Consensus on how to properly diagnose and monitor patients with low testosterone has largely eluded the medical community, resulting in some reluctance among doctors to take on patients suffering from this syndrome.
Until recently, Canada lacked a multidisciplinary guideline that specifically addressed this topic in the context of the Canadian health system. As a recent article in the Canadian Medical Association Journal (CMAJ) explains, the Canadian Men’s Health Foundation (CMHF) sought to remedy this problem by creating a multidisciplinary task force to analyze gaps in clinical practice—and develop a new set of guidelines on the topic of low testosterone management.
The guideline, which aims to educate primary care physicians and other clinicians, emphasizes that successful diagnosis of testosterone deficiency syndrome depends on two elements: documentation of testosterone at levels below local laboratory ranges, and clinical evidence or manifestation of a deficiency.
As part of the protocol for diagnosing patients with low testosterone, the guideline suggests that clinicians first take serum samples to measure total testosterone level. Sample collections should take place between 7 a.m. and 11 a.m., or within 3 hours after waking, for shift workers.
The document also emphasizes that patients’ testosterone levels should be assessed using assays traceable to internationally recognized standardized reference material. Commercial assays in particular should have certification from the U.S. Centers for Disease Control and Prevention’s testosterone standardization program.
In addition, the guideline suggests that measurement of sex hormone–binding globulin with calculated free or bioavailable testosterone should apply only to men who present with testosterone deficiency and equivocally low testosterone levels.
To effectively monitor these patients, clinicians should assess baseline hematocrit levels at 3 and 6 months, and then follow up on a yearly basis. Similar timelines were recommended to determine baseline prostate-specific antigen levels.
Although controversial, a great deal of research has taken place on the management of testosterone deficiency syndrome in recent years. As Geoffrey Hackett, MD, observes in a related editorial in CMAJ, “given the ongoing controversy and changes in our understanding of testosterone deficiency, it is not surprising that there are multiple guidelines available from other developers, including recent updates from the European Association of Urology and the International Society for Sexual Medicine.”
The new Canadian guideline “is welcomed in the light of the huge volume of research on this topic over the last five years,” Hackett indicated. “The current guideline will be a useful resource for Canadian physicians, but although research studies are bringing clarity to some aspects of caring for patients with testosterone deficiency syndrome, there are still many for which there is no consensus,” such as initial choices for biochemical testing, he noted.