Currentmedical mutual - ohioPolicy AHS - G2013 - Testosterone

Testosterone — Coverage Criteria for Laboratory Testing

Defines when measurement of serum total, free, bioavailable testosterone and related hormones (SHBG, albumin, estradiol, dihydrotestosterone) meet coverage criteria or do not meet coverage for members of Medical Mutual - Ohio.

Policy Summary

Payermedical mutual - ohio

PolicyTestosterone — Coverage Criteria for Laboratory Testing

Policy CodePolicy AHS - G2013 - Testosterone

Change TypeAdministrative review — no material coverage changes

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionObtain two separate morning total testosterone measurements (fasting) to confirm diagnosis before ordering free or bioavailable testosterone.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

10+coverage statements

±6.4%CDC HoSt acceptance

2confirmatory TT measurements

every 2–3 momonitoring frequency (first year)

~62references

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Equilibrium dialysis

gold standard free T

Coverage Criteria for Testosterone and Related Hormone Testing

inv-01: Covered indications for testosterone-related testing

Covered when ANY of the following indications are met:

Covered indications for serum total testosterone: 1) Measurement of serum total testosterone for: a) symptoms of androgen deficiency or androgen excess in males (initial screening requires two measurements at least 24 hours apart; if initial screening is normal but symptoms persist, repeat testing no sooner than 60 days after initial screening); b) monitoring treatment response in men taking enzyme inhibitors for prostate cancer; c) men receiving testosterone replacement therapy (every 2–3 months for the first year after initiation or after dose change; annually thereafter); d) gender-dysphoric/gender-incongruent persons (baseline, during treatment, and for therapy monitoring); e) symptomatic females being evaluated for androgen excess (e.g., PCOS, functional hypothalamic amenorrhea). 2) For males with total testosterone confirmed as low or borderline and who have hypogonadism, gynecomastia, or other testicular hypofunction: annual measurement of serum free testosterone, SHBG, and/or albumin. 3) For individuals suspected to have disorders that alter SHBG: measurement of serum free testosterone using a medically accepted algorithm based on total testosterone, SHBG, and albumin, or measurement of bioavailable testosterone. 4) Prior to initiating testosterone therapy for males with gynecomastia: one-time (lifetime) serum estradiol measurement. 5) For individuals with ambiguous genitalia, hypospadias, or microphallus: measurement of serum dihydrotestosterone for evaluation of 5-alpha reductase deficiency.

Follow specimen timing and assay guidance in Notes.

inv-02: Not medically necessary / Not covered

Not covered in these explicit situations:

Not covered tests: 1) Measurement of serum free testosterone and/or bioavailable testosterone as a primary test without prior serum total testosterone measurement DOES NOT MEET COVERAGE CRITERIA. 2) Testing in asymptomatic individuals or individuals with non-specific symptoms: measurement of total, free, and/or bioavailable testosterone DOES NOT MEET COVERAGE CRITERIA. 3) Measurement of serum testosterone to identify androgen deficiency in women DOES NOT MEET COVERAGE CRITERIA. 4) Use of saliva for testosterone measurement DOES NOT MEET COVERAGE CRITERIA. 5) Measurement of serum dihydrotestosterone in situations not specified above DOES NOT MEET COVERAGE CRITERIA.

Lack of sufficient published scientific literature supports exclusion.

Additional rationale: Routine population screening for hypogonadism and use of structured questionnaires for universal screening are not recommended by guideline bodies and therefore not covered when applied as population screening tools.

inv-03: Initial Diagnostic Criteria for Male Hypogonadism

Diagnosis of male hypogonadism: Covered when ALL of the following are met

Clinical and confirmatory laboratory criteria: Presence of clinical signs or symptoms consistent with testosterone deficiency AND at least two total testosterone measurements obtained on separate mornings (fasting) with unequivocally low values.two separate morning TT measurements

Guideline bodies (EAA, ES, AUA) recommend two morning measurements; assay variability should be considered.

Adjunct endocrine testing to determine etiology: Measure luteinizing hormone (LH) to distinguish primary from secondary hypogonadism; if LH is low or low–normal, measure prolactin; consider SHBG and albumin to calculate or measure free testosterone when total testosterone is borderline or conditions altering SHBG are present.as indicated

Recommended by Endocrine Society and AUA to distinguish causes and guide additional testing.

inv-04: Monitoring Criteria During Testosterone Therapy

Monitoring during testosterone therapy: Covered when ALL of the following are performed

Baseline and early monitoring: Obtain baseline total testosterone and hematocrit prior to initiating therapy; recheck total testosterone and hematocrit at 3–6 months after initiation or dosage change, then annually thereafter if stable.baseline and 3–6 months

Endocrine Society recommends baseline and 3–6 month checks; annual thereafter.

PSA and modality-specific monitoring: Monitor prostate-specific antigen (PSA) in men over 40 as clinically indicated; for transgender/gender-affirming regimens measure testosterone at baseline and every 3 months until in physiologic male range, then every 6–12 months; for parenteral preparations measure mid-interval (or peak/trough per agent) and for transdermal measure ≥1 week after initiation at least 2 hours post-application.every 3 months initially for gender-affirming care

Follow specific agent timing guidance (Hembree et al., ES).

inv-05: PCOS / Hyperandrogenism Testing

Evaluation of hyperandrogenism in people with ovaries (e.g., PCOS): Covered when ALL of the following are met

Diagnostic approach for PCOS: Diagnosis based on two of three criteria (androgen excess, ovulatory dysfunction, polycystic ovaries). If two clinical criteria are present, biochemical testing for androgen excess is not required. When biochemical testing is performed, measure total testosterone and SHBG or free/bioavailable testosterone to document hyperandrogenemia; no absolute assay-independent cut-off is defined due to variability in assays.two of three clinical criteria

ACOG and Endocrine Society recommend clinical-first approach and awareness of assay limitations.

inv-06: 5-Alpha Reductase Deficiency Evaluation

Investigation of suspected 5-alpha reductase deficiency: Covered when ALL of the following are met

Diagnostic tests available: Use stimulated T:DHT ratios after hCG stimulation, urinary steroid profiling (eg, THF/5alpha-THF ratios), and genetic testing of SRD5A2 as appropriate; urinary steroid profiling may detect cases missed by hCG-stimulated T:DHT and genetic testing confirms diagnosis.stimulated T:DHT >10 often used

Case series and historical studies document sensitivity and diagnostic approaches (hCG stimulation, urinary steroid profiling, genetic confirmation).

inv-07: Initial diagnostic criteria

Covered diagnostic evaluation for suspected male hypogonadism is supported when ALL of the following are met:

Confirmatory testing: Total testosterone measured with a validated assay on fasting morning blood samples obtained on two different days.morning before 11 am

EAA, CUA/CSAM, and EAU recommend two separate morning measurements.

Assessment to distinguish cause: Measure luteinizing hormone (LH) in all patients with suspected functional hypogonadism to differentiate primary versus secondary causes.

Recommended by EAA, CUA/CSAM, and other guideline bodies.

Free/bioavailable testosterone measurement: Measure or calculate free testosterone (eg, Vermeulen calculation based on TT, SHBG, albumin) in addition to total testosterone when SHBG-altering conditions exist or total testosterone is borderline (~8–12 nmol/L) and clinical suspicion is strong.≈8–12 nmol/L borderline range

inv-08: Monitoring/continuation criteria

Monitoring after initiation of testosterone therapy — covered when ALL of the following monitoring actions occur:

Early follow-up: Assess clinical response and adverse effects at 3 and 6 months after initiation of therapy.3 and 6 months

CUA/CSAM and other guideline bodies recommend assessment at these intervals.

Laboratory follow-up: Measure testosterone levels at 3 and 6 months after starting therapy and annually thereafter if stable.3 months, 6 months, then annually

CUA/CSAM guidance recommends laboratory assessment at these intervals.

Exclusion: The use of saliva specimens for measurement of testosterone does not meet coverage criteria and is excluded from coverage.

Assay limitations: Direct analog-based free testosterone immunoassays and commercially available kits for direct free testosterone measurement are not recommended due to documented inaccuracy; when free testosterone is needed, use either calculation from total testosterone, SHBG, and albumin (eg, Vermeulen method) or direct measurement by equilibrium dialysis or validated mass-spectrometry methods.

Screening guidance: Structured interviews and self-reported questionnaires should not be used for universal population screening for late-onset hypogonadism (LOH) because of low specificity; screening and testing should be targeted to symptomatic men only, per guideline recommendations.

Related guideline considerations: Providers should consider guideline recommendations from specialty bodies when assessing candidates for testosterone testing or therapy — for example, NCCN guidance on prostate cancer and the NCCN/other guidance on neuroendocrine and adrenal tumors, and the EAU and other society statements referenced in this policy — particularly where prostate cancer surveillance, tumor-related endocrine disorders, or contraindications to testosterone therapy may apply.

Not-covered contexts: Measurement of testosterone is not covered for asymptomatic individuals or for non-specific symptoms; measurement to identify androgen deficiency in women is not covered. Also excluded is saliva-based testosterone testing and routine or unspecified use of serum dihydrotestosterone outside the listed indications.

Recommendation against routine population screening: Multiple guideline statements (EAA, ES, AUA) recommend against routine population or universal screening for hypogonadism in middle-aged or older men; testing should be restricted to individuals with clinical symptoms consistent with testosterone deficiency.

Recommendation against universal screening using questionnaires or random TT: Guidelines explicitly advise against universal screening using structured interviews, self-reported questionnaires, or random total testosterone measurements for LOH; diagnostic testing should use morning, fasting total testosterone measurements and be reserved for symptomatic individuals.

Policy change note: The document was reviewed and updated on 12/03/2025; the literature review did not require any modifications to the existing coverage criteria, and therefore no explicit changes to coverage rules were made.

Coding, Thresholds, and Diagnostic Values

Listed laboratory CPT/HCPCS codesCPT

82040	Albumin; serum, plasma or whole blood.
82642	Dihydrotestosterone (DHT).
82670	Estradiol; total.
82681	Estradiol; free, direct measurement (eg, equilibrium dialysis).
84270	Sex hormone binding globulin (SHBG).
84402	Testosterone; free.
84403	Testosterone; total.
84410	Testosterone; bioavailable, direct measurement (eg, differential precipitation).

inv-18: Testosterone level thresholds cited in literature — example diagnostic thresholds from studies (e.g., adolescent PCOS)

Adolescent PCOS example thresholdTotal testosterone > 1.15 nmol/L cited as a diagnostic threshold in an adolescent PCOS study (Khashchenko et al., 2020).

Combined hormonal panel for adolescentsCombined thresholds (AMH, FAI, testosterone, androstenedione, LH/FSH) improved diagnostic accuracy to ~90–91%.

Implication for testingConsider total testosterone >1.15 nmol/L as an example study-derived cutoff in adolescents, but interpret alongside other clinical and assay-specific factors.

inv-19: Total testosterone diagnostic threshold (AUA) — < 300 ng/dL

AUA diagnostic cut-offTotal testosterone < 300 ng/dL is recommended by the AUA as a reasonable cut-off supporting the diagnosis of low testosterone.

Provider Actions, Documentation, and Billing Requirements

Documentation Required

Document Clinical Indication

Coverage for testosterone and related testing is contingent upon documentation of a clinical indication consistent with this policy and the member's benefits. Providers must document the patient’s symptoms, signs, and the clinical rationale for testing (for example: symptoms of androgen deficiency or excess, monitoring of testosterone therapy, evaluation of gynecomastia, suspected disorders affecting SHBG, ambiguous genitalia, or gender-affirming care). Requests for testing without an appropriate documented clinical indication may be denied.

Document patient symptoms/signs and clinical rationale when ordering any testosterone-related test
Verify member benefits and any applicable Medicare/Medicaid rules before ordering

Note

Background and Rationale

Background: Testosterone is a lipophilic androgen produced by the testes in males and by the ovaries and adrenal glands in females; it is a precursor for dihydrotestosterone (DHT) and estradiol. Only a small fraction (~1–4%) circulates as free testosterone; most is protein-bound (to SHBG and albumin) which affects bioavailability. Measurement considerations include diurnal variation (prefer morning, fasting samples), assay selection (LC-MS/MS preferred; equilibrium dialysis is the gold standard for free testosterone), and the need to correlate biochemical results with clinical signs and symptoms when diagnosing hypogonadism.

Definitions

inv-40: Total testosterone (TT) definition — circulating concentration of testosterone including bound and free fractions

Definition of total testosterone (TT)Concentration of circulating testosterone including protein-bound and free fractions; measurable by immunoassay or mass spectrometry.

CompositionTT comprises free testosterone plus fractions bound to SHBG and albumin (bioavailable = free + albumin-bound).

SamplingCollect TT in early morning, fasting samples due to diurnal variation and variability.

inv-41: Free testosterone — fraction not bound to proteins; equilibrium dialysis is gold standard

Free testosterone (fT) definitionFraction of circulating testosterone not bound to proteins; equilibrium dialysis is the gold standard method for measuring fT.

Measurement challenges

Revision History

2026-06-01Effective DateLatest

Policy effective date for this version of the Testosterone policy (AHS - G2013).

2025-12-03Revision/Review

Policy reviewed and updated: background, guidelines, recommendations, and evidence-based references were updated after literature review; no changes to coverage criteria were required.

Policy Summary

Payermedical mutual - ohio

PolicyTestosterone — Coverage Criteria for Laboratory Testing

Policy CodePolicy AHS - G2013 - Testosterone

Change TypeAdministrative review — no material coverage changes

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionObtain two separate morning total testosterone measurements (fasting) to confirm diagnosis before ordering free or bioavailable testosterone.

SourceLink

On This Page

EAA and CUA/CSAM guidance supports calculated or equilibrium dialysis methods rather than direct analog immunoassays.

Sample timing: Collect testosterone samples between 07:00 and 11:00 (or within 3 hours of waking for shift workers); fasting preferred.07:00–11:00

CUA/CSAM and EAU sample timing recommendations.

Analytic method: Use standardized, validated assays; LC–MS/MS is preferred for accuracy, and assays certified by CDC HoSt are recommended when available.

EAU and CUA/CSAM recommend standardized methods and CDC certification where available.

Confirmation requirement

Diagnosis should be made only after two total testosterone measurements on separate occasions, both in early morning samples.

Clinical correlationLow total testosterone must be combined with symptoms/signs to establish clinical diagnosis per AUA guidance.

inv-20: Endocrine Society PSA trigger for urology referral — > 1.4 ng/mL rise or absolute > 4 ng/mL

Endocrine Society PSA triggerRefer to urology if serum PSA rises > 1.4 ng/mL above baseline or reaches an absolute value > 4 ng/mL during testosterone therapy (Endocrine Society guidance).

Monitoring timingEndocrine Society recommends measuring PSA at 3 and 12 months after initiating therapy in men >50, with urologic referral per the PSA thresholds above.

Clinical noteTestosterone treatment can increase PSA; thresholds guide referral decisions rather than routine adjustment of biopsy criteria based on testosterone level.

inv-21: EAU LOH total testosterone threshold — 12 nmol/L

EAU LOH thresholdEAU recommends using total testosterone 12 nmol/L (≈3.5 ng/mL) as a threshold to aid diagnosis of late-onset hypogonadism (LOH).

Sampling guidanceMeasure fasting morning total testosterone between 07:00 and 11:00 hours and repeat when <12 nmol/L before starting therapy.

Adjunct testingConsider SHBG and free T calculation and measure LH/FSH to differentiate causes when indicated.

inv-22: Possible free T hypogonadism threshold (reported) — fT < 225 pmol/L (reported in some data sources)

Reported free T thresholdSome data indicate free testosterone (fT) levels below 225 pmol/L are associated with hypogonadism (reported in EAU discussions).

Uncertainty noteThere is uncertainty about an absolute fT threshold; interpretations depend on assay method and clinical context.

When to measureMeasure or calculate free T when SHBG-altering conditions exist or when total T is borderline (≈8–12 nmol/L).

Billing Rule

Procedure Codes

Use these procedure codes as references when ordering or billing for testosterone and related assays. Confirm payer-specific billing guidance prior to claim submission.

CPT 84403 — Testosterone; total
CPT 84402 — Testosterone; free
CPT 84410 — Testosterone; bioavailable, direct measurement (eg, differential precipitation)
CPT 82642 — Dihydrotestosterone (DHT)
CPT 82670 — Estradiol; total
CPT 82681 — Estradiol; free, direct measurement (eg, equilibrium dialysis)
CPT 84270 — Sex hormone binding globulin (SHBG)
CPT 82040 — Albumin; serum, plasma or whole blood

Prior Authorization

No changes were made to prior authorization requirements after review. Follow existing payer prior authorization processes where applicable for services that require it.

Check the member’s benefit plan for prior authorization requirements before ordering

Step Therapy

Step Order Requirement

Total serum testosterone should be measured first. Measurement of free or bioavailable testosterone as the primary/initial diagnostic test (without a prior total testosterone) does not meet coverage criteria.

Obtain morning, fasting total testosterone before ordering free or bioavailable testosterone
Exceptions: follow policy-specified indications where calculated or measured free/bioavailable testing is appropriate (e.g., conditions altering SHBG or borderline total T)

Documentation Required

Baseline & Monitoring

Baseline assessment and ongoing monitoring are required for covered testosterone therapies and diagnostic evaluations. Establish baseline total testosterone and hematocrit prior to initiating therapy. For men >40 years, obtain baseline PSA. Consider reproductive evaluation for men desiring fertility prior to treatment.

Baseline: total testosterone and hematocrit; PSA in men >40; reproductive evaluation when fertility is a consideration
On-therapy monitoring: assess TT and hematocrit at 3 and 6 months after initiation or dose change, then annually if stable

Documentation Required

Monitoring Intervals

After starting testosterone therapy, monitor response and safety at specified intervals. Assess clinical response and adverse effects at approximately 3 and 6 months after therapy initiation and check serum testosterone levels and hematocrit at those times as coverage conditions.

Assess clinical response and adverse effects at 3 and 6 months
Measure serum testosterone and hematocrit at 3 and 6 months; then annually if stable

Note

Guideline References

Clinical guidelines inform evaluation and monitoring approaches but do not by themselves create additional step therapy or coverage requirements beyond this policy. Use guideline recommendations (AUA, EAA, ES, EAU, CUA/CSAM, NCCN, ASRM, ACOG) to support clinical decision-making and documentation.

Guidelines are referenced for best practices; they do not override explicit coverage criteria in this policy

Documentation Required

Documentation & Specimen Collection

When ordering free or bioavailable testosterone tests, providers must document prior total testosterone results (when applicable), the clinical indication for additional testing, and specimen collection details (morning collection, fasting status, and collection time). Include prior test dates and values in the request.

Document prior total testosterone result and date when ordering free/bioavailable testing
Record specimen collection time (morning, fasting) and method on the requisition

Documentation Required

Diagnostic Lab Documentation

Diagnostic laboratory documentation required to establish testosterone deficiency includes two separate morning total testosterone measurements and additional hormone testing when indicated to characterize the cause.

Two morning (fasting) total testosterone measurements on separate days are required to support a diagnosis of low testosterone
Measure LH and FSH to differentiate primary vs secondary hypogonadism; consider prolactin, ferritin or iron studies when secondary causes are suspected

Documentation Required

Confirmatory Testing

Confirmatory testing requires fasting morning total testosterone measurements on two separate days (preferably before 11:00 AM). This confirms functional hypogonadism and is necessary before initiating testosterone therapy except in clearly defined clinical exceptions.

Two fasting, early-morning total testosterone tests on different days (preferably before 11:00 AM)
If initial test is normal but symptoms persist, repeat testing may be performed no sooner than 60 days after the initial screen

Note

Reference Guidelines

Providers should cite and reference current clinical guidelines (AUA, EAA, Endocrine Society, EAU, CUA/CSAM, NCCN, ASRM, ACOG) when documenting indications, diagnostic evaluation, and monitoring plans to support medical necessity and coverage determinations.

Include guideline references in clinical documentation when applicable to support testing or monitoring decisions

Denial Risk

Denial Triggers

Requests for free or bioavailable testosterone as the initial diagnostic test without a prior total testosterone, testing in asymptomatic individuals, use of saliva specimens, or routine testosterone testing in women for androgen deficiency are denial triggers under this policy. Also, testing that lacks appropriate supporting clinical documentation may be denied.

Denial triggers include: free/bioavailable T as primary test without prior total T; testing asymptomatic or non-specific symptom individuals; saliva-based testosterone measurements; routine testosterone for identifying androgen deficiency in women
Ensure clinical documentation and prior test results are submitted to avoid denials

Denial Risk

Assay Limitations

Direct analog-based free testosterone immunoassays and some commercial kits are discouraged due to inaccuracy. Use CDC-certified total testosterone assays, calculated free testosterone using accepted algorithms (total T, SHBG, albumin), or equilibrium dialysis methods where available. Using invalid assays may lead to incorrect clinical management and claim denial.

Do not use direct analog-based free testosterone immunoassays for clinical decision-making
Prefer CDC HoSt-certified assays for total testosterone and validated methods for free or bioavailable calculations

Note

Government Policy Override

If this policy conflicts with an applicable state or federal government policy (e.g., Medicare LCD/NCD or state Medicaid rules), the government policy governs the coverage determination. Verify and follow relevant government coverage rules for the member at the time of request.

Government coverage determinations (LCD/NCD/state Medicaid) take precedence over this policy when applicable
Check CMS and state Medicaid resources for the most current guidance

Note

Literature Review Conclusion

A literature review completed during the recent policy update did not necessitate changes to the coverage criteria. Existing coverage rules remain in effect; continue to follow the policy’s documentation, testing sequence, and monitoring requirements.

Recent review (12/03/2025) concluded no modifications to coverage criteria were needed

Equilibrium dialysis is technically difficult, sensitive to environmental conditions, and limited in availability.

Alternative approachesClinical guidelines recommend calculating fT using validated algorithms (TT, SHBG, albumin) rather than direct immunoassays which are inaccurate.

inv-42: Bioavailable testosterone — free T plus albumin-bound fraction

Bioavailable testosterone definitionBioavailable testosterone equals free testosterone plus the fraction weakly bound to albumin.

When to useMeasure or calculate bioavailable T when SHBG-altering conditions exist or when TT is borderline and clinical suspicion is strong.

Analytic methodsDirect bioavailable assays (e.g., ammonium sulfate precipitation) are technically challenging and less commonly used; calculation alternatives may be preferred.

inv-43: CDC HoSt/Testosterone — CDC Hormone Standardization program acceptance criteria

CDC HoSt acceptance criteriaCDC Hormone Standardization (HoSt) program certifies total testosterone assays standardized within ±6.4% of the CDC reference standard.

RecommendationIt is strongly recommended to use assays certified by the CDC HoSt/Testosterone program when available.

ResourceA list of CDC-certified assays is available on the HoSt website.

inv-44: Equilibrium dialysis — gold standard method for free testosterone measurement

Equilibrium dialysis roleEquilibrium dialysis is the gold standard method for free testosterone measurement, separating free T across a semipermeable membrane.

LimitationsMethod is technically demanding, sensitive to pH, temperature, and ionic strength, and has limited availability and higher cost.

DependenceAccuracy depends on precise total testosterone determination and controlled laboratory conditions.

inv-45: Vermeulen formula / calculated free testosterone — algorithmic estimate using total T, SHBG, and albumin

Vermeulen formula descriptionCalculated free testosterone (Vermeulen formula) estimates fT using total testosterone, SHBG, and albumin concentrations as a validated algorithmic alternative to direct measurement.

Clinical evidenceStudies report acceptable concordance between calculated methods and equilibrium dialysis in many settings; some limitations in females were noted.

Practical useGuidelines endorse calculation of fT when direct equilibrium dialysis is unavailable or when immunoassays are inaccurate.

inv-46: Functional hypogonadism — definition and diagnostic approach distinguishing reversible/secondary forms

Functional hypogonadism definitionA reversible or secondary form of testosterone deficiency diagnosed after excluding organic causes and confirmed by two morning fasting TT measurements and LH assessment.

Diagnostic approachMeasure LH to differentiate primary vs secondary causes; consider free T calculation when SHBG-altering conditions or borderline TT (≈8–12 nmol/L) exist.

Management implicationInvestigate and address reversible contributors (medications, obesity, systemic illness) before labeling functional hypogonadism.

inv-47: Late-onset hypogonadism (LOH) — symptomatic testosterone deficiency in older men; EAU threshold referenced

LOH definitionLate-onset hypogonadism (LOH) is symptomatic testosterone deficiency in older men; EAU recommends using TT threshold of 12 nmol/L to aid diagnosis.

Testing recommendationTest only symptomatic men for LOH; measure morning fasting TT and repeat when <12 nmol/L before initiating therapy.

Adjunct measuresConsider SHBG and free T calculations and assess LH/FSH and prolactin when indicated to determine etiology.

inv-48: Functional vs classical hypogonadism — distinctions discussed in registry and guideline literature

Distinction summaryGuideline and registry literature distinguish functional (reversible/secondary) hypogonadism from classical (organic) hypogonadism with implications for diagnosis and management.

Key differencesFunctional hypogonadism often linked to modifiable factors (obesity, medications, systemic illness) and requires exclusion of organic causes; classical hypogonadism is primary testicular failure or pituitary/ hypothalamic disease.

Testing strategyConfirm functional hypogonadism with ≥2 morning TT measurements, LH assessment, and targeted additional testing per guidelines before initiating therapy.