What is the target testosterone level for patients undergoing Testosterone Replacement Therapy (TRT)?

Target Testosterone Level in Testosterone Replacement Therapy (TRT)

Clinicians should adjust testosterone therapy dosing to achieve a total testosterone level in the middle tertile of the normal reference range, specifically 450-600 ng/dL. 1

Recommended Target Range

• The American Urological Association (AUA) recommends targeting a total testosterone level in the middle tertile of the normal reference range (450-600 ng/dL) as the goal for testosterone replacement therapy 1
• The normal physiological range for testosterone in adult men is generally considered to be 300-800 ng/dL in most laboratories 2
• When monitoring testosterone therapy, the target should be maintained within the physiological range, with the middle tertile being optimal for balancing efficacy and safety 1, 2

Monitoring Recommendations

• Testosterone levels should be tested 2-3 months after treatment initiation and/or after any dose change to ensure target levels are being achieved 1
• Once stable levels are confirmed on a given dose, monitoring every 6-12 months is typically sufficient 1
• The timing of testosterone measurements varies depending on the preparation:
  • For injectable testosterone: measure levels midway between injections, targeting a mid-normal value (500-600 ng/dL) 1
  • For transdermal preparations: levels can be measured at any time, with the understanding that peak values occur 6-8 hours after application 1

Clinical Considerations

• The goal of testosterone therapy is the normalization of total testosterone levels combined with improvement in symptoms or signs 1
• Treatment programs should use the minimal dosing necessary to drive testosterone levels to the normal physiologic range of 450-600 ng/dL 1
• If patients do not experience symptomatic relief after reaching the specified target testosterone levels, or remain testosterone deficient despite symptom improvement, testosterone therapy should be stopped 1
• Patients with a higher burden of systemic illness may be less likely to experience symptomatic improvement with TRT, regardless of achieving target testosterone levels 3

Safety Considerations

• Exogenous testosterone therapy should not be prescribed to men who are currently trying to conceive, as it can interrupt normal spermatogenesis 1
• Testosterone therapy should not be commenced for a period of three to six months in patients with a history of cardiovascular events 1
• Alkylated oral testosterone should not be prescribed due to potential liver toxicity 1
• Patients on testosterone therapy should be advised to report any possible cardiovascular symptoms during routine follow-up visits 1
• The FDA has required labeling to inform healthcare professionals and patients of a possible increased risk of heart attack and stroke with testosterone preparations used to treat age-related hypogonadism 1

Formulation Considerations

• Transdermal testosterone preparations (gel, patch) are often favored over intramuscular injections due to the relative stability of day-to-day testosterone levels 1
• Injectable testosterone may be associated with greater fluctuations in testosterone levels, with peaks and valleys between injections 1
• Testosterone gel has been shown to restore levels of testosterone in more than 75% of patients, with low risk of supraphysiologic testosterone levels 4

By targeting the middle tertile of the normal reference range (450-600 ng/dL), clinicians can optimize the benefits of testosterone replacement therapy while minimizing potential risks associated with both insufficient and excessive testosterone levels.