testosterone therapy – An FDA expert panel weighs expanded testosterone access, as evidence on benefits, risks, dosing and who should be tested remains mixed.
A hormone once dismissed and then reinvented is back at the center of a high-stakes medical debate: testosterone therapy and whether it is truly safe—and who. exactly. should receive it.. In a December meeting convened by the US Food and Drug Administration (FDA). an expert panel argued for major policy changes that would expand access to testosterone for people with a range of conditions.
The panel’s discussion intensified a disagreement that has been building for years: testosterone is already prescribed in the United States for people with low levels tied to a known medical problem. such as testicular damage.. Yet evidence is growing that more people—both men and women—might benefit from the hormone. which is administered in several forms including injections. patches. subcutaneous implants. and gels.
Some clinicians contend that most men with low testosterone. particularly younger people without an identifiable medical cause. may not need supplemental therapy.. In their view, lifestyle changes and weight loss can raise testosterone levels naturally.. Others argue that the decision should be symptom-driven. pointing to men who experience low libido. fatigue. or irritability as likely candidates for treatment.
Meanwhile, a third argument—supported by some members of the December panel—pushes for a broader approach centered on testing.. Proponents say all cis men should be screened. and those found to have low testosterone should be treated even without symptoms.. Urologist Abraham Morgentaler. who participated in the panel. emphasized the idea that maintaining a normal testosterone level matters for health and illness prevention.
Yet. the debate is unfolding in a climate where testosterone has increasingly been marketed as a wellness shortcut rather than a medical therapy.. Morgentaler and others on the panel stressed that testosterone should not be treated like a mere “lifestyle drug” for muscle building.. The report described a surge in online hype and testosterone clinics promising energy and transformation to people who may not have low hormone levels in the first place.
Concerns also remain about harms at higher doses.. The article notes that testosterone can carry risks such as infertility and increased mortality when used at high levels.. In the United States and several other countries. it is classified as a controlled substance. in part because of historical doping scandals in the 1990s and 2000s.. The FDA commissioner Marty Makary raised the question of whether that classification should be reconsidered. voicing enthusiasm for testosterone during the December panel.
The safety story behind testosterone has been shaped by changing scientific interpretations since the hormone was first synthesized in the 1930s.. After an early period of optimism in which it was described as a highly potent drug. interest faded due to fears it could cause cancer.. Those fears were connected to work by urologist Charles Huggins in 1941. which showed prostate cancer depends on testosterone and that lowering hormone levels could shrink tumors—an achievement that later earned him a Nobel Prize in Physiology or Medicine in 1966.
Morgentaler said that when he trained in the 1980s. many clinicians believed testosterone therapy might promote prostate cancer. based on the earlier findings.. He described still believing the hormone could help select patients with low testosterone and sexual issues. and began treating them with close monitoring.. He later argued that his own clinical experience and the fact that Huggins’s most dire warnings were based on observations from a single person helped create space for renewed interest in testosterone therapy.
Other safety signals emerged later.. Two retrospective studies published in 2013 and 2014 reported a higher risk of heart attack among men taking testosterone. which prompted the FDA to add warnings to testosterone product labels in 2015.. But the picture shifted with a randomized clinical trial called TRAVERSE, involving about 5,200 men.. The study focused on middle-aged and older men with low testosterone and a high cardiovascular risk profile. and it found no increase in severe cardiovascular events such as heart attack and stroke compared with placebo.
The FDA removed the cardiovascular warning from testosterone products last year, based on TRAVERSE results.. Importantly. the article frames the trial’s safety evidence as applying to men with confirmed low testosterone levels—below 300 nanograms per decilitre—who were treated to bring levels into a normal range.. It also underscores a key caution: pushing testosterone well above the natural range can bring very different risks.
At high doses, testosterone can thicken heart muscle, impairing the heart’s ability to pump blood, a condition called cardiomyopathy.. The article also reports that very high testosterone levels can cause infertility, shrunken testicles, reduced sperm count, and erectile dysfunction.. Neuropsychiatric effects are also described. including irritability and even psychosis. which could plausibly increase risks related to violence and domestic abuse.
Jayasena. an endocrinologist at Imperial College London. added that clinicians and researchers do not fully understand why very high doses appear to behave differently from therapeutic dosing.. The article also discussed a Danish study tracking roughly 500 men who used high-dose anabolic steroids. with mortality reported at three times the level of non-users over about seven years.. Jayasena compared the magnitude of risk to that seen with cocaine use. while noting the study participants were identified through a doping control program and that risk-taking behaviors associated with steroid misuse could explain part of the higher mortality.
The misuse issue also appears to have an addictive element. The report says about 30% of men using high doses become dependent. “They are flooding our clinics,” Jayasena added, describing how prevalent high-dose, non-medical use can be.
Beyond safety, the debate hinges on what benefits—if any— testosterone reliably produces.. The report described clinicians who argue the hormone can be life-changing for some people with low testosterone. including Morgentaler’s account of patients reporting improvements such as renewed patience. more energy. and a return to feeling like themselves.. These experiences. however. are complicated by the reality that many people discontinue therapy. and the evidence base is narrower than popular claims.
TRAVERSE offered a stark measure of real-world adherence and continued benefit: about 61% of participants who received testosterone discontinued treatment.. The report noted limited research on why men stop. though Morgentaler suggested it may relate to how the medication is administered or to patients not experiencing expected effects. potentially due to incorrect dosing or unrealistic expectations.
When researchers look for benefits in clinical trials, the most consistent effects appear in sexual function.. The article describes a TRAVERSE subanalysis of around 1. 100 men with low libido. where both testosterone and placebo increased sexual activity. but the treated group improved more—about 25% more than placebo.. Sexual desire improved as well, while erectile function did not show the same pattern.
A meta-analysis commissioned by the Endocrine Society concluded that testosterone is linked to small but statistically significant improvements in sexual function. sexual satisfaction. and libido among men with low testosterone.. It also found a small improvement in erectile function, differing from the TRAVERSE results.. At the same time, the review reported no statistically significant differences in energy, mood, or cognition.
Other studies in specific areas add nuance.. Testosterone treatment has been associated with treating anemia and improving bone density.. But the report notes a surprising finding from TRAVERSE: men taking testosterone had more fractures than those taking placebo.. Jayasena suggested a possible explanation—that participants may have become more active—which could increase exposure to situations where fractures occur.
Smaller trials also described gains in fat-free body mass and muscle strength in both younger and older men, reinforcing that some physical changes occur, though not necessarily in ways that match widespread expectations.
The question of who benefits becomes even more complex for women. as testosterone use rises in some circles and the debate has often left them out.. The article emphasized that for trans men. testosterone is recommended as part of gender-affirming care. while postmenopausal women have drawn particular attention in hormone research.
For women, the report identifies the main situation where evidence is strongest: low sexual desire after menopause that causes distress.. A systematic review and meta-analysis of 36 randomized trials concluded that testosterone can help in this specific setting.. Susan Davis. an endocrinologist at Monash University in Melbourne and a co-author of the review. described large individual variability in response.
Davis argued that for some women. even the act of being heard by a clinician—validated and cared for—may be enough to improve how they feel.. She also described a “huge” placebo effect across her research and said that while testosterone does perform better than placebo for sexual function. the data do not show significant differences in well-being. cognitive health. or body composition.
The report outlines side effects tied to dosing in women.. Recommended doses aim to restore testosterone levels to premenopausal ranges and are generally described as safe. with side effects such as acne and changes including body and facial hair.. Higher doses, however, are associated with more distressing effects, including hair loss, weight gain, voice changes, and an enlarged clitoris.
Davis also described behavioral and psychological side effects in some patients on higher doses, including agitation and aggression.. She recounted seeing cases where individuals experienced changes such as road rage and even disturbing dreams with episodes of violence.. The report also says stopping treatment can be difficult. with some women feeling “flat” and miserable after abrupt discontinuation following high-dose use.
Regulatory availability for women is limited.. According to the article. only four countries have testosterone products approved specifically for women: Australia. New Zealand. South Africa. and. as of last year. the United Kingdom.. Elsewhere. Davis warned that women often use formulations designed for men. which may put them at risk. and argued that regulatory bodies could protect women by approving female dose-specific options.
Notably, the December FDA panel did not discuss testosterone use for women or for trans men, even as the hormone’s broader use and marketing continue to affect those groups.
Regulation in the United States currently restricts testosterone approvals to “classical hypogonadism. ” where low testosterone results from genetic conditions or disorders of the brain or testicles.. By contrast. in the United Kingdom. Europe. and Australia. testosterone is approved for men with laboratory-confirmed low testosterone accompanied by symptoms. without requiring a specific identifiable cause.. The report states that many clinical guidelines from urology and endocrinology organizations worldwide follow that less restrictive approach.
Even within the United States, the regulatory landscape appears to be shifting.. In April. the FDA announced it was inviting pharmaceutical companies to submit applications for testosterone therapy to treat low libido in men with low testosterone when the cause is unknown.. For now. the report notes. no further changes have been made to US rules based on proposals discussed by the expert panel. including removing controlled-substance classification or recommending routine testosterone testing for all men.
One argument for wider testing comes from panelist Helen Bernie, a urologist at Indiana University.. The report describes a rationale tied to risk markers: low testosterone has been associated with a range of health risks.. It cites work by endocrinologist Bu Yeap and colleagues at the University of Western Australia. who reported higher stroke risk among older men with low testosterone. and a higher risk of death from any cause and from cardiovascular disease at very low levels.. Their research also linked low testosterone to increased risk of dementia and Alzheimer’s disease.
Yet Yeap cautioned that association does not automatically justify screening asymptomatic men.. If clinicians treat everyone with low testosterone, he said, it remains unproven whether that would actually prevent illness.. Proving that would require a large randomized trial. potentially involving around 10. 000 older men with low testosterone and increased risk of poor health. followed for at least four years—an expensive and complex effort. Yeap said.. He argued that the medical field cannot simply pre-emptively assume that lowering testosterone-related risks will translate into preventive benefit without definitive evidence.
This article was reproduced with permission and was first published on May 5, 2026.
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