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Cited by 965Hormonal and reproductive studiesAdrenal Hormones and DisordersMenopause: Health Impacts and Treatments

Testosterone therapy in adult men with androgen deficiency syndromes: an endocrine society clinical practice guideline.

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Bhasin, Shalender, Cunningham, Glenn R., Hayes, Frances J., Matsumoto, Alvin M., Snyder, Peter J., Swerdloff, Ronald S., Montori, Victor M.·2006·The Journal of Clinical Endocrinology & Metabolism
DOI 10.1210/jc.2005-2847
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Abstract

OBJECTIVE: The objective was to provide guidelines for the evaluation and treatment of androgen deficiency syndromes in adult men. PARTICIPANTS: The Task Force was composed of a chair, selected by the Clinical Guidelines Subcommittee of The Endocrine Society, five additional experts, a methodologist, and a professional writer. The Task Force received no corporate funding or remuneration. EVIDENCE: The Task Force used systematic reviews of available evidence to inform its key recommendations. The Task Force used consistent language and graphical descriptions of both the strength of recommendation and the quality of evidence, using the recommendations of the Grading of Recommendations, Assessment, Development, and Evaluation group. CONSENSUS PROCESS: Consensus was guided by systematic reviews of evidence and discussions during three group meetings, several conference calls, and e-mail communications. The drafts prepared by the panelists with the help of a professional writer were reviewed successively by The Endocrine Society's Clinical Guidelines Subcommittee, Clinical Affairs Committee, and Council. The version approved by the Council was placed on The Endocrine Society's web site for comments by members. At each stage of review, the Task Force received written comments and incorporated needed changes. CONCLUSIONS: We recommend making a diagnosis of androgen deficiency only in men with consistent symptoms and signs and unequivocally low serum testosterone levels. We suggest the measurement of morning total testosterone level by a reliable assay as the initial diagnostic test. We recommend confirmation of the diagnosis by repeating the measurement of morning total testosterone and in some patients by measurement of free or bioavailable testosterone level, using accurate assays. We recommend testosterone therapy for symptomatic men with androgen deficiency, who have low testosterone levels, to induce and maintain secondary sex characteristics and to improve their sexual function, sense of well-being, muscle mass and strength, and bone mineral density. We recommend against starting testosterone therapy in patients with breast or prostate cancer, a palpable prostate nodule or induration or prostate-specific antigen greater than 3 ng/ml without further urological evaluation, erythrocytosis (hematocrit > 50%), hyperviscosity, untreated obstructive sleep apnea, severe lower urinary tract symptoms with International Prostate Symptom Score (IPSS) greater than 19, or class III or IV heart failure. When testosterone therapy is instituted, we suggest aiming at achieving testosterone levels during treatment in the mid-normal range with any of the approved formulations, chosen on the basis of the patient's preference, consideration of pharmacokinetics, treatment burden, and cost. Men receiving testosterone therapy should be monitored using a standardized plan.

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Crossref · 10.1210/jc.2005-2847

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  • Third-generation inhibitors such as letrozole and anastrozole are potent and do not inhibit related enzymes.

    “Third-generation inhibitors such as letrozole and anastrozole are potent and do not inhibit related enzymes.”

    From Aromatase inhibitors in men: effects and therapeutic options (2011) · cites this paper as [27]

    The guideline’s Section 2.4.2.D discusses testosterone formulations, not third-generation inhibitors. Searches of our copy for letrozole, anastrozole, and aromatase-inhibitor selectivity found no passage addressing their potency or effects on related enzymes. (LLM, conf=0.76)

    Experimental — accuracy not yet measured

  • Third-generation aromatase inhibitors are well tolerated and apart from their effects on estrogen metabolism their use does not appear to be associated with important side effects in postmenopausal women.

    “They are well tolerated and apart from their effects on estrogen metabolism their use does not appear to be associated with important side effects in postmenopausal women [27].”

    From Aromatase inhibitors in men: effects and therapeutic options (2011) · cites this paper as [27]

    The guideline’s “2.1.1 Non-placebo-controlled studies” and “Adverse Outcomes Associated with Testosterone Therapy” sections discuss testosterone treatment and adverse events in men, not aromatase inhibitors in postmenopausal women. Searches for third-generation aromatase inhibitors, postmenopausal women, and estrogen metabolism found no passage addressing the claimed tolerability or side-effect profile. Page numbers were not available in our copy. (LLM, conf=0.78)

    Experimental — accuracy not yet measured

  • Calculated free testosterone levels correlate well with measurements of free testosterone as determined by equilibrium dialysis.

    “The cFT levels (20) correlate well with measurements of free testosterone as determined by the gold standard of equilibrium dialysis (22).”

    From Low testosterone levels are common and associated with insulin resistance in men with diabetes (2008) · cites this paper as [22]

  • Testosterone replacement can improve performance, mood, and libido in men with hypogonadism and augments insulin sensitivity.

    “Certainly, testosterone replacement can improve performance, mood, and libido in men with hypogonadism (22) and augments insulin sensitivity (11,15).”

    From Low testosterone levels are common and associated with insulin resistance in men with diabetes (2008) · cites this paper as [22]

  • Findings from the cross-sectional component are limited because a single low testosterone level is inadequate for making the diagnosis of hypogonadism, given variability in serum testosterone levels.

    “Findings from the cross-sectional component of our study are also limited because a single low testosterone level is inadequate for making the diagnosis of hypogonadism, given the variability in serum testosterone levels that can result from circadian rhythms, the pulsatile nature of its secretion, use of concomitant medications, and measurement variations (22).”

    From Low testosterone levels are common and associated with insulin resistance in men with diabetes (2008) · cites this paper as [22]

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Research works printed but not linked: 1

  1. Matsumoto AM 2001 The testis. In: Felig P, Frohman LA, eds. Endocrinology and metabolism, 4th ed. New York: McGraw-Hill; 635-705

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Authors
Bhasin, S., Cunningham, G. R., Hayes, F. J., Matsumoto, A. M., Snyder, P. J., Swerdloff, R. S., & Montori, V. M.
Affiliations
  • Boston University (US)
  • Baylor College of Medicine (US)
  • Harvard University (US)
  • University of Washington (US)
  • University of Pennsylvania (US)
  • Los Angeles Medical Center (US)
ORCID
Venue
The Journal of Clinical Endocrinology & Metabolism
Publisher
The Endocrine Society
Published
2006-06
Volume
91
Issue
6
Pages
1995-2010
ISSN
  • 0021-972X (ISSN-L)
  • 1945-7197
DOI
10.1210/jc.2005-2847
OpenAlex
W3036378166
Cited by
965
References
110
Citations by year
2026: 7 · 2025: 10 · 2024: 11 · 2023: 19 · 2022: 18 · 2021: 21 · 2020: 20 · 2019: 20 · 2018: 35 · 2017: 46 · 2016: 30 · 2015: 46 · 2014: 53 · 2013: 54 · 2012: 64
FWCI
76.75
Type
journal article
Language
en
Open access
Licence
cc-by-nc-nd
Locations
  • The Journal of Clinical Endocrinology & Metabolism (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
Funders
  • Eli Lilly and Company
  • Pfizer
  • AstraZeneca
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
Keywords
testosterone replacement therapy, hypogonadism, androgen deficiency, testosterone measurement, secondary sexual characteristics, sexual function, muscle mass and strength, bone mineral density, prostate cancer, obstructive sleep apnea, heart failure, treatment burden, patient preferences, pharmacokinetics
MeSH terms
Glucocorticoids, Humans, Male, Sexual Dysfunction, Physiological, Testosterone, HIV Infections, Evidence-Based Medicine

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