Cited by 656Hormonal and reproductive studiesMenopause: Health Impacts and TreatmentsAdrenal Hormones and Disorders

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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

Wang, Christina, Cunningham, Glenn, Dobs, Adrian, Iranmanesh, Ali, Matsumoto, Alvin M., Snyder, Peter J., Weber, Thomas, Berman, Nancy, Hull, Laura, Swerdloff, Ronald S.·2004·The Journal of Clinical Endocrinology & Metabolism

DOI 10.1210/jc.2003-032006

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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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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: Wang, Christina
Cunningham, Glenn
Dobs, Adrian
Iranmanesh, Ali
Matsumoto, Alvin M.
Snyder, Peter J.
Weber, Thomas
Swerdloff, Ronald S.
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
DOI: 10.1210/jc.2003-032006
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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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

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