The American Urological Association is now offering formal guidance on diagnosing, treating, and monitoring men with testosterone deficiency.
Use of testosterone therapy has been an area of concern. Many men are receiving therapy who do not need it, hypogonadal men who need treatment do not receive it, and patients receiving treatment often fail to be monitored properly.
An expert panel conducted a systematic review of 546 articles published 1980 to February 2017 to support the new guideline statements. The strength of the evidence for each statement was graded A (high) to C (low). In the absence of sufficient evidence, the panel offered information as Clinical Principles and Expert Opinions.
Following is a selective list of statements from the new guidelines, which are available at https://www.auanet.org/guidelines/evaluation-and-management-of-testosterone-deficiency
Diagnosis of testosterone deficiency:
Clinicians should measure total testosterone more than once and obtain a symptom history before making a diagnosis. Validated questionnaires are not sufficient for either diagnosis or monitoring.
According to the guidelines:
Clinicians should use a total testosterone level below 300 ng/dL as a reasonable cut-off in support of the diagnosis of low testosterone. (Moderate Recommendation; Evidence Level: Grade B)
The diagnosis of low testosterone should be made only after two total testosterone measurements are taken on separate occasions with both conducted in an early morning fashion. (Strong Recommendation; Evidence Level: Grade A)
The clinical diagnosis of testosterone deficiency is only made when patients have low total testosterone levels combined with symptoms and/or signs.(Moderate Recommendation; Evidence Level: Grade B)
Clinicians should consider measuring total testosterone in patients with a history of unexplained anemia, bone density loss, diabetes, exposure to chemotherapy, exposure to testicular radiation, HIV/AIDS, chronic narcotic use, male infertility, pituitary dysfunction, and chronic corticosteroid use even in the absence of symptoms or signs associated with testosterone deficiency. (Moderate Recommendation; Evidence Level: Grade B)
In patients with low testosterone, clinicians should measure serum luteinizing hormone levels. (Strong Recommendation; Evidence Level: Grade A)
Serum prolactin levels should be measured in patients with low testosterone levels combined with low or low/normal luteinizing hormone levels. (Strong Recommendation; Evidence Level: Grade A)
Patients with persistently high prolactin levels of unknown etiology should undergo evaluation for endocrine disorders. (Strong Recommendation; Evidence Level: Grade A)
Prior to offering testosterone therapy, clinicians should measure hemoglobin and hematocrit and inform patients regarding the increased risk for polycythemia. (Strong Recommendation; Evidence Level: Grade A)
Clinicians should inform testosterone deficient patients that low testosterone is a risk factor for cardiovascular disease. (Strong Recommendation; Evidence Level: Grade B)
Patients should be informed that testosterone therapy may result in improvements in erectile function, low sex drive, anemia, bone mineral density, lean body mass, and/or depressive symptoms. (Moderate Recommendation; Evidence Level: Grade B)
Patients should be informed that the evidence is inconclusive whether testosterone therapy improves cognitive function, measures of diabetes, energy, fatigue, lipid profiles, and quality of life measures. (Moderate Recommendation; Evidence Level: Grade B)
Treatment of Testosterone Deficiency: Treatment should target therapeutic testosterone levels and ease symptoms.
Clinicians should adjust testosterone therapy dosing to achieve a total testosterone level in the middle tertile of the normal reference range. (Conditional Recommendation; Evidence Level: Grade C)
Clinicians should not prescribe alkylated oral testosterone. (Moderate Recommendation; Evidence Level: Grade B)
Clinicians should discuss the risk of transference with patients using testosterone gels/creams. (Strong Recommendation; Evidence Level: Grade A)
Follow-up of Men on Testosterone Therapy
Testosterone levels should be measured every 6 to 12 months while on testosterone therapy. (Expert Opinion)
Clinicians should discuss the cessation of testosterone therapy 3 to 6 months after commencement of treatment in patients who experience normalization of total testosterone levels but fail to achieve symptom or sign improvement. (Clinical Principle)
The panel also offered guidance for special populations. Whether testosterone therapy increases or decreases the risk for cardiovascular events is still unclear. The panel suggested not starting testosterone therapy in patients with a history of cardiovascular events.
PSA should be measured in men older than 40 years before starting testosterone therapy to exclude a prostate cancer (PCa) diagnosis. Currently, there is insufficient evidence to weigh the benefits and risks of testosterone therapy in men with PCa. Evidence has not confirmed a link between testosterone therapy and PCa development.
Men interested in preserving their fertility should have a reproductive health evaluation before considering testosterone treatment. Exogenous testosterone may affect spermatogenesis over the long term and should not be prescribed to men who are trying to conceive. Clinicians may use aromatase inhibitors, human chorionic gonadotropin, selective estrogen receptor modulators, or a combination in these men.