Laboratory Monitoring for Testosterone Therapy
Patients on testosterone therapy should be monitored with baseline and follow-up laboratory tests including testosterone levels, PSA, hematocrit/hemoglobin, and lipid profile to prevent serious complications related to therapy. 1, 2
Baseline Testing (Before Starting Therapy)
- Total testosterone levels: Confirms diagnosis and establishes baseline
- PSA (Prostate-Specific Antigen): Establishes baseline prostate health
- Hematocrit or hemoglobin: Screens for polycythemia risk
- Digital rectal examination: Assesses prostate health
- Voiding symptoms assessment: Using standardized questionnaire (e.g., International Prostatic Symptoms Score)
- Sleep apnea history: Document any pre-existing sleep-disordered breathing
Additional recommended baseline tests:
- Lipid profile: Assesses cardiovascular risk
- LH and FSH: Determines if hypogonadism is primary or secondary
- Fasting glucose or HbA1c: Screens for diabetes
- SHBG (Sex Hormone-Binding Globulin): Particularly in men with borderline low total testosterone
Monitoring Schedule
Initial Follow-up (1-2 months)
- Assess efficacy and adjust dosage if needed
Regular Monitoring
- First year: Every 3-6 months
- Subsequent years: Annually if stable
Specific Laboratory Parameters to Monitor
1. Testosterone Levels
- Target range: 450-600 ng/dL (mid-normal range)
- Timing:
- Injectable testosterone: Measure 2-5 days after injection (peak levels)
- Transdermal preparations: Measure anytime after patient has been on therapy for at least 1 week
2. Prostate Health
- PSA: Monitor every 3-6 months for first year, then annually
- Action thresholds:
- PSA > 4.0 ng/mL: Consider prostate biopsy
- PSA increase > 1.0 ng/mL in any year: Perform biopsy
- PSA increase of 0.7-0.9 ng/mL in one year: Repeat PSA in 3-6 months and perform biopsy if further increase 1
3. Hematologic Parameters
- Hematocrit/Hemoglobin: Monitor every 3-6 months for first year, then annually
- Action threshold: Discontinue therapy if hematocrit exceeds 54% 2
- Polycythemia is one of the most common adverse effects of testosterone therapy
4. Cardiovascular Parameters
- Lipid profile: Monitor annually
- Testosterone therapy may improve lipid profiles in some patients 3
Special Considerations
Liver Function
- Liver function tests: Not routinely required for injectable or transdermal preparations
- Only necessary with oral 17-alpha-alkylated testosterone preparations (which should be avoided due to hepatotoxicity) 1, 4
Sleep Apnea
- Assess for development or exacerbation of sleep apnea symptoms at each visit
- Higher risk in men receiving higher doses of parenteral testosterone who have other risk factors for sleep apnea 1
Additional Side Effects to Monitor
- Gynecomastia: Physical examination at follow-up visits
- Skin reactions: More common with patches (up to 66%) than with gels (5%) 1
- Fertility concerns: Inform patients about potential for decreased fertility
Common Pitfalls in Monitoring
- Failure to establish proper baseline: Always obtain comprehensive baseline labs before initiating therapy
- Inconsistent timing of testosterone measurements: Levels can vary significantly based on time since administration, especially with injectable forms
- Overlooking PSA velocity: The rate of PSA change is often more important than absolute values
- Ignoring hematocrit elevations: Polycythemia is a common and potentially serious side effect
- Not discussing fertility implications: Testosterone therapy suppresses spermatogenesis
By following this structured monitoring approach, clinicians can maximize the benefits of testosterone therapy while minimizing potential risks to patients' health.