compared with the recommended dose of the permeation-enhanced T patch.




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 NEJMHome page
E. L. Rhoden and A. Morgentaler
Risks of Testosterone-Replacement Therapy and Recommendations for Monitoring
N. Engl. J. Med., January 29, 2004; 350(5): 482 - 492.
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 Journals of Gerontology Series A: Biological Sciences and Medical SciencesHome page
A. M. Kenny, G. Fabregas, C. Song, B. Biskup, and S. Bellantonio
Effects of Testosterone on Behavior, Depression, and Cognitive Function in Older Men With Mild Cognitive Loss
J. Gerontol. A Biol. Sci. Med. Sci., January 1, 2004; 59(1): M75 - 78.
[Abstract] [Full Text] [PDF]

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 Journals of Gerontology Series A: Biological Sciences and Medical SciencesHome page
S. Bhasin, W. E. Taylor, R. Singh, J. Artaza, I. Sinha-Hikim, R. Jasuja, H. Choi, and N. F. Gonzalez-Cadavid
The Mechanisms of Androgen Effects on Body Composition: Mesenchymal Pluripotent Cell as the Target of Androgen Action
J. Gerontol. A Biol. Sci. Med. Sci., December 1, 2003; 58(12): M1103 - 1110.
[Abstract] [Full Text] [PDF]

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 J. Clin. Endocrinol. Metab.Home page
S. von Eckardstein, G. Noe, V. Brache, E. Nieschlag, H. Croxatto, F. Alvarez, A. Moo-Young, I. Sivin, N. Kumar, M. Small, et al.
A Clinical Trial of 7{alpha}-Methyl-19-Nortestosterone Implants for Possible Use as a Long-Acting Contraceptive for Men
J. Clin. Endocrinol. Metab., November 1, 2003; 88(11): 5232 - 5239.
[Abstract] [Full Text] [PDF]

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 Journals of Gerontology Series A: Biological Sciences and Medical SciencesHome page
S. Bhasin
Testosterone Supplementation for Aging-Associated Sarcopenia
J. Gerontol. A Biol. Sci. Med. Sci., November 1, 2003; 58(11): M1002 - 1008.
[Abstract] [Full Text] [PDF]

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 EndocrinologyHome page
R. Singh, J. N. Artaza, W. E. Taylor, N. F. Gonzalez-Cadavid, and S. Bhasin
Androgens Stimulate Myogenic Differentiation and Inhibit Adipogenesis in C3H 10T1/2 Pluripotent Cells through an Androgen Receptor-Mediated Pathway
Endocrinology, November 1, 2003; 144(11): 5081 - 5088.
[Abstract] [Full Text] [PDF]

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 J AndrolHome page
A. Ojumu and A. S. Dobs
Is Hypogonadism a Risk Factor for Sexual Dysfunction?
J Androl, November 1, 2003; 24(6_suppl): S46 - S51.
[Full Text] [PDF]

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 J AndrolHome page
K. K. Lee, N. Berman, G. M. Alexander, L. Hull, R. S. Swerdloff, and C. Wang
A Simple Self-Report Diary for Assessing Psychosexual Function in Hypogonadal Men
J Androl, September 1, 2003; 24(5): 688 - 698.
[Abstract] [Full Text] [PDF]

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 J AndrolHome page
J. K. Amory, G. K. E. Scriba, D. W. Amory, and W. J. Bremner
Oral Testosterone-Triglyceride Conjugate in Rabbits: Single-Dose Pharmacokinetics and Comparison With Oral Testosterone Undecanoate
J Androl, September 1, 2003; 24(5): 716 - 720.
[Abstract] [Full Text] [PDF]

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 J AndrolHome page
G. F. Weinbauer, C.-J. Partsch, M. Zitzmann, S. Schlatt, and E. Nieschlag
Pharmacokinetics and Degree of Aromatization Rather Than Total Dose of Different Preparations Determine the Effects of Testosterone: A Nonhuman Primate Study in Macaca fascicularis
J Androl, September 1, 2003; 24(5): 765 - 774.
[Abstract] [Full Text] [PDF]

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 QJMHome page
C.J. Malkin, P.J. Pugh, T.H. Jones, and K.S. Channer
Testosterone for secondary prevention in men with ischaemic heart disease?
QJM, July 1, 2003; 96(7): 521 - 529.
[Full Text] [PDF]

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 J AndrolHome page
M. M. Cherrier, S. Craft, and A. H. Matsumoto
Cognitive Changes Associated With Supplementation of Testosterone or Dihydrotestosterone in Mildly Hypogonadal Men: A Preliminary Report
J Androl, July 1, 2003; 24(4): 568 - 576.
[Abstract] [Full Text] [PDF]

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 Journals of Gerontology Series A: Biological Sciences and Medical SciencesHome page
G. A. Wittert, I. M. Chapman, M. T. Haren, S. Mackintosh, P. Coates, and J. E. Morley
Oral Testosterone Supplementation Increases Muscle and Decreases Fat Mass in Healthy Elderly Males With Low-Normal Gonadal Status
J. Gerontol. A Biol. Sci. Med. Sci., July 1, 2003; 58(7): M618 - 625.
[Abstract] [Full Text] [PDF]

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 Am. J. Physiol. Endocrinol. Metab.Home page
I. Sinha-Hikim, S. M. Roth, M. I. Lee, and S. Bhasin
Testosterone-induced muscle hypertrophy is associated with an increase in satellite cell number in healthy, young men
Am J Physiol Endocrinol Metab, July 1, 2003; 285(1): E197 - E205.
[Abstract] [Full Text] [PDF]

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 J. Clin. Endocrinol. Metab.Home page
C. Steidle, S. Schwartz, K. Jacoby, T. Sebree, T. Smith, and R. Bachand
AA2500 Testosterone Gel Normalizes Androgen Levels in Aging Males with Improvements in Body Composition and Sexual Function
J. Clin. Endocrinol. Metab., June 1, 2003; 88(6): 2673 - 2681.
[Abstract] [Full Text] [PDF]

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 J. Clin. Endocrinol. Metab.Home page
R. A. Anderson, A. M. Wallace, N. Sattar, N. Kumar, and K. Sundaram
Evidence for Tissue Selectivity of the Synthetic Androgen 7{alpha}-Methyl-19-Nortestosterone in Hypogonadal Men
J. Clin. Endocrinol. Metab., June 1, 2003; 88(6): 2784 - 2793.
[Abstract] [Full Text] [PDF]

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 Diabetes CareHome page
S. Bhasin and K. Herbst
Testosterone and Atherosclerosis Progression in Men
Diabetes Care, June 1, 2003; 26(6): 1929 - 1931.
[Full Text] [PDF]

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 J AndrolHome page
S. Bhasin, A. B. Singh, R. P. Mac, B. Carter, M. I. Lee, and G. R. Cunningham
Managing the Risks of Prostate Disease During Testosterone Replacement Therapy in Older Men: Recommendations for a Standardized Monitoring Plan
J Androl, May 1, 2003; 24(3): 299 - 311.
[Full Text] [PDF]

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 Am. J. Physiol. Endocrinol. Metab.Home page
L. J. Woodhouse, S. Reisz-Porszasz, M. Javanbakht, T. W. Storer, M. Lee, H. Zerounian, and S. Bhasin
Development of models to predict anabolic response to testosterone administration in healthy young men
Am J Physiol Endocrinol Metab, May 1, 2003; 284(5): E1009 - E1017.
[Abstract] [Full Text] [PDF]

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 Endocr. Rev.Home page
F. C. W. Wu and A. von Eckardstein
Androgens and Coronary Artery Disease
Endocr. Rev., April 1, 2003; 24(2): 183 - 217.
[Abstract] [Full Text] [PDF]

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 J. Clin. Endocrinol. Metab.Home page
T. W. Storer, L. Magliano, L. Woodhouse, M. L. Lee, C. Dzekov, J. Dzekov, R. Casaburi, and S. Bhasin
Testosterone Dose-Dependently Increases Maximal Voluntary Strength and Leg Power, but Does Not Affect Fatigability or Specific Tension
J. Clin. Endocrinol. Metab., April 1, 2003; 88(4): 1478 - 1485.
[Abstract] [Full Text] [PDF]

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 J. Clin. Endocrinol. Metab.Home page
K. L. Herbst, B. D. Anawalt, J. K. Amory, A. M. Matsumoto, and W. J. Bremner
The Male Contraceptive Regimen of Testosterone and Levonorgestrel Significantly Increases Lean Mass in Healthy Young Men in 4 Weeks, but Attenuates a Decrease in Fat Mass Induced by Testosterone Alone
J. Clin. Endocrinol. Metab., March 1, 2003; 88(3): 1167 - 1173.
[Abstract] [Full Text] [PDF]

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 Am. J. PsychiatryHome page
H. G. Pope Jr., G. H. Cohane, G. Kanayama, A. J. Siegel, and J. I. Hudson
Testosterone Gel Supplementation for Men With Refractory Depression: A Randomized, Placebo-Controlled Trial
Am J Psychiatry, January 1, 2003; 160(1): 105 - 111.
[Abstract] [Full Text] [PDF]

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 Am. J. Physiol. Endocrinol. Metab.Home page
E. T. Schroeder, A. Singh, S. Bhasin, T. W. Storer, C. Azen, T. Davidson, C. Martinez, I. Sinha-Hikim, S. V. Jaque, M. Terk, et al.
Effects of an oral androgen on muscle and metabolism in older, community-dwelling men
Am J Physiol Endocrinol Metab, January 1, 2003; 284(1): E120 - E128.
[Abstract] [Full Text] [PDF]

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 J. Clin. Endocrinol. Metab.Home page
K. T. Brill, A. L. Weltman, A. Gentili, J. T. Patrie, D. A. Fryburg, J. B. Hanks, R. J. Urban, and J. D. Veldhuis
Single and Combined Effects of Growth Hormone and Testosterone Administration on Measures of Body Composition, Physical Performance, Mood, Sexual Function, Bone Turnover, and Muscle Gene Expression in Healthy Older Men
J. Clin. Endocrinol. Metab., December 1, 2002; 87(12): 5649 - 5657.
[Abstract] [Full Text] [PDF]

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 Hum ReprodHome page
P. T. Ellison, R. G. Bribiescas, G. R. Bentley, B. C. Campbell, S. F. Lipson, C. Panter-Brick, and K. Hill
Population variation in age-related decline in male salivary testosterone
Hum. Reprod., December 1, 2002; 17(12): 3251 - 3253.
[Abstract] [Full Text] [PDF]

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 Journals of Gerontology Series A: Biological Sciences and Medical SciencesHome page
J. K. Anderson, S. Faulkner, C. Cranor, J. Briley, F. Gevirtz, and S. Roberts
Andropause: Knowledge and Perceptions Among the General Public and Health Care Professionals
J. Gerontol. A Biol. Sci. Med. Sci., December 1, 2002; 57(12): M793 - 796.
[Abstract] [Full Text] [PDF]

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 ANN INTERN MEDHome page
W. L. Isley
Growth Hormone Therapy for Adults: Not Ready for Prime Time?
Ann Intern Med, August 6, 2002; 137(3): 190 - 196.
[Abstract] [Full Text] [PDF]

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 Journals of Gerontology Series A: Biological Sciences and Medical SciencesHome page
A. M. Kenny, K. M. Prestwood, C. A. Gruman, G. Fabregas, B. Biskup, and G. Mansoor
Effects of Transdermal Testosterone on Lipids and Vascular Reactivity in Older Men With Low Bioavailable Testosterone Levels
J. Gerontol. A Biol. Sci. Med. Sci., July 1, 2002; 57(7): M460 - 465.
[Abstract] [Full Text]

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 Am. J. Physiol. Endocrinol. Metab.Home page
I. Sinha-Hikim, J. Artaza, L. Woodhouse, N. Gonzalez-Cadavid, A. B. Singh, M. I. Lee, T. W. Storer, R. Casaburi, R. Shen, and S. Bhasin
Testosterone-induced increase in muscle size in healthy young men is associated with muscle fiber hypertrophy
Am J Physiol Endocrinol Metab, July 1, 2002; 283(1): E154 - E164.
[Abstract] [Full Text] [PDF]

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 J. Clin. Endocrinol. Metab.Home page
A. S. Dobs, T. Nguyen, C. Pace, and C. P. Roberts
Differential Effects of Oral Estrogen versus Oral Estrogen-Androgen Replacement Therapy on Body Composition in Postmenopausal Women
J. Clin. Endocrinol. Metab., April 1, 2002; 87(4): 1509 - 1516.
[Abstract] [Full Text] [PDF]

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 Journals of Gerontology Series A: Biological Sciences and Medical SciencesHome page
A. M. Matsumoto
Andropause: Clinical Implications of the Decline in Serum Testosterone Levels With Aging in Men
J. Gerontol. A Biol. Sci. Med. Sci., February 1, 2002; 57(2): M76 - 99.
[Full Text]

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 J. Clin. Endocrinol. Metab.Home page
A. B. Singh, S. Hsia, P. Alaupovic, I. Sinha-Hikim, L. Woodhouse, T. A. Buchanan, R. Shen, R. Bross, N. Berman, and S. Bhasin
The Effects of Varying Doses of T on Insulin Sensitivity, Plasma Lipids, Apolipoproteins, and C-Reactive Protein in Healthy Young Men
J. Clin. Endocrinol. Metab., January 1, 2002; 87(1): 136 - 143.
[Abstract] [Full Text] [PDF]

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 Am. J. Physiol. Endocrinol. Metab.Home page
S. Bhasin, L. Woodhouse, R. Casaburi, A. B. Singh, D. Bhasin, N. Berman, X. Chen, K. E. Yarasheski, L. Magliano, C. Dzekov, et al.
Testosterone dose-response relationships in healthy young men
Am J Physiol Endocrinol Metab, December 1, 2001; 281(6): E1172 - E1181.
[Abstract] [Full Text] [PDF]

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 J. Clin. Endocrinol. Metab.Home page
A. Vermeulen
Androgen Replacement Therapy in the Aging Male--A Critical Evaluation
J. Clin. Endocrinol. Metab., June 1, 2001; 86(6): 2380 - 2390.
[Full Text] [PDF]

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 J. Clin. Endocrinol. Metab.Home page
P. Cohan and S. G. Korenman
Erectile Dysfunction
J. Clin. Endocrinol. Metab., June 1, 2001; 86(6): 2391 - 2394.
[Full Text] [PDF]


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