Men
What Are the Symptoms of Low Testosterone?
Low libido, fewer erections and some physical changes can signal low testosterone. Guidelines say diagnosis also needs two low early-morning blood tests.
Less interest in sex, fewer morning erections, a tiredness that won’t lift. Somewhere online, a symptom quiz is ready to call that “low T” before your coffee cools. At Humanic Blue, the useful question is which symptoms point toward a hormone problem and which might have other explanations.
The Endocrine Society, the professional body for hormone specialists, lists the main symptoms of low testosterone as a lower sex drive, erection problems and loss of spontaneous erections, and a lower sperm count. Over time, some men also lose body hair and muscle, notice breast tenderness or enlargement, or develop weaker bones or a low red-blood-cell count. Fatigue, low mood and poor concentration can happen too, but they have many other causes. For men thinking about living longer and better, symptoms are a reason to get checked, not a diagnosis: the Society requires symptoms plus at least two low early-morning blood tests.
In This Article
- Sex drive and erections are the symptoms researchers tie most closely to low levels
- Physical changes that tend to build slowly
- Why tiredness and low mood are hard to pin on testosterone
- Two morning blood tests, not one
- Finding the cause comes before any treatment
- What the FDA changed in 2025 and 2026
- The guidelines, trials and numbers behind all of this
Key Takeaways
- Low sex drive, fewer morning erections and erection problems were the only symptoms that moved together with lower testosterone in the European Male Aging Study.
- The Endocrine Society says tiredness, low mood and poor focus have many possible causes and cannot identify low testosterone on their own.
- Diagnosis needs symptoms plus at least two low early-morning blood tests, followed by a search for the cause, according to the Endocrine Society and the American Urological Association.
- In 2026 the FDA asked makers to drop a label line saying testosterone’s safety and benefit in age-related low testosterone weren’t established. The Endocrine Society still describes long-term safety, including for the prostate, as unestablished. The regulatory decision does not settle that longer-term question.
- No trial has tested whether treating low testosterone helps men live longer.
Which sexual symptoms track with low testosterone?
The Endocrine Society lists a drop in sex drive, erectile dysfunction and loss of spontaneous erections, and lower sperm count and infertility among the symptoms of male hypogonadism, the medical name for low testosterone.
A large population study backs up the sexual symptoms in particular. Researchers led by Frederick Wu at the University of Manchester surveyed about 3,400 men aged 40 to 79 across eight European centers for the European Male Aging Study. Several symptoms, including fatigue and depression, were related to testosterone levels. Only three, though, formed a pattern that tracked lower levels together: poor morning erections, low sexual desire and erectile dysfunction. How the study worked
That still doesn’t make them proof. The American Urological Association (AUA), whose guideline covers how urologists diagnose low testosterone, says erection problems and low desire can also stem from chronic stress, chronic fatigue or depression.
Treatment results point the same direction. In the National Institutes of Health (NIH)-funded Testosterone Trials, men aged 65 or older with symptoms and testosterone averaging below 275 ng/dL used testosterone gel or a placebo gel for a year. The testosterone group had a moderate improvement in sexual function and slightly better mood. The trials did not show a benefit for energy or their main walking-distance outcome; walking results differed when all trial participants were analyzed together. AbbVie, which made the gel used in the trial, was one of the funders and donated it. (Note 1) The trial details
Physical changes that tend to build slowly
The Endocrine Society says that over time, low testosterone may cause:
- Loss of body hair
- Loss of muscle bulk
- Smaller or shrinking testes
- Breast enlargement or tenderness
- Weak bones (osteoporosis)
- A low red-blood-cell count (anemia)
- Hot flashes, when testosterone is very low
None of these is unique to low testosterone. The AUA notes that loss of muscle and physical strength can come from other conditions, and weak bones and anemia each have their own list of possible causes that a clinician will want to check.
The Society advises telling a doctor about your medical history, all medications, sexual problems and any major life changes. The exam it describes checks body hair, breast tissue and the size and consistency of the testes.
Do tiredness, mood and focus changes point to low testosterone?
Fatigue, low mood, poor concentration and weight gain often get packaged online as a “low T” profile. The AUA describes the symptoms linked to low testosterone as very nonspecific, and says tiredness, mood changes, poor focus, loss of muscle and extra belly fat can all come from chronic stress, chronic fatigue or depression instead.
In a July 2026 statement on testosterone replacement therapy, the Endocrine Society put it plainly: “Symptoms alone are not diagnostic of hypogonadism.” It notes that low energy, libido and mood are common in aging men and have many causes. It asks clinicians to rule out reversible contributors first, such as obesity and medicines like corticosteroids or opioids.
Weight matters here. The Society estimates that 30% to 50% of men with obesity or type 2 diabetes have hypogonadism. For men whose low testosterone is tied to excess weight and has no other cause, its 2026 statement says weight loss is typically the first treatment.
What limits a symptom checklist's ability to identify testosterone deficiency?
Two morning blood tests, not one
Testosterone peaks in the morning and falls through the day, according to the Endocrine Society. It can dip temporarily with severe illness, poor nutrition, too much exercise and some medications. That’s why both main guidelines insist on repeat morning testing.
The Endocrine Society’s 2026 statement calls for at least two early-morning, fasting tests, with a “common clinical threshold near 300 ng/dL.”
The AUA treats a total testosterone below 300 ng/dL as a reasonable cutoff, but says a number below 300 isn’t enough on its own to define testosterone deficiency. Symptoms have to be there too. If one test is low and the second is normal, the AUA leaves a third test to the clinician’s judgment. Unlike the Endocrine Society, it doesn’t insist on fasting.
Timing isn’t the only trap. The AUA warns that an acute illness can artificially lower a result. In a small study of young men with respiratory infections, which it cites, average testosterone fell about 10% during the illness.
The lab matters too. The Endocrine Society warns that testosterone tests aren’t all standardized, so the same blood sample can read low at one lab and normal at another. It points to laboratory testing methods, or assays, certified by the Centers for Disease Control and Prevention’s (CDC) Hormone Standardization Program, which publishes a list of tests that match its reference method within a set margin. What each test answers
What uncertainty does repeat testing address that a single measurement leaves open?
What “normal” means at 70
Testosterone drifts down with age, but the Endocrine Society’s 2026 statement says the diagnosis works “the same for a man of any age.” It argues that labels like “age-related” or “late-onset” hypogonadism “blur the line between treatable disease and normal aging.”
The Society also advises against routine testosterone screening of men without symptoms. The AUA goes a step further: it asks clinicians not to measure testosterone in men who have no symptoms, no signs and no condition linked to low levels.
Reference ranges depend on the lab. Researchers working with the CDC calibrated four large studies to one reference method and found a normal range of about 264 to 916 ng/dL in healthy, non-obese European and American men aged 19 to 39. Where a result sits near the bottom of the range, or a condition changes the protein that carries testosterone in the blood (sex hormone-binding globulin, or SHBG), the Endocrine Society recommends also checking free testosterone, the portion not bound to proteins in the blood. The reference-range research
Why does finding the cause come before treatment?
Low testosterone can start in the testes (primary hypogonadism) or in the pituitary gland and hypothalamus, the parts of the brain that signal the testes (secondary hypogonadism). The Endocrine Society recommends measuring two pituitary hormones, luteinizing hormone (LH) and follicle-stimulating hormone (FSH), to tell them apart. The AUA also recommends checking prolactin, another pituitary hormone, when LH is low or low-normal.
The Endocrine Society lists these possible causes:
- Testicular injury or infection
- Radiation or chemotherapy for cancer
- Some medications, such as opioid painkillers and corticosteroids
- Pituitary tumors or disease, and high prolactin
- Chronic conditions, including liver and kidney disease, obesity, sleep disorders, type 2 diabetes and HIV
- Genetic conditions such as Klinefelter syndrome, hemochromatosis (iron overload) and Kallmann syndrome
- Anabolic steroid use
The workup depends on the man. The Society says it may include more blood tests and sometimes magnetic resonance imaging (MRI), a scan of the pituitary gland. Fertility plans change the conversation, because testosterone therapy can lower sperm production, and the Society advises men planning to have children not to use it.
What the FDA changed in 2025 and 2026
The FDA has revisited testosterone labeling twice in about 16 months.
- February 2025. After reviewing the TRAVERSE trial, the US Food and Drug Administration told makers to remove cardiovascular-risk language from the boxed warning on testosterone products. It kept the “Limitation of Use” for age-related hypogonadism, and required class-wide warnings that testosterone can raise blood pressure.
- June 2026. The Department of Health and Human Services announced that the FDA was asking makers to remove that limitation, saying the agency “has concluded that the limitation of use is no longer warranted.” The request also narrows the prostate-cancer prohibition on treatment (contraindication) to men with metastatic prostate cancer, meaning cancer that has spread to other parts of the body, and revises warnings about an enlarged prostate.
As of September 26, 2026, the FDA’s testosterone information page still says no approved testosterone product is approved for men with low testosterone who lack an associated medical condition. In April 2026, the agency also invited makers to talk to it about seeking approval to treat low libido in men whose low testosterone has no known cause.
TRAVERSE, the trial behind these changes, enrolled men aged 45 to 80 who had symptoms, two fasting testosterone levels below 300 ng/dL, and heart disease or a high risk of it. Over about three years, about 7% of men in each group experienced the combined outcome: a first nonfatal heart attack, nonfatal stroke or cardiovascular death. Testosterone met the trial’s preset limit for ruling out a large increase in that outcome; smaller differences were not excluded. Atrial fibrillation (an irregular heart rhythm), sudden kidney injury and blood clots in the lungs were more common with testosterone, and the Endocrine Society notes that fractures were too. The trial was funded by AbbVie and other testosterone makers. (Note 2) TRAVERSE and the FDA timeline
The Endocrine Society’s 2026 statement says testosterone therapy has “clear benefits” for men with properly diagnosed hypogonadism caused by disease of the testes, pituitary or hypothalamus. It also says long-term safety, including for prostate cancer, “remains unestablished,” and calls for a long-term “Men’s Health Initiative” study. Before therapy, its 2018 guideline advises against starting testosterone in men planning a family soon or with conditions including breast or prostate cancer, a high red-blood-cell level, untreated severe sleep apnea, uncontrolled heart failure, or a heart attack or stroke in the past six months. The wider benefits and risks of therapy are covered in our article on testosterone therapy and healthy aging.
What’s Interesting
Two big authorities read the same trial and landed a few weeks apart on different notes. In June 2026 the FDA asked makers to remove the line saying testosterone’s value in age-related low testosterone wasn’t established. In July 2026 the Endocrine Society said terms like “age-related” hypogonadism blur the line between disease and normal aging, and called for a long-term study before treating the safety question as settled.
Both cite TRAVERSE. The FDA judged the evidence enough to drop the label line, while noting that prostate questions remain. The Endocrine Society stresses what TRAVERSE didn’t settle: long-term prostate safety, plus the extra lung clots and fractures. For a man sitting with a borderline result, that disagreement is useful to know about: it’s the kind of thing worth asking your doctor to explain.
What This Means in Practice
For living longer and better, the practical value of a testosterone test is finding the right explanation for symptoms. No trial has tested whether treating low testosterone helps men live longer. Guidance from the Endocrine Society and the AUA points to a few steps:
- Start with a clinician, not a quiz. A primary care doctor, endocrinologist or urologist can review sleep, weight, medications, mood and fertility plans.
- Timing and repeat tests. Both guidelines require repeat morning testing; the AUA warns that an acute illness can temporarily lower the result.
- Laboratory method. The Endocrine Society points to CDC-certified testing methods; the reference range also affects interpretation.
- Finding the cause. The Endocrine Society recommends LH and FSH testing to distinguish causes; the AUA recommends prolactin testing when LH is low or low-normal.
- Fertility. Testosterone therapy can lower sperm production; the Endocrine Society advises against it for men planning to have children.
Every man’s history is different, and these guidelines are built from averages across many men.
Because symptoms and a laboratory diagnosis are only part of the picture, Testosterone and Aging covers normal change and Visceral Fat in Men After 50 covers a closely related body-composition question.
Bottom Line
Low testosterone can lower sex drive and erections, affect fertility, and over time thin body hair, muscle and bone and lower red-blood-cell counts. Tiredness, low mood and poor focus are common but not specific. The Endocrine Society and the AUA require symptoms plus two low early-morning tests, then a search for the cause. The FDA removed cardiovascular boxed-warning language in 2025 and requested further label changes in 2026, while the Endocrine Society says long-term safety isn’t established. Whether treatment helps anyone live longer hasn’t been tested. An endocrinologist or urologist can help interpret a borderline result.
A NOTE FROM LONGEVITY365
We read research, consult expert perspectives and work to make complicated health information easier to understand. What you’re reading here reflects how we’ve interpreted and organized that information. It is educational content—not personal medical advice, diagnosis or treatment guidance.
We’re not perfect, and neither is the available research. Evidence changes, new studies emerge and what’s appropriate for one person may not be appropriate for another.
Use this article as a starting point for your own research and conversations with qualified professionals. Always talk with your doctor or another trusted healthcare professional before making decisions that could affect your health, particularly if you take medications, are receiving treatment, have existing health conditions, are pregnant or have other circumstances that could affect what’s appropriate for you.
Reader Questions
A few questions to carry into the comments or your next conversation. Please leave out identifying or personal medical details.
- 01After reading this, what would you want a test result to actually help you decide?
- 02What does confirming low testosterone with repeat tests tell us that a symptom checklist cannot?
- 03What would you ask a clinician, lab, or qualified professional before letting a number change a health decision?
Extra Insights & Sources
For readers who want the details behind each claim above.
What We Know
- Sexual and reproductive changes are among the listed symptoms of testosterone deficiency, and in the European Male Aging Study only the three sexual symptoms clustered together as testosterone levels fell. Supported.
- Fatigue, mood and concentration symptoms are nonspecific. Established (AUA, Endocrine Society).
- Diagnosis requires symptoms or signs plus consistently low morning testosterone on at least two tests. Established (guidelines).
- In older men with confirmed low levels, a year of testosterone moderately improved sexual function and slightly improved mood, but not vitality or walking distance. Supported (randomized trial).
- In symptomatic men with confirmed low testosterone and heart disease or high heart risk, testosterone met TRAVERSE’s preset safety limit for its combined cardiovascular outcome over about three years; smaller differences remained possible and some other risks rose. Supported (randomized trial).
- Testosterone therapy can suppress sperm production and needs monitoring. Established.
What We Don’t Know
- Whether one man’s fatigue, weight change or low mood comes from testosterone, without testing and evaluation. Unknown from symptoms alone.
- A single “optimal” testosterone number for every age, assay and situation. Unsupported.
- The long-term balance of benefit and harm for the prostate, bones and other outcomes. Unresolved (Endocrine Society, 2026).
- Whether diagnosing or treating low testosterone in aging men extends lifespan. Unknown.
The symptom lists in detail
Endocrine Society patient page (dated January 24, 2022). The page describes male hypogonadism as “a combination of low testosterone levels and the presence of any of these symptoms”: drop in sex drive; erectile dysfunction and loss of spontaneous erections; lowered sperm count and infertility; breast enlargement or tenderness; reduced energy; reduced muscle mass; shrinkage of testes; increased irritability, inability to concentrate and depressed mood; and hot flashes when testosterone is very low. It adds: “Over time, low testosterone may cause a man to lose body hair, muscle bulk, cause weak bones (osteoporosis), low red blood cells and smaller testes.” It estimates that about 35% of men older than 45 and 30% to 50% of men with obesity or type 2 diabetes have hypogonadism, and says levels are “highest in the morning; lowest at night” and “can temporarily lower due to too much exercise, poor nutrition, severe illness, and with certain medications.”
AUA guideline. The Evaluation and Management of Testosterone Deficiency guideline (Mulhall and colleagues, Journal of Urology, 2018; the AUA lists it as reviewed, with its validity confirmed, in 2024) says symptoms associated with low testosterone are very nonspecific and can be signs of other conditions, such as chronic fatigue, chronic stress or depression. It lists changes in mood, decreased focus, decreased strength and physical function, loss of muscle mass, increased fat, especially fat around the abdominal organs (visceral fat), erectile dysfunction including absent nocturnal or early-morning erections, and decreased sex drive as symptoms that may come from chronic stress, chronic fatigue or depression rather than low testosterone. It describes fatigue, especially in the afternoon, as nonspecific.
European Male Aging Study (Wu and colleagues, New England Journal of Medicine, 2010). Researchers surveyed a random sample of 3,369 men aged 40 to 79 at eight European centers and measured morning total testosterone by mass spectrometry, a laboratory method for measuring hormones. Poor morning erection, low sexual desire, erectile dysfunction, inability to perform vigorous activity, depression and fatigue were significantly related to testosterone level, but only the three sexual symptoms showed a syndromic association with lower testosterone, meaning they clustered together as levels fell. The authors proposed defining late-onset hypogonadism as at least three sexual symptoms plus total testosterone below 11 nmol/L (3.2 ng/mL, or 320 ng/dL) and free testosterone below 220 pmol/L (64 pg/mL). (Note 3)
Testing in detail
AUA guideline statements (paraphrased). Statement 1: clinicians should use a total testosterone level below 300 ng/dL as a reasonable cutoff supporting a diagnosis of low testosterone (Moderate Recommendation; Grade B). Statement 2: the diagnosis should be made only after two total testosterone measurements, each taken early in the morning on a separate occasion (Strong Recommendation). Statement 3: the clinical diagnosis requires low total testosterone together with symptoms or signs. The guideline adds that if a first test is below 300 ng/dL and the second is normal, the clinician should use judgment about a third test; that there’s no definitive evidence on the ideal interval between tests; and that it doesn’t recommend that clinicians insist on fasting before testing. The variability figures need care: in the underlying Brambilla study, 65% to 153% were the 95% confidence limits for a man’s estimated stable mean testosterone, expressed as percentages of one measured result. They were not a 65% to 153% rise between tests. Averaging two or three results narrowed that uncertainty interval by about 30% or 43%, respectively. Those estimates depend on the study’s sampling and assays; they are not personal thresholds for an acceptable fluctuation. In the cited study of young men with acute respiratory infections, mean total testosterone declined 10%, with some groups seeing reductions of up to 30%. The AUA also recommends measuring luteinizing hormone in men with low testosterone (Strong Recommendation; Grade A) and prolactin when LH is low or low-normal.
Here the AUA’s Grade A means high confidence in the supporting evidence; Grade B means moderate confidence. Strong and Moderate Recommendation describe the panel’s judgment that net benefit or harm is substantial or moderate, respectively; they are separate from evidence certainty.
Endocrine Society 2018 guideline (Bhasin and colleagues, Journal of Clinical Endocrinology & Metabolism). The guideline recommends diagnosing hypogonadism only in men who have symptoms and signs consistent with testosterone deficiency and whose blood testosterone is clearly and consistently low, measuring fasting morning total testosterone with an accurate assay and repeating it to confirm, and obtaining free testosterone by equilibrium dialysis (a laboratory method that separates unbound hormone) or an accurate formula when total testosterone is near the lower limit of normal or SHBG is altered. It recommends against routine screening of men in the general population and recommends measuring LH and FSH to distinguish primary from secondary hypogonadism. (Note 4)
Endocrine Society statement (July 16, 2026). The statement calls for “at least two early-morning, fasting testosterone tests (common clinical threshold near 300 ng/dL),” says the approach “is the same for a man of any age,” and describes testing as “often inaccurate,” because non-standardized assays can read the same sample as low or normal depending on the lab and method, which “drives both over- and under-diagnosis.” It recommends assays certified by the CDC HoSt program.
CDC Hormone Standardization (HoSt) Program. Certified testosterone assays must differ on average by no more than ±6.4% from the CDC reference method across concentrations of 2.50 to 1,000 ng/dL. ng/dL means nanograms per deciliter, a unit of concentration. Certification requires four consecutive passing quarters and is valid for one year. The certified-assay list was last updated in April 2026 (archived copy of July 25, 2026).
| Part of the diagnosis | What it answers | What it can’t answer alone |
|---|---|---|
| Symptoms and signs | Is there a compatible clinical pattern? | Whether testosterone is actually low |
| Two morning total-testosterone tests | Is the low result consistent rather than isolated? | Why the level is low |
| Free testosterone in selected cases | Could altered binding proteins be distorting total testosterone? | The whole diagnosis without symptoms and context |
| LH and FSH | Does the problem start in the testes or the pituitary and hypothalamus? | The specific cause in every case |
| Further evaluation (prolactin, iron studies, pituitary imaging) | Could pituitary disease, iron overload or another condition be involved? | A universal panel for every patient |
Reference ranges in detail
Travison and colleagues (Journal of Clinical Endocrinology & Metabolism, 2017) measured testosterone in 100 men from each of four cohorts (Framingham Heart Study, European Male Aging Study, Osteoporotic Fractures in Men Study and the Male Sibling Study of Osteoporosis; 9,054 men in total) against the CDC reference method and adjusted the results onto the same measurement scale. In healthy non-obese men aged 19 to 39, the 2.5th, 5th, 50th, 95th and 97.5th percentiles were 264, 303, 531, 852 and 916 ng/dL. A percentile gives the share of that reference group below a value: for example, half had levels below the 50th-percentile value of 531 ng/dL. These are population reference values, not individual treatment targets. The authors concluded that much of the variation in testosterone levels between cohorts came from differences between assays. The Endocrine Society’s 2018 guideline slides cite this harmonized range. (Note 5)
The Testosterone Trials in detail
Snyder and colleagues (New England Journal of Medicine, 2016) enrolled 790 men aged 65 or older whose serum testosterone averaged less than 275 ng/dL and who had symptoms suggesting low testosterone. Each man joined one or more of three trials (Sexual Function, Physical Function and Vitality) and used testosterone gel (AndroGel 1%) or placebo for one year. Testosterone raised levels to the mid-normal range for men aged 19 to 40 and significantly increased sexual activity, sexual desire and erectile function. The share of men whose 6-minute walking distance rose by at least 50 meters didn’t differ significantly in the Physical Function Trial, but did when all participants were included (20.5% versus 12.6%). There was no significant benefit for vitality on the fatigue scale. The authors concluded that testosterone moderately benefited sexual function and somewhat benefited mood and depressive symptoms, with no benefit for vitality or walking distance. They added that the trials had too few participants to draw conclusions about the risks of testosterone treatment. The results apply only to men 65 or older with testosterone that averaged below 275 ng/dL, which the authors called an intentional limitation. The Endocrine Society’s 2018 guideline advises against routinely prescribing testosterone to all men 65 or older with low levels, while offering it individually to those with symptoms such as low libido or unexplained anemia and consistently low morning levels.
TRAVERSE and the FDA timeline in detail
TRAVERSE (Lincoff and colleagues, New England Journal of Medicine, 2023) was conducted at several centers, with men randomly assigned to testosterone or inactive gel. Neither the men nor investigators knew which gel they received. Its noninferiority design required the upper confidence limit for the hazard ratio to stay below 1.5, ruling out a 50% or greater relative increase in the rate of the combined primary outcome rather than proving identical safety. It enrolled 5,246 men aged 45 to 80 who had existing cardiovascular disease or a high risk of it, reported symptoms of hypogonadism and had two fasting testosterone levels below 300 ng/dL. Men used daily 1.62% testosterone gel, dose-adjusted to keep levels between 350 and 750 ng/dL, or placebo gel. Mean treatment lasted 21.7 months and mean follow-up 33.0 months. The primary outcome (cardiovascular death, nonfatal heart attack or nonfatal stroke) occurred in 182 men (7.0%) on testosterone and 190 (7.3%) on placebo (hazard ratio 0.96; 95% CI 0.78 to 1.17; noninferiority met). A hazard ratio compares rates over time, with 1.0 meaning no difference; the confidence interval (CI) expresses statistical uncertainty. Meeting this trial margin does not exclude smaller differences or other risks. Atrial fibrillation, sudden kidney injury and pulmonary embolism (blood clots in the lungs) were more frequent with testosterone. The Endocrine Society’s 2026 statement summarizes the TRAVERSE trials as showing “roughly a 50% relative increase in pulmonary embolism and an increased incidence of bone fractures among testosterone-treated men.”
FDA, February 28, 2025. The FDA told makers to add TRAVERSE results to all testosterone labels, retain “Limitation of Use” language for age-related hypogonadism and remove boxed-warning language about increased cardiovascular risk. Based on studies measuring blood pressure during everyday activities, which “confirmed an increase in blood pressure with use of all testosterone products, class-wide,” it required blood-pressure information or a new warning on every product.
FDA, April 16, 2026. The FDA encouraged makers of approved testosterone products to contact it about a potential new indication for low libido in men with idiopathic hypogonadism (low testosterone without a known cause), following a December 2025 expert panel. It said any approval would still require “substantial evidence of effectiveness.”
HHS and FDA, June 18, 2026. The FDA requested label updates to remove the limitation of use stating that safety and effectiveness in men with age-related hypogonadism “have not been established”; to make testosterone contraindicated only in men with metastatic prostate cancer; and to revise warnings about noncancerous prostate enlargement (benign prostatic hyperplasia), since available trial data “do not demonstrate worsening symptoms in men with mild to moderate benign prostatic hyperplasia.” The announcement adds that “important uncertainties remain because prostate cancer can take years to develop,” and that the proposed labeling still recommends assessing risk, screening before treatment and monitoring during therapy. The FDA’s testosterone information page (content current as of June 23, 2026) describes TRAVERSE as conducted by “an industry consortium led by manufacturers of AndroGel and Androderm.”
Sources
- Endocrine Society: Hypogonadism in Men (patient page, January 24, 2022)
- Endocrine Society: Statement on Testosterone Replacement Therapy (July 16, 2026)
- Endocrine Society: Testosterone Therapy for Hypogonadism Guideline Resources
- Bhasin S, et al. Testosterone Therapy in Men With Hypogonadism, Journal of Clinical Endocrinology & Metabolism, 2018: PubMed 29562364
- American Urological Association: Testosterone Deficiency Guideline and unabridged guideline PDF (Mulhall JP, et al., Journal of Urology, 2018; validity confirmed 2024)
- Wu FC, et al. European Male Aging Study, New England Journal of Medicine, 2010: PubMed 20554979
- Snyder PJ, et al. Testosterone Trials, New England Journal of Medicine, 2016: PubMed 26886521
- Lincoff AM, et al. TRAVERSE, New England Journal of Medicine, 2023: PubMed 37326322
- Travison TG, et al. Harmonized reference ranges for testosterone, Journal of Clinical Endocrinology & Metabolism, 2017: PubMed 28324103
- US Food and Drug Administration: FDA issues class-wide labeling changes for testosterone products (February 28, 2025)
- US Food and Drug Administration: FDA Takes Step Forward on Testosterone Therapy for Men (April 16, 2026)
- US Department of Health and Human Services: HHS Announces Requested Updates to Testosterone Therapy Product Labels (June 18, 2026)
- US Food and Drug Administration: Testosterone Information (content current as of June 23, 2026)
- Centers for Disease Control and Prevention: Hormones Certified Assays and Participants
Notes
Note 1: Funded by the National Institutes of Health and others. AbbVie, one of the funders, donated the testosterone and placebo gels; the paper says it did not take part in the design, conduct, analysis or reporting of the trials.
Note 2: Funded by AbbVie and others, according to the paper. The FDA describes the trial as FDA-required and conducted by an industry consortium led by the manufacturers of AndroGel and Androderm.
Note 3: The PubMed record for this study doesn’t list its funding.
Note 4: Guideline data in this article comes from published summaries, not the full journal report: the guideline’s PubMed abstract, and the Endocrine Society’s own guideline-resources page and 2018 guideline slides.
Note 5: Supported primarily by the National Institutes of Health, with additional support from the Endocrine Society and a National Institute on Aging center grant. Three authors reported research grants from or consulting for drug companies, including AbbVie; the others reported nothing to disclose.
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