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. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. Hypogonadotropic hypogonadism (congenital or acquired)-idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. 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
The EU Authorization guidelines for hypogonadism are not explicitly mentioned in the provided drug labels. However, the labels do provide information on the indications and dosage of testosterone cypionate injection for replacement therapy in males with hypogonadism.
- The indications for testosterone cypionate injection include primary hypogonadism and hypogonadotropic hypogonadism 1.
- The dosage for replacement in hypogonadal males is 50 to 400 mg every two to four weeks 1. It is essential to note that these guidelines are based on the provided drug labels and may not be comprehensive or up-to-date.
From the Research
The European Association of Urology (EAU) guidelines for hypogonadism recommend testosterone replacement therapy (TRT) for men with symptomatic hypogonadism and consistently low testosterone levels, as supported by the most recent study 2.
Diagnosis and Treatment
Diagnosis requires both clinical symptoms (sexual dysfunction, fatigue, decreased muscle mass, cognitive issues) and biochemical confirmation with at least two morning total testosterone measurements below 12 nmol/L (350 ng/dL).
- Treatment options include:
- Injectable testosterone undecanoate (1000mg initially, followed by 1000mg at 6 weeks, then every 10-14 weeks)
- Testosterone enanthate or cypionate (50-250mg every 2-3 weeks)
- Transdermal gels (50-100mg daily)
- Patches (2-6mg daily)
Contraindications and Monitoring
Before initiating TRT, clinicians should screen for prostate cancer with PSA and digital rectal examination in men over 40, and assess for cardiovascular risk factors.
- Contraindications include:
- Prostate cancer
- Male breast cancer
- Severe heart failure
- Hematocrit >54%
- Desire for fertility
- Monitoring should include testosterone levels, hematocrit, PSA, and symptom improvement at 3,6, and 12 months after starting therapy, then annually.
Fertility Concerns
TRT aims to restore testosterone to mid-normal range while improving symptoms, sexual function, bone density, and body composition.
- Fertility concerns require specialized management as TRT suppresses spermatogenesis, and alternative treatments such as human chorionic gonadotropin, selective estrogen receptor modulator, estrogen antagonist, or an aromatase inhibitor may be used 2.