New Treatment Approved for Men with Certain Forms of Hypogonadism

Officials with the FDA approved Wednesday testosterone undecanoate (Jatenzo, Clarus Therapeutics), an oral testosterone capsule for treating men with certain forms of hypogonadism.

Officials with the FDA approved Wednesday testosterone undecanoate (Jatenzo, Clarus Therapeutics), an oral testosterone capsule for treating men with certain forms of hypogonadism.

The drug is indicated to for men with low testosterone levels due to specific medical conditions, such as genetic disorders, including Klinefelter syndrome or tumors that have damaged the pituitary gland.

“Jatenzo’s oral route of administration provides an important addition to current treatment options available for men with certain hypogonadal conditions who up until now have most commonly been treated with testosterone products that are applied to the skin or injected,” said Hylton V. Joffe, MD, MMS., director of the Division of Bone, Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research, in a prepared statement.

According to the FDA, testosterone undecanoate should not be used to treat men with “age-related hypogonadism,” in which testosterone levels decline due to aging, even if these men have symptoms that appear to be related to low testosterone. Jatenzo’s benefits do not outweigh its risks for that use.

“Jatenzo’s effects on raising blood pressure can increase the risks of heart attack, stroke and cardiovascular death in this population,” said Joffe.

The efficacy of testosterone undecanoate was demonstrated in a 4-month clinical trial involving 166 men with hypogonadism. Study participants initially were given the drug at a dose of 237 mg twice per day, and the dose was adjusted downward or upward to a maximum of 396 mg twice per day on the basis of testosterone levels. Eighty-seven percent of men treated with testosterone undecanoate achieved an average testosterone level within the normal range, which was the primary study endpoint.

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