Updates to the Endocrine Society's 2010 clinical practice guidelines for testosterone therapy in men with hypogonadism discourage screening and treating all healthy men older than 65 years with low testosterone.
“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,” the authors of the updated guidelines stated in the Journal of Clinical Endocrinology & Metabolism (2018;103:1–30).
The guidelines recommend that only men with overt symptoms who understand testosterone therapy's long-term risks and benefits should be treated, after consideration of their co-morbid conditions.
For an accurate diagnosis, clinicians should measure fasting morning total testosterone using an assay certified by the CDC's accuracy-based standardization program or verified by an external quality control program, according to the updated guidelines. Rather than rely on a single measurement, repeat testing and look for a trend of low testosterone. In men whose total testosterone is on the cusp of normal or who have a condition that alters sex hormone–binding globulin, the task force recommends obtaining a free testosterone concentration using equilibrium dialysis or a precise formula. Those with testosterone deficiency should have additional workup to determine possible causes.
The goal of therapy is to increase testosterone concentrations to the mid-normal range, the guidelines state. When choosing an approved formulation, consider patient preference, pharmacokinetics, adverse effects, treatment burden, and cost. For monitoring, follow a standardized plan: Evaluate symptoms, adverse effects, and compliance. Measure serum testosterone and hematocrit concentrations. Also evaluate prostate cancer risk during the first year after initiating therapy.
Men planning fertility should not be treated with testosterone therapy. Neither should men with breast or prostate cancer, a palpable prostate nodule or induration, PSA more than 4 ng/mL, or PSA more than 3 ng/mL at increased prostate cancer risk due to such factors as race or heredity, without further urologic evaluation. Other exclusions include men with elevated hematocrit, untreated severe obstructive sleep apnea, severe lower urinary tract symptoms, uncontrolled heart failure, myocardial infarction or stroke within the previous 6 months, or thrombophilia.
Possible adverse events associated with testosterone therapy include erythrocytosis, acne, subclinical prostate cancer, growth of metastatic prostate cancer, and reduced sperm production and fertility.
“We hope these recommendations will help clarify and dispel much of the misinformation about testosterone therapy,” Shalender Bhasin, MD, of Brigham and Women's Hospital in Boston, and chair of the task force that authored the guidelines, stated in a news release from the Endocrine Society. “With this updated guideline, we were able to incorporate data from some of the most important randomized trials on testosterone conducted during the past 3 years. Relying on the latest and highest quality scientific evidence will help men and their healthcare providers determine when testosterone treatment is appropriate and when it is unlikely to benefit an individual's health.”