The Evolution of Oral Testosterone
For decades, oral testosterone replacement therapy (TRT) was associated with significant liver toxicity due to older formulations like methyltestosterone. However, modern pharmaceutical advancements have led to the development of safer alternatives that bypass the liver's first-pass metabolism. These newer oral pills, which contain testosterone undecanoate (TU), are absorbed primarily through the intestinal lymphatic system, mitigating the risk of liver damage and making oral TRT a viable and convenient option for many men.
These FDA-approved oral TU formulations are prescribed for men with hypogonadism, a condition characterized by low testosterone levels and associated symptoms. The goal of therapy is to restore testosterone to a normal, healthy range, which can lead to improvements in energy, mood, bone density, libido, and sexual function.
Key FDA-Approved Oral Testosterone Undecanoate Pills
Today, there are three main FDA-approved oral testosterone undecanoate products, each with distinct features. A thorough medical evaluation is necessary to determine which option is most suitable for an individual's specific circumstances.
- Jatenzo (testosterone undecanoate): Approved in 2019, Jatenzo features a self-emulsifying drug delivery system (SEDDS) that facilitates absorption with typical meals. The prescribed amount and frequency of administration are determined by a healthcare provider based on the patient's medical needs. While effective, the retail cost can be high, though insurance coverage and manufacturer rebates may help.
- Kyzatrex (testosterone undecanoate): Approved in 2022, Kyzatrex uses a different formulation involving phytosterols to maximize lymphatic absorption. It has demonstrated high effectiveness in normalizing testosterone levels and is often more affordable through certain pharmacies. The prescribed amount and frequency of administration are determined by a healthcare provider based on the patient's medical needs.
- Tlando (testosterone undecanoate): Also approved in 2022, Tlando utilizes a unique predigested triglyceride lipid formulation. It is available in a specific strength, which the manufacturer claims reduces the need for frequent adjustments. Patients are monitored to ensure they reach therapeutic levels, and the medication may be discontinued if levels are not optimized.
Comparison of Oral Testosterone Pills
To aid in the decision-making process, the following table compares the key features of the primary oral testosterone undecanoate medications. This is for informational purposes only; a healthcare provider's consultation is essential for personalized advice.
| Feature | Jatenzo | Kyzatrex | Tlando |
|---|---|---|---|
| Approval Year | 2019 | 2022 | 2022 |
| Administration Frequency | Twice daily | Twice daily | Twice daily |
| Available Strengths | Multiple strengths available | Multiple strengths available | One strength available |
| Potential for Adjustment | Yes, based on blood levels | Yes, based on blood levels | Designed for fixed administration |
| Mechanism | Self-emulsifying drug delivery system (SEDDS) | Phytosterol-based formulation | Predigested triglyceride lipid formulation |
| Cost | Often high retail cost; potentially reduced with insurance | Generally more affordable, depending on pharmacy and insurance | Cost effective, especially for patients with insurance |
Benefits and Risks of Oral Testosterone
While a convenient option, oral TRT involves considering its unique benefits and risks.
Benefits
- Convenience: The pill format is often preferred by patients who wish to avoid injections or messy topical gels.
- Discreet: Oral administration is discreet and eliminates the risk of transference to partners, women, or children, which is a significant concern with topical gels.
- Flexibility: Some oral formulations offer the possibility of adjusting the amount taken, allowing for fine-tuning based on blood test results. In case of adverse effects, cessation of therapy leads to a rapid return of testosterone levels to baseline.
- Stable Hormone Levels: Oral TU bypasses liver metabolism, leading to a more stable hormonal profile compared to some older formulations.
Risks and Side Effects
- Cardiovascular Risks: Oral testosterone undecanoate can increase blood pressure, which raises the risk of heart attack and stroke, especially in patients with pre-existing heart conditions.
- Blood Clotting: A potential side effect is anN increase in red blood cell count (polycythemia), which can increase the risk of blood clots.
- Worsening Conditions: Oral TRT can worsen symptoms in men with an enlarged prostate (BPH) or pre-existing sleep apnea.
- Effect on Fertility: Testosterone therapy can decrease sperm production, leading to infertility. Men planning to have children should discuss this with their doctor.
- Monitoring Required: All patients on oral TRT require regular monitoring, including blood tests for testosterone levels, red blood cell counts, and prostate-specific antigen (PSA), in addition to regular blood pressure checks.
Alternatives to Oral Testosterone
For patients for whom oral medication is not the best fit, or if there are contraindications, several alternative TRT options exist.
- Injectable Testosterone (e.g., Testosterone Cypionate, Testosterone Enanthate): Injections are often a cost-effective option and remain a first-line treatment for many patients. They can provide steady hormone levels, though some patients may experience fluctuations in mood or energy between administrations.
- Topical Gels and Patches: These transdermal options deliver testosterone through the skin. They are convenient but carry a risk of transferring the medication to others.
- Intranasal Gels (e.g., Natesto): This method involves applying a gel inside the nostrils. It provides another needle-free option, though it requires more frequent administration.
- Subcutaneous Pellets (e.g., Testopel): Pellets are implanted under the skin, providing a long-lasting and convenient form of TRT that lasts for months.
- Oral Alternatives (e.g., Clomiphene Citrate): For men concerned about fertility, certain oral medications like clomiphene can stimulate the body's own testosterone production without suppressing sperm count.
Conclusion
There is no single “best” oral testosterone pill for everyone. The FDA-approved oral testosterone undecanoate products—Jatenzo, Kyzatrex, and Tlando—offer a safe and effective oral option for men with hypogonadism by bypassing liver metabolism. The choice between these depends on individual factors like the potential for adjusting the amount taken, potential cost, and lifestyle preferences. All oral TRT requires a doctor's prescription and careful monitoring due to potential risks, including cardiovascular and hematological effects. Ultimately, the best course of action is a comprehensive discussion with a healthcare provider who can assess a patient's overall health and recommend the most suitable treatment plan, which may or may not be an oral medication.
