No Oral Form of Testosterone Enanthate is Available in the United States
There is no FDA-approved oral form of testosterone enanthate available in the United States, and oral testosterone preparations are strongly discouraged due to significant hepatotoxicity risks. 1
Available Testosterone Formulations
Testosterone enanthate is primarily available as an injectable formulation in the United States. According to clinical guidelines, the following formulations of testosterone enanthate exist:
- Injectable testosterone enanthate:
- Supplied as 200 mg/mL
- Typical dosing: 100-200 mg every 2 weeks or 50 mg weekly
- Administration: Intramuscular injection (thigh for self-injection, gluteal when administered by another person) 1
Oral Testosterone Preparations and Hepatotoxicity
Oral preparations of testosterone have been associated with significant health risks:
- Hepatotoxic effects
- Benign and malignant liver tumors
- Other serious adverse effects 1
While testosterone undecanoate is an oral preparation with less hepatotoxicity, it was not available in the United States as of 2004 1. Although the FDA approved an oral formulation of testosterone undecanoate in 2020, it is specifically contraindicated for "age-related hypogonadism" that is not associated with structural or genetic etiologies due to:
- Demonstrated increases in blood pressure
- Lack of established efficacy 1
Alternative Testosterone Delivery Methods
For patients requiring testosterone replacement therapy, safer alternatives to oral formulations include:
Intramuscular injections:
- Testosterone enanthate or cypionate
- Advantages: Relatively inexpensive, flexible dosing, no risk of transference
- Disadvantages: Requires injection, fluctuating testosterone levels 1
Transdermal preparations:
- Gels, patches, solutions
- Advantages: Easy application, good skin tolerability
- Disadvantages: Potential for transfer to others, skin irritation, sometimes more expensive 1
Other formulations:
- Buccal tablets
- Subcutaneous implants (pellets)
- Extra-long-acting injections (testosterone undecanoate) 1
Research on Oral Testosterone Enanthate
Some research has explored oral testosterone enanthate in oil combined with dutasteride, which showed potentially therapeutic increases in serum testosterone 2. However, this approach remains experimental and is not FDA-approved for clinical use.
Clinical Implications
When considering testosterone replacement therapy, clinicians should:
- Avoid oral testosterone preparations due to hepatotoxicity risks
- Select appropriate formulations based on patient preference, cost considerations, and clinical factors
- Monitor patients receiving testosterone therapy for potential adverse effects including polycythemia, elevated PSA, increased blood pressure, and fluid retention 1
- Perform baseline and follow-up assessments including PSA, hematocrit/hemoglobin, and digital rectal examination 1
The injectable form of testosterone enanthate remains the most commonly used and safest option when this specific ester is required for treatment.