What About Oral Forms of Testosterone?
By Jay Campbell
September 6th, 2018
When it comes to Testosterone Optimization Therapy (TOT), there is more than one way to optimize your testosterone levels. There are injections; however, not everyone is a fan of needles. A fear of needles shouldn’t stop you from getting the treatment you need which is why many men turn to transdermal testosterone gel. But what about the oral approach? Oral forms of testosterone address the issues that are typical in topicals and injectables. Topicals are messy to apply, and you have to wait for them to dry. There’s also the potential for skin irritation. Injectables, on the other hand, mean scarring or injection site reactions. There’s also pain from the injections and risk of infection. Oral forms of testosterone seem to be a more comfortable option with minimal side effects. Are oral forms of Testosterone the better alternative? Two oral forms of testosterone undecanoate recently awaited FDA review: Jatenzo and TLANDO. Both were designed to overcome many of the issues related to TOT products on the U.S. market. Each medication is a capsule form of testosterone undecanoate. Jatenzo, formerly known as Rextoro, of Clarus Therapeutics, re-applied for FDA approval after previously getting rejected. And in January 2018, the FDA handed a no-go vote to Jatenzo. Also in the same month, the FDA voted six in favor and thirteen against the benefit/risk profile of Lipocine Inc.’s TLANDO. In theory, both medications offer great promise when dosed as recommended (twice per day). They are absorbed via the lymphatic system, bypassing the liver (avoiding any potential liver issues). Additionally, many men prefer the convenience of an oral formulation over injections and creams. Other advantages of an oral delivery system exist, as stated by Dr. Theodore M. Danoff, Chief Medical Officer of Clarus Therapeutics (T = testosterone): “An oral T-replacement product would not only be convenient but would avoid many of the safety issues associated with an accidental transfer of T to women or children that can occur from transdermal T products. Moreover, published data indicates that men on transdermal T products often do not adhere to their treatment plan and we believe an oral option may improve this.” Most doctors prefer oral formulations for their patients due to better long-term adherence to their prescribed TOT protocol. In a recent survey of 28 leading endocrinologists and urologists, 94% responded that they believed an oral TOT formulation would improve patient compliance. However, previously created oral testosterone formulations of testosterone undecanoate like Andriol, haven’t lived up to their promise. Buccal Preparations The newest oral formulations showed promise as they can improve long-term patient adherence and compliance due to a common fear of needles. The Buccal preparation method involves oral testosterone absorbed by your gums, which then go directly into your bloodstream. Known as a “cyclodextrin-complexed testosterone sublingual formulation,” or a troche, this form of TOT is rapidly absorbed into circulation while the testosterone is released from the cyclodextrin shell. However, this is not an efficient method of getting testosterone into your system due to its poor bioavailability and absorption in the body. There are also the following potential side effects:
- dislodged tablets
- bleeding gums
- mouth sores
There is also the potential to transfer the substance to your partner via kissing! Overall, oral testosterone is an ill-advised TOT option. Additionally, when you use this method of TOT, you have to avoid eating and drinking for a while following administration so that you don’t negatively affect absorption. And there’s also a good reason why the FDA has denied approval. Ultimately, the choice is yours. To find out much more about Testosterone and its role in helping us achieve optimal mental health and physical performance, purchase The TOT Bible.