From the Guidelines
The recommended protocol for testosterone replacement therapy (TRT) in patients with hypogonadism typically involves several treatment options tailored to the individual's needs, with transdermal testosterone preparations being the most commonly recommended due to their ability to produce normal serum testosterone concentrations and convenience for patients 1.
Treatment Options
- Injectable testosterone: testosterone cypionate or enanthate is usually administered at 50-100 mg weekly or 100-200 mg every two weeks intramuscularly.
- Transdermal options: testosterone gel (AndroGel, Testim) applied daily at 50-100 mg, or testosterone patches (Androderm) at 2-6 mg daily.
- Testosterone pellets (Testopellet) can be implanted subcutaneously every 3-6 months at 150-450 mg doses.
- Oral testosterone undecanoate may be prescribed at 120-160 mg daily in divided doses, though it's less commonly used due to potential liver effects.
Monitoring and Evaluation
Treatment should begin with lower doses and be titrated based on symptom improvement and serum testosterone levels, aiming for the mid-normal range (400-700 ng/dL) 1. Monitoring should include:
- Testosterone levels
- Hematocrit
- PSA
- Liver function tests at baseline, 3-6 months after starting therapy, and annually thereafter. Patients should be evaluated for symptom improvement, potential side effects like erythrocytosis, and prostate health.
Considerations
TRT works by replacing deficient testosterone, which helps restore sexual function, increase muscle mass, improve bone density, and enhance mood and energy levels in hypogonadal men 1. The method of testosterone replacement should be individualized for each patient, taking into account factors such as cost, convenience, and potential side effects 1.
From the FDA Drug Label
Testosterone Enanthate Injection, USP is indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired) – Testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy Hypogonadotropic hypogonadism (congenital or acquired) – Gonadotropin or luteinizing hormone‑releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.
The recommended protocol for testosterone replacement therapy (TRT) in patients with hypogonadism is to use Testosterone Enanthate Injection, USP for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone, including:
- Primary hypogonadism: testicular failure due to various conditions
- Hypogonadotropic hypogonadism: gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation 2 Key points to consider:
- Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary
- Prolonged androgen treatment will be required to maintain sexual characteristics in males who develop testosterone deficiency after puberty
- Safety and efficacy of Testosterone Enanthate Injection, USP in men with age-related hypogonadism have not been established 2
From the Research
Testosterone Replacement Therapy (TRT) Protocol
The recommended protocol for testosterone replacement therapy (TRT) in patients with hypogonadism involves several key considerations:
- Assessing testosterone levels when an adult man exhibits signs of hypogonadism, and as part of normal medical screening in men starting at age 40 to 50 years, to establish a baseline 3
- Discussing the possibility of TRT with symptomatic patients who have a serum total testosterone level < 300 ng/dL 3
- Selecting a specific testosterone preparation based on the patient's preference, cost, availability, and formulation-specific properties 4
- Monitoring a patient's response and adverse events every 3 to 6 months, and adjusting therapy accordingly 3
Treatment Options
Various treatment options are available for hypogonadism, including:
- Testosterone gel and intramuscular injections, which are the most frequently used and are registered and included in international guidelines 4
- Gonadotropins, which are a good alternative to TRT when fertility is desired in the near future 5
- Clomiphene citrate and tamoxifen, which may be a safe alternative for the treatment of functional central hypogonadism in men, but their use is off-label and data supporting their efficacy are insufficient 5
Considerations and Risks
When considering TRT, it is essential to weigh the benefits and risks, including:
- Potential side effects such as polycythemia, benign prostate hypertrophy (BPH), prostate cancer, gynecomastia, testicular atrophy, and infertility 6
- The need for prophylactic co-therapies to reduce the prevalence of these side effects 6
- The importance of carefully designed clinical trials to investigate TRT in symptomatic age-related hypogonadism 6