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Long-Term Testosterone Gel (AndroGel) Treatment Maintains Beneficial Effects on Sexual Function and Mood, Lean and Fat Mass, and Bone Mineral Density in Hypogonadal Men
Abstract
Transdermal testosterone (T) delivery represents an effective alternative to injectable androgens. We studied 163 hypogonadal men who applied 5, 7.5, or 10 g AndroGel (T gel) 1% CIII per day for up to 42 months. Efficacy data were presented in 123 subjects considered evaluable. Continuous AndroGel treatment normalized mean serum T and free T levels. Mean serum 5alpha-dihydrotestosterone concentrations and 5alpha-dihydrotestosterone/T ratio slightly increased, mean serum estradiol/T ratio doubled, and mean serum FSH and LH levels were suppressed by T replacement. Sexual function and mood parameters improved rapidly and were maintained throughout T treatment. Lean body mass increased (P = 0.0001) and fat mass decreased (P = 0.0001), and these changes were maintained with treatment but were not accompanied by significant increases in muscle strength. Increases in serum bone markers suggestive of increased bone formation were followed by gradual and progressive increases in bone mineral density more in the spine (P = 0.0001) than the hip (P = 0.0004). Mild local skin irritation occurred in 12 subjects, resulting in discontinuation in only one subject. Except for the anticipated increase in hematocrit and hemoglobin, there were no clinically significant changes in blood counts or biochemistry. In three subjects with elevated serum prostate-specific antigen, prostate biopsies showed cancer. We conclude that continued application of AndroGel resulted in beneficial effects similar to those with injectables and other transdermal preparations. This study was neither placebo controlled nor powered to determine the effects of T treatment on prostate cancer risk. Thus, monitoring for prostatic disease and assessment for erythrocytosis are strongly advised to reduce the risk of adverse events with T treatment of hypogonadal men.
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“Treatment increases BMD (132-135) and improves trabecular structure (136) and bone mechanical properties (137).”
From Hormonal Replacement in Hypopituitarism in Adults: An Endocrine Society Clinical Practice Guideline (2016) · cites this paper as [137]
In the citing paper
“Prostate-specific antigen and volume rise, marginally, plateauing at 12 months; further increase should be related to aging rather than therapy.”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [87]
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“In a study of 123 subjects over 42 months of testosterone gel application, there was significant increase in serum PSA over the first 6 months and then no further significant increases with continued testosterone treatment was found (87).”
From Onset of effects of testosterone treatment and time span until maximum effects are achieved (2011) · cites this paper as [87]
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Metadata
- Authors
- Wang, C., Cunningham, G., Dobs, A., Iranmanesh, A., Matsumoto, A. M., Snyder, P. J., Weber, T., Berman, N., Hull, L., & Swerdloff, R. S.
- Affiliations
- University of California, Los Angeles (US)
- Baylor College of Medicine (US)
- Johns Hopkins University (US)
- Veterans Health Administration (US)
- University of Washington (US)
- University of Pennsylvania Health System (US)
- Duke Medical Center (US)
- Corresponding author
- Wang, Christina
- ORCID
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2004-05
- Volume
- 89
- Issue
- 5
- Pages
- 2085-2098
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- OpenAlex
- W2001118572
- Semantic Scholar
- 2114ced4c5aa202f6d1a0eee503c76ffef92a68a
- Cited by
- 656
- References
- 48
- Citations by year
- 2026: 8 · 2025: 14 · 2024: 4 · 2023: 14 · 2022: 24 · 2021: 6 · 2020: 15 · 2019: 23 · 2018: 23 · 2017: 36 · 2016: 22 · 2015: 30 · 2014: 36 · 2013: 37 · 2012: 40
- FWCI
- 32.97
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
- PubMed (publishedVersion)
- Funders
- U.S. Department of Veterans Affairs
- University of Pennsylvania
- Johns Hopkins University
- Deutsches Krebsforschungszentrum
- National Institutes of Health (RR00425)
- National Center for Research Resources (M01RR000030, M01RR000425)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
- Keywords
- testosterone replacement therapy, transdermal testosterone, hypogonadism, sexual function, mood, lean body mass, fat mass, bone mineral density, dihydrotestosterone, estradiol, gonadotropin suppression, erythrocytosis, prostate-specific antigen, prostate cancer risk, long-term treatment
- MeSH terms
- Adolescent, Adult, Affect, Aged, Androgens, Body Composition, Dose-Response Relationship, Drug, Drug Administration Schedule, Estradiol, Follicle Stimulating Hormone, Gels, Hematocrit, Hemoglobins, Humans, Hypogonadism, Luteinizing Hormone, Male, Prostatic Hyperplasia, Sexual Behavior, Sex Hormone-Binding Globulin, Testosterone, Ultrasonography, Biomarkers, Bone Density, Bone Remodeling, Prostate-Specific Antigen
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