Dr. Ramasamy discusses investigational oral testosterone treatment

“While there’s benefit in improving access, there’s also potential for harm when providers fail to follow evidence-based guidelines, or when the benefits and risks of treatment are not appropriately communicated," said Joshua A. Halpern, MD.

Hamilton discusses findings from a recent study published in European Urology.

Testosterone undecanoate (Tlando), an oral testosterone replacement therapy, was approved in March 2022 for the treatment of men with hypogonadism.

The pivotal trial supporting approval of the oral testosterone undecanoate was Study 16-002, which included 95 hypogonadal males.

"We didn't see any clinically significant changes on the prostate gland, which is very important for the urologists who see people who have prostate cancer or prostate enlargement," says Ronald Swerdloff, MD.

Researchers from the FDA’s Center for Drug Evaluation and Research determined that the benefits of androgen receptor inhibitors outweighed the risks in men aged ≥80 years with nonmetastatic castration-resistant prostate cancer.