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Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Clinical Guideline Update for Testosterone Therapy

J Clin Endocrinol Metab; ePub 2018 Mar 17; Bhasin, et al

The Testosterone Therapy in Men with Androgen Deficiency Syndromes guideline published in 2010 has recently been updated. Participants in this project include an Endocrine Society-appointed task force of 10 medical content experts and a clinical practice guideline methodologist. 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 2 systematic reviews and used the best available evidence from other published systematic reviews and individual studies. Key highlights include:

  1. It is recommended that a diagnosis of hypogonadism be made only in men with symptoms and signs consistent with testosterone (T) deficiency and unequivocally and consistently low serum T concentrations.
  2. It is recommended that fasting morning total T concentrations be measured using an accurate and reliable assay as the initial diagnostic test.
  3. It is recommended that the diagnosis be confirmed by repeating the measurement of fasting morning total T concentrations.
  4. In men whose total T is near the lower limit of normal or who have a condition that alters sex hormone-binding globulin, it is recommended that a free T concentration be obtained using either equilibrium dialysis or estimating it using an accurate formula.
  5. In men determined to have androgen deficiency, an additional diagnostic evaluation is recommended to ascertain the cause of androgen deficiency.


Bhasin S, Brito JP, Cunningham GR, et al. Testosterone therapy in men with hypogonadism: An Endocrine Society clinical practice guideline. [Published online ahead of print March 17, 2018]. J Clin Endocrinol Metab. doi:10.1210/jc.2018-00229.

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