Oral testosterone in the form of an ingestible pill is not currently approved by the powerful organisation called FDA for use in the United States of America.
Although oral testosterone may be found in the underground market, most such forms pose significant health risks to the user, such as severe liver damage, because the testosterone must be modified so that it can pass through the liver.
Because of this, oral testosterone is not currently available for use in testosterone replacement therapy in the United States.
Summary of How Oral Testosterone Affects the Human Body
Because the liver neutralizes oral testosterone, the testosterone molecule must be modified in order for it to make its first pass through the liver unchanged. In particular, the testosterone molecule has a methyl group installed at the 17th carbon (C-17) position.
However, in addition to allowing the molecule to survive the first pass through the liver, methylating the C-17 alpha position causes substantial liver toxicity. Furthermore, this modified form of testosterone impacts negatively on the lipid profile (lowering of HDL cholesterol).
Testosterone unecanoate is the only form of oral testosterone proven to be safe as it does not need to pass through the liver since it is delivered in an oily vehicle that is initially absorbed by the lymphatic system. Testosterone unecanoate is marketed under several brand names, such as Andriol, Undestor, and Nebido; however, it is not available for use in the United States. For men outside of the United States, it is moderately safe and simple to dose.
Although a 10-year study has proven long-term use to be safe, it still has the potential for liver toxicity. In addition, it has a short half-life. Because of this, it needs to be taken up to four times a day and may cause fluctuation in testosterone levels throughout the day.
A new drug application for the first orally obtainable testosterone formulation was submitted to the US Food and Drug Administration (FDA) by Clarus Therapeutics in January 2014. However, in September of that year, a US FDA advisory committee voted to deny the approval of Clarus Therapeutics’ testosterone unecanoate gel capsules as a testosterone replacement therapy option.
Benefits of Orally Available Testosterone:
• It is simple to calculate dosage and to ingest.
• Outside of the United States, testosterone undecanoate is the only safe form because, unlike other oral forms, it does not damage the liver. However, the FDA has not approved any form of oral testosterone for use in the United States.
Negatives of Orally Available Testosterone:
• Potential liver damage
• Needs to be taken multiple times per day
• May cause fluctuation in testosterone levels
• Not FDA-approved for use in the United States
There are no FDA approved suppliers of oral testosterone in the United States at this time.
In the United States, oral testosterone is not used in testosterone replacement therapy in men. It should be noted that oral testosterone differs from testosterone lozenges, as oral testosterone is actually swallowed while the lozenges are absorbed through the user’s gums. More commonly used treatment options are injections, transdermal gels, nasal gels and pellets.
While testosterone injections have been available for decades, testosterone gels are relatively new. Testosterone cypionate and enanthate are the two most common generic injectable forms available in the United States. If self-administered, the generic injectable forms are very inexpensive.
On the other hand, because testosterone gels are only available under a brand name (such as Androgel, Axiron, Bio-T-Gel, Fortesta, and Testim), they are more expensive. A third testosterone replacement therapy option is pellets, which a physician implants under the skin.
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