Is testosterone the following miracle drug? That appeared to be the consensus of an expert panel convened by the US Meals and Drug Administration (FDA) in December. It argued for main modifications in coverage that might increase entry to the hormone for individuals with a spread of circumstances. Committee members known as testosterone alternative “a cornerstone of preventive well being” and “a multibillion-dollar preventive-care alternative.”
Testosterone is already obtainable in the US for individuals who have low ranges of the hormone owing to a identified medical challenge, reminiscent of testicular harm. However proof is rising that extra males — and ladies — would possibly profit from the hormone, which is delivered by injections, patches, subcutaneous implants or gels. (This text makes use of ‘males’ and ‘ladies’ to replicate the language utilized by the panels and research cited, whereas recognizing that trans, non-binary and intersex persons are additionally affected by this challenge.)
The panel’s suggestions intensify a debate that has been brewing about who would possibly profit from the remedy. Some clinicians say that the majority males with low testosterone, particularly younger ones with no medical challenge contributing to the issue, don’t want supplemental remedy in any respect and will have the ability to increase their testosterone ranges by adopting a more healthy way of life and losing a few pounds. Others argue that males with low testosterone who’ve signs reminiscent of low libido, fatigue and irritability might achieve from the remedy.
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Extra-enthusiastic proponents, together with many members of the FDA panel on the December assembly, take a 3rd view: that every one cis males must be examined, and people with low testosterone ranges must be handled even when they don’t have any signs. “You possibly can make a really sturdy argument that having a standard testosterone stage is necessary for well being and prevention of sickness,” says Abraham Morgentaler, a urologist at Harvard Medical College in Boston, Massachusetts, who took half within the December panel.
Morgentaler and different panellists harassed on the assembly that testosterone is not only a ‘way of life drug’ that males take to construct muscle and really feel good. But it’s more and more being marketed that method. Podcasters reminiscent of Joe Rogan and his visitors have sung the hormone’s praises. And scores of testosterone clinics are popping up all over the world, promising fitter our bodies and a lift in power ranges to individuals who won’t even have low testosterone to start with.
At excessive doses, testosterone use probably comes with dangers starting from infertility to elevated mortality. The drug is at the moment labeled as a managed substance with potential for abuse in the US and several other different international locations, owing partly to doping scandals within the Nineties and 2000s. That classification is price reconsidering based on statements made by FDA commissioner Marty Makary, who additionally voiced his enthusiasm for testosterone on the December panel.
So what’s the proof for the protection and advantages of testosterone alternative?
Security report
Testosterone’s fame has had its ups and downs because the hormone was first synthesized within the Nineteen Thirties. After an preliminary golden interval, through which it was described as “some of the potent medication not too long ago launched to medication,” the remedy fell out of favour for concern that it might trigger most cancers. This concept originated from the work of urologist Charles Huggins who, in 1941, discovered that prostate most cancers will depend on testosterone and that decreasing the hormone ranges prompted tumours to shrink. It was a groundbreaking discovery for which he was awarded a share within the Nobel Prize in Physiology or Medication in 1966.
Morgentaler says that when he was coaching as a urologist within the Nineteen Eighties, there was a widespread perception, primarily based on Huggins’s findings, that testosterone remedy might promote prostate most cancers. Regardless of the presumed dangers, he says he nonetheless thought that the hormone might assist a few of his sufferers who had low testosterone and sexual issues. So, he began treating them whereas monitoring them intently.
They didn’t get most cancers, Morgentaler says, they usually benefited from the remedy vastly. A few of his medical findings — together with the revelation that Huggins’s most dire warnings concerning the hormone inflicting most cancers have been primarily based on observations of a single individual — helped to clear the way in which for renewed curiosity in testosterone remedy. Morgentaler is well known for his testosterone-safety work, though some clinicians disagree with him on how a lot males stand to profit from the hormone. Morgentaler notes he has consulted for corporations that promote testosterone previously, however says that he has no present monetary pursuits.
Different potential dangers cropped up over time. Two retrospective research from 2013 and 2014 discovered an elevated threat of coronary heart assault in males on testosterone remedy, which led the FDA so as to add a warning to testosterone product labels in 2015.
However a randomized medical trial involving round 5,200 males — known as TRAVERSE — discovered that middle-aged and older males with low testosterone and a excessive threat of heart problems who took the hormone didn’t have the next incidence of extreme cardiovascular occasions, together with coronary heart assault and stroke, than did these on placebo. “This research solely picked very sick individuals, the greatest-risk inhabitants, and nothing dangerous occurred to them,” says co-author Mohit Khera, a urologist on the Baylor School of Medication in Houston, Texas. He additionally participated within the FDA skilled panel and says that he consults for testosterone corporations.
On the idea of the TRAVERSE findings, the FDA removed the cardiovascular warning from testosterone merchandise final 12 months.
The protection proof from TRAVERSE refers to males with confirmed low testosterone ranges — beneath 300 nanograms per decilitre of blood serum — who’re handled to convey their ranges again to the traditional vary of 350–750 nanograms. Larger doses, nonetheless, that push ranges effectively above the pure vary, carry radically totally different dangers.
At excessive doses, testosterone can thicken the center’s muscle tissues, impairing its means to pump blood, a situation known as cardiomyopathy. Excessive testosterone ranges also can trigger infertility, shrunken testicles, diminished sperm depend and erectile dysfunction, says Channa Jayasena, an endocrinologist at Imperial School London. There are additionally neuropsychiatric results, together with irritability and even psychosis, which could enhance the chance of violent crimes and home abuse, says Jayasena, who advises corporations that promote testosterone, however says that he declines cost to keep away from a battle of curiosity. “For causes we don’t absolutely perceive, very excessive doses of testosterone do one thing that therapeutic testosterone doesn’t do,” he says.
A Danish research that adopted some 500 males utilizing high doses of anabolic steroids — which embody medically accredited testosterone merchandise and different variations of the hormone — discovered that their mortality fee was thrice greater than that of non-users over a interval of round seven years, a threat that Jayasena says is just like that of cocaine use. The research members have been caught by a doping management programme that inspects health centres in Denmark and checks individuals suspected of steroid abuse. The authors acknowledge that steroid use has been related to risk-taking behaviours, which might clarify a part of the elevated mortality.
This type of misuse can be addictive: about 30% of males on excessive doses change into dependent. “They’re flooding our clinics,” Jayasena provides.
Who can profit?
Clinicians pushing for broader testosterone use usually share putting anecdotes of the hormone reworking individuals’s lives. Morgentaler says that when he began treating individuals who had low testosterone ranges within the late Nineteen Eighties, they reported again issues reminiscent of “My spouse likes me once more”, and “I’ve by no means had a lot endurance with my babies”. Regularly, they inform him that they lastly really feel like themselves once more, with improved temper, vigour and libido. They go from feeling depleted, as if their gasoline tank is empty, to regaining stamina and thriving at work, Morgentaler says.
These accounts are from individuals who keep on the remedy; many drop out. Within the TRAVERSE trial, round 61% of members receiving testosterone discontinued remedy. There may be restricted analysis into why males cease testosterone, however Morgentaler guesses that some don’t like the way it’s administered and others simply don’t really feel the profit (maybe, he argues, as a result of they’re taking the fallacious dose or have unrealistic expectations).
Scientific trials assist solely a modest portion of the advantages that testosterone followers are likely to attribute to it.
The clearest impact is in sexual operate. A subanalysis of the TRAVERSE trial, which included round 1,100 males with low libido, discovered that each the remedy and the placebo teams elevated their sexual exercise, however the enhance was 25% larger in handled males. Sexual need additionally improved with testosterone remedy, though erectile operate didn’t.
A meta-analysis commissioned by the Endocrine Society, a company primarily based in Washington DC, concluded that testosterone was related to a “small however statistically vital” enchancment in sexual operate, sexual satisfaction and libido in males with low testosterone. It additionally discovered a small enchancment in erectile operate, opposite to the TRAVERSE trial. The overview discovered no statistically vital distinction in power, temper or cognition.
Different research have proven that testosterone remedy can successfully deal with anaemia and that it improves bone density. Surprisingly, males receiving testosterone within the TRAVERSE trial had extra fractures than these on placebo. “It have to be that these inactive males have been turning into extra energetic,” which may very well be a very good factor if which means they’re getting extra train, says Jayasena.
Smaller trials confirmed that testosterone can be related to a rise in fat-free physique mass and muscle energy, each in youthful and older males.
Potential advantages for ladies
As testosterone use surges in some teams, many individuals who may benefit have largely been omitted of the talk, together with trans males, for whom the hormone is really helpful as part of gender-affirming care, and postmenopausal women.
For girls, the one indication for which there’s clear proof of profit is low sexual need after menopause that causes misery, based on a scientific overview and meta-analysis of 36 randomized managed trials.
Susan Davis, an endocrinologist at Monash College in Melbourne, Australia, and a co-author of the overview, says that there’s big variation in how ladies reply to testosterone remedy. Simply having a doctor listening to their considerations, validating them and caring for them is sufficient for some ladies to report feeling higher. “I’ve now studied testosterone in 1000’s of girls and doubtless carried out extra medical trials than anyone else with testosterone,” says Davis, who consults for corporations that promote testosterone and has acquired grant funding from one. “What we’ve seen over and over in all our research is an unbelievable placebo impact.” Testosterone does do higher than placebo in sexual operate, however the knowledge don’t present a big distinction in well-being, cognitive well being and physique composition.
Beneficial doses — which purpose to revive testosterone ranges to these of premenopausal ladies — are usually secure, resulting in negative effects reminiscent of zits, and physique and facial hair.
Excessive doses, nonetheless, are related to negative effects that some sufferers would possibly discover extra disagreeable, reminiscent of hair loss, weight achieve, voice change and an enlarged clitoris. “It’s fairly distressing,” says Davis.
She has seen individuals who have been beforehand prescribed excessive doses and report agitation and aggression. Some say they’ve skilled street rage for the primary time. “One lady advised me she wakened in the midst of the night time together with her arms round her husband’s neck from a dream,” Davis says. Stopping remedy can be difficult. Some ladies who abruptly cease after being on excessive doses “can really feel very flat and depressing”, she says.
Solely 4 international locations have testosterone merchandise accredited particularly for ladies: Australia, New Zealand, South Africa and, as of final 12 months, the UK.
Elsewhere, ladies are utilizing testosterone formulations designed for males, which could put them in danger, Davis says. The sort of off-label use is widespread in the US. “It could appear to me that the FDA would really be defending ladies by approving a feminine dose-specific formulation,” she says. The FDA panel in December didn’t focus on testosterone use for ladies or for trans males.
Regulatory hurdles
The FDA at the moment limits approval of testosterone merchandise to deal with ‘classical hypogonadism’, through which low testosterone is brought on by genetic circumstances or issues of the mind or testicles. In the UK, Europe and Australia, testosterone is accredited for the remedy of males with laboratory-confirmed low testosterone accompanied by signs. They don’t must have an recognized explanation for the deficiency. That is additionally the place of most medical pointers from urology and endocrinology associations all over the world.
However the extra restrictive regulatory situation in the US is already beginning to change. In April, the FDA introduced it was inviting pharmaceutical corporations to submit purposes for testosterone remedy for the remedy of low libido in males with low testosterone ranges from an unknown trigger.
To this point, there have been no additional modifications to US laws on the idea of proposals mentioned by the skilled panel, reminiscent of eradicating testosterone’s controlled-substance classification or recommending routine testosterone testing for all males. However extra modifications might nonetheless comply with.
One argument for together with testosterone testing in routine preventive care, stated panellist Helen Bernie, a urologist at Indiana College in Carmel, is that low ranges have been related to a spread of well being dangers. For instance, Bu Yeap, an endocrinologist on the College of Western Australia in Perth, and his colleagues have reported that older males with low testosterone have the next threat of stroke. At very low ranges, the chance of loss of life from any trigger and from heart problems additionally will increase. Their work additionally linked low testosterone to the next threat of dementia and Alzheimer’s illness.
“We’re actually conscious from the work we’ve carried out that low testosterone is sort of a strong biomarker for poorer well being outcomes, significantly in older males,” says Yeap, who has suggested and acquired analysis assist from corporations that promote testosterone. However, he provides, the info don’t justify testing asymptomatic males. “Should you deal with all males with low testosterone, will it really forestall in poor health well being? We haven’t proved that.”
Answering that query would require a big randomized medical trial, probably involving 10,000 older males with low testosterone and elevated threat of poor well being, adopted for no less than 4 years, Yeap says. His workforce is now working to get funding for such an initiative, which he anticipates will probably be costly and complicated. “However you’ve obtained to get the proof,” he says. “You’ll be able to’t simply pre-emptively make assumptions, which is what some individuals may be doing.”
This text is reproduced with permission and was first published on Might 5, 2026.
