Recommended Starting Dose of Topical Testosterone for Men
The recommended starting dose of topical testosterone for men requiring testosterone replacement therapy is 40.5 mg of testosterone (2 pump actuations or a single 40.5 mg packet) applied topically once daily in the morning to the shoulders and upper arms. 1
Dosing Guidelines
Topical testosterone therapy should be initiated and adjusted according to the following protocol:
- Initial dose: 40.5 mg of testosterone daily (2 pump actuations or a single 40.5 mg packet) 1
- Dose range: Can be adjusted between a minimum of 20.25 mg (1 pump actuation) and a maximum of 81 mg (4 pump actuations) 1
- Target level: Adjust dosing to achieve total testosterone levels in the middle tertile of the normal reference range (450-600 ng/dL) 2, 3
Dose Adjustment Protocol
Dose titration should be based on pre-dose morning serum testosterone concentration:
- At 14 and 28 days after starting treatment or following dose adjustment 1
- Periodically thereafter to ensure proper dosing 1
| Pre-Dose Morning Total Serum Testosterone | Dose Adjustment |
|---|---|
| Greater than 750 ng/dL | Decrease daily dose by 20.25 mg |
| 350-750 ng/dL | No change: continue current dose |
| Less than 350 ng/dL | Increase daily dose by 20.25 mg |
Application Instructions
- Apply to clean, dry, intact skin of the upper arms and shoulders only 1
- Do not apply to abdomen, genitals, chest, armpits, or knees 1
- Limit application area to what will be covered by a short-sleeve t-shirt 1
- Use palm of hand to apply and spread across maximum surface area 1
- Once dry, cover application site with clothing 1
- Avoid swimming, showering, or washing the application site for at least 2 hours after application 1
Important Considerations
- Secondary exposure risk: Virilization has been reported in children and women who come into contact with application sites. Patients should wash hands thoroughly after application and cover application sites with clothing 1
- Cardiovascular risk: FDA requires labeling about possible increased risk of heart attack and stroke with testosterone preparations 2
- Fertility impact: Exogenous testosterone therapy should not be prescribed to men who are currently trying to conceive as it can cause severe oligospermia or azoospermia 2
- Post-cardiovascular events: Delay testosterone therapy for 3-6 months in patients with a history of cardiovascular events 2, 3
Monitoring Protocol
- Initial monitoring (3-6 months): Testosterone levels, hematocrit, PSA, and symptom response 3
- Long-term monitoring (annually): Testosterone levels, hematocrit, PSA (in men ≥40 years), and symptom evaluation 3
- Action thresholds:
Advantages of Topical Formulations
Topical testosterone gels offer several advantages over other formulations:
- Easy application with good skin tolerability 2
- More stable serum testosterone levels compared to injections 2
- Fewer fluctuations in mood and sexual function 4
- Restoration of normal hormonal values within 24 hours 5
Potential Pitfalls
- Application site matters: Arms/shoulders provide better absorption than chest/abdomen or legs 6
- Secondary exposure: Strict adherence to application instructions is critical to prevent transfer to women and children 1
- Dose variability: Testosterone concentrations can vary substantially with gel use, not in a predictable way 2
- Cost considerations: Topical formulations are generally more expensive than injectable options 2, 7
- Contraindications: Avoid in men with breast or prostate cancer, hematocrit >50%, severe untreated sleep apnea, severe lower urinary tract symptoms, or uncontrolled heart failure 3
By following these dosing guidelines and monitoring protocols, clinicians can effectively initiate and manage topical testosterone replacement therapy to improve quality of life and reduce morbidity in men with testosterone deficiency.