Testosterone testing

Testosterone is the main androgen (male hormone) secreted by the testes, and testes are the major source of circulating androgens. Testosterone testing is multifaceted. When low testosterone is suspected, serum total testosterone is initially measured, sometimes followed by measurement of free testosterone or bioavailable testosterone (BAT). Additional laboratory tests may be required to characterize the etiology of hypogonadism as primary (testicular failure) or secondary (defect of the hypothalamus or pituitary). In certain clinical situations, genetic testing is also appropriate to identify etiology.

Status: Decision completed

View findings and decision

Why is testosterone testing being reviewed?

Considerable controversy and uncertainty exist concerning the diagnostic criteria for hypogonadism, techniques for measuring testosterone levels, the cutoff value for normal testosterone, the benefits and harms of treatment, and the optimal interval for repeat testing. In recent years new topical formulations of testosterone have been developed and marketed, obviating the requirement of administration by intramuscular injection and encouraging broader application of testosterone replacement therapy for milder and potentially nonpathological forms of hypogonadism. A review of the evidence on the risks and benefits of testing, taking into account what is known about the benefits of treatment, is warranted to guide coverage policy on testosterone testing.

Primary criteria ranking

  • Safety = High
  • Efficacy = High
  • Cost = High

Documentation

Type Materials
Assessment (2015)

Assessment timeline

  • Draft Key Questions Published: July 14, 2014
    • Public Comment Period: July 15 to July 29, 2014
  • Final Key Questions Published: August 8, 2014
  • Draft Report Published: December 17, 2014
    • Public Comment Period: December 17, 2014 to January 19, 2015
  • Final Report Published: February 11, 2015
  • HTCC Public Meeting: March 20, 2015

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