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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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E. T. Schroeder, L. Zheng, K. E. Yarasheski, D. Qian, Y. Stewart, C. Flores, C. Martinez, M. Terk, and F. R. Sattler Treatment with oxandrolone and the durability of effects in older men J Appl Physiol, March 1, 2004; 96(3): 1055 - 1062. [Abstract] [Full Text] [PDF] |
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N. A. Evans Current Concepts in Anabolic-Androgenic Steroids Am. J. Sports Med., March 1, 2004; 32(2): 534 - 542. [Abstract] [Full Text] [PDF] |
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L. J. Woodhouse, N. Gupta, M. Bhasin, A. B. Singh, R. Ross, J. Phillips, and S. Bhasin Dose-Dependent Effects of Testosterone on Regional Adipose Tissue Distribution in Healthy Young Men J. Clin. Endocrinol. Metab., February 1, 2004; 89(2): 718 - 726. [Abstract] [Full Text] [PDF] |
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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. [Full Text] [PDF] |
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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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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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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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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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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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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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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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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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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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