Category Archives: Testosterone Replacement Therapy

Hormone changes affect everyone, yet 73 percent of women in the U.S. do not seek medical help for menopause, according to the 2021 State of Menopause Study by Bonafide. These changes are one of the top reasons women come to see me. As a functional medicine doctor, Ive helped women manage this stage of their lives for more than 20 years. Its the visible symptoms that bring them in: night sweats or loss of hair. However, there are silent results of changing hormones that are equally as important to address. Before I explain a solution, I want to walk you through why women experience those symptoms, the different types of symptoms, and finally, what you can do to combat some of the issues.

In typical cases, hormones start to change in your early forties. Most women will feel like they have estrogen dominance symptoms. This is not because they make too much estrogen, but rather their ability to make enough progesterone which counters the effects of estrogen slows down. The symptoms may be heavy, irregular, and painful periods, breast tenderness and moodiness, insomnia, painful sex, vaginal dryness, and loss of libido. Symptoms tend to be worse, especially just before they start their period.

Several years later, usually between 48-52 years old, woman transition to menopause. This is a particularly difficult time as women may start having heavy periods off and on, worsening mood swings, highs and lows with irritability, insomnia, hot flashes, night sweats, weight gain, painful intercourse, vaginal dryness, urinary frequency, loss of libido, hair thinning and loss. Then, when a woman hasnt had a period for a year, she has officially entered menopause.

When it comes to hormone changes, women see me for two specific reasons: feelable and invisible symptoms. Feelable symptoms are the ones you can physically feel. These affect your daily life. They can range from hot flashes to night sweats, insomnia to mood swings, irritability to memory loss, and even weight gain and hair loss.

These are symptoms you cannot feel but greatly impact your life. Hormone changes can wreak havoc on your bones and muscles in the form of osteoporosis or osteopenia, leading to hip fractures which can be life-changing. Your cognitive health can decline as well as increasing fears of memory loss and Alzheimers dementia. You may experience heart disease in the forms of high blood pressure and high cholesterol which are leading causes of strokes and heart attacks. Another silent symptom is an increase in insulin resistance leading to belly fat weight gain and diabetes.

Many women feel they just have to deal with all of these changes. That could not be further from the truth. The information Im about to provide can be an absolute game changer in your life.

Bioidentical hormone replacement, as opposed to synthetic hormone replacement, is using hormones like estradiol, that your body recognizes as biologically identical to the hormones that you naturally make. Synthetic hormones, like the ones found in Premarin, come from a horses urine and are not identical to what your body naturally makes.

The old thoughts that hormones are dangerous for you are based on studies done on synthetic hormones that are bad for you. However, Ive found that bioidentical hormones are recognized by your body and it reacts accordingly.

I use specialized testing to look at how a woman is breaking down estrogen. The goal is to make sure her body can process the hormones properly. The next step is to balance hormones using bio-identical estrogen, progesterone, and testosterone. Once a balance is established, there is lab testing before and during to make sure the dosage is correct. Of course, I have follow-up visits to make sure symptoms have improved. When you combine all this together, not only do you not have to live with these menopause symptoms, but you can safely navigate this period of your life and improve longevity and vitality for years to come.

If hormone replacement therapy is done properly, it can reduce the risk of heart attacks, strokes, Alzheimers dementia, and broken hip bones. Not to mention improving quality of life, improving libido, vaginal dryness complaints, insomnia, hot flashes/night sweats, mood stabilization and decreasing risk of depression.

Clinical trials, including Heart and Estrogen/Progestin Replacement Study I and the Womens Health Initiative, have shown that conventional hormone replacement results in increased thrombotic events, an increased risk of breast cancer, and dementia. However, biodentical hormone therapy used by functional medicine doctors do not carry these increased risks.

Using transdermal creams or patches or bioidentical estrogen hormones and progesterone, not progestin, does not afford the same risks. This is why current and more advanced hormone replacement therapy is safer.

I have found additional ways to help my patients navigate their changing hormones. However, you would want to consult your doctor if you have any questions about trying these yourself.

In addition to bioidentical hormone replacement therapy, there are things you can do to limit your symptoms and yes, it does start with your diet. I recommend limiting your processed foods. Essentially, this is anything that comes out of a box or a bag. Try to eat about 3 to 4 cups of vegetables, 1 to 2 servings of fruit, healthy fats, and proteins every day.

Get a good nights sleep, exercise, and make sure you incorporate self-care, like a bath, sauna, or massage to alleviate stress. I also recommend taking magnesium, taurine, NAC, and B complex vitamins to help mitigate some symptoms.

You can help your bone density by doing weight-bearing exercises or joining a club called OsteoStrong. There are some supplements I recommend like Ossopan MD. Its a highly absorbable form of calcium plus essential minerals that you can get from a functional medicine doctor along with Vitamin K2 and D3.

If youre concerned about heart disease, you should limit simple sugars, basically anything white like bread, pasta, candy, and ice cream. The foods I recommend are whole food oils like avocado and olives, proteins, and foods found in the Mediterranean diet. I will also recommend Omega-3 fatty acids, magnesium, CoQ10, niacin, bergamot, berberine, alpha lipoic acid, and taurine based on a specialized lipid study. HITT workouts and intermittent fasting can also help lower your risk for heart disease. Always consult with your doctor first.

The final invisible symptom I would like to address is cognitive decline. In addition to exercise and sleep, I highly recommend Grain Brain by Dr. David Permutter. You can also find other suggestions in my previous article about improving cognitive function.

Hormone changes are inevitable. I strongly recommend arming yourself with information and asking lots of questions. You may have to live with changing hormones, but that does not have to adversely change your life.

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The One Thing This Doctor Says Is A Game Changer When It Comes To Hormones And Aging - TravelAwaits

Strictly Come Dancings Head Judge Shirley Ballas has forged a glittering career to date and is gracing our screens once more, as the latest celebrities take to the dance floor for a new Strictly series.

But, as Shirley explains in her own words, its not all baubles, bangles and beads. Behind the scenes, Shirley has been managing her ongoing menopause journey, and she describes the early part of her experience as one of the darkest periods of her life.

Following her own difficulties, Shirley decided to speak out to help other women and has now joined the new Menopause Your Way campaign with QVC.

According to research commissioned by the campaign, only one in 10 women feel prepared for the landmark change. Of those who believed they knew what symptoms to expect, two in five still felt they did not have a clear understanding of how to manage them.

Here, Shirley opens up to Good Housekeeping about her experience with menopause, how she found support and where she is on her journey today.

I didnt know what was wrong to begin with, I didnt put the menopause tag on it. It started with all those sweats and the bad skin and generally feeling low all the time. It was overwhelming.

I can only say it feels like a volcano in your tummy, and it goes all the way up and starts erupting. You start sweating, you're uncomfortable, you're agitated. I didn't want to go out anymore, I was struggling to go to work. Doctors gave me anti-anxiety medication and then they gave depression medicine, nobody understood it.

Your body starts to change during menopause, it gets a little more rounded because it starts to protect itself and thats absolutely fine. But at the time, I didnt know why I was gaining weight when Id always been physically fit.

My skin was drying out, my nails were chipping, I felt dehydrated all the time and I had no libido.

It was my son, Mark, who first sat me down and said, Okay, lets talk about it. He was willing to take a whole afternoon to listen to me. He introduced me to his doctor in the United States, where we were living at the time. From there, I started taking bio-identical hormones (an alternative to HRT, hormone replacement therapy) which was life changing.

Allen Berezovsky

Other than my brother taking his own life [Shirleys brother, David, died in 2003 after battling depression], I would say it was one of the other darkest periods of my life. Some women, like my mother, they sail through the menopause, but that certainly wasn't the case for me. I just wanted to get up in the morning and feel better.

Not everyone can take hormones, but I found hormone replacement life changing and I regularly check my oestrogen and testosterone levels with a doctor. Its all about understanding your own body and using a combination of approaches.

Ive always had a healthy way of eating, Ive always exercised. I love yoga and going for a walk in the park. I try to find time for myself, even just half an hour is better than no time at all.

I want women to know that its not all baubles, bangles and beads just because Im seen dressed up in glad rags on a Saturday.

Being on Strictly has given me a platform. I feel like I have a responsibility to try to help women understand what their bodies are going through when they hit menopause at 45 or 50 or whenever they go through it, because early menopause can happen even in your 20s.

I do a lot of work around other causes like cancer and suicide and I feel that menopause is just as a strong conversation that needs to be happening. Thats why I joined the campaign with QVC, to help educate people and move conversations forward.

The key for me is education. This message is not just for women, it's also for men, for workplaces, for families and younger generations. We learn about puberty when were younger, but we dont know about how our bodies will change after that. I think its just as key to understand the whole biological process all the way up until menopause is complete.

If you notice a sudden change in your body, particularly around the age of menopause, then you have to find help. Go and see a doctor because if you start early enough when it comes to taking hormones or accessing support, then it can be a non-frightening experience.

You can also find information to read up on and links for support through the QVC campaign.

We want to help put the message out to help women of all ages and educate the whole family. The people around you need to understand the high and the low moods, the night sweats and whats going on in your body. Dont suffer in silence. Thats the key message, no more suffering.

I would say its ongoing with my hormones but generally, Im in a much better period now than 10 years ago which was horrific. Id say when I was around 57 my body started to balance out.

Of course, Ive been looking forward to the new Strictly series so it's a very exciting period, but Ill still be going to get my hormone levels checked during the Strictly run. Its an ongoing journey.

Shirley Ballas is partnering with QVC UK's Menopause Your Way campaign, to offer reassurance, insight and inspiration to empower women experiencing the menopause.

You can get tickets to join Shirley Ballas for fizz and cake at Good Housekeeping Live in partnership with Dyson on Friday 14 October.

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Shirley Ballas on her difficult experience with menopause - Good Housekeeping

Testosterone is essential for your reproductive and general health. Certain foods and lifestyle changes may encourage your body to produce more of this hormone.As you age, your bodys testosterone production naturally decreases, according to 2022 research. Some medications and health conditions can also cause low levels of testosterone.

Low testosterone, also known as hypogonadism, can affect your bone health, sex drive, and mood.

Regardless of what causes the decrease, it is important to work with a medical professional to return your levels to a healthy range for you. In some cases, you may need testosterone replacement therapy, but you can also try to increase this hormone naturally.

Keep reading to learn which foods to eat and which to avoid to increase your bodys testosterone production.

Research suggests that honey enhances serum testosterone levels in males. Serum testosterone refers to testosterone found in the blood.

In a peer review of studies from 2019, researchers found that honey may enhance the bodys luteinizing hormone production. The luteinizing hormone stimulates testosterone production.

Other factors, like honeys antioxidant properties, may enhance the performance of Leydig cells. These cells are responsible for testosterone production.

Consuming eggs may increase your testosterone levels, but make sure you consume the yolk. The yolk of one medium egg contains about 225 milligrams (mg) of cholesterol. Your body uses cholesterol to make testosterone.

One 2021 study examined the effect of consuming just egg whites versus whole eggs. In the study, the group who consumed whole eggs experienced an increase in testosterone levels.

A 2021 study indicates that diets low in beans and legumes may have links to low testosterone levels.

Researchers in 2020 also linked low zinc levels to hypogonadism in males. Separately, researchers in 2018 linked low protein intake to hypogonadism in a study on rats.

Beans and legumes are high in protein and zinc.

In fact, 100 grams (g) of dried black beans contain 24.4 g of protein and 3.37 mg of zinc. For reference, the National Institutes of Health (NIH) recommends 11 mg of zinc for males and 8 mg for females daily.

The amount of protein you need varies based on your activity level and body weight, per 2016 research.

Research suggests that magnesium increases free and total testosterone values in males. Free testosterone refers to testosterone that, unlike most of your testosterone, is not bound to a protein in your blood.

One particular 2014 study demonstrated an increase in magnesium consumption leads to an increase in testosterone in men. The increase occurred in both athletes and people who live a sedentary lifestyle.

Dark leafy greens and vegetables contain high magnesium levels. In fact, 100 g of spinach contains 93 mg of magnesium.

The NIH recommends 400420 mg of magnesium daily for males and 310320 mg for females.

Avocados are another good source of magnesium. The U.S. Department of Agriculture reports that 100 grams of avocado contain 29 mg of magnesium.

There is also another reason why avocados may increase testosterone. A 2015 research review states that this fruit contains boron, a chemical element linked with increased testosterone.

Increased boron intake may relate to higher levels and better use of testosterone in the body, according to the same review.

However, a 2018 study suggests that supplementing with boron supplementation is likely ineffective for increasing testosterone levels specifically for athletic performance purposes.

One 2020 study found a correlation between fish oil supplementation and higher free testosterone in males. Other research from 2020 also suggests a positive relationship between DHA-enriched fish oil and increased testosterone in males.

You do not need to take a supplement to get fish oil into your diet. Fatty fish contain high levels of fish oil.

Types of fatty fish include:

A 2018 study by researchers at Taipei Medical University suggests that following a diet high in Western-style foods may decrease serum testosterone levels. These Western-style foods include bread, pastries, dairy products, and desserts.

The study participants who ate diets high in these foods and ate out often had lower serum testosterone levels.These diets were also low in homemade meals and leafy greens.

Learn more about low testosterone levels.

Exercising is good for your overall health, including your hormone health, 2020 research suggests. Avoiding testosterone-affecting behaviors can also help increase levels naturally.

One peer review of studies in 2016 examined the effects of smoking cigarettes and testosterone levels. The results suggest that smoking cigarettes may actually increase testosterone levels in males. This is because nicotine prevents your body from disposing of testosterone.

Yet other researchers in an older 2007 study noted that this correlation might mask borderline hypogonadism.

Read our tips for quitting smoking.

BPA exposure can also decrease testosterone in males, a 2019 research review suggests. Avoiding plastics with this chemical may help with low levels.

Learn more about BPA plastics.

Fish oil, zinc, and magnesium supplements may increase testosterone. You should always consult with your doctor before starting a new supplement. Additionally, taking certain testosterone-boosting supplements may pose a health risk, according to a 2018 case report.

The Food and Drug Administration (FDA) does not extensively regulate dietary supplements. Contact your doctor before starting use.

Here are some frequently asked questions about testosterone.

How can I raise my testosterone levels fast?

Eating a nutrient-rich diet, exercising, and avoiding activities that lower your testosterone levels may help raise your testosterone levels quickly.

Hormone replacement therapy may be the fastest option for aging males experiencing symptoms of low testosterone, per 2021 research.

Does milk increase testosterone?

There is conflicting information on whether milk increases testosterone. Researchers at the National Taipei University of Nursing and Health Sciences hypothesized in 2021 that low fat dairy products may have a positive effect on male fertility, whereas full fat dairy products may have a negative effect.

Yet they note that more research is necessary to draw a conclusion.

Nutrient- and antioxidant-rich foods may boost your bodys ability to produce testosterone. Eating a diet high in fatty fish, avocados, and leafy greens can have a positive effect on your overall health.

Other natural methods for increasing your testosterone include exercising. While some supplements may improve your testosterone levels, you should talk with your doctor before taking any of these.

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Foods That Boost Testosterone: 7 Options and How They Work - Healthgrades

A few months ago, a friend of mine in her early 40s said she was having hot flashes, mood swings, and a lower sex drive. She wondered if she could be experiencing symptoms of menopause. Youre too young, I thought. But, as it turns out, shes not. After speaking to her OB/GYN, my friend realized she is experiencing perimenopause symptoms of menopause without actual menopause (which is marked by a year without a menstrual cycle). She learned it can start as early as your mid-30s (though mid-40s is more common).

It turned out my friend wasnt alone in her surprise and lack of knowledge of this hormonal phase. Earlier this year, Bonafide, a wellness company that makes non-prescription products to help alleviate common health issues in women, came out with their Second Annual State of Menopause Survey. The goal was is to shed light on the need to destigmatize talking about menopause and perimenopause for that matter. The company surveyed more than 2,000 women ages 40 to 65 about various menopausal-related things, from their knowledge about the process to their general feelings and sentiments surrounding it.

Twenty-five percent were not aware of when perimenopause typically starts while 31% did not know their treatment options. In addition, just 28% knew how to care for themselves during perimenopause before it started.

Ahead, womens health experts weigh in and unpack what, exactly, perimenopause is and how you can best be prepared for it.

Perimenopause begins years before actual menopause, OB/GYN Kecia Gaither, tells TZR in an email. It reflects a period of time when the ovaries begin to gradually make less estrogen and when no more eggs are released by the ovaries. Perimenopause ends when women have gone a year without having a menstrual cycle. She also says its important to note that each woman is different and, as such, perimenopause will occur at different ages. However, in general, perimenopause typically begins for a woman in her 40s. Again, this transition period varies from woman to woman from months in some to a decade or so in others.

Dr. Sherry Ross, womens sexual health expert, and author of she-ology and she-ology the she-quel, agrees. This hormonal change typically happens within a couple years of menopause, which usually happens around age 51, she tells TZR in an email. But for some, it can happen much earlier. Every decade brings about some emotional and physical change, but for women, the decade of ones 40s may pack the biggest punches of all.

Echoing Gaither, Ross says that every woman will experience perimenopause differently, including when the hormonal storm begins. There is also evidence that women who smoke, have a family history of early menopause, undergo treatment for cancer with chemotherapy or radiation, or have a hysterectomy (without removing the ovaries) may experience perimenopause earlier than other women, she explains.

Symptoms of perimenopause are similar to menopause, so you may wonder what the difference is. Perimenopause is a transitional period before and after a woman is still menstruating, but beginning to experience symptoms, Dr. Tamika K. Cross, OB/GYN and pH-D Feminine Health advisor, tells TZR in an email. While menopause is defined as 12 months without a menstrual cycle.

Ross says symptoms may include:

And not every woman will have symptoms, Cross says. This just varies with genetics, but more often than not, there are at least a few of the symptoms experienced, although the severity may vary.

Gaither says diagnosis of perimenopause is made clinically by presenting symptoms and getting your hormonal levels (FSH) checked. Although there is no treatment, per se, she says there are many options to help alleviate symptoms.

It depends on each womans specific situation and medical history, Cross explains. Its important to talk with your doctor to see what options are best for you. Ross also points out that different symptoms will require different treatments.

That said, there are some avenues to explore for specific concerns. For instance, for heavy and irregular periods, The best treatment for this tends to be with hormones, such as low-dose oral contraception (as a way to control erratic periods), says Ross. Experiment with different pills in order to find the one with the least side effects. Other options include cyclic progesterone, IUDs with progesterone, hormone replacement therapy (HRT), and non-hormonal alternatives, such as acupressure and herbal therapy. Ross says your healthcare provider can explain the ins and outs of these, and what may work best for you.

For the dreaded hot flashes, Dressing in layers and staying in cool temperatures are the first steps in dealing with hot flashes, explains Ross. Air conditioning is your friend! Plan ahead. Bring a cooler with ice for your hands or feet. If you know that hot beverages, spicy foods, red wine, and hot climates bring on hot flashes, avoid them (if possible). And she says herbal remedies (more on those below) may include black cohosh and other traditional Chinese medicine. Acupressure may help with mild hot flashes, as well, she adds.

For mood swings, Antidepressants are effective in controlling depression, anxiety, and panic attacks, and a therapist may also give added support, says Ross. And, of course, exercise, the elixir to all. When you exercise, theres a natural release of mood-boosting endorphins and serotonin, the feel-good hormones that your body can naturally produce.

For those experiencing low sex drive, low libido, and/or vaginal dryness, Testosterone therapy may be helpful for a low libido, says Ross. For help with vaginal dryness, lubricants (such as KY and extra virgin coconut oil) are a good and affordable investment. Sometimes, once you gain control of the annoying hot flashes, irregular bleeding, and emotional distress of perimenopause, sexual interest is regained and your libido is rescued. She also points out that there is an FDA-approved medication called Addyi, known as the pink pill for women. It works on neurotransmitters in the brain, including serotonin, dopamine, and norepinephrine, all found to be involved with sexual desire.

When it comes to trying to combat perimenopause or at least manage its effects better a great initial plan of attack against symptoms is with a thoughtful and healthy lifestyle. A well-balanced, and colorful, diet of fruit, vegetables, whole grains, and nuts and a limited amount of saturated fats, oils, sugar, and dairy will help, says Ross. Drinking water, warm or hot, helps relax the uterine muscles, too. In fact, drink as much water as possible, 2-3 liters a day, to help minimize water retention and bloating. She adds that you can also try consuming water-based foods, including berries (strawberries, blueberries), celery, cucumber, lettuce, and watermelon. Adding ginger to hot water is another useful remedy, she says. And find an exercise routine that will keep you interested well beyond this perimenopausal period, too.

If diet and lifestyle changes dont curb the symptoms of perimenopause, Ross says there are some safe alternatives to help you get through your day. There are many scientifically studied herbs and vitamins that can help manage the symptoms, so you can avoid prescription medications given to you by your healthcare provider, she explains. Passion flower extract, chasteberry, royal jelly, ashwagandha, and maca root are some of the more researched herbs that can actually improve your symptoms and life. She notes that herbs are not FDA-approved like pharmaceutical medications, but that using a well-regulated manufactured herbal supplement can achieve the same effects as prescription medication. And they will safely treat hormonal unrest caused by perimenopause, she adds. Vitamins are important, too. Ross suggests taking calcium, vitamins E and D, thiamine, magnesium, and omega 3-fish oil to help relieve the period bloat and swelling.

Getting a good nights sleep is imperative, too. Hot flashes can mess with ones sleep patterns, Ross explains. First and foremost, avoid excessive caffeine and alcohol (if you dont care to give it up entirely). Seriously, consume your favored vices in moderation. Theyre not bad, per se its just better to have less. She recommends one large cup of coffee in the morning and not more than three to four alcoholic beverages a week (if at all). Set a regular bedtime, limit your liquids after dinner (so you need not take a midnight bathroom break), and try a warm bath before bed, she adds. And is your mattress comfortable and supportive? If not, make it so. Lastly, put your electronic devices (phone included) far from your night table. You dont need the lure (or the light) of them at bedtime.

And acupuncture is another way to manage perimenopauses symptoms. This ancient Chinese treatment for maintaining health and vitality by balancing energy flow works for many medical conditions, says Ross. For women especially, headaches, lower back pain, and menstrual cramps are helped through acupuncture. Even though the studies are not conclusive, hot flashes and heart palpitations may improve with acupuncture treatment, too.

But in addition to the above, getting psychological support and reassurance from others is also key. Sometimes, what we need most is a thorough understanding of exactly what is happening physiologically, if only to realize that what were going through is completely normal, says Ross. Therapy and support groups are often helpful in navigating this hormonal obstacle course.

Lastly, Ross says that women in their 40s (give or take) who are experiencing unusual hormonal symptoms need to find a healthcare provider to help them navigate the changes caused by perimenopause. There are simple treatment remedies, along with reassurance, that these are natural symptoms that need to be taken seriously not just by the patient, but also by the healthcare provider.

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What To Know About Perimenopause, And How To Manage Symptoms Once They Kick In - The Zoe Report

RALEIGH, N.C., Sept. 21, 2022 (GLOBE NEWSWIRE) -- In a release issued under the same headline on August 2, 2022 by Marius Pharmaceuticals, please note that the correct number for reporting side effects ofKYZATREX to Marius is 1-833-949-5040. The corrected release follows:

Marius Pharmaceuticals, a patient-centric healthcare company, today announced the approval of KYZATREX (testosterone undecanoate) by the U.S. Food and Drug Administration (FDA). KYZATREX is an oral testosterone replacement therapy ("TRT") indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism. The approval of KYZATREX provides an important option in treating hypogonadism or more commonly known as, Testosterone Deficiency, which affects approximately 40% of men older than 45 years of age and 30-50% of men with obesity or type 2 diabetes have hypogonadism1. KYZATREX has been approved in three dosage strengths, 100mg, 150mg, and 200mg.

I would like to congratulate our scientific team on this major milestone, and now it is up to our commercial team to make KYZATREX a leading therapy and a go-to brand for millions of hypogonadal men in the U.S. Low Testosterone affects numerous metabolic factors as well as often overlooked, true quality of life, hence annual testosterone testing should be mandatory for men over age 40, remarked Himanshu H. Shah, Chairman of Marius.

KYZATREX is a proprietary oral softgel capsule that is absorbed primarily via the lymphatic system, avoiding liver toxicity. The oral delivery method eliminates the risk of application site reactions common with intramuscular testosterone injections as well as potential transference to women or children that can occur with topical testosterone gels and creams. With daily dosing in the morning and evening (with food), KYZATREX more closely mimics the daily rhythm of natural testosterone production compared to long-acting therapies.

With so many men suffering daily effects of Testosterone Deficiency and often abandoning or not electing to get treatment, we see FDA-approved KYZATREX as a newly viable oral option that has demonstrated safety and effectiveness. Further, Testosterone Deficiency is a big blind spot in medicine today and our research will continue to explore the importance of testosterone in both male and female health, commented Shalin Shah, CEO of Marius.

KYZATREX has the potential to become the new gold standard of care for treating patients with hypogonadism. There are at least six million symptomatic men suffering from hypogonadism in the U.S., and over 100 million men globally.

Please see additional Important Safety Information for KYZATREX below.

1 Endocrine Society

About Testosterone and Hypogonadism

Hypogonadism, often referred to as Testosterone Deficiency, is a condition that occurs when the body does not produce adequate levels of testosterone. Primary hypogonadism (testicular failure due to certain conditions) and hypogonadotropic hypogonadism both result in low serum testosterone concentrations. In addition to testosterones widely accepted role in sexual and reproductive function, it also has important roles in numerous other metabolic and inflammatory process and is one of the most common causes of secondary osteoporosis in men. Patients with hypogonadism may experience fatigue, low energy, decreased muscle mass, weight gain, low libido, poor cognition, difficulty sleeping, and other mood disorders, such as depression and anxiety. Because low levels of testosterone can also increase the risk of developing type 2 diabetes and obesity, hypogonadism is a common comorbidity in a broader set of conditions, including type 2 diabetes and Non-Alcoholic Steatohepatitis (NASH).

About KYZATREX

KYZATREX is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX reported improvements in quality of life, energy/fatigue, erectile function, intercourse satisfaction, and positive mood. The most common side effect reported in 2 percent of KYZATREX patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX in males less than 18 years old have not been established.

Please see additional Important Safety Information below, including Boxed Warning for potential increased blood pressure, for KYZATREX.

About Marius Pharmaceuticals

Marius Pharmaceuticals is a patient-centric healthcare company focusing on therapies designed for hypogonadism or Testosterone Deficiency. The companys mission is to improve the functional lives of patients by reducing the downstream effects of Testosterone Deficiency, which include multiple comorbidities, such as type 2 diabetes and obesity. For more information, please visit http://www.mariuspharma.com

Important Safety Information for KYZATREX (testosterone undecanoate)

Use

KYZATREX (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. KYZATREX is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX is not meant for use by women.

Important Safety Information for KYZATREX

KYZATREX can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.

Do not take KYZATREX if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX may harm your unborn baby); are allergic to KYZATREX or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX if you have low testosterone due to age).

Before you take KYZATREX, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines.

KYZATREX may cause other serious side effects including:

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effect of KYZATREX is high blood pressure. Other side effects may include headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels.

These are not all the possible side effects of KYZATREX. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius by calling 1-833-949-5040.

Keep KYZATREX and all medicines out of the reach of children.See Full Prescribing Information and Medication Guide for KYZATREX.

Media Contact:Lilly Washburn lilly@mariuspharma.com

Photos accompanying this announcement are available at:

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CORRECTION -- Marius Pharmaceuticals Receives FDA Approval of KYZATREX, an Oral Testosterone Replacement Therapy - GlobeNewswire

Background: The aim of testosterone replacement therapy (TRT) is to improve symptoms and signs of testosterone deficiency including decreased libido, erectile dysfunction, depressed mood, anaemia, loss of muscle and bone mass, by increasing serum testosterone levels to physiologic range. TRT has been used in the last 70 years, and overtime, numerous preparations and formulations have been developed to improve pharmacokinetics (PKs) and patient compliance. The routes of delivery approved for use in the Western world include buccal, nasal, subdermal, transdermal and intramuscular (IM).

Objectives: The aim of this narrative review was to describe and compare all available and approved testosterone preparations according to pharmacology, PKs and adverse effects.

Materials and methods: We have performed an extensive PubMed review of the literature on TRT in clinical practice. Contraindications and monitoring of TRT were analyzed by comparing available guidelines released in the last five years. We provide a review of advantages and disadvantages of different modalities of TRT and how to monitor treatment to minimize the risks.

Results: TRT is associated with multiple benefits highly relevant to the patient. However, the recommendations given in different guidelines on TRT are based on data from a limited number of randomized controlled trials (RCTs), as well as non-randomized clinical studies and observational studies. This is the case for the safety of a long-term TRT in late-onset hypogonadism (LOH). No evidence is provided indeed on the effects of TRT on endpoints such as deterioration of heart failure suggesting a cautious approach to T replacement in older men with a history of heart failure.

Conclusion: Clinicians must consider the unique characteristics of each patient and make the necessary adjustments in the management of LOH in order to provide the safest and most beneficial results.

Keywords: androgen deficiency; hormonal therapy; late-onset hypogonadism; testosterone.

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Testosterone replacement therapy - PubMed

Indian J Urol. 2014 Jan-Mar; 30(1): 27.

Department of Urology, New York Presbyterian Hospital, Weill Cornell Medical College, Starr 900, New York, NY, USA

Department of Urology, New York Presbyterian Hospital, Weill Cornell Medical College, Starr 900, New York, NY, USA

Department of Urology, New York Presbyterian Hospital, Weill Cornell Medical College, Starr 900, New York, NY, USA

Department of Urology, New York Presbyterian Hospital, Weill Cornell Medical College, Starr 900, New York, NY, USA

This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Testosterone replacement therapy (TRT) is a widely used treatment for men with symptomatic hypogonadism. The benefits seen with TRT, such as increased libido and energy level, beneficial effects on bone density, strength and muscle as well as cardioprotective effects, have been well-documented. TRT is contraindicated in men with untreated prostate and breast cancer. Men on TRT should be monitored for side-effects such as polycythemia, peripheral edema, cardiac and hepatic dysfunction.

Keywords: Hypogonadism, side-effects, testosterone replacement therapy

Testosterone has many beneficial effects, including increasing bone strength and density, inducing hematopoiesis, driving sexual function and libido, providing a cardioprotective effect and increasing muscle strength.[1] Testosterone levels are known to decline as men age. The Baltimore Longitudinal Study of Aging reported the incidence of hypogonadism as 20% in men over 60 years of age, 30% in men over 70 years and 50% in men over 80 years of age.[2]

As men age, a decline in testicular production of testosterone are seen, as well as an increase in sex hormone binding globulin, both of which act to decrease bioavailable testosterone.[3] With this gradual decline, the beneficial effects of testosterone could be diminished and negatively affect physical and emotional well-being. Testosterone replacement therapy (TRT) is a reasonable treatment option often discussed for men with low testosterone levels and symptoms of hypogonadism. When replaced, many of the positive effects of testosterone are regained.[4] These positive results have led to a drastic increase in the use of testosterone replacement for men with symptomatic hypogonadism, though long-term data is lacking on the safety.

While the beneficial effects of testosterone are rarely disputed and widely publicized, there is a paucity of the literature on the risks of testosterone use. Any man who has a comorbidity that precludes TRT should be informed of all risks. Factors such as exacerbation of prostate cancer, male breast cancer, worsening benign prostatic hyperplasia (BPH), polycythemia and an increased risk of obstructive sleep apnea (OSA) should be considered when administering TRT to a patient. The goal of this review is to highlight the risks and summarize the current literature on safety of TRT.

One of the major risk factors associated with the administration of testosterone supplementation is its effect on the prostate. We know the prostate to be an androgen-dependent gland and conversely, anti-androgen agents can decrease prostate volume in patients with BPH. As the population continues to age, both the incidence of BPH and late-onset male hypogonadism will continue to rise and practitioners will need to be comfortable with counseling men on the effect of TRT on the prostate.[5]

In a landmark randomized, double-blind, placebo-controlled trial of 44 hypogonadal men, Marks et al. showed that TRT for 6 months improves serum androgen levels, but had little effect on prostate tissue androgen levels, tissue biomarkers and/or gene expression.[6] Testosterone supplementation has been shown to increase prostate size by 12%,[7] but lower urinary tract symptoms (LUTS) and urinary retention do not worsen in men on testosterone therapy.[8,9] Similarly, the presence of hypogonadism in 312 men with reportable LUTS was not predictive of worsening International Prostate Symptom Scores (IPSS) or maximal urinary flow rates.[10]

In fact, some series report an improvement in LUTS after 1 year of TRT.[11,12] In the most recent, randomized controlled trial, 52 men were randomly assigned to receive TRT. At 1 year, the 23 men randomized to 250 mg of testosterone enanthate every 4 weeks reported significant improvements in IPSS and maximal urinary flow rates compared with baseline and controls.[12] At no point in this trial did any patient require additional medication or suffer urinary retention.

While older men on testosterone therapy do have an increase in overall prostate size, this increase in size does not differ from the increase in prostatic hypertrophy seen in elderly men not on testosterone therapy.[13] Taken together, TRT does not appear to grossly worsen LUTS and is not contraindicated in men diagnosed with BPH.

It has been over 60 years since Hodges and Huggins described a relationship between serum testosterone levels and prostate cancer progression.[14] Later in 1982, Fowler and Whitmore reported that exogenous testosterone given to patients with metastatic prostate cancer had worse outcomes.[15] Today androgen deprivation therapy remains a cornerstone of treatment for men with advanced prostate cancer, so it is no surprise that TRT is contraindicated in men with diagnosed prostate cancer, as well as high-risk patients, which includes men with first-degree relatives with prostate cancer and African-Americans who have a prostate-specific antigen (PSA) >3 ng/mL.[4,16]

Recently, there has been a paradigm shift whereby TRT usage has increased despite this potential risk. Many longitudinal studies investigating the relationship of endogenous testosterone levels and subsequent risk of prostate cancer failed to find any association.[17] As such, prostate cancer incidence in men on testosterone therapy is similar to men not on testosterone therapy.[18,19] Similarly, in a 3-year prospective trial, the incidence of prostate cancer was similar among men receiving TRT and controls.[20] In a large meta-analysis of 18 prospective studies that included over 3500 men, there was no association between serum androgen levels and the risk of prostate cancer development.[21] Morgentaler et al. proposed a saturation theory where prostate growth becomes insensitive to changes at normal androgen levels due to saturation of the androgen-receptor; however, there is exponential growth at castrate levels.[22] This theory may explain why testosterone does not directly cause prostate cancer,[23] but it has been shown to accelerate the development of prostate cancer.[24,25]

For premalignancy, prostatic intraepithelial neoplasia (PIN) appears to be a risk factor for developing prostate cancer, however this association has been mostly demonstrated for high-grade disease.[26,27] There is a lack of long-term data on the use of TRT in men with PIN. In one study, 12 months after TRT, only one patient out of 20 men with previous PIN developed overt prostate cancer.[28]

For men who have previously undergone definitive treatment for prostate cancer, the usage of TRT is becoming more accepted. TRT does not appear to increase cancer recurrence in hypogonadal men following radical prostatectomy.[29] In the most recent study by Pastuszak et al., the authors retrospectively reviewed a cohort of 103 men who underwent prior radical prostatectomy and were treated with TRT. Despite a significant increase in PSA in men receiving TRT, there were twice as many cancer recurrences in the control group after 36 months of follow-up.[30]

For men with untreated prostate cancer on active surveillance, TRT remains controversial. However, several studies have shown that TRT is not associated with progression of prostate cancer as evidenced by either PSA progression or gleason grade upstaging on repeat biopsy.[31,32] In the most recent study by Morgentaler et al., 13 men with symptomatic hypogonadism and untreated prostate cancer received TRT for a median of 2.5 years and no local prostate cancer progression or distant disease was observed.[33]

While there have been reports of metastatic prostate cancer in older men who are on testosterone therapy,[20] these are mostly anecdotal. Because of this potential risk, practitioners are often reluctant to administer testosterone in patients they believe may be at high risk for prostate cancer or whom they suspect may have the low-grade disease. Men on TRT should have frequent PSA monitoring; any major change in PSA (>1 ng/mL) within the first 3-6 months may reflect the presence of a pre-existing cancer and warrants cessation of therapy.[34] Current guidelines on the frequency of PSA monitoring and role of pre-treatment transrectal ultrasound guided prostate biopsy are lacking.[35] Taken together, there has been consistent rejection that TRT causes development of prostate cancer in men, however administration of TRT for hypogonadal men previously treated for high-risk prostate cancer should be taken with caution.

While there is no known physiologic link of testosterone directly to the development of breast cancer, it has been suggested that high levels of testosterone may lead to increased aromatization to an active derivative of estrogen, which ultimately may stimulate breast tissue receptors and increase the risk of male breast cancer.[36]

The role of testosterone in breast cancer development is yet to be fully understood.[37] Currently, several case reports exist[38] and one retrospective review sites an incidence 11% in 45 men on long term TRT over 10 years.[39] Future prospective studies with longer follow-up will determine if such association between TRT and male breast cancer truly exists.

Testosterone leads to an increase in hemoglobin by as much as 5-7%[1,25] through its effect on the production of erythropoietin, which can dramatically improve symptoms of anemia in men.[40,41]

Studies looking at the occurrence of polycythemia as a negative side-effect in men on testosterone therapy are rare. Despite this, polycythemia is an accepted side-effect of TRT. While testosterone exerts a positive effect in men with baseline anemia, it can lead to polycythemia in over 20% of men treated on TRT.[42] Polycythemia may lead to an increased incidence of vascular events, including stroke, myocardial infarction and deep vein thrombosis with possible pulmonary embolus.[42] While these complications are all possible with polycythemia, their theoretical occurrence has not been demonstrated to occur in men on TRT.[43]

Because of this risk of polycythemia, men undergoing TRT should not only have their complete blood count (CBC) monitored during their therapy, but should also have a baseline CBC drawn before testosterone therapy is initiated. While on testosterone therapy, if the hematocrit (HCT) rises greater than 54%, testosterone therapy should be held until the HCT normalizes. If it is restarted after normalization, it should be performed so at a lower dose with continued careful monitoring.[16]

OSA is a risk associated with TRT in men, but its etiology is not particularly well understood. While some studies suggested that there is no association between OSA and TRT,[44] others have demonstrated that that OSA occurs in men undergoing TRT and when supplementation is stopped, the OSA resolves.[45]

While no clear link has been established, men on TRT should be counseled on the risk of potential OSA when therapy is started. They should be monitored for increased symptoms, such as snoring while sleeping or fatigue. If patients starting TRT already carry a diagnosis of OSA, physicians should counsel these patients that TRT may worsen their symptoms. While, OSA remains to be a relative contraindication to initiation of TRT, more research needs to be completed on this association in order to gain a better understanding of its etiology if there is one at all.

The systemic effects of TRT may be exacerbated in men with limited cardiovascular reserve. Previous dogma held that androgens could have atherogenic potential. In a randomized, placebo-controlled trial, Basaria et al. reported an increased risk of cardiovascular events in men randomized to TRT; however, this small cohort had a high prevalence of chronic disease.[46] Today, current literature suggests that TRT has a neutral to beneficial effect on reported cardiovascular events.[47,48] Because some men may have a limited cardiovascular capacity, clinicians prescribing TRT must be cautious with respect to its ability to cause edema.[49] Until date, no longitudinal studies examine the impact of TRT on the cardiovascular system, however some studies suggest that TRT may serve as an adjunct rehabilitative therapy in patients with congestive heart failure (CHF).[50,51,52]

While topical testosterone delivery systems avoid first-pass hepatic metabolism, there remains concern regarding TRT in patients with chronic liver disease. The majority of reports of liver toxicity and jaundice are limited to orally-administered alkylated forms of testosterone.[53] However, a small prospective study representing a cohort of cirrhotic patients demonstrated topical gels to be safe and efficacious.[54] It has also been shown that TRT may improve hepatic function in patients with end-stage liver disease.[55] Because of these mixed results, clinicians should be aware of the possible risks associated with TRT in men with hepatic dysfunction and counsel these men accordingly.

Because TRT is known to cause water retention, caution with testosterone use in patients with chronic renal insufficiency is often advised. In patients with end-stage renal disease (ESRD) on dialysis, fluid shifts are less of a concern in patients on TRT since the fluid retention can be handled with dialysis. While polycythemia may be an adverse side-effect, this is a potential benefit in patients with chronic renal failure and anemia.[56] Furthermore, the half-life of testosterone elimination after withdrawal appears similar between patients with and without ESRD.[56] Few studies have assessed the effects of TRT in patients with chronic kidney disease; however, small studies have suggested that TRT has anabolic effects among ESRD patients, even in the absence of hypogonadism. Aside from frequent monitoring of congestive symptoms and peripheral edema in this select population, TRT appears to be safe for patients with chronic kidney disease without dose adjustment.[57]

When testosterone reaches supra-therapeutic levels, aggressive behavior and increased rates of suicide among adolescent users have been reported;[58] however, no study has documented a negative impact on cognition in men patients receiving TRT. In fact, studies have shown that testosterone replacement to eugonadal levels may improve or stabilize cognitive function.[59,60,61] Lower levels of testosterone have a negative impact on spatial and verbal abilities, as well as cognitive function; therefore, it is no surprise that normalizing testosterone levels results in cognitive improvements.[62,63]

With exogenous testosterone supplementation, the pulsatile release of gonadotropin-releasing hormone is blunted and the release of follicle-stimulating hormone and luteinizing hormone are depressed. As such, a decrease in spermatogenesis is seen.[64] While this effect may not be of importance to many men who have completed their families, physicians prescribing TRT need to be aware.

When serum levels of testosterone are increased, a concurrent increase in the secretion of sebum occurs, which can lead to acne. Despite this known association, this effect is typically minimal.[65] Case reports regarding testosterone supplementation leading to changes in hair patterns have been documented; however no randomized, placebo-controlled trials exist. Various topical and intramuscular injectable forms of testosterone are associated with a variety of skin reactions, mainly erythema and pruritus in up to 60% of users.[20]

TRT is associated with external, physical changes in the men. Exogenous testosterone is known to cause an imbalance in the hypothalamic-pituitary axis. As such, testosterone can be converted to estrogen by aromatization. Excess estrogens may lead to gynecomastia and/or breast pain, both of which may be seen in 10-25% of men on TRT.[66] The ratio of estradiol to androgens is the key factor in the development of gynecomastia rather than absolute increases in androgens themselves.[66] Clinicians must be aware of non-iatrogenic causes of gynecomastia and therefore the appropriate work-up should be sought out to rule out other pathology, especially if there is any breast tenderness or unilateral gynecomastia. Only a few case-reports describe a relationship between male breast cancer and TRT.[38,39]

In addition, excess estrogens may cause an increase in visceral obesity. With vigilant monitoring of serum estrogen levels, TRT has been shown to promote weight loss.[67] Well-known to many prescribers of TRT is a risk of water retention and/or edema. The etiology of this association remains unclear to date.[68] The degree of retention is generally mild. As mentioned above, men on TRT with a history of CHF should follow closely[69].

TRT has numerous benefits that can great enhance a patient's quality-of-life. Before prescribing TRT, one must be conscientious of its adverse effects. Data on the safety of TRT specific to our aging population is not currently available; however TRT has been linked to prostate cancer, BPH, polycythemia and OSA. A full assessment of the morbidity of TRT would require a large-scale, randomized, controlled trial. To date, physicians remain in a quandary about the best approach to care for men with symptoms of hypogonadism. TRT, when given to appropriately selected patients with vigilant monitoring as outlined in this review and in , can bring improvements in quality-of-life, energy level, libido, muscle mass, cognition and bone density.

Potential risks of TRT and associated monitoring strategies

Source of Support: Nil

Conflict of Interest: None declared.

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Risks of testosterone replacement therapy in men - PMC

ReportLinker

Global Testosterone Replacement Therapy Market 2022-2026 The analyst has been monitoring the testosterone replacement therapy market and it is poised to grow by $ 402. 87 mn during 2022-2026, accelerating at a CAGR of 3.

New York, Sept. 13, 2022 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Testosterone Replacement Therapy Market 2022-2026" - https://www.reportlinker.com/p04046949/?utm_source=GNW 1% during the forecast period. Our report on the testosterone replacement therapy market provides a holistic analysis, market size and forecast, trends, growth drivers, and challenges, as well as vendor analysis covering around 25 vendors.The report offers an up-to-date analysis of the current global market scenario, the latest trends and drivers, and the overall market environment. The market is driven by initiatives to increase awareness about hypogonadism among population, rise in chronic diseases, and untapped potential in developing countries.The testosterone replacement therapy market analysis includes the product segment and geographic landscape.

The testosterone replacement therapy market is segmented as below:By Product Injectables Topicals Others

By Geographic North America Europe Asia Rest of World (ROW)

This study identifies the rise in novel therapeutic approaches as one of the prime reasons driving the testosterone replacement therapy market growth during the next few years. Also, patient assistance programs and the development of new therapies will lead to sizable demand in the market.

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This robust vendor analysis is designed to help clients improve their market position, and in line with this, this report provides a detailed analysis of several leading testosterone replacement therapy market vendors that include AbbVie Inc., Acerus Pharmaceuticals Corp., Acrux Ltd., Actiza Pharmaceutical Pvt. Ltd., Antares Pharma Inc., Aytu BioPharma Inc., Bausch Health Co. Inc., Bayer AG, BIOTE MEDICAL LLC, Cipla Ltd., Clarus Therapeutics Inc., Eli Lilly and Co., Endo International Plc, Novartis AG, Pfizer Inc., Sun Pharmaceutical Industries Ltd., Teva Pharmaceutical Industries Ltd., The Simple Pharma Co. UK Ltd., Upsher Smith Laboratories LLC, and Viatris Inc. Also, the testosterone replacement therapy market analysis report includes information on upcoming trends and challenges that will influence market growth. This is to help companies strategize and leverage all forthcoming growth opportunities.The study was conducted using an objective combination of primary and secondary information including inputs from key participants in the industry. The report contains a comprehensive market and vendor landscape in addition to an analysis of the key vendors.

The analyst presents a detailed picture of the market by the way of study, synthesis, and summation of data from multiple sources by an analysis of key parameters such as profit, pricing, competition, and promotions. It presents various market facets by identifying the key industry influencers. The data presented is comprehensive, reliable, and a result of extensive research - both primary and secondary. Technavios market research reports provide a complete competitive landscape and an in-depth vendor selection methodology and analysis using qualitative and quantitative research to forecast accurate market growth.Read the full report: https://www.reportlinker.com/p04046949/?utm_source=GNW

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The Global Testosterone Replacement Therapy Market is expected to grow by $ 402.87 mn during 2022-2026, accelerating at a CAGR of 3.1% during the...

FROM NORTH AMERICA SYNDICATE, 300 W 57th STREET, 15th FLOOR, NEW YORK, NY 10019

CUSTOMER SERVICE: (800) 708-7311 EXT. 236

TO YOUR GOOD HEALTH #12345_20220929

FOR RELEASE WEEK OF SEPT. 26, 2022 (COL. 4)

BYLINE: By Keith Roach, M.D.

TITLE: Testosterone injections most likely led to a very severe stroke

---

DEAR DR. ROACH: My 75-year-old husband was frustrated with not being able to retain an erection. He talked to his doctor about it, and she prescribed 200 mg of testosterone cypionate, which he would inject into his bottom once a week. He did this for four months, and then had a severe bilateral stroke (as in, he does not know where he is, what happened to him, cannot read or write, cannot walk, etc.).

After spending two weeks in the ICU, he went to a rehabilitation hospital for three weeks. The hematologist there told me his hemoglobin level was up to 20, and there was no reason a 75-year-old should have been prescribed testosterone when it can elevate his hemoglobin so much. I looked at my husband's labs over the last three years, and his hemoglobin was never above 15. Of course, I had no idea testosterone would elevate hemoglobin, or that it should not be prescribed to a 75-year-old.

What are the normal protocols for testosterone with older men? Could his testosterone injections have led to his stroke? -- D.H.

ANSWER: I am very sorry to hear about your husband.

Testosterone replacement therapy is commonly prescribed to men in their 70s and 80s. Elevations of the hemoglobin levels are certainly well-described, but levels above normal only happen about 1% of the time. Experts recommend checking a blood count to look for these elevations three to six months after starting treatment. Testosterone should be stopped if the hemoglobin level is above normal.

Sometimes, there are other causes for the hemoglobin to go up, but a rise that high, when he had never had it before, makes it seem very likely to me that the testosterone was the cause. A hemoglobin level that high, from any cause, is a risk for stroke and heart attack. It is very possible the testosterone prescription led directly to the stroke.

I am publishing this in the column so that men who are taking testosterone know they should be periodically tested for this unusual complication.

DEAR DR. ROACH: I had carpal tunnel surgery two years ago. I now have trigger fingers in my index and ring fingers. I had cortisone injections but that didn't cure it. I, at one point, was not able to open my fingers. Now, my fingers are really stiff, and I can't bend them. When they get down too far, they lock, but usually, they're so stiff I can't bend them. Surgery was suggested. I'm hesitant, because I'm wondering if this will get better on its own with exercises. -- J.T.

ANSWER: Trigger finger is caused by the tendon getting stuck inside one of the pulleys of the hand. To the best of my knowledge, carpal tunnel surgery doesn't predispose to trigger finger, but there are some conditions that put people at risk for both conditions. Initial treatment of trigger finger is conservative, with splinting and anti-inflammatory drugs. If that doesn't work, injection of cortisone by a hand surgeon is usually successful.

Most of the hand surgeons I know will try injection three times before recommending surgery. People who have not gotten better with conservative treatment and injection generally do not get better on their own; though, a few people will. Unfortunately, postponing surgery too long can lead to the finger getting a contracture, where it will not straighten at all. It's best to have surgery before this complication occurs.

* * *

Dr. Roach regrets that he is unable to answer individual letters, but will incorporate them in the column whenever possible. Readers may email questions to ToYourGoodHealth@med.cornell.edu or send mail to 628 Virginia Dr., Orlando, FL 32803.

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Testosterone injections most likely led to a very severe stroke - The Independent

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DHEA supplements are a boon for people who want to escape aging skin, bone, and cardiovascular problems and want to lead an energetic life.

Despite the effective results of using this product, there is no doubt that many users do not find it easy to pick up the best version. Most buyers are clueless about the difference between certain varieties, ingredients, etc.

This can be attributed to the lack of proper information regarding these natural hormone boosters available on the market. Here, we have tried to address all your queries with proper facts and figures in our dehydroepiandrosterone review and buying guide.

To have the best list of DHEA products, we followed strict evaluation criteria to probe other supplements on the market. Our team invested several hours in researching the DHEA market high and low.

With a primary goal to find out the safest and purest formula, we picked all the supplements brands offering DHEA supplements. Later, we looked into the company details, store policies, and health benefits of all the products on our list. We unhandled all the ineffective products and only picked the ones with the right formulas, dosage, and benefits.

The assessment criteria we designed for ranking the best DHEA supplements encompassed several factors. We check each product on our list against different benchmarks to ensure our just evaluation.

Brand Reputation: Brand reputation is one of the primary factors that helped our team to pick the best products. Primarily, we delved into the information of the supplement manufacturer offering DHEA products to learn if they opt for safe manufacturing.

For unbiased evaluation, we chose only brands with a prominent name in the industry with a wide portfolio of supplements. Additionally, we kept all the brands at arms length whose reputation was questionable. Hence, all the DHEA supplements on our list are from highly esteemed supplement manufacturers in the USA market.

Natural Ingredients: Prescription medications are great for instant benefits, but their effects are usually short-term. Contrary to that, natural health supplements offer long-term effects with constant use and often have minimal to zero side effects.

Therefore, our priority was to pick the DHEA supplements that contain a blend of natural and organic ingredients without unnecessary binders and fillers. Furthermore, we searched each ingredient in every product to know whether the company was using science-backed ingredients in the formula.

Safety: When there is low DHEA in the body, your immune systems ability to fight off the harmful chemicals also drops. Therefore, we confirmed the safety of all the ingredients and final products before referring the supplements to our readers.

Customer Reviews: DHEA supplements that received rave reviews from customers were our favorite. For this purpose, we visited official company websites and different forums to learn the pros and cons of each supplement. Hence, we preferred the products that were reviewed by hundreds of customers with a positive rating.

DHEA is great for fixing the natural declines in the concentrations of several human sex hormones. While DHEA supplements are great for boosting libido, they offer many health benefits that one cannot enjoy with growing age.

Similar to other health-boosting supplements on the market, hundreds of manufacturers are selling DHEA products. With that fact, the chances of buying risky and counterfeit DHEA supplements increase. Therefore, checking several important factors in a DHA supplement can be wise.

The first and foremost factor you should consider is what your body is trying to convey. Your body is the first to show symptoms in multiple ways, even before you realize something is wrong with you.

Generally, sexual function in the human body is of the least important as it is one of those functions you can live without. That is also why many forms of sexual enhancement have less than significant support from scientific studies.

When your body is under stress, the sexual system and related functions are one of the primary systems that collapse. Your bodys adrenal glands produce DHEA, which is the same gland that makes and secretes cortisol.

Both of these hormones are released as a response to your stress, increasing stress levels in the body. Therefore, sexual dysfunction is a common symptom obvious in people who handle high-stress levels. So, when you are stressed, your body will save energy and nutrients to build up stamina and protect you from the harmful effects of stress.

Several studies have concluded the positive health benefits of DHEA with doses of up to 200 mg. Therefore, the supplements that deliver up to 200 mg of DHEA to your system are considered safe.

Supplement manufacturers offer DHEA pills in different doses, but you should stick to lower doses (25 mg, 50 mg) only as a beginner. For instance, the featured supplements contain 25 mg to 100 mg of DHEA per capsule.

What we suggest is you should prefer DHEA supplements with 50 mg. Mainly, 50 mg DHEA capsules offer a strong enough dose to significantly change your DHEA levels with just one capsule per day.

However, most individuals will have to try and test these supplements by gradually increasing doses to find the best therapeutic amount. Another vital factor that can affect the DHEA dose is your age.

An important factor you must consider before purchasing any supplement with a stronger dose is the size of the capsules. Maximum strength DHEA supplements often come in large capsules and are difficult to swallow.

Also, if you intend to consume more products in your healthcare regimen, choosing such supplement with a smaller size is best. The good thing with safe and effective DHEA supplements is that the capsule size will be small enough if you choose a 50 mg dosage.

On the market, hundreds of DHEA supplements contain additional ingredients like minerals and vitamins. Many supplement manufacturers add them to the blend to boost the efficacy of the main ingredient.

However, it cannot always work out well as you might have insufficient DHEA dose to feel the effects. Moreover, the additional ingredients will be quite low in concentrations to cover your daily requirements.

You will probably have to invest in other products to get the ideal amount of both primary and secondary ingredients. Thats why we suggest you stick with the pure DHEA supplements only and consume other products for the health benefits you want.

DHEA is a shorthand for Dehydroepiandrosterone, a hormone produced by your adrenal glands. It acts as a precursor in synthesizing and releasing crucial male and female sex hormones in the human body.

For instance, it plays a great role in forming testosterone and estrogen. Both are vital hormones that boost the development of masculine and feminine secondary biological features. Not only that, but they also hold significant importance for your general health and well-being.

If you have excessive estrogen-like endocrine disruptors, your body will be disrupted by hormonal disruption, leading to reproductive weakening. Since testosterone and estrogen levels differ in both male and female bodies, their symptoms will differ.

Individuals with Y chromosomes will face many debilitating symptoms due to low testosterone production. This includes irrational mood swings, sudden weight gain, fatigue or low stamina, frequent memory failure, and underdeveloped muscle tone. Additionally, they might have underdeveloped testicles, low libido, erectile dysfunction, and joint/bone tissue loss.

Likewise, individuals who lack a Y chromosome will witness unwanted symptoms in response to low estrogen levels in the body. Some common signs are headaches, mental health problems, fatigue, mood swings, hot flashes, and trouble concentrating. Furthermore, many women have other symptoms like breast tenderness, irregular or absent menstrual cycle, lack of vaginal lubrication, and urinary tract infections (UTIs).

Other health effects of low DHEA levels that are common to both males and females are important, just like the regulation of sex hormones. DHEA synchronizes your energy levels, mental health, bone health, metabolic health, immune function, stress resistance, skin health, and cognitive and memory health.

Many double-blind, placebo-controlled research trials have shown the proven benefits that the human body can get from DHEA supplementation. Since DHEA levels dip with age, older men and postmenopausal women can greatly benefit by adding DHEA supplements into their regimens.

The research on DHEA supplementation mostly focuses on retrieving youthful health benefits as we age. Generally, DHEA has plenty of health benefits as it is involved in the complex process of hormonal production and balancing.

Science has proved that DHEA is good for the bones of postmenopausal women. If you are a gym-goer, adding DHEA supplements into your weight training routine can help to boost muscle strength.

Since its not only the muscle strength that counts for a youthful body, DHEA also plays a helpful role in shaping your body composition. While DHEA is thought to help you gain muscle strength, it also increases the fat-burning process.

One of the worst features of aging is the loss of sexual stamina and attraction, resulting in a lack of physical intimacy. In such situations, people can even try anti-aging products . However, sexual intercourse can help release the love hormone, oxytocin. So, as you age, you are not sexually interested in your partner, which keeps you from enjoying the benefits of oxytocin. No worries anymore; DHEA can help with that as it supports libido and sexual interest in both sexes.

Besides, DHEA can benefit adrenal insufficiency, healthy arteries, healthy glucose metabolism, youthful skin, optimal brain health, healthy inflammatory response, and more.

Scientific society considers DHEA an anabolic steroid. However, DHEA does not produce the typical results of anabolic steroids. While DHEA boosts testosterone levels, strength, and muscle mass, compared to steroids, it does so in much lower amounts. Therefore, DHEA has a nominal effect on your testosterone levels, and studies have not proven its benefits in boosting muscle size, strength or endurance yet.

Dosage is the primary factor that decides the effectiveness of DHEA supplementation. Some additional factors affecting its effectiveness are how consistently and for which health goals you are consuming it.

Still, the timeline for visible results from DHEA supplementation varies from a few weeks to a few months. Furthermore, not many scientific studies have analyzed the long-term effects of DHEA. Therefore, you should plan your DHEA consumption anywhere from a few months to a max of one year.

In the USA, DHEA was once banned for over-the-counter sales in 1985. Since then, all the DHEA supplements have been approved for retail distribution and are not forbidden in the United States. However, the World Anti-Doping Agency (WADA) has banned DHEA as it can alter user testosterone levels.

DHEA supplements are no longer just for people suffering from a low testosterone level or for postmenopausal women who want to reverse the effects of menopause. If you feel your health is declining and you know it has something to do with aging, DHEA supplements can be the best solution.

To help you ease your legwork, we have found the topmost DHEA supplement brands for you. Natrol, Life Extension, and PureFormulas offer effective DHEA supplements with the benefits of natural ingredients.

These products offer a safe, pure, natural alternative that can give your body all the hormones it needs to stay healthy and young, including DHEA and growth hormone. These are not aphrodisiac drugs, so there are no side effects or interactions with other drugs.

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