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Because of several physiologic barriers to safe and effective oral absorption of testosterone, it generally has been delivered transdermally or by injection. In 2019, an orally administered formulation of testosterone undecanoate (Jatenzo) was approved by the U.S. FDA; researchers now have published results of the phase 3 study that facilitated approval.
Two hundred twenty-one men (age range, 18–65) with hypogonadism (i.e., at least 2 morning total testosterone levels <300 ng/dL, ≈7 days apart) were randomized to receive either oral testosterone undecanoate or a topical testosterone solution for ≈4 months; the oral drug was dosed twice daily. Both products were titrated to achieve eugonadal serum levels of testosterone; achieved levels, aver…