Goal Testosterone Level for Testosterone Replacement Therapy
Clinicians should adjust testosterone therapy dosing to achieve a total testosterone level of 450-600 ng/dL, which represents the middle tertile of the normal physiologic range. 1
Target Range and Monitoring Strategy
The American Urological Association explicitly recommends using minimal dosing necessary to drive testosterone levels to the normal physiologic range of 450-600 ng/dL, combined with improvement in symptoms or signs. 1 This target represents the middle tertile of the normal reference range and balances efficacy with safety considerations. 2
Initial Monitoring Timeline
- Check testosterone levels at 2-3 months after treatment initiation or any dose adjustment 1, 2
- Recheck at 14 and 28 days for dose titration decisions with gel formulations 3
- Once stable levels are confirmed, monitor every 6-12 months 1, 2
Timing of Blood Draw Varies by Formulation
The timing of testosterone measurement depends critically on the delivery method:
- For intramuscular injections: Measure midway between injections, targeting a mid-normal value of 500-600 ng/dL 1
- For transdermal preparations (gels/patches): Can measure at any time after steady state is reached, though peak values occur 6-8 hours after gel application 1
- For dose adjustment with 1.62% gel: Use pre-dose morning total serum testosterone concentration 3
Dose Adjustment Algorithm
Based on FDA labeling for testosterone gel 1.62%, adjust dosing as follows: 3
- If testosterone >750 ng/dL: Decrease daily dose by 20.25 mg (1 pump actuation)
- If testosterone 350-750 ng/dL: Continue current dose (therapeutic range achieved)
- If testosterone <350 ng/dL: Increase daily dose by 20.25 mg (1 pump actuation)
Critical Safety Considerations
Stop therapy if patients achieve target testosterone levels but report no symptom improvement after 3-6 months, as there is no utility in continuing treatment without clinical benefit. 2 The goal is normalization of testosterone levels combined with improvement in symptoms—not just achieving a laboratory number. 1
Cardiovascular Risk Mitigation
- Avoid initiating therapy within 3-6 months of cardiovascular events 1, 2
- Transdermal preparations may be preferable for patients with cardiovascular risk factors, as they provide more physiologic testosterone levels with less fluctuation compared to injections 2
- Injectable testosterone may be associated with greater cardiovascular risk due to increased time spent in both supratherapeutic and subtherapeutic ranges between injections 1
Common Pitfall to Avoid
Do not aim for high-normal or supraphysiologic levels. The evidence supports targeting the middle tertile (450-600 ng/dL), not the upper limit of normal. 1 Higher levels increase risks without additional clinical benefit and may increase cardiovascular complications. 1