From the Guidelines
Topical testosterone replacement therapy is generally considered more effective and safer than oral testosterone replacement for most patients requiring testosterone replacement. This is based on the most recent and highest quality study available, which suggests that topical formulations provide steady hormone levels with fewer fluctuations and are more bioavailable, reducing liver-related side effects compared to oral options 1. Topical options like AndroGel, Testim, or Androderm patches deliver testosterone directly through the skin, and typical dosing for AndroGel is 50-100 mg applied daily to clean, dry skin on shoulders, upper arms, or abdomen.
Some key points to consider when choosing between topical and oral testosterone replacement therapy include:
- Liver function: Topical formulations bypass first-pass liver metabolism, making them a better option for patients with liver disease or concerns about liver stress.
- Skin sensitivity: Topical applications carry risks of skin irritation, so patients with sensitive skin may need to consider alternative options.
- Convenience: Oral formulations offer convenience, but may cause greater fluctuations in testosterone levels and potentially more liver stress.
- Cost considerations: The annual cost of transdermal testosterone formulations can be higher than intramuscular formulations, according to paid pharmaceutical claims provided in the 2016 Medicare Part D Drug Claims data 1.
- Patient preference: Patient preferences among treatment options should be considered, with some studies suggesting that most patients prefer topical gel over injection or patch for reasons attributed to convenience, ease of use, and nonstaining of clothes, among others 1.
Regular monitoring of testosterone levels, hematocrit, PSA, and liver function is essential regardless of administration route, with testosterone levels typically measured 2 to 3 months after treatment initiation, and/or after any dose change 1. The method of testosterone replacement should be individualized for each patient, taking into account their unique needs and circumstances.
From the FDA Drug Label
Testosterone gel, 1.62% is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) (1) Hypogonadotropic hypogonadism (congenital or acquired) (1)
The FDA drug label does not answer the question.
From the Research
Effectiveness of Testosterone Replacement Therapies
- Topical testosterone replacement therapy is considered effective for patients requiring testosterone replacement, as it delivers testosterone at a controlled rate into the systemic circulation, avoiding hepatic first pass and reproducing the diurnal rhythm of testosterone secretion 2.
- Transdermal testosterone preparations, including patches and gels, have an attractive pharmacokinetic profile and are valuable contributions to androgen replacement treatment 2, 3.
- Oral testosterone replacement therapy, such as oral testosterone undecanoate, can also be effective, but may have a less favorable pharmacokinetic profile compared to transdermal preparations 3.
Comparison of Topical and Oral Testosterone Replacement
- Topical testosterone gel produces fewer skin irritations than patches and offers greater flexibility in dosage 3.
- Oral testosterone undecanoate dissolved in castor oil bypasses the liver via its lymphatic absorption, but may have elevated plasma DHT levels 3.
- Transdermal testosterone preparations, including gels, may have a risk of unintentional transfer to children or women by skin contact with the application site 4, 5.
Safety and Efficacy Considerations
- Testosterone replacement therapy is usually life-long, and patient compliance is of utmost importance 2, 3.
- Short-acting testosterone preparations, such as transdermal gels, may be better suited for aging androgen-deficient men, as they allow for a fast reduction of circulating testosterone levels and may have a lower risk of adverse effects on the prostate and cardiovascular system 2, 3.
- The risk of secondary exposure to topical testosterone gel formulations poses a challenge, and patients should be aware of this potential risk 4, 6, 5.