From the Guidelines
Testosterone dosing depends on the specific formulation and the individual's needs, with injectable testosterone cypionate or enanthate typically administered at 50-100mg weekly or 100-200mg every two weeks via intramuscular injection, as recommended by the most recent and highest quality study 1.
Key Considerations
- The dosing regimen should be individualized based on blood tests measuring total and free testosterone levels, with target ranges of 400-800 ng/dL for total testosterone.
- Treatment requires regular monitoring of testosterone levels, hematocrit, PSA, and liver function.
- Side effects may include acne, fluid retention, breast enlargement, and increased red blood cell production.
Formulation Options
- Injectable testosterone cypionate or enanthate: 50-100mg weekly or 100-200mg every two weeks via intramuscular injection.
- Testosterone gel (AndroGel, Testim): applied daily to clean, dry skin, usually at doses of 50-100mg.
- Testosterone patches (Androderm): applied nightly at 2-6mg doses.
- Pellet implants: release 150-450mg over 3-6 months.
Patient Preferences
- Patient preferences may vary, with some preferring injectable testosterone over gel-based pellet regimens due to lower cost, while others prefer topical gels for convenience and ease of use 1.
Long-term Safety
- Evidence for long-term safety is lacking, with most studies excluding men with recent cardiovascular disease, and no consistent differences observed in harms according to transdermal versus intramuscular formulations 1.
From the FDA Drug Label
DOSAGE AND ADMINISTRATION Testosterone cypionate injection is for intramuscular use only. It should not be given intravenously. Intramuscular injections should be given deep in the gluteal muscle. The suggested dosage for testosterone cypionate injection varies depending on the age, sex, and diagnosis of the individual patient Dosage is adjusted according to the patient's response and the appearance of adverse reactions. Various dosage regimens have been used to induce pubertal changes in hypogonadal males; some experts have advocated lower dosages initially, gradually increasing the dose as puberty progresses, with or without a decrease to maintenance levels Other experts emphasize that higher dosages are needed to induce pubertal changes and lower dosages can be used for maintenance after puberty. The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose. For replacement in the hypogonadal male, 50 to 400 mg should be administered every two to four weeks
2 DOSAGE AND ADMINISTRATION Dosage and Administration for testosterone gel, 1.62% differs from testosterone gel, 1%. For dosage and administration of Testosterone Gel, 1% refer to its full prescribing information. (2) Prior to initiating Testosterone Gel, 1. 62%, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range. 2.1 Dosing and Dose Adjustment The recommended starting dose of testosterone gel, 1.62% is 40. 5 mg of testosterone (2 pump actuations) applied topically once daily in the morning to the shoulders and upper arms. The dose can be adjusted between a minimum of 20. 25 mg of testosterone (1 pump actuation) and a maximum of 81 mg of testosterone (4 pump actuations).
The dosing of testosterone depends on the specific product and the individual patient's needs.
- For testosterone cypionate injection 2, the dose is adjusted according to the patient's response and the appearance of adverse reactions, with a typical dose of 50 to 400 mg administered every two to four weeks for replacement in hypogonadal males.
- For testosterone gel, 1.62% 3, the recommended starting dose is 40.5 mg of testosterone (2 pump actuations) applied topically once daily, with dose adjustments made based on pre-dose morning serum testosterone concentration. The dose can be adjusted between a minimum of 20.25 mg and a maximum of 81 mg of testosterone.
From the Research
Testosterone Dosing Methods
- Weekly-to-biweekly injections of testosterone cypionate or testosterone enanthate are widely used for the treatment of male hypogonadism, as they are economical and generally well tolerated 4
- Once-daily transdermal therapies, including patch and gel systems, have become increasingly popular for testosterone replacement therapy 4
- Intramuscular injection of testosterone undecanoate is an attractive new therapy that can be administered quarterly 4
- Subcutaneous testosterone enanthate autoinjector (SCTE-AI) is a novel treatment option that provides a lower testosterone peak-to-trough ratio, mitigating significant rises in estradiol, hematocrit, and prostate-specific antigen 5
Dosing Considerations
- Assessment of clinical responses and measurement of serum testosterone levels are generally sufficient to confirm an adequate replacement dosage 4
- Serial measurement of bone mineral density during androgen therapy may be helpful to confirm end-organ effects in selected men 4
- For men aged >50 years, measurement of hematocrit and a digital rectal examination with a serum prostate-specific antigen level measurement are recommended for detection of polycythemia and prostate cancer screening during the first few months of androgen therapy 4
Guidelines for Testosterone Replacement Therapy
- The Society for Endocrinology has commissioned guidelines for testosterone replacement therapy in male hypogonadism, providing a multidisciplinary approach to treating patients with MH 6
- Urologists may commonly diagnose hypogonadism in adult men, and careful dosing and monitoring are necessary to achieve therapeutic benefit reliably and sustainably 7