Written by Keen Meds  ·  Reviewed by Licensed Clinical Providers  ·  March 1, 2026

Key Insight: The 2018 Endocrine Society Clinical Practice Guidelines recommend testosterone therapy for men with classic hypogonadism and sexual dysfunction, fatigue, or low bone density caused by confirmed testosterone deficiency -- with the goal of symptom improvement, not achieving a specific testosterone number.

When someone describes testosterone replacement therapy as "evidence-based," they mean it is supported by clinical practice guidelines developed by medical organizations that systematically review scientific evidence and translate it into treatment recommendations. Understanding what these guidelines say -- and what they leave to clinical judgment -- helps patients participate more meaningfully in treatment decisions and evaluate whether the care they are receiving aligns with the current evidence base. This article explains the major guideline frameworks for TRT, what they agree on, where they differ, and what the guideline-recommended approach to testosterone therapy evaluation and treatment looks like in practice.

The Major Guideline-Issuing Bodies

Clinical practice guidelines for testosterone therapy have been published by several major endocrinology and urology organizations. The most referenced are:

The Endocrine Society (United States), which published its most recent Clinical Practice Guideline on testosterone therapy in the Journal of Clinical Endocrinology and Metabolism (JCEM) in 2018. This is the most cited guideline in North American clinical practice and sets the standard threshold-based framework most providers follow.

The European Academy of Andrology (EAA), in collaboration with the European Society of Endocrinology (ESE), published updated recommendations in 2020 in the journal Andrology (Corona et al.). This document includes specific attention to the diagnosis and management of age-related or late-onset hypogonadism.

The British Society for Sexual Medicine (BSSM) published updated testosterone therapy guidelines in 2023, authored by Hackett and colleagues in the World Journal of Men's Health (WJMH). The BSSM 2023 guidelines are notable for specifically incorporating findings from the TRAVERSE trial and providing updated cardiovascular safety guidance.

The International Consultation on Sexual Medicine (ICSM) published the most recent international guidance in 2024 in Sexual Medicine Reviews (Khera et al.). This is the most current major guideline document as of 2026 and incorporates the full body of evidence including TRAVERSE sub-studies.

Understanding how these bodies approach the same clinical question -- who should receive TRT, when, and how -- helps clarify the areas of strong consensus versus areas requiring individualized clinical judgment.

What the Endocrine Society 2018 Guidelines Recommend

The Endocrine Society 2018 guidelines are built around a two-part diagnostic requirement: confirmed biochemical testosterone deficiency plus consistent symptoms.

Biochemical deficiency is defined as total testosterone below the normal reference range, established on two separate morning fasting blood draws using a reliable assay. The guideline specifies that liquid chromatography-tandem mass spectrometry (LC-MS/MS) is the most accurate measurement method, though immunoassay is acceptable in most clinical settings. If SHBG abnormality is suspected or symptoms and total testosterone do not align, free or bioavailable testosterone should be measured.

The guideline's recommended indication for TRT is classic hypogonadism -- meaning hypogonadism caused by known pathology of the hypothalamus, pituitary, or testes. It is most definitive about TRT for men with sexual dysfunction (reduced libido, erectile dysfunction), fatigue and reduced energy, and low bone mineral density or osteoporosis in the context of confirmed testosterone deficiency.

The guideline is more cautious about age-related testosterone decline without a clear pathological cause -- sometimes called "functional" or "late-onset" hypogonadism. It does not recommend universal TRT for aging men with low-normal testosterone, and it emphasizes individualized assessment.

Key monitoring recommendations include: testosterone level check at 3 months after starting treatment to confirm therapeutic range achievement; PSA measurement at 3 and 12 months; hematocrit at 3 and 12 months; and ongoing periodic review of all parameters. Target testosterone range is mid-physiological: approximately 400 to 700 ng/dL.

What the EAA 2020 Guidelines Add

The EAA 2020 guidelines (Corona et al.) cover similar ground to the Endocrine Society framework but add specificity on age-related hypogonadism. They introduce the concept of the "healthy aging male" as a specific diagnostic consideration -- a man whose testosterone decline is part of normal aging but who also has concurrent conditions (obesity, sleep apnea, metabolic syndrome) that accelerate and exacerbate that decline beyond the typical trajectory.

The EAA emphasizes the importance of free testosterone in borderline cases and provides specific guidance on SHBG interpretation. They note that the clinical decision to treat should be made not on a single threshold but on the balance of biochemical evidence, symptom burden, and individual risk-benefit analysis.

The EAA 2020 document also specifically addresses the fertility implications of TRT, providing guidance on the alternatives (hCG, clomiphene) for men who wish to preserve spermatogenesis. This guidance is particularly relevant for younger men in whom fertility remains a consideration.

The BSSM 2023 Update: Post-TRAVERSE Guidance

The BSSM 2023 guidelines are notable because they were published after the TRAVERSE trial results became available in late 2023 and explicitly incorporate those findings into their recommendations.

On cardiovascular safety, the BSSM 2023 document states that TRT does not significantly increase the risk of major adverse cardiovascular events in appropriately selected men with confirmed hypogonadism, citing TRAVERSE. This represents a meaningful update from prior editions that expressed more caution in men with cardiovascular risk factors.

The BSSM 2023 guidelines support TRT for sexual dysfunction as the best-documented primary indication, consistent with the Endocrine Society framework. They also provide specific guidance on monitoring frequency, dose adjustment principles, and managing common side effects including polycythemia and estradiol elevation.

The ICSM 2024: Most Current International Guidance

The ICSM 2024 guidelines (Khera et al.) are the most current major international document and incorporate all evidence available through the end of 2023, including TRAVERSE sub-studies on depression, sexual function, and bone density.

The ICSM 2024 reinforces the consistent theme across all guidelines: TRT should be offered to men with both confirmed biochemical testosterone deficiency and symptoms attributable to that deficiency. It emphasizes that the goal of treatment is symptom improvement and maintenance of physiological testosterone levels, not optimization of testosterone numbers for their own sake.

The ICSM 2024 document also addresses the practical question of which formulation to use, acknowledging that different delivery methods have different pharmacokinetic profiles, monitoring needs, and patient preferences, and that formulation choice should be individualized.

Where All Guidelines Agree

Despite their differences in emphasis and publication date, all four major guideline frameworks agree on the following core principles:

Diagnosis requires two confirmed morning fasting testosterone measurements below the reference range, combined with consistent symptoms.

Sexual dysfunction is the best-documented and most consistently supported indication for TRT in confirmed hypogonadal men.

Bone density improvement is a documented and guideline-supported indication in men with hypogonadism and osteoporosis or fracture history.

Monitoring must include testosterone level, PSA, and hematocrit at 3 months and then periodically thereafter.

TRT is contraindicated in men with active or metastatic prostate cancer and in men with hematocrit above 54%.

The goal of therapy is symptom improvement and maintenance of mid-physiological testosterone levels -- not maximizing testosterone numbers.

Where Guidelines Differ: Areas of Clinical Judgment

No guideline consensus exists on the precise threshold for treating men with low-normal testosterone (300 to 400 ng/dL) who have mild to moderate symptoms. Different organizations take slightly different positions, and clinical judgment is explicitly required.

The role of TRT in metabolic disease prevention -- inspired by trials like T4DM -- is not yet reflected in most guidelines, which were written before that evidence was fully synthesized.

The role of TRT in treating age-related hypogonadism without a discrete pathological cause remains a contested area where guidelines express more caution than practicing clinicians often apply.

Frequently Asked Questions

Do I need a specific diagnosis to be considered for TRT?
You need two things: biochemical confirmation of testosterone deficiency (two morning fasting total testosterone measurements below the normal range, or confirmed low free testosterone with SHBG elevation), and consistent symptoms that clinical guidelines recognize as attributable to testosterone deficiency. The specific cause of the deficiency (primary vs. secondary hypogonadism, classical vs. late-onset) affects which treatment options are most appropriate but does not change the basic diagnostic requirement.

What symptoms do clinical guidelines recognize as valid indications for TRT evaluation?
The Endocrine Society lists: reduced sexual desire and activity, decreased spontaneous erections, breast discomfort or gynecomastia, reduced testicular size, reduced fertility, height loss or low trauma fracture, hot flashes, decreased energy and vitality, depressed mood, poor concentration, sleep disturbance, and reduced muscle and increased fat. These symptoms are not all unique to testosterone deficiency, which is why biochemical confirmation is required alongside them.

Why do guidelines recommend aiming for mid-physiological testosterone, not the maximum?
Supraphysiological testosterone levels (above the physiological range) are associated with higher rates of polycythemia, potential cardiovascular stress, and unnecessary side effect burden without additional benefit. The clinical target is restoration of normal physiological function, not enhancement beyond normal. Mid-physiological range (400 to 700 ng/dL) achieves the therapeutic goals without the risks of excess.

Are the guidelines the same as what a specific provider might recommend?
Guidelines are the evidence-based framework; clinical practice is the individualized application of that framework. A provider may appropriately treat a man at 310 ng/dL with prominent symptoms, or may appropriately monitor without treatment a man at 280 ng/dL with mild or no symptoms. Clinical judgment within the guideline framework is expected and appropriate. The guidelines inform, but do not replace, individualized assessment.


What This Means for Your Treatment Decisions

Understanding the guideline framework for TRT helps you evaluate whether your evaluation process aligns with current evidence. Two morning fasting tests, a symptom assessment, LH and FSH, SHBG and free testosterone, baseline hematocrit, and PSA are the building blocks of a complete guideline-consistent workup.

Keen Meds connects you with licensed clinical providers for a telehealth evaluation and lab review. If your testosterone is clinically low, you may qualify for Testosterone Spray Rx.

Learn about the Keen Testosterone Spray Program →