Testosterone course · Evidence base
Guidelines & Evidence Watch
What is current, what is pending, and what would actually change your prescribing if it lands. Every entry names the practice implication, not just the citation.
Sources verified August 2026. Reviewed quarterly.
Current guidance
- AUA 2018 / 2024Source
Evaluation and Management of Testosterone Deficiency: AUA Guideline (Mulhall JP, Trost LW, Brannigan RE, et al.) — published 2018, reviewed and validity confirmed 2024.
Current — validity reconfirmed 2024, no amendment issued since.
- Endocrine Society 2018Source
Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline (Bhasin S, et al., J Clin Endocrinol Metab. 2018;103(5):1715–1744).
Still the operative guideline. Reaffirmed by the Society's July 2026 statement on testosterone replacement therapy; a formal revision has not been published.
- Endocrine Society 2026 statementSource
Endocrine Society. Statement on Testosterone Replacement Therapy (July 2026) — reaffirms symptom-plus-confirmed-low-level diagnosis at any age, discourages the terms 'age-related', 'late-onset', and 'functional' hypogonadism, and states there is insufficient evidence for population-level screening of asymptomatic men.
Most recent society position statement.
- TRAVERSE 2023Source
Lincoff AM, Bhasin S, Flevaris P, et al. Cardiovascular Safety of Testosterone-Replacement Therapy. N Engl J Med. 2023;389(2):107–117. Noninferior for MACE in 5,246 men with, or at high risk of, cardiovascular disease; excess atrial fibrillation, acute kidney injury, and pulmonary embolism observed.
Defining cardiovascular safety trial; basis of the 2025 FDA labeling revision.
- TRAVERSE fracture substudy 2024Source
Snyder PJ, Bhasin S, Cunningham GR, et al. Testosterone Treatment and Fractures in Men with Hypogonadism. N Engl J Med. 2024;390(3):203–211. Clinical fracture incidence was higher, not lower, with testosterone — bone density gains did not translate into fracture reduction.
Counsel accordingly: do not prescribe testosterone for fracture prevention.
- FDA 2025 labelingSource
FDA class-wide labeling change for all testosterone products (February 2025): the boxed-context cardiovascular warning language was revised in light of TRAVERSE, a warning regarding blood-pressure increases was added, and the indication remains limited to classical hypogonadism due to established disease.
Current labeling standard for all marketed testosterone products.
- T4DM 2021Source
Wittert G, Bracken K, Robledo KP, et al. Testosterone treatment to prevent or revert type 2 diabetes in men enrolled in a lifestyle programme (T4DM). Lancet Diabetes Endocrinol. 2021;9(1):32–45.
Supports the lifestyle-first framing; testosterone is not a diabetes therapy.
- TTrialsSource
Snyder PJ, et al. The Testosterone Trials — a coordinated set of seven placebo-controlled trials in 790 men aged 65+ addressing sexual function, physical function, vitality, cognition, anemia, bone, and coronary plaque.
Historical benchmark for realistic benefit expectations in older men.
Pending reviews, trials, and regulatory action
None of the items below change practice today. They are listed so you know what is coming and can recognize it when it publishes.
- Guideline review
Endocrine Society clinical practice guideline revision
The 2018 guideline is past the Society's usual revision interval. The July 2026 statement reaffirmed the existing recommendations rather than replacing them, and signals where a revision would land: diagnosis anchored to symptoms plus confirmed low measured levels, retirement of 'age-related' and 'functional' hypogonadism as operational categories, and continued opposition to screening asymptomatic men.
Open sourceWhat would changeIf revised, expect tighter language on telehealth and direct-to-consumer prescribing and on treating men whose only abnormality is a single low level.
- Guideline review
AUA testosterone deficiency guideline — next validity review
AUA confirmed the validity of the 2018 guideline in 2024 without amendment. AUA guidelines are re-reviewed on a rolling basis, so the next look is expected in the 2027 cycle. The most likely amendments are the post-TRAVERSE cardiovascular counseling language and the 300 ng/dL diagnostic threshold.
Open sourceWhat would changeWatch for whether AUA moves off the flat 300 ng/dL cut point toward an assay- and SHBG-aware threshold.
- Trial or analysis
TRAVERSE secondary and subgroup analyses
The parent trial continues to generate prespecified secondary papers — atrial fibrillation, pulmonary embolism, acute kidney injury, prostate safety, diabetes progression, sexual function, and anemia. Each addresses one of the signals that the primary MACE result did not resolve.
Open sourceWhat would changeThe atrial fibrillation and pulmonary embolism analyses are the ones most likely to change how you counsel a man with paroxysmal AF or prior VTE.
- RegulatoryDocket FDA-2025-N-6743
FDA review of a potential low-libido indication
In April 2026 the FDA published a Federal Register notice stating it had reviewed published literature that appears promising regarding testosterone replacement therapy for men with decreased libido associated with idiopathic hypogonadism, and encouraged application holders to pursue the indication.
Open sourceWhat would changeNothing changes today — no product carries this indication. If an application succeeds, low libido would move from an off-label rationale to a labeled one, which will change payer and documentation expectations.
- Regulatory
Enclomiphene citrate — still unapproved, still compounded
Two Phase 3 registrational trials (ZA-301, ZA-302) met their testosterone-normalization endpoints while preserving spermatogenesis, but the FDA issued Complete Response Letters in 2015–2016 and no approval has followed. As of 2026 there is no approved product and no publicly disclosed active IND for resubmission; all clinical use is compounded under FDCA 503A/503B. The FDA's stated open question is venous thromboembolism risk.
What would changeEnclomiphene has no FDA-approved label, no standardized potency, and no approved dosing. Counsel it as compounded and unapproved, document the discussion, and do not present it as an equivalent alternative to approved therapy.
- Trial or analysis
Kisspeptin and GnRH-pathway agents
Early-phase work is testing kisspeptin analogues to restore pulsatile GnRH signaling in secondary hypogonadism without exogenous testosterone. Phase 1/2 stage only; no efficacy data adequate for practice.
What would changeNothing to act on. Relevant only for anticipating the fertility-preserving pipeline over the next five years.
- Trial or analysis
GLP-1 receptor agonists and functional testosterone recovery
Weight loss of 10–15% raises endogenous testosterone in men with obesity-associated secondary hypogonadism, and analyses of semaglutide and tirzepatide cohorts examining testosterone and sexual-function endpoints are accumulating. This is currently observational and secondary-endpoint evidence, not a licensed use.
What would changeStrengthens the case for treating obesity first in the man with obesity-associated low testosterone and a normal LH, before committing him to lifelong therapy.