Dr. 50 Something

S1 E6 Testosterone for Men: The Truth Revealed

Nicole Norris MD Season 1 Episode 6

The FDA has quietly made one of the biggest medical reversals of the century that affects millions of American men. After 11 years of misleading warnings, the FDA has finally acknowledged that testosterone replacement therapy does NOT increase the risk of heart attacks or strokes. This monumental shift removes the ominous black box warning that has prevented countless men from addressing declining testosterone levels.

What changed? The Traverse Trial, published in the New England Journal of Medicine, followed over 5,200 men aged 46-80 with cardiovascular risk factors. The results were crystal clear—testosterone replacement showed absolutely no increase in cardiac events compared to placebo, with a 95% confidence interval. This validates what many specialists have known for years: natural, bioidentical testosterone replacement is safe and beneficial for aging men.

The confusion stems from conflating prescription testosterone with illegal anabolic steroids. These synthetic compounds used at 10-100 times therapeutic doses cause numerous health problems, unfairly tainting natural testosterone replacement by association. The truth is that properly optimized testosterone levels can reverse diabetes, reduce arterial plaque, prevent dementia, improve bone density, enhance cholesterol profiles, help resolve sleep apnea, and even prevent prostate cancer—all supported by randomized controlled trials.

Despite this vindication, accessing quality testosterone optimization remains challenging. Insurance typically only covers treatment for severely low levels (below 300 ng/dL), though men feel optimal at 900-1100 ng/dL. Many providers also take a simplistic approach, prescribing testosterone without proper evaluation, monitoring, or lifestyle guidance. True hormone optimization requires comprehensive testing, nutritional support, sleep improvement, exercise recommendations, and ongoing monitoring of multiple biomarkers.

Ready to explore how testosterone optimization might improve your health, energy, and longevity? Follow the links in our show notes to learn more about evidence-based approaches to hormone replacement that go beyond just "replacement" to true optimization for long-term health.

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Want to learn more about our concierge preventative medicine programs or fill out an eligibility form?
GET FAB (for women) Get Fabulous! Hormone Optimization for Women | Nicole Norris MD Medical Spa
GET FIRM (for men) Get Firm! Hormone Optimization for Men | Nicole Norris MD Medical Spa

Speaker 1:

Welcome to the Dr 50-something podcast. I'm your host, dr Nicole Norris. Whether you are in the midst of midlife or you want to prevent the physical and mental signs of aging that occur in midlife, this is the podcast for you. This is a show where I share my knowledge gleaned in family practice, preventative medicine and aesthetic medicine, to shed light on aging or, better yet, how not to feel or look like you are aging. We should be taking an active role in how we age from an early age. We should not settle with growing old gracefully or letting nature take its course. How we age directly affects our confidence, which impacts all of our relationships with those around us. The length of time in our lives that we feel really good in terms of energy, aches and pains and thought clarity has a definite impact on the mark we can leave on this world. My wish for my listeners is to always be mistaken for being 50-something or less in mind, action and appearance. Let's go. Welcome to episode six of the Dr 50-something show. Today I have to share some really big news with you. Everyone who has done the research about testosterone replacement therapy already knows this, but this has been a thorn in my side starting my preventative medicine practice in terms of the hurdle it causes in reassuring men that TRT is safe. So for the past 11 years, the Food and Drug Administration, the FDA has maintained that any patient prescribed testosterone by their doctor must be told there is a black box warning on it. A black box warning is the most serious level of warning that the FDA places on medication labels to alert healthcare providers and patients about potentially dangerous side effects of a drug. Specifically, men are to be told. The black box warning on testosterone is the following Testosterone replacement therapy could increase your risk of heart attack and stroke. This has been proven false by multiple studies outside of the US. But finally the FDA was persuaded by a large US randomized control trial to change their tune. In February 2025, the FDA made one of the biggest announcements of the century Drug manufacturers can now remove the black box warning that says testosterone replacement could increase the risk of heart attack and stroke. This label has been misleading men since 2014, and this false FDA warning has kept millions, if not more, of US men from replacing this natural hormone in their bodies. This black box warning was based on flawed studies and general regulatory overreach. So this is a major step in preventative medicine what I practice now in improving the quality of life and longevity in all US men.

Speaker 1:

So let's talk about the study that led to the FDA's decision. It was called the Traverse Trial. It was published in 2023 in the New England Journal of Medicine. There were 5,246 men aged 46 to 80 years old who had pre-existing history of heart attack or stroke or who were considered high risk for heart attack or stroke, meaning they had hypertension, high cholesterol or diabetes. They were all enrolled in the study and half of them were put on topical testosterone gel and the other half were put on a placebo gel, meaning the gel had no active medication in it. So in a randomized controlled trial, the two study groups do not know if they are on the real stuff or the fake stuff. So, after years of monitoring both the large groups for a major cardiac event, which in this study was a heart attack or stroke, it was found that a major cardiac event occurred in 7% of the men taking testosterone and 7.3% of the men taking the placebo gel. That means the risk was the same in both groups and testosterone replacement did not increase the risk of a major cardiac event. The study also had a 95% confidence interval, which means that these results could be extrapolated to 95% of the whole population of other men like this.

Speaker 1:

So you know how, at the beginning of my podcast, of the whole population of other men like this. So you know how, at the beginning of my podcast, I promised you I would only talk about good studies, randomized control studies. This is one of those. I just wish I could shout this out to the whole world. I wish I could fax it to all the medical schools and group text it to all my medical professional friends, but alas, I only have this podcast to spread the word. So do me a favor and share this episode with at least one guy, or even your health care provider.

Speaker 1:

So our natural testosterone is made in the testicles in men, and it does not cause the blood to be thick. It does not cause elevated hemoglobin or hematocrit. Testosterone does not cause blood clots. It is not the cause for heart attack and it is definitely not the cause of strokes. For Pete's sake, it actually does the opposite, literally. For Pete's sake, all of you Pete's, mike's, john's should be replacing your testosterone as you age without the fear of adverse side effects. So where did this fear come from? It? Really, it wasn't from a study.

Speaker 1:

Probably a lot of it has come from illegal anabolic steroids that mimic or copy the effects of testosterone on the body. These are not body identical testosterone, but they can enhance performance in sports and build outlandish muscle mass. The doses used in anabolic steroid use for sports enhancement or for creating crazy muscles is usually 10 to 100 times that what we use for health optimization. They're typically not prescribed by legitimate healthcare providers, they have their own black market and they have a ton of side effects. So listen to this list Hair loss, breast development, acne, erectile dysfunction, stomach pain, facial hair, deep voice, heart attack, stroke, blood clots, liver failure, kidney failure, high blood pressure, fluid retention, high cholesterol yeah, those are a lot of things.

Speaker 1:

That guys come into my office and they say well, I don't think I should be on testosterone because of all those things I just listed. And it is not the case. Testosterone is natural to our body and it does not cause the same side effects of synthetic anabolic illegal steroids. These synthetic ones, manufactured for performance and outlawed in every country in every professional sport, are there, even outlawed in other mammals like horse racing. These are the bad guys. All anabolic steroids, including testosterone, are categorized as controlled substances like opioids. Because of this, basically, testosterone gets a bad rap because of the category of chemical that it is Guilt by association. Just like how I talked about estrogen as a category of drugs. Estrogen certain types of estrogen can have a lot of negative side effects when we use the synthetic, non-body identical ones. But estradiol, which is the type of estrogen made in men and women's bodies, is the good guy, but he gets a bad rap because of its similar chemical structure.

Speaker 1:

I'm sorry if sometimes I seem so repetitive. I hope it is getting clearer to you. The basic premise is that any hormone that is identical to what our body makes is essentially good for us, with little or no negative side effects. But the hormones that are manufactured to be similar to our natural hormones but are not identical to what the body makes have a lot of risks and side effects. Bioidentical means body identical. Bioidentical hormone replacement therapy is good for most people in terms of feeling good and preventing chronic disease.

Speaker 1:

Okay, so now you're a guy listening and you had your aha moment. It is safe for me to take testosterone. Hallelujah, I'm not doing something illegal and I won't die if I do it. So what's next? How do I get it? Should I be tested? Do I need it? In episode four I discussed the symptoms of andropause. You should go back and listen if you missed that one. If you have any of these symptoms, or even you just don't have the same energy or ability to build muscle as you did in your 20s, you should be screened. Every man owes it to himself to be screened for testosterone deficiency.

Speaker 1:

When you come for your first visit in my male preventative medicine program. We draw your blood, we do your vitals. We put you on a body analyzer which gives us a baseline of your percent body fat and muscle mass. Besides checking testosterone levels, we check other hormones that are important to your health and longevity too. We do very specific thyroid testing. We test your vitamin D Yep, vitamin D is actually a hormone. We also test for important nutrients and other less commonly known hormones called DHEA and sometimes pregnenolone. We monitor your cholesterol, blood sugar, prostate health, blood pressure, blood counts, kidney and liver function. We also monitor your protein intake.

Speaker 1:

Lifestyle habits we spend a lot of time focusing on improving sleep, sleep, food choices and exercise. They are foundational to your health. Hormone optimization is actually the second step in creating well-being and longer, healthier lives. This is a full-service preventative medicine practice here, not just a script for tea and a slap on the shoulder. Don't get me wrong. Testosterone is foundational to men's health, but sometimes it takes more than just replacement to optimize a man's health. When we see patients with current risk factors for heart disease and cancer, or they actually have known history of heart disease or cancer, we can offer more in-depth testing. Calcium score screenings, genetic cancer screening through a company called Grail could also be offered to you.

Speaker 1:

So there are three reasons men seek TRT therapy in my office. There's the woo-woo side of testosterone replacement, in that it really does give men a sense of happiness, confidence, better mental health, better relationships and more thought clarity. There's the manly side of testosterone, which is everything you might notice in the bedroom, ie libido. My sons listen to my podcast, so I'm trying to keep this PG. And lastly, and probably most importantly, men seek TRT to live a longer, healthier life. There are many randomized control trials that show natural testosterone optimization not just replacement reverses diabetes, reverses plaque in the arteries of the heart and brain, prevents and reverses dementia, reverses osteoporosis, improves cholesterol, reverses sleep apnea and prevents prostate cancer. This podcast would be way too long if I delved into those studies, but I will probably get to them all eventually as of right now.

Speaker 1:

Despite the fda admitting there should not be a black box warning on testosterone therapy, if you ask any doctor or nurse practitioner to check your testosterone, they may or may not do it. The reason is due to lack of education on it and also it's not covered by insurance. It's only covered by your insurance to test for it or to replace it if your levels are those of an old, sick guy which is less than 300. To put that in perspective, men feel best and are healthiest at levels 900 to 1100. So it will cost you around $1,000 to have it checked because it's not covered by insurance and then if it is not less than 300, they won't treat it. So right now, testosterone replacement therapy is really only available and financially feasible by preventative medicine physicians and functional medicine providers.

Speaker 1:

Trt is becoming more and more talked about and more popular to offer it in cash-based offices like medical spas or standalone hormone clinics. But buyer beware you need to do your homework on that provider because there are a lot of bad ones out there. In my professional opinion, just giving a guy a testosterone pellet or a vial of tea and a slap on the shoulder is not good medicine. These providers do not educate you. They do not take a thorough health history or symptom history. They really don't care about optimizing your overall health. Sometimes they don't even check labs. They put your weight in an app and it spits out a testosterone dose. Okay, guys, testosterone is not weight-based dosing.

Speaker 1:

I will continue to educate my peers and any guy that will listen to the hard data and research that proves testosterone should not be replaced, but optimized in men as they age, not just replaced. If you are interested in my preventative medicine program for men in Illinois called Get Firm, see the link in the show notes to fill out an eligibility form or contact me through our website and I'm happy to hook you up with another provider who practices like me in another state. Thank you for joining this episode of the Dr 50-something show. If you are intrigued by this show and never want to miss an episode, click follow. If you are a really great friend, share it. The content of this episode is not intended to be a substitute for professional medical advice, diagnosis or treatment. Always seek the advice of your physician or other qualified healthcare provider to answer any questions you may have about your personal medical conditions. Until next time, get fit, get fabulous, get firm and take care of yourself.