New Testosterone Treatment for Certain Forms of Hypogonadism

Majority of Trial Patients Achieved Normal Testoserone Levels

The FDA has approved testosterone undecanoate (Jatenzo, Clarus Therapeutics) an oral testosterone capsule for men with certain types of hypogonadism. These men have low testosterone levels caused by specific medical conditions, such as Klinefelter syndrome or tumors that have damaged the pituitary gland.

The oral method of administration is an important addition to the current options available for men with certain hypogonadal conditions who up until now have typically been treated with testosterone products that are applied to the skin or injected.

Testosterone undecanoate should not be used to treat men who have age-related hypogonadism, even if they have symptoms that seem to be related to low testosterone, as the benefits of the drug do not outweigh its risks for that use. The effects of testosterone undecanoate on raising blood pressure can increase the risks of heart attack, stroke, and cardiovascular death in this population.

The drug’s efficacy was demonstrated in a clinical trial with 166 men with hypogonadism. At the outset, participants received testosterone undecanoate 237 mg twice daily, then the dose was adjusted downward or upward to a maximum of 396 mg twice daily based on testosterone levels. Eighty-seven percent of patients treated with the drug achieved an average testosterone level within normal range, which was the primary endpoint.

Common side effects included headache, an increase in hematocrit, a decrease in high-density lipoprotein cholesterol, high blood pressure, and nausea. An increase in prostate specific antigen was also observed.

Testosterone undecanoate carries a boxed warning stating that the drug can cause a rise in blood pressure, increasing the risk for heart attack, stroke, and cardiovascular death. Before prescribing testosterone undecanoate, health care providers should consider the patient’s heart disease risks and ensure that blood pressure is adequately controlled.

Source: FDA, March 27, 2019