What are the guidelines for prescribing testosterone to men?

Guidelines for Prescribing Testosterone to Men

Testosterone therapy should only be prescribed to men with consistent symptoms of hypogonadism AND confirmed low testosterone levels below 300 ng/dL on at least two separate morning measurements. 1, 2

Diagnostic Criteria

• Confirmation of diagnosis requires:

  • Morning total testosterone levels < 300 ng/dL on at least two separate occasions 1, 2
  • Presence of symptoms consistent with testosterone deficiency 2
  • Consider free or bioavailable testosterone measurement when total testosterone is borderline or SHBG abnormality is suspected 2

• Symptoms to evaluate:

  • Sexual symptoms (decreased libido, erectile dysfunction)
  • Physical symptoms (fatigue, decreased muscle mass)
  • Cognitive symptoms (difficulty concentrating, depressed mood) 2

Approved Indications

Testosterone therapy is indicated for:

• Primary hypogonadism (testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy) 3
• Hypogonadotropic hypogonadism (idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury) 3

Contraindications

Absolute contraindications:

• Breast or prostate cancer
• Palpable prostate nodule without further urological evaluation
• PSA > 4 ng/mL (or > 3 ng/mL in high-risk men)
• Hematocrit > 50%
• Untreated severe obstructive sleep apnea
• Severe lower urinary tract symptoms (IPSS > 19)
• Uncontrolled heart failure
• Recent cardiovascular events (within 6 months)
• Desire for near-term fertility 2

Treatment Options and Administration

1. Formulation selection:

   • Intramuscular injections: 50-400 mg every 2-4 weeks 3
   • Transdermal preparations (gels, patches): Provide more stable day-to-day levels 2
   • Consider patient preference, pharmacokinetics, treatment burden, and cost 2

2. Target levels:

   • Aim for mid-normal range (450-600 ng/dL) 2
   • Dose adjustment based on pre-dose morning testosterone:

     • 750 ng/dL: Decrease daily dose by 20-25%

     • 350-750 ng/dL: No change
     • <350 ng/dL: Increase daily dose by 20-25% 2

Monitoring Protocol

• Initial follow-up: Evaluate symptoms after 3 months 2
• Laboratory monitoring:
  • Testosterone levels: After starting treatment and every 6-12 months while on therapy 2
  • Hemoglobin/hematocrit: Discontinue if Hct > 54% 2
  • PSA: According to AUA guidelines 2
• Efficacy assessment: Consider discontinuation if no improvement in sexual function after 12 months 2

Benefits and Limitations

• Established benefits:

  • Small but significant improvements in sexual function 2
  • Maintenance of secondary sex characteristics 2
  • Small improvements in quality of life 2

• Limited or no effect on:

  • Physical functioning
  • Depressive symptoms
  • Energy/vitality
  • Cognition 1, 2

Special Considerations

• Fertility concerns: Exogenous testosterone suppresses spermatogenesis and can cause oligospermia or azoospermia 2

  • For men interested in fertility, consider alternatives like hCG, SERMs, or aromatase inhibitors 2

• Common adverse effects:

  • Erythrocytosis (dose-dependent: 2.8-17.9%)
  • Suppression of spermatogenesis
  • Peripheral edema
  • Emotional lability 2

• Lifestyle modifications: Weight loss through diet and physical activity can reverse obesity-associated secondary hypogonadism and should be considered first-line for metabolic benefits 2

Pitfalls to Avoid

• Up to 25% of men receiving testosterone therapy do not meet diagnostic criteria 1
• Nearly half of men on testosterone therapy don't have their levels checked after starting therapy 1
• Avoid prescribing for "age-related hypogonadism" without structural or genetic etiologies 1
• Avoid prescribing testosterone for non-specific symptoms without confirmed low testosterone levels 2