Oral Capsules for Testosterone Replacement

Understanding Low Testosterone

Low testosterone, also known as hypogonadism, occurs when the body does not produce enough testosterone, a critical hormone that influences various bodily processes, including growth, development, cognitive function, and sexual health. Insufficient testosterone can lead to significant health issues, disrupting normal body functions and resulting in various symptoms.

Symptoms of Low Testosterone

• Lack of energy
• Reduced sex drive
• Depression or anxiety
• Weight gain
• Lower bone density
• Reduced muscle mass
• Difficulty sleeping

These symptoms can also be associated with other medical conditions. Therefore, a thorough evaluation by a healthcare provider is necessary to accurately diagnose low testosterone before initiating any treatment.

Testosterone Replacement Therapy

Testosterone replacement therapy (TRT) is the primary treatment for low testosterone. This therapy can be administered in several forms:

• Gels: These are easy to apply but can lead to inconsistent dosages and pose a risk of transferring testosterone to others through skin contact before the gel has dried
• Injections: Provide consistent dosages and are commonly used despite the discomfort some may feel from the injections. This method requires monitoring for fluctuating hormone levels, potentially necessitating medical visits every two weeks
• Pellets: Implanted under the skin, these release a steady dose of testosterone for up to six months, minimizing daily management. However, their placement can be painful and may cause scarring
• Oral Capsules: Offer a consistent dosage and are simple to take, making them a pain-free option compared to other methods

Choosing the right form of testosterone replacement involves considering factors such as convenience, side effects, medical advice, and personal preferences. Always consult a healthcare provider to select the most appropriate treatment based on your needs and lifestyle.

Oral Testosterone Replacement Therapy (TRT)

The major advantage of oral TRT is the convenience and non-invasiveness of the treatment. With the development and approval of oral testosterone undecanoate, testosterone therapy has become more accessible and convenient, significantly enhancing patient compliance and satisfaction.

Testosterone Undecanoate

Normally, when testosterone is taken orally, it quickly gets broken down by the liver before it can have any effect. One way to modify testosterone for oral medication is by combining it with another chemical called undecanoic acid. This process is known as "esterification." When testosterone is "esterified" with undecanoic acid, it results in a new form called testosterone undecanoate, the active ingredient in all FDA-approved oral TRT products.

By being esterified, testosterone undecanoate can be absorbed through the lymphatic system (a part of the immune system) rather than going directly through the liver. This allows it to enter the bloodstream effectively and in a more controlled manner.

Oral Testosterone Replacement Options

As of now, several FDA-approved oral testosterone undecanoate products are available on the market:

• Jatenzo: Approved in 2019, Jatenzo is the first oral option approved that does not require liver monitoring
• TLando: Offers a unique dosing flexibility that can be tailored to the needs of individual patients
• Kyzatrex: The latest to receive approval, Kyzatrex emphasizes its dosing efficacy and patient-friendly regimen

The mechanism of action is consistent across these products. They all rely on the presence of dietary fats for optimal absorption. Because these products bypass the liver, they are generally considered safe for long-term use.

Administration and Strengths

Each of these medications must be taken with food, specifically with meals that include fats, to ensure proper absorption of testosterone undecanoate. This dietary requirement is crucial for the effectiveness of the therapy.

Available strengths:

• Jatenzo: 158 mg, 198 mg, 237 mg
• TLando: 112.5 mg
• Kyzatrex: 100 mg, 150 mg, 200 mg

Supplements vs. FDA-Approved Testosterone

Many over-the-counter supplements claim to boost testosterone levels, but their safety and efficacy are questionable. Unlike FDA-approved medications, which undergo rigorous testing to confirm their safety and effectiveness, supplements are regulated as food products. They do not adhere to the stringent regulations that govern pharmaceutical drugs. As a result, few supplements have been scientifically proven to significantly increase testosterone levels, and some may pose serious health risks.

It is vital to critically evaluate the claims made by supplement manufacturers and consult a healthcare provider regarding health concerns. If symptoms of low testosterone are present, identifying the underlying cause is crucial to obtaining safe and effective treatment. For those diagnosed with a condition that causes low testosterone, the best course of action is treatment with an FDA-approved medication prescribed by a healthcare provider. If there is no medical need for testosterone replacement, the potential risks of taking supplements likely outweigh any benefits.