Testosterone and Laboratory Monitoring in Transgender Individuals on Testosterone Therapy
Direct Recommendation
For transgender individuals starting testosterone therapy, measure testosterone levels at 2-3 months after initiation or any dose change, then every 3-6 months during the first year, and every 6-12 months thereafter once stable therapeutic levels are achieved. 1, 2
Initial Monitoring Phase (First Year)
Testosterone Level Timing
- Check testosterone at 2-3 months after starting therapy or making any dose adjustments to assess treatment efficacy and determine if dose modifications are needed 1
- Continue monitoring every 3-6 months throughout the first year 1, 3
- Most laboratory values reach stable levels within 6 months (particularly red blood cell indices and creatinine) 4
Critical Blood Draw Timing
- For injectable testosterone: Measure midway between injections (typically day 5-7 for weekly injections), targeting mid-normal values 1
- For all formulations: Morning timing is essential due to diurnal variation 2
Target Testosterone Levels
- Goal: 300-1,000 ng/dL (male physiological range) 3
- More specifically, aim for 450-600 ng/dL (middle tertile of normal range) 1, 2
- In one study, mean levels after 18 months were approximately 545 ng/dL 6
Maintenance Monitoring (After First Year)
Testosterone Monitoring Frequency
- Every 6-12 months once stable therapeutic levels are achieved 1, 2, 3
- This ensures maintenance of therapeutic levels and early detection of supraphysiologic levels that could increase adverse event risk 1, 2
When to Discontinue Therapy
Additional Laboratory Monitoring
Complete Blood Count
- Hemoglobin/hematocrit monitoring is mandatory at each visit to detect erythrocytosis 5, 1
- Red blood cell indices stabilize within 6 months and remain stable long-term 4
- Hemoglobin increases by approximately +1.72 g/dL and hematocrit by +4.76% 4, 6
- Polycythemia risk is significant (up to 46.67% in some testosterone formulations) 7
- If hematocrit rises above reference range, consider temporarily withholding therapy, reducing dose, or performing phlebotomy 5
Metabolic Panel
- Monitor electrolytes, renal function, and liver enzymes 4
- Creatinine levels shift toward affirmed gender reference ranges after 1 year of therapy 5
- For individuals on testosterone >1 year: Interpret creatinine and most lab values based on affirmed gender (male) reference ranges 5
- For those <1 year on therapy: Values are transitioning; interpret with caution 5
- Aspartate transaminase may increase modestly (+4.3 U/L) 6
- Blood glucose typically decreases slightly (-5.33 mg/dL) 6
Lipid Panel
- Monitor lipids regularly as testosterone therapy affects lipid metabolism 4, 6
- LDL and triglycerides may increase beyond the first year 4, 8
- HDL may decrease beyond the first year 4
- One study showed no significant lipid changes, while others demonstrated mild cholesterol and triglyceride elevations 6, 8
Body Composition
- Track body mass index at each visit 6
- Expect approximately 4 kg increase in lean body mass after 1 year on testosterone 5
- BMI typically increases by approximately +1.23 kg/m² 6
Long-Term Considerations
Laboratory Values Beyond First Year
- Some analytes continue to change beyond 1 year: LDL, HDL, and liver enzymes may show ongoing trends 4
- Maximum virilization effects are usually achieved after 3-5 years of regular testosterone use 3
After Discontinuation
- If testosterone is stopped, laboratory values typically return to baseline within 10 weeks (approximately 3 months) 5, 4
- After 3 months off therapy, interpret lab values based on sex assigned at birth 5
Common Pitfalls to Avoid
Timing Errors
- Never measure testosterone at random times: Injectable testosterone requires midway measurement between doses; morning measurement is essential for all formulations 1
- Failure to account for peak/trough variations with injectable formulations leads to inappropriate dose adjustments 5, 1
Reference Range Misinterpretation
- After 1 year on testosterone, use male reference ranges for most laboratory values, particularly creatinine and hemoglobin 5
- During the first year, recognize that values are transitioning and may not fit either male or female reference ranges cleanly 5
Inadequate Hematocrit Monitoring
- Polycythemia is a significant risk and requires vigilant monitoring at every visit 5, 1, 7
- This is particularly important with certain formulations like testosterone pellets 7