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Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline.
J Clin Endocrinol Metab. 2018 05 01; 103(5):1715-1744.JC

Abstract

Objective

To update the "Testosterone Therapy in Men With Androgen Deficiency Syndromes" guideline published in 2010.

Participants

The participants include an Endocrine Society-appointed task force of 10 medical content experts and a clinical practice guideline methodologist.

Evidence

This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation approach to describe the strength of recommendations and the quality of evidence. The task force commissioned two systematic reviews and used the best available evidence from other published systematic reviews and individual studies.

Consensus Process

One group meeting, several conference calls, and e-mail communications facilitated consensus development. Endocrine Society committees and members and the cosponsoring organization were invited to review and comment on preliminary drafts of the guideline.

Conclusions

We recommend making a diagnosis of hypogonadism only in men with symptoms and signs consistent with testosterone (T) deficiency and unequivocally and consistently low serum T concentrations. We recommend measuring fasting morning total T concentrations using an accurate and reliable assay as the initial diagnostic test. We recommend confirming the diagnosis by repeating the measurement of morning fasting total T concentrations. In men whose total T is near the lower limit of normal or who have a condition that alters sex hormone-binding globulin, we recommend obtaining a free T concentration using either equilibrium dialysis or estimating it using an accurate formula. In men determined to have androgen deficiency, we recommend additional diagnostic evaluation to ascertain the cause of androgen deficiency. We recommend T therapy for men with symptomatic T deficiency to induce and maintain secondary sex characteristics and correct symptoms of hypogonadism after discussing the potential benefits and risks of therapy and of monitoring therapy and involving the patient in decision making. We recommend against starting T therapy in patients who are planning fertility in the near term or have any of the following conditions: breast or prostate cancer, a palpable prostate nodule or induration, prostate-specific antigen level > 4 ng/mL, prostate-specific antigen > 3 ng/mL in men at increased risk of prostate cancer (e.g., African Americans and men with a first-degree relative with diagnosed prostate cancer) without further urological evaluation, elevated hematocrit, untreated severe obstructive sleep apnea, severe lower urinary tract symptoms, uncontrolled heart failure, myocardial infarction or stroke within the last 6 months, or thrombophilia. We suggest that when clinicians institute T therapy, they aim at achieving T concentrations in the mid-normal range during treatment with any of the approved formulations, taking into consideration patient preference, pharmacokinetics, formulation-specific adverse effects, treatment burden, and cost. Clinicians should monitor men receiving T therapy using a standardized plan that includes: evaluating symptoms, adverse effects, and compliance; measuring serum T and hematocrit concentrations; and evaluating prostate cancer risk during the first year after initiating T therapy.

Authors+Show Affiliations

Brigham and Women's Hospital, Boston, Massachusetts.Mayo Clinic, Rochester, Minnesota.Baylor College of Medicine, Houston, Texas.Massachusetts General Hospital, Boston, Massachusetts.Keck School of Medicine, University of Southern California, Los Angeles, California.Veterans Affairs Puget Sound Health Care System, Seattle, Washington.Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.Harbor-UCLA Medical Center, Torrance, California.University of Manchester, Manchester, United Kingdom.Brigham and Women's Hospital, Boston, Massachusetts.

Pub Type(s)

Journal Article
Practice Guideline
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29562364

Citation

Bhasin, Shalender, et al. "Testosterone Therapy in Men With Hypogonadism: an Endocrine Society Clinical Practice Guideline." The Journal of Clinical Endocrinology and Metabolism, vol. 103, no. 5, 2018, pp. 1715-1744.
Bhasin S, Brito JP, Cunningham GR, et al. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018;103(5):1715-1744.
Bhasin, S., Brito, J. P., Cunningham, G. R., Hayes, F. J., Hodis, H. N., Matsumoto, A. M., Snyder, P. J., Swerdloff, R. S., Wu, F. C., & Yialamas, M. A. (2018). Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. The Journal of Clinical Endocrinology and Metabolism, 103(5), 1715-1744. https://doi.org/10.1210/jc.2018-00229
Bhasin S, et al. Testosterone Therapy in Men With Hypogonadism: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018 05 1;103(5):1715-1744. PubMed PMID: 29562364.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. AU - Bhasin,Shalender, AU - Brito,Juan P, AU - Cunningham,Glenn R, AU - Hayes,Frances J, AU - Hodis,Howard N, AU - Matsumoto,Alvin M, AU - Snyder,Peter J, AU - Swerdloff,Ronald S, AU - Wu,Frederick C, AU - Yialamas,Maria A, PY - 2018/01/26/received PY - 2018/01/26/accepted PY - 2018/3/22/pubmed PY - 2018/12/12/medline PY - 2018/3/22/entrez SP - 1715 EP - 1744 JF - The Journal of clinical endocrinology and metabolism JO - J Clin Endocrinol Metab VL - 103 IS - 5 N2 - Objective: To update the "Testosterone Therapy in Men With Androgen Deficiency Syndromes" guideline published in 2010. Participants: The participants include an Endocrine Society-appointed task force of 10 medical content experts and a clinical practice guideline methodologist. Evidence: This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation approach to describe the strength of recommendations and the quality of evidence. The task force commissioned two systematic reviews and used the best available evidence from other published systematic reviews and individual studies. Consensus Process: One group meeting, several conference calls, and e-mail communications facilitated consensus development. Endocrine Society committees and members and the cosponsoring organization were invited to review and comment on preliminary drafts of the guideline. Conclusions: We recommend making a diagnosis of hypogonadism only in men with symptoms and signs consistent with testosterone (T) deficiency and unequivocally and consistently low serum T concentrations. We recommend measuring fasting morning total T concentrations using an accurate and reliable assay as the initial diagnostic test. We recommend confirming the diagnosis by repeating the measurement of morning fasting total T concentrations. In men whose total T is near the lower limit of normal or who have a condition that alters sex hormone-binding globulin, we recommend obtaining a free T concentration using either equilibrium dialysis or estimating it using an accurate formula. In men determined to have androgen deficiency, we recommend additional diagnostic evaluation to ascertain the cause of androgen deficiency. We recommend T therapy for men with symptomatic T deficiency to induce and maintain secondary sex characteristics and correct symptoms of hypogonadism after discussing the potential benefits and risks of therapy and of monitoring therapy and involving the patient in decision making. We recommend against starting T therapy in patients who are planning fertility in the near term or have any of the following conditions: breast or prostate cancer, a palpable prostate nodule or induration, prostate-specific antigen level > 4 ng/mL, prostate-specific antigen > 3 ng/mL in men at increased risk of prostate cancer (e.g., African Americans and men with a first-degree relative with diagnosed prostate cancer) without further urological evaluation, elevated hematocrit, untreated severe obstructive sleep apnea, severe lower urinary tract symptoms, uncontrolled heart failure, myocardial infarction or stroke within the last 6 months, or thrombophilia. We suggest that when clinicians institute T therapy, they aim at achieving T concentrations in the mid-normal range during treatment with any of the approved formulations, taking into consideration patient preference, pharmacokinetics, formulation-specific adverse effects, treatment burden, and cost. Clinicians should monitor men receiving T therapy using a standardized plan that includes: evaluating symptoms, adverse effects, and compliance; measuring serum T and hematocrit concentrations; and evaluating prostate cancer risk during the first year after initiating T therapy. SN - 1945-7197 UR - https://www.unboundmedicine.com/medline/citation/29562364/Testosterone_Therapy_in_Men_With_Hypogonadism:_An_Endocrine_Society_Clinical_Practice_Guideline_ L2 - https://academic.oup.com/jcem/article-lookup/doi/10.1210/jc.2018-00229 DB - PRIME DP - Unbound Medicine ER -