From the Guidelines
Management of low free testosterone typically involves testosterone replacement therapy (TRT), and the primary recommendation is to initiate TRT in men with consistently low testosterone levels and associated symptoms, as supported by the most recent evidence from 1.
Treatment Options
The following treatment options are available for TRT:
- Testosterone gels (e.g., AndroGel, Testim): Apply 5-10 g daily to the skin.
- Testosterone patches (e.g., Androderm): Apply 2-4 mg patch daily.
- Injectable testosterone (e.g., testosterone cypionate): 50-100 mg weekly or 100-200 mg every 2 weeks, intramuscularly.
- Testosterone pellets (e.g., Testopel): 150-450 mg implanted subcutaneously every 3-6 months.
Implementation of TRT
To implement TRT, the following steps should be taken:
- Confirm low testosterone with two morning blood tests.
- Assess for contraindications (e.g., prostate cancer, severe sleep apnea).
- Monitor PSA and hematocrit levels regularly during treatment.
- Evaluate symptom improvement and adjust dosage as needed. TRT aims to restore testosterone levels to the normal physiological range, typically 300-1000 ng/dL, which helps improve symptoms such as low libido, fatigue, and reduced muscle mass, as noted in 1 and 1.
Important Considerations
It's essential to note that TRT is a long-term treatment, and patients should be monitored regularly for potential side effects and treatment efficacy, as highlighted in 1, 1, and 1.
Key Recommendations
The most recent and highest-quality study, 1, recommends considering screening with a morning serum testosterone level in men with diabetes who have symptoms or signs of hypogonadism, such as decreased sexual desire or activity, or erectile dysfunction.
Monitoring and Follow-up
Regular monitoring of PSA and hematocrit levels, as well as evaluation of symptom improvement, is crucial to ensure the safe and effective use of TRT, as emphasized in 1 and 1.
From the FDA Drug Label
Testosterone gel 1.62% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: • Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals • Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation 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 management options for hypogonadism (low free testosterone) include:
- Testosterone replacement therapy with topical testosterone products such as testosterone gel 1.62% 2
- Testosterone replacement therapy with intramuscular injections of testosterone enanthate 3 Key considerations:
- Diagnosis of hypogonadism should be confirmed by measuring serum testosterone concentrations on at least two separate days 2
- Dose adjustments should be based on pre-dose morning serum testosterone concentration 2
- Safety and efficacy of testosterone therapy in men with age-related hypogonadism have not been established 2 3
From the Research
Management Options for Hypogonadism
The management of hypogonadism, also known as low free testosterone, involves various treatment options. The following are some of the management options:
- Testosterone replacement therapy (TRT) is a common treatment for hypogonadism, which can be administered through topical gels, intramuscular injections, or other formulations 4, 5, 6.
- The choice of TRT formulation depends on factors such as cost and patient preference 4.
- Nonhormonal pharmacotherapies are available for patients who wish to avoid exogenous hormones, are not candidates for TRT, or are unable to tolerate its adverse effects 4.
- Diagnosis and treatment of testosterone deficiency can be challenging, and clinicians should be aware of the current literature on this condition 7.
- The Endocrine Society recommends making a diagnosis of hypogonadism only in men with symptoms and signs consistent with testosterone deficiency and unequivocally and consistently low serum T concentrations 8.
Considerations for Testosterone Replacement Therapy
Before initiating TRT, the following considerations should be taken into account:
- Patients should meet criteria for hypogonadism, which is defined as a low testosterone level and signs or symptoms of hypogonadism 4.
- Counseling before therapy should include shared decision-making regarding risks, benefits, and expectations 4.
- Patients receiving TRT require close monitoring, including evaluating symptoms, adverse effects, and compliance, measuring serum T and hematocrit concentrations, and evaluating prostate cancer risk 8.
- The goal of TRT is to achieve T concentrations in the mid-normal range during treatment, taking into consideration patient preference, pharmacokinetics, formulation-specific adverse effects, treatment burden, and cost 8.
Contraindications and Precautions
The following are contraindications and precautions for TRT:
- Breast or prostate cancer, palpable prostate nodule or induration, prostate-specific antigen level > 4 ng/mL, or elevated hematocrit are contraindications for TRT 8.
- Untreated severe obstructive sleep apnea, severe lower urinary tract symptoms, uncontrolled heart failure, myocardial infarction or stroke within the last 6 months, or thrombophilia are also contraindications for TRT 8.
- Patients planning fertility in the near term should not start TRT 8.