From the Guidelines
Liposomal testosterone is not a recommended or FDA-approved method for testosterone replacement therapy, and patients should instead consider established treatment options such as injections, transdermal patches, gels, pellets, or buccal systems. The use of liposomal delivery systems, which encapsulate medications in lipid vesicles to potentially improve absorption, lacks sufficient clinical evidence regarding safety, efficacy, and proper dosing for testosterone therapy 1. Established testosterone formulations have well-documented pharmacokinetics and safety profiles, making them more reliable choices for treating testosterone deficiency.
The most common methods of testosterone replacement include topical preparations, such as transdermal gels or patches, which have been favored over intramuscular injections due to the relative stability of testosterone levels from day-to-day and the ability to avoid the discomfort of intramuscular injections 1. Testosterone injections, however, offer the benefit of avoiding daily administration and can be advantageous in patients with reduced personal disease-management skills or resources. Implantable testosterone pellets also offer a longer-term alternative but require a procedure for implantation.
Proper testosterone therapy requires regular monitoring of hormone levels, hematocrit, PSA (in older men), and other parameters to ensure safety and effectiveness 1. The method of testosterone replacement should be individualized for each patient, taking into account factors such as personal preference, disease-management skills, and resources. Patients seeking testosterone therapy should consult with healthcare providers who can prescribe established treatment options based on their specific needs.
It is essential to note that data regarding the safety of testosterone therapy have been conflicting, and the FDA has required a labeling change to inform both healthcare professionals and patients of a possible increased risk of heart attack and stroke with the use of testosterone preparations to treat age-related hypogonadism 1. However, multiple associations, societies, and agencies support the use of testosterone in hypogondessent men, citing the cardiometabolic benefits of testosterone replacement therapy 1.
In summary, while liposomal testosterone may seem like an attractive alternative, established testosterone formulations are the preferred choice for treating testosterone deficiency due to their well-documented safety and efficacy profiles. Patients should consult with healthcare providers to determine the best course of treatment for their specific needs.
From the Research
Definition and Purpose of Testosterone Replacement Therapy
- Testosterone replacement therapy (TRT) is a treatment used to improve symptoms and signs of testosterone deficiency, including decreased libido, erectile dysfunction, depressed mood, anemia, loss of muscle and bone mass, by increasing serum testosterone levels to a physiologic range 2.
- The aim of TRT is to correct selected symptoms and induce and maintain secondary sex characteristics in men with testosterone deficiency 3.
Forms of Testosterone Replacement Therapy
- Numerous testosterone formulations are available, ranging from topical gels to intramuscular injections 4.
- The routes of delivery approved for use in the Western world include buccal, nasal, subdermal, transdermal, and intramuscular (IM) 2.
- However, there is no mention of liposomal testosterone in the provided studies.