From the Guidelines
Testosterone preparations are primarily used to treat hypogonadism in males, where the body doesn't produce sufficient testosterone, and should be used with caution due to potential cardiovascular risks and other side effects, as reported in the most recent study by 1.
Therapeutic Uses of Testosterone Preparations
Testosterone preparations are available in several forms, including injections (testosterone cypionate, enanthate), transdermal patches (Androderm), gels (AndroGel, Testim), buccal systems (Striant), and pellet implants (Testopel).
- Typical starting doses include 50-400mg of testosterone cypionate or enanthate injected every 2-4 weeks, or 5-10g of gel (containing 50-100mg testosterone) applied daily to the shoulders, upper arms, or abdomen, as outlined in 1.
- Treatment is typically lifelong for primary hypogonadism, while secondary hypogonadism may be temporary depending on the cause.
Monitoring and Side Effects
Testosterone therapy can improve symptoms like decreased libido, fatigue, reduced muscle mass, and depression, but patients should be monitored for potential side effects, including:
- Polycythemia
- Sleep apnea
- Gynecomastia
- Potential cardiovascular risks Regular blood tests to check testosterone levels, complete blood count, and prostate-specific antigen are necessary during treatment, as recommended by 1 and 1.
Contraindications and Precautions
Testosterone is contraindicated in men with breast or prostate cancer and should be used cautiously in those with cardiovascular disease, as stated in 1.
- The FDA has required companies that manufacture these products to conduct a controlled clinical trial to evaluate the effects of testosterone therapy on cardiovascular outcomes, as mentioned in 1.
From the FDA Drug Label
INDICATIONS AND USAGE Testosterone Cypionate Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. INDICATIONS AND USAGE Males Testosterone Enanthate Injection, USP is indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone.
The therapeutic uses of testosterone preparations include:
- Replacement therapy in males with conditions associated with symptoms of deficiency or absence of endogenous testosterone, such as:
- Primary hypogonadism (congenital or acquired)
- Hypogonadotropic hypogonadism (congenital or acquired)
- Delayed puberty in carefully selected males with clearly delayed puberty
- Metastatic mammary cancer in women with advancing inoperable metastatic (skeletal) mammary cancer who are one to five years postmenopausal 2, 3
From the Research
Therapeutic Uses of Testosterone Preparations
- Testosterone replacement therapy (TRT) is used to treat hypogonadism, a condition characterized by low serum testosterone levels and hypogonadal symptoms 4, 5, 6, 7.
- The goal of TRT is to restore normal serum testosterone concentrations and relieve symptoms in hypogonadal men 4.
- Selection of the testosterone preparation depends on the patient's preference, cost, availability, and formulation-specific properties 5.
- Different testosterone preparations, such as gel and intramuscular injections, have varying effects on stability of testosterone levels, hematocrit, bone mineral density, and patient satisfaction 5.
- Testosterone therapy may improve cardiovascular outcomes, rather than increase risks, although the evidence base for this association is weak and inconclusive 7.
- A comparison of intramuscular testosterone cypionate (IM-TC) and subcutaneous testosterone enanthate autoinjector (SCTE-AI) found that SCTE-AI was associated with lower levels of post-therapy estradiol and hematocrit compared to IM-TC 8.
Treatment Options
- Testosterone replacement methods, including gel, intramuscular injections, and subcutaneous injections, can be used to treat hypogonadism 4, 5, 8.
- Human chronic gonadotropin, selective estrogen receptor modulator, estrogen antagonist, or an aromatase inhibitor may be used to stimulate endogenous testosterone production if fertility is desired in the near future 4.
- Primary care NPs play an essential role in managing patients with hypogonadism and should comprehensively understand TRT to provide evidence-based care 6.
Safety and Efficacy
- Testosterone therapy can induce reversible suppression of spermatogenesis 4.
- The use of hepatotoxic androgens should be avoided 4.
- Testosterone treatment may have varying effects on cardiovascular disease, osteoporotic fractures, and health-related quality of life, although more research is needed to fully understand these effects 5, 7.
- SCTE-AI may have a potentially preferable safety profile over IM-TC due to its association with lower levels of post-therapy estradiol and hematocrit 8.