
Testosterone deficiency: FAQs from the AUA guideline
Key Takeaways
- Policy and labeling shifts include DoD screening/optional TRT access and FDA updates removing age-related limitations and revising prostate/BPH language, after the boxed CV warning was removed post-TRAVERSE.
- Diagnostic confirmation requires symptoms/signs plus two early-morning total testosterone values, using <300 ng/dL as a reasonable cutoff; neither symptoms alone nor a single low value is sufficient.
A reference on the key recommendations from the AUA Testosterone Deficiency guideline.
Testosterone deficiency has become a subject of national discussion in recent months. In July 2026, the US Department of Defense (DoD) announced it would begin annual testosterone deficiency screening for active-duty service members 30 years and older, with voluntary testing available to younger troops and testosterone replacement therapy (TRT) offered to those who screen positive and choose treatment.1
The DoD initiative arrives alongside an evolving regulatory landscape for testosterone products. In June 2026, the FDA requested additional label revisions for TRT products, including removing the longstanding limitation of use in men with age-related hypogonadism and updating prostate cancer– and benign prostatic hyperplasia–related language,2 building on 2025 changes that removed the boxed cardiovascular warning following the TRAVERSE trial (NCT03518034).
These announcements have renewed attention on how testosterone deficiency should be diagnosed and managed. Urology Times® recently spoke with Janelle Bunce, PA-C, a urology physician assistant at Advanced Urology Institute, about the American Urological Association (AUA)’s guideline for testosterone deficiency3 amidst these updates.
“One of the biggest messages with the AUA guidelines is that testosterone deficiency is both a clinical diagnosis but also a biochemical diagnosis,” Bunce emphasized. “I tell my patients that I'm not treating lab numbers; I'm treating you, and I want to make sure that we have an understanding of what [your] goals are.”
The following FAQ walks through the AUA guideline’s core recommendations surrounding diagnosis, adjunctive testing, counseling, treatment, and follow-up.
1. What threshold and testing protocol does the AUA recommend for diagnosing testosterone deficiency?
The guideline recommends using a total testosterone level below 300 ng/dL as a reasonable cut-off in support of a diagnosis of low testosterone. That diagnosis should be made only after 2 total testosterone measurements taken on separate occasions, with both conducted in the early morning.
2. Is a single low testosterone reading enough to make the diagnosis?
No. Per the guideline, the clinical diagnosis of testosterone deficiency is made only when patients have low total testosterone levels combined with symptoms and/or signs—biochemistry alone, or symptoms alone, are not sufficient.
“If we're going to replace testosterone, we don't want to forget to ask the question, why are they feeling this way?” Bunce explained. “Sometimes treating those underlying conditions is actually the answer, and not necessarily replacing their testosterone.”
3. Which patients should be considered for testosterone testing, and are symptom questionnaires recommended?
Clinicians should consider measuring total testosterone in patients with a history of unexplained anemia, bone density loss, diabetes, exposure to chemotherapy, exposure to testicular radiation, HIV/AIDS, chronic narcotic use, male infertility, pituitary dysfunction, and chronic corticosteroid use, even in the absence of symptoms or signs of testosterone deficiency. The guideline does not currently recommend the use of validated questionnaires to determine candidacy for testosterone therapy or to monitor symptom response during treatment.
4. What adjunctive testing should follow a confirmed low testosterone level?
In patients with low testosterone, the guideline recommends measuring serum luteinizing hormone (LH). Serum prolactin should be measured in patients with low testosterone combined with low or low/normal LH, and patients with persistently elevated prolactin of unknown etiology should be evaluated for endocrine disorders. Serum estradiol should be measured in testosterone-deficient patients who present with breast symptoms or gynecomastia before starting therapy.
5. What baseline evaluations are needed before starting testosterone therapy?
Before offering testosterone therapy, clinicians should measure hemoglobin and hematocrit and counsel patients on the increased risk of polycythemia. Prostate-specific antigen (PSA) should be measured in men over 40 years of age before starting therapy to help exclude a prostate cancer diagnosis. Men with testosterone deficiency who are interested in fertility should undergo a reproductive health evaluation prior to treatment.
“I ask all men when we're considering replacement therapy: Do you think you want kids in the future? And if they pause, or if the answer is ‘yes,’ then that's going to completely change my conversation,” Bunce added.
6. What should patients be told about testosterone therapy and prostate cancer risk?
The guideline directs clinicians to inform patients of the absence of evidence linking testosterone therapy to the development of prostate cancer. For patients with testosterone deficiency and a history of prostate cancer, the guideline notes there is inadequate evidence to quantify the risk-benefit ratio of therapy, so this conversation should be individualized.
“It doesn't cause cancer, but it certainly could fuel it. And if we see that change in the PSA, then we sometimes actually can detect cancer earlier,” Bunce noted.
7. What role do lifestyle modifications play in managing testosterone deficiency?
All men with testosterone deficiency should be counseled regarding lifestyle modifications as a treatment strategy, per the guideline.
“I think that we do our patients a disservice [if they] come in [to be] evaluated—maybe they're obese, maybe they have poor sleep habits—and they leave our practice and we tell them just go home, lose weight, and get in the gym and start lifting weight. I think that that's really a lousy way to approach this,” Bunce noted. “But I think that if we explain to them that obesity affects testosterone levels, it affects estradiol levels, a lot of our patients look at their habits [and understand that] all of these things contribute to low testosterone levels, but also a lot of the symptoms that they're describing. If we can improve their overall health and work on some of these lifestyle changes, then ultimately, they're going to feel better.”
8. How should testosterone therapy be dosed and what formulations should be avoided?
Clinicians should adjust dosing to achieve a total testosterone level in the middle tertile of the normal reference range. Alkylated oral testosterone should not be prescribed, and commercially manufactured testosterone products should be used rather than compounded testosterone when possible. Clinicians should discuss the risk of transference with patients using testosterone gels or creams.
9. How can fertility be preserved in men who need testosterone support but want to conceive?
Exogenous testosterone therapy should not be prescribed to men who are currently trying to conceive, and the long-term impact of exogenous testosterone on spermatogenesis should be discussed with patients interested in future fertility. The guideline notes clinicians may use aromatase inhibitors, human chorionic gonadotropin, selective estrogen receptor modulators, or a combination of these in men with testosterone deficiency who wish to maintain fertility.
10. What does appropriate monitoring look like once therapy begins?
Clinicians should measure an initial follow-up total testosterone level after an appropriate interval to confirm target levels have been achieved, and testosterone should be checked every 6 to 12 months while patients remain on therapy.
11. When should testosterone therapy be discontinued?
The guideline advises that clinicians discuss cessation of therapy 3 to 6 months after initiation in patients who achieve normalization of total testosterone levels but do not experience symptom or sign improvement.
Bunce explained, “An important takeaway on this aspect is if you see a guy anywhere from 3 to 6 months [after starting therapy], and they don't feel better, I would stop the therapy because the question is why? Did I miss an underlying diagnosis? Is there something else going on with their health in general? If we're going to look at thoughtful prescribing, then we have to look at the patient as a whole and not just treat the numbers.”
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