New Therapy Granted FDA Approval for Certain Forms of Hypogonadism in Men


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.

Common adverse effects, occurring in more than 2% of patients in the testosterone undecanoate clinical trial, included headache, an increase in red blood cell count, a decrease in high-density lipoprotein cholesterol, high blood pressure and nausea. An increase in prostate specific antigen (PSA) was also observed. According to the FDA, patients should have their hematocrit, cholesterol and PSA monitored regularly to check for changes. Those with benign prostate hyperplasia should be monitored for worsening of symptoms.

The newly approved product contains a boxed warning on its labeling stating that testosterone undecanoate can cause blood pressure to rise, increasing the risk of heart attack, stroke and cardiovascular death. Health care providers should consider a patient’s individual heart disease risks and ensure that blood pressure is adequately controlled before prescribing testosterone undecanoate; and they should also periodically monitor patient blood pressure during treatment, FDA officials said, in a press release. This therapy is currently one of 2 testosterone products that have this boxed warning.

The FDA is requiring all testosterone product manufacturers to conduct blood pressure postmarketing trials to more clearly address whether these products increase blood pressure.


FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism [news release]. Silver Spring, MD; March 27, 2019: FDA website. Accessed March 27, 2019.

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