Testosterone therapy should be limited mostly to men with hypogonadism, new guideline says

A new clinical practice guideline for testosterone deficiency clarifies the disorder’s diagnosis and recommends limiting testosterone treatment primarily to men with hypogonadism. The guideline, authored by medical experts appointed by the Endocrine Society, was published recently in The Journal of Clinical Endocrinology & Metabolism.

According to the guideline, a diagnosis of hypogonadism should be made only in men with symptoms and signs consistent with testosterone deficiency and “unequivocally and consistently low” serum testosterone concentrations. Men who are otherwise healthy do not need to be screened for hypogonadism.

Testosterone therapy is recommended for men diagnosed with hypogonadism to correct symptoms of testosterone deficiency. The guideline advises against routinely prescribing testosterone therapy to all men 65 years of age or older with low testosterone concentrations.

“In a reflection of the growing attention paid to men’s health issues, men’s health clinics have mushroomed all over the country,” said endocrinologist Shalender Bhasin, MD, Brigham and Women’s Hospital, Boston, MA, and chair of the task force that authored the guideline. “Yet recent surveys indicate many men are prescribed testosterone treatment without an appropriate diagnostic workup or monitoring plan. Some men receiving testosterone therapy do not have adequately documented hypogonadism, while others who have hypogonadism are not receiving the needed treatment.”

The guideline recommends against testing and treating healthy men for whom the risks and benefits of testosterone therapy are unclear.

Low serum testosterone concentrations should be confirmed “because 30% of men with an initial testosterone concentration in the hypogonadal range have a normal testosterone concentration on repeat measurement,” the authors of the guideline wrote. “Also, a small fraction of healthy young men have a testosterone concentration below the normal range during a 24-hour period.”

They recommend using an accurate and reliable assay and measuring fasting morning total testosterone concentrations.

In addition, the guideline recommends:

• Measuring free testosterone concentration in men whose total testosterone is near the lower limit of normal or who have a condition that alters sex hormone-binding globulin.
• Distinguishing between primary (testicular) and secondary (pituitary-hypothalamic) hypogonadism by measuring serum luteinizing hormone and follicle-stimulating hormone concentrations.
• Expanding the diagnostic evaluation in men with androgen deficiency to determine the cause of the deficiency.
• Avoiding testosterone therapy in men who are planning fertility in the near term. Also, men should not start therapy if they have breast cancer, prostate cancer (or an increased risk for prostate cancer), elevated hematocrit, untreated severe obstructive sleep apnea, severe lower urinary tract symptoms, uncontrolled heart failure, myocardial infarction or stroke within the past 6 months, or thrombophilia.
• Achieving testosterone concentrations in the mid-normal range when instituting treatment.
• Monitoring men during the first year of testosterone therapy for symptoms, compliance, serum testosterone concentrations, hematocrit levels, and prostate cancer risk.

“We hope these recommendations will help clarify and dispel much of the misinformation about testosterone therapy,” Dr. Bhasin said. “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 health-care providers determine when testosterone treatment is appropriate and when it is unlikely to benefit an individual’s health.”