Testosterone Therapy Pre-Treatment Checklist
Before initiating testosterone therapy, you must confirm BOTH biochemical hypogonadism (total testosterone <300 ng/dL on two separate early morning measurements) AND the presence of clinical symptoms, while systematically ruling out absolute contraindications. 1
PART 1: Confirm Diagnosis
Laboratory Requirements (MANDATORY)
Two separate early morning (7-11 AM) total testosterone measurements <300 ng/dL 1
- Must be fasting samples
- Use same laboratory and methodology for both measurements
- Measurements should be on different days
Measure LH and FSH levels 2, 1
- Low/normal LH = secondary (central) hypogonadism
- Elevated LH = primary (testicular) hypogonadism
- This determines etiology and guides further workup
Clinical Symptoms Assessment (MUST HAVE AT LEAST ONE)
Document presence of:
- Sexual symptoms: Reduced libido, erectile dysfunction
- Physical symptoms: Reduced energy/endurance, diminished work performance, fatigue, reduced muscle mass
- Psychological symptoms: Depression, reduced motivation, poor concentration, impaired memory, irritability 1
Physical Examination Findings
Document:
- Body mass index or waist circumference
- Gynecomastia (present/absent)
- Testicular size and consistency
- Body hair pattern in androgen-dependent areas
- Prostate examination findings 1
PART 2: Screen for ABSOLUTE CONTRAINDICATIONS
If ANY of the following are present, DO NOT prescribe testosterone: 2
Cancer-Related (STOP if present)
- ❌ Breast cancer (current or history)
- ❌ Prostate cancer (current or history)
- ❌ Palpable prostate nodule or induration on exam
- ❌ PSA >4 ng/mL
- ❌ PSA >3 ng/mL + high risk features for prostate cancer (without urologic evaluation first)
Hematologic (STOP if present)
- ❌ Elevated hematocrit (>50%)
- ❌ Known thrombophilia
Cardiovascular (STOP if present)
- ❌ Myocardial infarction within last 6 months
- ❌ Stroke within last 6 months
- ❌ Uncontrolled heart failure
Other (STOP if present)
- ❌ Severe untreated obstructive sleep apnea
- ❌ Severe lower urinary tract symptoms (IPSS >19)
- ❌ Planning fertility in near term (testosterone suppresses spermatogenesis)
PART 3: Baseline Laboratory Panel
Before starting therapy, obtain:
- PSA level (mandatory for prostate cancer screening)
- Hematocrit/hemoglobin (testosterone increases red blood cell production)
- Lipid panel (monitor metabolic effects)
- Liver function tests (baseline for monitoring)
- Consider: HbA1c if diabetic, bone density if osteoporosis risk 2
PART 4: Special Populations - Additional Considerations
Men >65 Years Old
- Do NOT routinely prescribe to all older men with low testosterone 2
- Only offer therapy if:
- Consistently and unequivocally low morning testosterone
- Clear symptoms (low libido, unexplained anemia)
- After explicit discussion of risks/benefits on individualized basis
High-Risk Conditions (Consider testing even without symptoms)
Screen testosterone in patients with: 1
- Unexplained anemia
- Bone density loss/osteoporosis
- Type 2 diabetes
- HIV/AIDS
- History of chemotherapy or testicular radiation
- Chronic opioid use
- Chronic corticosteroid use
- Pituitary dysfunction
- Male infertility
PART 5: Patient Counseling Documentation
Document discussion of:
- Expected benefits: Improved sexual function, energy, body composition, bone density
- Potential adverse effects: Polycythemia, acne, gynecomastia, testicular atrophy, infertility, fluid retention 3
- Monitoring requirements: Labs at 3 months, then every 6-12 months
- Cardiovascular and prostate safety profile
- Patient preference for formulation (gel vs injection vs other)
- Cost and treatment burden 2
DECISION ALGORITHM
1. Two morning testosterone <300 ng/dL?
NO → Do not treat
YES → Continue to #2
2. Clinical symptoms present?
NO → Do not treat
YES → Continue to #3
3. Any absolute contraindications present?
YES → Do not treat (or defer until resolved)
NO → Continue to #4
4. Baseline labs acceptable (PSA, hematocrit)?
NO → Address abnormalities first
YES → Continue to #5
5. Patient counseled and agrees to monitoring?
NO → Do not treat
YES → INITIATE THERAPYCritical Pitfall to Avoid
The most common error is prescribing testosterone based on symptoms alone without confirming biochemical hypogonadism with two separate early morning measurements. Up to 25% of men receiving testosterone do not meet diagnostic criteria. 1 Additionally, nearly half of treated men never have follow-up testosterone levels checked, which is substandard care.