Helen Bernie, DO, discusses potential TRT label expansion for idiopathic hypogonadism

As the FDA signals openness to expanding testosterone replacement therapy (TRT) labeling for men with idiopathic hypogonadism, Helen L. Bernie, DO, MPH, said a formal indication could help resolve longstanding uncertainty for both patients and clinicians while improving access to evidence-based care. Bernie is a urologist and the Director of Sexual and Reproductive Medicine at Indiana University as well as an assistant professor of urology at Indiana University School of Medicine in Indianapolis, Indiana.

Bernie explained that men with idiopathic hypogonadism often present with significant symptoms including low libido, fatigue, mood changes, reduced well-being, and sexual dysfunction, yet frequently leave appointments frustrated. Many have documented low testosterone levels and may have already seen multiple clinicians, but because they lack a recognized structural or genetic cause for hypogonadism, they are often told there is no clear approved treatment pathway. According to Bernie, this can leave patients feeling dismissed and create inconsistency in care, particularly when some clinicians remain hesitant to prescribe testosterone under the current labeling framework.

She noted that existing FDA-approved TRT indications are limited to men with hypogonadism tied to known structural or genetic causes, leaving many symptomatic men outside labeled use. The FDA’s recent announcement encouraging manufacturers to discuss supplemental applications for idiopathic hypogonadism suggests a possible regulatory shift, driven by emerging clinical data and expert input. If an expanded indication were ultimately approved, Bernie said it would allow physicians to have more transparent, grounded conversations with patients about who qualifies for treatment, what benefits may be expected, and what monitoring and safety considerations are required.

Bernie added that clearer labeling could also help distinguish evidence-based care from misinformation circulating through online clinics, social media, and direct-to-consumer marketing. At the same time, she cautioned that any expansion should be implemented carefully to avoid inappropriate prescribing. In her view, the larger current problem is that men who may legitimately benefit from therapy are often not treated because of outdated stigma, clinician discomfort, and historical perceptions surrounding testosterone therapy. While the FDA has not approved a new indication, she said, the agency has taken an important first step by opening the door to formal review.