JAMA reports on the HHS proposal to revise FDA testosterone therapy labels, citing TRAVERSE trial evidence. Proposed updates address age-related hypogonadism, prostate cancer warnings, and BPH labeling while reigniting debate over appropriate prescribing.
Written By: Anamika Koshti, PharmD
Reviewed By: Pharmacally Editorial Team
Published in JAMA on July 10, 2026, this medical news report examines the US Department of Health and Human Services (HHS) proposal to revise FDA prescribing labels for testosterone replacement therapy, following a December 2025 FDA panel review. The change could reduce current labeling restrictions and allow more clinically eligible people to access the treatment beyond the current approval for classic hypogonadism. It has also sparked a long-standing debate about prescribing practices in the field.
The Three Proposed Label Changes
HHS is requesting three specific revisions to existing testosterone therapy product labeling. First, the agency wants to remove the restriction that states safety and effectiveness have not been established for age-related hypogonadism, which is currently not part of the approved indication. Second, it proposed narrowing the prostate cancer contraindication to men with metastatic disease only, while still recommending ongoing screening and monitoring. Third, it seeks an update to the benign prostatic hyperplasia (BPH) warning to show that testosterone therapy does not worsen urinary symptoms in most men.
Brian J. Christine, MD, Assistant Secretary for Health at HHS, said that prescribing information should keep up with the best available science as our understanding of testosterone therapy continues to improve.
The Evidence That Prompted the Review
The primary evidence supporting the HHS proposal is the TRAVERSE trial (NCT03518034), a Phase 4, randomised, double-blind, placebo-controlled study involving more than 5,200 men aged 45 to 80 years with symptomatic hypogonadism and either preexisting or high cardiovascular risk. In 2023, the primary results showed that testosterone therapy did not increase the risk of major adverse cardiovascular events compared with placebo. This finding addressed the cardiovascular safety question that prompted the FDA’s postmarketing requirement in 2015. In a trial in which patients were followed for an average of approximately 33 months, AndroGel, a transdermal gel formulation, was the only testosterone product evaluated. Men at elevated baseline risk of prostate cancer were excluded from the study, limiting the applicability of the findings to that population.
Secondary outcomes from TRAVERSE, however, showed a statistically significant increase in atrial fibrillation, a higher incidence of pulmonary embolism, a modest rise in acute kidney injury, and an unexpected increase in fracture risk in the testosterone arm. Approximately 61% of patients in both groups discontinued treatment, and 21% withdrew entirely.
Following review of the TRAVERSE findings, the FDA in 2025 removed the boxed cardiovascular warning from testosterone products while requiring updated labeling regarding blood pressure monitoring, reflecting the evolving safety evidence.
The federally funded Testosterone Trials (NCT00799617), led by Peter Snyder, MD of the University of Pennsylvania, evaluated testosterone’s effects across several domains in older men. Results showed modest gains in walking distance, mood, and sexual function, with no improvement in overall vitality or cognitive performance.
The sexual function benefit, while present, was smaller than that seen with erectile dysfunction medications. Similarly, TRAVERSE reported only modest improvements in sexual desire, sexual activity, mood, and energy levels among men receiving testosterone therapy.
Where the Experts Stand?
Expert opinion is divided. Steven Nissen, MD, senior author of TRAVERSE and cardiologist at the Cleveland Clinic, believes the data will be applied more broadly than their design intended, raising concern about a return to the prescribing patterns of the early 2000s, when prescriptions more than tripled over a decade among older men and increased fourfold among those aged 18 to 45 years. Snyder, principal investigator of the Testosterone Trials, shared similar reservations.
Shalender Bhasin, MD of Harvard Medical School, holds a more nuanced position, he supports the BPH update but considers randomised data in prostate cancer survivors insufficient to justify narrowing that contraindication.
Abraham Morgentaler, MD, a urologist who has long pressed for testosterone prescribing, argues that treating an age-related hormonal decline is no different in principle from treating other age-related conditions routinely addressed in adult medicine.
Defining Who Qualifies
Medical organisations differ on the threshold for clinically low testosterone, the American Urological Association uses consistently below 300 ng/dL, and the Endocrine Society places the lower limit of normal at 264 ng/dL. Classic hypogonadism, the current approved indication, is typically defined by levels below 150 ng/dL.
Testosterone also falls approximately 1% per year from a man’s 30s onward. Distinguishing a treatable hormonal deficiency from normal ageing, when both can produce the same symptoms, remains one of the core clinical questions this label change will not resolve on its own.
Path Forward
The HHS proposal does not change prescribing practice immediately. Drug manufacturers must submit updated label language to the FDA for formal review and approval before changes appear in official prescribing information. If approved, the revisions could reduce access barriers for patients who qualify clinically but fall outside the current label, and may ease insurance coverage challenges.
Regardless of whether the labeling changes are adopted, experts broadly agree that testosterone therapy should be prescribed only after confirming low testosterone with appropriate laboratory testing and compatible symptoms, with ongoing monitoring to maintain physiologic hormone levels and detect adverse effects. Whether broader labelling leads to more appropriate prescribing or lowers the treatment threshold in less experienced settings is a question the field has not resolved.
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About the Writer
Anamika Koshti (LinkedIn) is a PharmD professional and healthcare writer with interests in clinical research, pharmacovigilance, and evidence-based medicine. She has authored peer-reviewed publications on Alzheimer’s disease and PCOS, presented research at national conferences, and gained hands-on experience in medical content development and clinical data interpretation. She is committed to translating complex medical research into accurate, accessible content for healthcare professionals and patients.
