Current Guidelines for Treating Low Testosterone
Testosterone treatment should only be initiated in men with age-related low testosterone who have sexual dysfunction and specifically want to improve sexual function, with treatment discontinued at 12 months if no improvement occurs. 1
Diagnostic Criteria
Before considering treatment, confirm the diagnosis with:
- Two separate fasting morning total testosterone measurements showing levels consistently below 300-350 ng/dL 2, 3
- Documented symptoms and signs consistent with testosterone deficiency 3
- For borderline cases or conditions affecting sex hormone-binding globulin, obtain free testosterone using equilibrium dialysis or validated calculation formulas 3
When to Treat: Evidence-Based Indications
The American College of Physicians recommends treatment ONLY for sexual dysfunction improvement 1:
- Discuss potential benefits, harms, costs, and patient preferences before initiating therapy 1
- Expected benefits are modest: standardized mean difference of 0.35 for global sexual function and 0.27 for erectile function 4
- Do NOT initiate testosterone for energy, vitality, physical function, or cognition—evidence shows no clinically meaningful benefit in these domains 1, 4
Absolute Contraindications
Do not start testosterone in men with 3:
- Breast or prostate cancer
- Palpable prostate nodule or induration
- PSA >4 ng/mL (or >3 ng/mL in high-risk men without urological evaluation)
- Elevated hematocrit
- Untreated severe obstructive sleep apnea
- Severe lower urinary tract symptoms
- Uncontrolled heart failure
- Myocardial infarction or stroke within the last 6 months
- Thrombophilia
- Planning fertility in the near term
Formulation Selection
Prefer intramuscular over transdermal formulations 1, 5:
- Intramuscular preparations have considerably lower costs with similar clinical effectiveness and adverse effect profiles 1
- Target mid-normal testosterone range during treatment 3
Monitoring Protocol
Mandatory reassessment timeline 1, 5, 4:
- Reevaluate symptoms at 12 months after initiation
- Continue periodic reassessment thereafter
- Discontinue treatment if no improvement in sexual function by 12 months—this is the only evidence-based indication 1, 4
Safety monitoring during treatment 3, 6:
- Evaluate symptoms, adverse effects, and compliance
- Measure serum testosterone and hematocrit concentrations
- Assess prostate cancer risk during the first year
- Monitor for cardiovascular events 5
Critical Caveats
Age-specific limitations: Current guidelines primarily address age-related low testosterone in older men, with limited specific guidance for young adults 5. FDA labeling specifies testosterone products are approved only for low testosterone due to known medical causes 5.
Optimize reversible factors first: Address sleep quality and duration before considering testosterone replacement, as poor sleep may contribute to low testosterone levels 5.
Set realistic expectations: Testosterone will NOT increase penile size and provides only small improvements in erectile function and libido 4. Quality of life improvements (SMD 0.33) appear driven primarily by sexual function benefits rather than broader effects 4.