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Testosterone replacement therapy (TRT) has advanced significantly in recent decades. Today, TRT is available in countless forms, offering more convenience and ensuring better treatment compliance for patients. Oral testosterone, in particular, has brought many benefits and few side effects.
Your doctor may prescribe TRT if your testosterone levels are too low and if lifestyle changes don’t yield sufficient results. Depending on your preferences and individual needs, your provider may recommend oral testosterone, injections, pellets, or topical treatments, such as patches or gels.
FDA-approved oral testosterone undecanoate has been around for some time but newer forms of it have emerged in recent years. With oral medications usually being the first line of treatment, oral testosterone undecanoate approved by the FDA can offer patients more flexibility and control.
Oral Testosterone History
While testosterone replacement therapy has changed over the years, testosterone was first synthesized for medical use a long time ago. In 1935, Ernst Lacquer, a Swiss pharmacologist, was able to isolate testosterone from bull testes. That same year, Adolf Butenadt from Germany and Leopold Ruzicka from Switzerland, independently synthesized a pure form of testosterone for the first time.
Today testosterone is available in many forms and continues to advance rapidly — enhancing efficacy, providing more flexible and pain-free therapy options, and reducing the risk of side effects.
Since the 1950s, however, injectables have been the most commonly prescribed form of testosterone, with longer-acting formulations being especially popular. Today, physicians primarily prescribe testosterone enanthate or testosterone cypionate for patients requiring testosterone injections.
Nonetheless, there are many downsides to injectables, generally requiring frequent administration visits and having a certain level of pain tolerance. They can also cause side effects like erythrocytosis.
Erythrocytosis refers to an excess of red blood cells in your blood, which can lead to headaches and fatigue. It can also increase blood viscosity so much that you become at risk of blood clots and stroke.
Oral testosterone undecanoate was developed in the 1970s after valuable lessons were learned from oral testosterone’s initial formulation — known as 17α-methyltestosterone.
Today, oral testosterone is designed to bypass the liver and is absorbed into the lymphatic system. Because oral testosterone doesn’t simply replace your testosterone through exogenous therapy, its effects on your own testosterone production are considered less severe.
The Food and Drug Administration (FDA) approved the first oral testosterone, Jatenzo, in 2019, with currently two more versions of oral testosterone undecanoate, Tlando and Kyzatrex, on the market.
All FDA-approved oral testosterone undecanoate is taken twice daily with food, once in the morning and once in the evening. Oral testosterone is especially convenient and easy to administer so that treatment compliance becomes a breeze.
Jatenzo is usually administered as a 237 mg capsule, albeit higher and lower doses are available. Tlando contains 112.5 mg per capsule and is generally administered as 2 capsules at a time. Kyzatrex, in turn, is available in three doses: 100 mg, 150 mg, and 200 mg.
Oral Testosterone Side Effects
As with all medications, testosterone replacement therapy can potentially lead to side effects. All forms of testosterone therapy, regardless of their route of administration, can have side effects — albeit they can differ. For most patients, the benefits of testosterone therapy, however, outweigh the risks, providing symptomatic relief and raising testosterone levels.
Despite the high efficacy of testosterone, you should be aware of the side effects of oral testosterone (or other testosterone therapies) and discuss your symptoms with a qualified healthcare professional.
Your doctor will also monitor your health and an array of lab values that could potentially be tied to side effects. Many side effects of oral testosterone are not common but can occur.
Some of the side effects of oral testosterone include:
- indigestion and heartburn,
- dizziness,
- enlarged prostate,
- headache,
- loss of appetite,
- bone and muscle pain, and
- irritability.
Another common side effect of oral testosterone (Jatenzo, Tlando, and Kyzatrex) can be high blood pressure which could potentially increase your risk of cardiovascular disease. At regular office visits, however, your doctor will check your vitals, including your blood pressure, to ensure you can continue to safely take testosterone.
In addition, all forms of testosterone can potentially cause erythrocytosis — an increase in red blood cells. Interestingly, oral testosterone formulations (and intranasal testosterone) have the lowest rates of erythrocytosis. Oral testosterone erythrocytosis rates are 0.03%, which means their risk is very low.
A further aspect to consider for the testosterone treatment of your choice is that many forms of TRT suppress the gonads and impair the synthesis of LH (luteinizing hormone) and FSH (follicle-stimulating hormone) so much that your in-house testosterone and sperm production are near to zero.
FDA-approved oral testosterone undecanoate, however, seems to preserve LH and FSH, keeping your own production of testosterone functional.
Benefits of FDA-Approved Oral Testosterone Undecanoate
Oral testosterone undecanoate approved by the FDA offers patients benefits over some of the more conventional testosterone treatment options. The oral testosterone vs. injection comparison is particularly important because injections remain popular among some providers.
Oral testosterone vs. injection benefits:
- No pain
- No mess
- Easy and convenient
- Doesn’t require additional appointments for drug administration
- Available in multiple doses
- Lower rates of erythrocytosis
- Preserves your own testosterone production
To increase compliance and ensure you’re able to abide by your testosterone regimen, FDA-approved oral testosterone undecanoate marks an easy and effective therapy option.
Which Route of Administration Works Best for You?
Testosterone comes in many forms and sizes thanks to extensive research and advances in medicine. Today, oral testosterone alone is available under three brand names with testosterone deficiency being well understood by physicians and researchers alike.
But low testosterone is also becoming more and more prevalent due to poor lifestyle choices and widely spread unhealthy dietary patterns. This means that research into mechanisms of testosterone synthesis and impaired testosterone production remains highly relevant.
Testosterone therapy is available via various routes including pellets, intranasal gels, and topical agents. However, oral testosterone undecanoate approved by the FDA remains a reliable option for patients who seek convenience and limited side effects. Ask your doctor for more information about oral testosterone today!
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