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Study Finds Oral Testosterone Therapy Undecanoate Is Effective With No Liver Toxicity

Safety profile consistent with non-oral testosterone replacement products

The Endocrine Society

WASHINGTON–An industry-supported study of an oral testosterone replacement therapy , testosterone undecanoate finds it is an effective, long-term treatment for men with low testosterone levels, with no evidence of liver toxicity. The findings are being presented virtually at ENDO 2021, the Endocrine Society’s annual meeting.

TST is currently available in multiple modes of administration, including implantable pellets, transdermal gels and intramuscular injections.

“For many men with low testosterone levels, an oral option is preferred to avoid issues associated with other modes of administration, such as injection site pain or transference to partners and children,” said lead researcher Ronald S. Swerdloff, M.D., of the Lundquist Research Institute in Torrance, California. “Before TU was approved, the only orally approved TST in the United States was methyl-testosterone, which was known to be associated with significant chemical-driven liver damage.”

The U.S. Food and Drug Administration approved TU in March 2019, and the medication was made commercially available in February 2020.

“Our study finds TU is an effective oral therapy for men with low testosterone levels and has a safety profile consistent with other approved testosterone products, without the drawbacks of non-oral modes of administration,” Swerdloff said.

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Advisory Committee Unpersuaded By New Trial Data For Tlando Jatenzo

This article is a collaboration between MedPage Today and:

HYATTSVILLE, Md. — An FDA advisory committee voted 13-6 today against recommending the approval of the oral testosterone undecanoate capsule Tlando for the treatment of hypogonadism in adult males.

Just one day prior, the same Bone, Reproductive, and Urologic Drugs Advisory Committee split on whether to recommend another oral testosterone undecanoate capsule, Jatenzo , for the same indication. That vote was 10-9 against approval.

Both companies were seeking an indication for the class of approved therapies for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, including congenital or acquired primary hypogonadism and congenital or acquired hypogonadotropic hypogonadism.

Hypogonadism in males is marked by a lack of testosterone production, which may lead to symptoms such as infertility, osteoporosis, erectile dysfunction, emotional changes, and more.

Currently, there is only one available form of oral treatment approved for testosterone therapy, methyltestosterone . However, it is seldom prescribed because of hepatotoxicity risk. Most commonly prescribed forms of treatment currently include injectable and topical treatments. The undecanoate formulation makes testosterone more lipophilic, allowing absorption through the intestinal lymphatic system and thereby bypassing liver metabolism.



Why Do We Need A Pct

Types of Testosterone Replacement Therapy

Loading your body with testosterone is like kryptonite for Superman. It enhances the male characteristics.

It makes you feel more of a man, and creates stronger, leaner and more alpha version of yourself.

This means more muscle, more strength, less fat plus more confidence and less of the dreaded irritable male syndrome basically helps control that grumpy side of you.

This issue faced is that when you take the drugs your body can recognize the need to stop producing testosterone, this is very clever and very efficient.

It is almost like cylinder de-activation in a car.

The car recognizes that theres no need for 8 cylinders gobbling up fuel on a highway run so shuts 4 cylinders down.

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Diseases And Conditions That Affect Testosterone

Men can experience a drop in testosterone due to conditions or diseases affecting the:

  • Testes direct injury, castration, infection, radiation treatment, chemotherapy, tumors
  • Pituitary and hypothalamus glands tumors, medications , HIV/AIDS, certain infections and autoimmune conditions

Genetic diseases, such as and hemochromatosis can also affect testosterone.

Women may have a testosterone deficiency due to diseases of the pituitary, hypothalamus or adrenal glands, in addition to removal of the ovaries. Estrogen therapy increases sex hormone binding globulin and, like aging men, this reduces the amount of free, active testosterone in the body.

Low Levels Due To Aging

Testosterone levels may decline gradually with age. The United States Food and Drug Administration stated in 2015 that neither the benefits nor the safety of testosterone supplement have been established for low testosterone levels due to aging. The FDA has required that labels on testosterone include warnings about increased risk of heart attacks and stroke.

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Eat Plenty Of Fat And Cholesterol

Like you would on the Bulletproof Diet.

Heres how your body makes testosterone:

Cholesterol > pregnenolone > androstenedione > testosterone

Testosterone begins with cholesterol. In fact, every single sex hormone you make you synthesize from cholesterol thats one reason a heart healthy low-fat, low-cholesterol diet limits your performance. Fat and cholesterol dont make you fat. They give your body the building blocks to create abundant testosterone and other sex hormones, which actually makes you lose weight and build muscle, especially if your current testosterone levels are low .

You may find this hard to believe, but some common breakfast foods like Kelloggs corn flakes and Graham crackers were invented 100 years ago to lower male libido. Kellogg and Graham believed that male sexual desire was the root of societys problems, so they set out to make bland foods that would take away libido . That low fat, grain-based thing absolutely works wonders for lowering testosterone.

The other component of that study is that the subjects ate much less saturated fat. Saturated fats are common in meat, butter, and coconut products, and theyre crucial for your body to function. Saturated fats keep the integrity of your cell membranes, and if you limit carbs and/or do Bulletproof Intermittent Fasting, saturated fats become a phenomenal source of energy for your brain.

If I Take Testosterone Pellets Will I Need Dhea Supplementation

Testosterone Undecanoate – Oral & Intramuscular: Safe, Effective, Ethical? – Doctors Analysis

The reason someone might need DHEA is because their testosterone level is good, but they still have sagging skin. In this case, we recommend only 7 keto-DHEA in doses of 25 mg or less. Other types or doses above 25 can cause an increase in estrone which means weight gain and and increased risk of breast cancer.

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How Can I Boost My Libido Male

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How To Take A Testosterone Booster When Fasting

Its best to take supplements with meals, which is why you should probably avoid taking testosterone boosters while fasting. Moreover, bear in mind that not enough research is done on the correlation between testosterone and fasting. Studies on the connection between the two and how they affect each other are still inconclusive.

Can You Drink Testosterone Cypionate

Should You Use An Oral Steroid During Your Bulk Cycle?

Ask U.S. doctors your own question and get educational, text answers â it’s anonymous and free!

Ask U.S. doctors your own question and get educational, text answers â it’s anonymous and free!

HealthTap doctors are based in the U.S., board certified, and available by text or video.

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Why Are Pellets Better Than Patches Shots Or Pills

The reason we use pellets at BioBalance Health is because they contain the pure hormone and are not metabolized into byproducts that will cause side effects or inactivate the testosterone before you use them. This unique delivery system allows this pure hormone to be delivered directly to the blood stream. Pellets act as a reservoir of hormone that allows your body to take as much testosterone or estradiol as your body needs at any one time. When you are exercising, you have an increased pulse and cardiac output so you absorb more hormone. Because BioBalance pellets are bioidentical, and because of their efficient delivery system, women are more likely to feel better on pellets than with any other form of estrogen or testosterone replacement.

Jatenzo An Oral Testosterone Replacement Therapy Now Available

Jatenzo® , an oral testosterone replacement therapy, is now available for the treatment of hypogonadism.

Specifically, Jatenzo is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

  • Primary hypogonadism : testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone, luteinizing hormone above the normal range.
  • Hypogonadotropic hypogonadism : gonadotropin or luteinizing hormone-releasing hormone deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.

Jatenzo is not intended for use in males with age-related hypogonadism and its safety and efficacy have not been established in males < 18 years old.

Jatenzo, a Schedule III controlled substance, is available in 158mg, 198mg, and 237mg softgels. Dosage should be individualized based on serum testosterone concentrations.

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Risks Of Testosterone Therapy

Testosterone replacement therapy side effects most often include rash, itching, or irritation at the site where the testosterone is applied.

However, there is also evidence of a possible increased risk of heart attack or stroke associated with testosterone use. Experts emphasize that the benefits and risks of long-term testosterone therapy are unknown, because large clinical trials haven’t yet been done.

There are a few health conditions that experts believe testosterone therapy can worsen:

It will be years before large clinical trials bring any answers on the long-term benefits and risks of testosterone therapy. As with any medicine, the decision on whether the possible benefits outweigh any risks is up to you and your doctor.

Prescription Testosterone Pills Why We Prefer Testosterone Injections

Testosterone + Anavar Cycle – Harm Reduction
Theres a reason why we prefer testosterone injections over prescription testosterone pills, but why is that? Heres why you should be choosing injections.

When we think about testosterone, we link it to sex drive. But did you know that it affects other factors in mens health? These include body fat, muscle mass, red blood cell count, and mood.

A comparison study shows that the testosterone drug industry in the US has grown from 2.4 to 3.8 billion. Men all over the country have begun taking advantage of new technology to ensure that their bodies are in tip-top shape.

There are several testosterone supplements on the market that can help boost your testosterone levels. Prescription testosterone pills and testosterone injections are two popular options.

While you may be tempted to try testosterone pills because it seems much easier, you may want to rethink your options. Although prescription pills are widely available, medical professionals do not recommend this option.

Read on to learn about why testosterone injections are much better than prescription testosterone pills.

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Under What Circumstances Would I Have To Stop Biobalance Health Pellets

About 5% of our patients are not cured of the problems they wanted to treat. Sometimes, this is because the pellets are causing an effect that does not fit their lifestyle, such as a libido when they are unmarried or feel they are too old to engage in intercourse.

In some cases, women will not experience healing as quickly as they would like. Patients with chronic fatigue are helped by testosterone replacement, but they dont feel the resolution of symptoms as quickly as women who do not have that illness. Women who have psychiatric illnesses and are on multiple medications may not feel as healthy as women who do not have those illnesses. Lastly, if a patient develops breast cancer, then the estradiol pellets are not continued, although the testosterone pellets are safe to continue.

What Is Androgel And How Does It Work

AndroGel is synthetic testosterone mixed into a gel with alcohol that is applied to the skin once daily. The testosterone is absorbed into the skin for continuous 24-hour delivery into the body. The medication can cost as much as $500 a month, but some insurance companies cover it.

The drug is available in two strengths: 1 percent and 1.62 percent. Patients dispense the gel through a multi-dose pump or use single-dose packets. It is quick-drying, clear and odorless when dry.

The two dose strengths have different application sites. Patients can apply the 1-percent gel to the upper arms and shoulders as well as on both sides of the abdomen. For the 1.62-percent gel, the gel should only be applied to the upper arms and shoulders.

In men with Low T, the medication is intended to increase the total amount of circulating testosterone in the body to a normal range found in healthy men. According to the drug insert, this measurement is somewhere between 298 1043 ng/dl . If men use lotion or sunscreen, the amount of testosterone absorbed increases.

After applying AndroGel, men should wash their hands thoroughly with soap and water. It is also important to know that the drug is flammable until dry, and patients should avoid flames, smoking or fire.

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