FDA Approves New Option for Hypogonadism

The FDA has approved Jatenzo (testosterone undecanoate), an oral testosterone capsule for the treatment of men with certain forms of hypogonadism caused by specific medical conditions, including Klinefelter syndrome or pituitary tumors. It should not be used for the treatment of age-related hypogonadism.

The efficacy of Jatenzo was evaluated in a 4-month clinical trial involving 166 men with hypogonadism who initially received 237 mg twice per day adjusted downward or upward to a maximum of 396 mg twice per day. Of the participants treated with Jatenzo, 87% achieved an average testosterone level within the normal range.

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Idiopathic Hypogonadotropic Hypogonadism

A Boxed Warning for Jatenzo states that the drug can cause blood pressure increases as well as increases in the risk of heart attack, stroke, and cardiovascular death.

Common adverse effects include headache, increased hematocrit, decreased high-density lipoprotein cholesterol, high blood pressure, and nausea.

—Michael Potts

Reference:

FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism [press release]. March 27, 2019. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634585.htm.