Urologic evaluation before treatment is indicated when baseline prostate specific antigen (PSA) is ≥4 ng/mL (3 ng/mL for those at increased risk of prostate cancer, such as African-Americans and men with first-degree relatives with the disease) or when there are suspicious findings on digital rectal examination (DRE).

The guideline recommends diverse formulations and routes of administration, including:

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Intramuscular testosterone enanthate or cypionate: 75-100 mg weekly, or 150-200 biweekly

Transdermal patch: One to two 5-mg patches applied daily to back, thigh, or upper arm

Gel: 5-10 g of 1% testosterone gel daily to covered, nongenital skin. Advise patients to wash before skin-to-skin contact to avoid transferring the hormone to women or children.

Buccal tablet: 30 mg applied to buccal mucosa every 12 hours.

Subcutaneous pellet: implanted every three to six months


Follow-up is essential to track hormone levels, symptoms, adverse effects, and risks associated with effects on the prostate and hematocrit elevation.

Side effects of testosterone therapy include mood and libido fluctuations (particularly with injectable formulations), skin reactions to transdermal administration, and oral mucosa irritations and alterations in taste with buccal tablets.

The guideline recommends repeating PSA measurement at three months and six months after treatment initiation and then annually or according to the standard age- and race-based protocol for prostate cancer screening. Urologic consultation is called for if PSA increases more than 1.4 ng/mL within any 12-month period, prostate abnormality is detected on DRE, or lower-urinary-tract symptoms become severe.

Hematocrit testing should follow a similar schedule. If hematocrit rises above 54%, discontinue therapy until it returns to safe levels; rule out sleep apnea and hypoxia, then reinitiate therapy at a lower dose.

Special populations

Short-term therapy is recommended for HIV-infected men with low testosterone levels and weight loss to promote gains in lean body mass and muscle strength. Men receiving high doses of glucocorticoids who have low testosterone levels might be offered therapy to preserve lean body mass and BMD.

Standard diagnostic and treatment recommendations apply to men with sexual dysfunction. Testosterone therapy should be offered to men with low libido when hormone levels are unequivocally low; in cases of erectile dysfunction and low testosterone, hormone treatment might be an option after considering underlying causes of the dysfunction and standard therapies (i.e., a PDE5 inhibitor, such as sildenafil [Viagra]).

The guideline’s authors advise against treating all older men with low testosterone without taking into account clinical manifestations of androgen deficiency. In light of equivocal findings about clinical benefits, opinions differed on whether 300 ng/dL (the lower limit of normal) or 200 ng/dL is an appropriate threshold for treatment.

“Older men are at greater risk of potential prostate and hematocrit complications of treatment, and since we have no large clinical trials to address safety issue in this group, we have to be more cautious than with younger people,” observes Dr. Cunningham.

Mr. Sherman is a freelance medical writer in New York City.