What I Learned From Taking Testosterone For A Decade

There are a ton of short articles telling you to eat some kind of new superfood to boost your testosterone, but there is a surprising shortage of real talk about how normal people (men and women) really change their lives by gaining control of their testosterone levels.

I used bioidentical testosterone replacement therapy for almost a decade because I had a medical need for it, then stopped it a few years ago to make sure that it was not a confounding factor during the development of The Bulletproof Diet. I verified that I had found a way to raise my natural production with biohacking.

Ive been very public with my use of smart drugs like modafinil and anti-aging hormones like testosterone for years, and have talked about them with national TV reporters many times, but Ive never written about the experience as a whole until now.

Here is my story, and some real info for both men and women.

See what I learned

This post can absolutely change your life, and probably help you avoid some pitfalls. Like shrunken balls. (I am not an expert in the synthetic anabolic testosterone drugs used by bodybuilders they carry lots of risks but pack a big punch if you want to get swole. Bulletproof is all about having massive clean energy, looking good, and living a very long timeso anabolic steroids arent on my roadmap.)

Testosterone does a lot more than youd think, whether were talking about male or female biology. Its the hormone that helps you burn fat, build muscle [1], and increase your sex drive [2], and its power doesnt stop there. Keeping your testosterone levels in a normal range can make you happier, too [3], and testosterone can even improve your cardiovascular health and decrease your risk of mortality (from all causes!), according to a study of 83,000 older men who underwent testosterone replacement therapy [4].

In my late 20s, I visited an anti-aging doctor who was one of the pioneers of what we now call functional medicine. I got a full hormone test. Shockingly, my testosterone was lower than my mothers. No wonder I felt crappy and was overweight. My other sex hormones were out of whack too, especially my estrogen levels. They were high because the little testosterone I did make my body converted into estrogen. I went on a mix of topical replacement testosterone cream, plus small doses of pharmaceuticals like clomid and arimidex in order to keep my other sex hormones functioning properly.

The doctor regularly measured my levels to be sure they were within the normal range for a male my age. In other words, I wasnt taking roids to get big; I was getting control of hormones that were not functioning well. This is how you should look at testosterone therapy it is a gentle nudge to help you be in normal ranges, not a big push to get you huuu-yge. If youre like me, you want normal ranges of a 27-year-old, not of a 60-year-old. Its my plan to keep my testosterone where it is now (around 700) no matter what it takes. Right now, the Bulletproof Diet and the other biohacks Ive written about do that! Im 43.

The TLDR version of the rest of my story is that within days I found more zest for life than Id had in a long time. I felt better and got sick less. I woke up with a kickstand again. That said, there were some significant side effects too, which you can read about below.

Im telling you all of this because no matter who you are, keeping your testosterone levels balanced is more important now than ever before. Modern living has not been kind to our hormones. In American men, serum testosterone levels have declined by about 1% each year for the past 30 years [5], and you can make a few educated guesses about why. Hormone-disrupting chemicals are more prevalent than ever before, physical activity is less and less common, veganism is popular (I was a raw vegan for a while), and many doctors insist on pushing a low-fat, low-cholesterol diet for health (by the way, the concept of a low-fat diet began in the mid-70s, shortly before the nationwide testosterone decline. It could be a coincidence, but I doubt it).

Here are the 7 most powerful ways I know to increase your testosterone, both medically and naturally. Many of these recommendations are for you too, ladies men may have more testosterone, but its plenty important for women. Read on to learn more.

This is one of the most controversial recommendations I make, but it shouldnt be. Its no different than using thyroid medication. If your levels are low, and the other techniques here dont work, use TRT. You will like your life again. If your levels are low, bioidentical testosterone will make you live longer and better, provided you use it right.

There is no compelling legal, moral, or ethical argument against keeping your hormones wherever you want them, and anyone who tries to tell you otherwise does not have your best interests at heart. That said, you can screw yourself up with self-medication; we have medical schools for a reason.

If you have low testosterone, your functional medicine or anti-aging physician will help you diagnose it. There are several different hormones your physician should measure, but the most important two are your free testosterone and estrogen levels, because converting too much testosterone to estrogen is a problem thats different from not making enough testosterone in the first place. In my case, I wasnt making very much testosterone, and what I was making my body converted to estrogen way too effectively.

You can also order your own labs online from companies like WellnessFX, but unless youre using diet and inflammation control to raise your T, youll want to work with a doctor to treat it.

If you do have a sex hormone imbalance, and fixing your food and stress the way I recommend in The Bulletproof Diet doesnt work, you have a few options for correcting it.

When I first started TRT, my physician prescribed a cream that you rub into your skin. The cream version of TRT is not too convenient, because if someone touches you while you have the cream on, the testosterone can rub off on him/her. This can be really bad around kids or pregnant women. If youre sleeping next to someone, the cream can get on the sheets and transfer over that way, too. The cream can be annoying, but it works. Theres also a gel version called AndroGel; I skipped it because it doesnt absorb as well as the cream does.

The best place to put the cream or gel is on the scrotum (or perineum for women, but a different dose for sure!). However, no one likes greasy balls. The next best place is the armpits, so like many men on TRT I shaved my armpits and put the cream there. Greasy armpit hair = no bueno.

There is a dirty little secret about testosterone cream that almost no one knows, and Im going to share it here. Please dont abuse it. If you take a vanishingly small dose of testosterone cream and apply it to your labia and the vulva (or your partners), you will witness a form of vasodilation rarely seen no matter how good you are in bed. It has a profound local effect and will produce a night you wont forget for years.

You are still messing with hormones, and you dont want to do this all the time, but on an occasional basis, it is unlikely to be harmful, and very likely to blow your mind. (REMEMBER: THIS IS A DRUG. DO NOT DO THIS WITH SOMEONE WHO HAS NOT CONSENTED. That would be evil.)

In the last few years, a lot of men and women have switched over to a pellet that goes under your skin. This is probably the best way to take testosterone now. The pellet is life-changing for both men and women (the dose for women is much lower than it is for men). Women, you wont get bulky and grow a beard when you take testosterone to achieve normal levels, but you will probably lean out a little without losing your curves, and your energy and sex drive will be amazing. Female bodybuilders who experience weird scary side effects are taking anabolic steroids.

Some anti-aging physicians also use sublingual ( taken under the tongue) forms of non-bioidentical testosterone like oxandrolone. I took oxandrolone with a physicians guidance for about two weeks, and I got pimples and hair loss. I quit and was bummed that it didnt generate enough impact to write a blog post about it. I have continued to recommend bioidentical testosterone since.

Before TRT, I recommend trying the natural testosterone-balancing methods I outline in the rest of this post. (If you decide to do TRT, work with a doctor, use bioidentical testosterone, and keep your levels right where they should be. Taking too much is dangerous, and I do not advocate TRT without a qualified physicians guidance.

Be sure you cycle testosterone, too. After taking it for a couple years, I forgot to cycle, and I suffered gonadal hypotrophy my balls shrank. Dont let this happen to you!

Im all good now, by the way. I talked with a doctor about it and we decided to use a short course of HcG (another hormone) to correct the problem. Fortunately, the boys are full-size and happy again.

Like you would on the Bulletproof Diet.

Heres how your body makes testosterone:

Cholesterol > pregnenolone > androstenedione > testosterone

Testosterone begins with cholesterol. In fact, every single sex hormone you make you synthesize from cholesterol thats one reason a heart healthy low-fat, low-cholesterol diet limits your performance. Fat and cholesterol dont make you fat. They give your body the building blocks to create abundant testosterone and other sex hormones, which actually makes you lose weight and build muscle, especially if your current testosterone levels are low [1].

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

There are two keys to incorporating fat in your diet: getting enough fat, and getting the right kinds of it. A study from 1984 (done, no doubt, with Big Brother watching) looked at 30 healthy men who switched from eating 40% fat (much of it saturated) to 25% fat (much of it unsaturated), with more protein and carbs to make up the difference in calories. After 6 weeks, their average serum testosterone, free testosterone, and 4-androstenedione (an important hormone for testosterone synthesis) all dropped significantly [6]. I think getting 40% of your calories from fat is too little I recommend 50-70% of calories from fat, or even more in some cases.

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

Great sources of fat include grass-fed beef and lamb, butter from grass-fed animals, pastured egg yolks, coconut oil, Brain Octane oil, raw nuts, avocados, and wild-caught fatty fish (sockeye salmon is my favorite). You can check out a full list of Bulletproof-approved fats here.

Sugar is to testosterone what kryptonite is to Superman. Eliminating sugar is probably the single most powerful way to increase your performance, in part because sugar absolutely devastates your testosterone levels (but all carbs do not, especially under heavy training.) In one study of 74 men, a 75g dose of sugar about the equivalent of a bottle of soda decreased serum testosterone by 25% in under an hour, and levels stayed low for at least 2 hours [7]. On top of that, 15% of the men who started with normal testosterone dipped into the hypogonadal range after they ate sugar thats the range in which doctors diagnose mens testes and womens ovaries as failing. When you do eat carbs, stick to Bulletproof ones like sweet potatoes and squash. My recommendations for types of carbs and how often to eat them are here.

You can still enjoy sweet flavors on the Bulletproof Diet, including desserts, but use birch syrup (xylitol from trees) or erythritol or stevia, not artificial sweeteners.

Exercise is the original testosterone booster, and its one of the most powerful full-body hacks around. Men see a sharp increase in both testosterone and human growth hormone (HGH) after lifting weights, and the boost is greater with shorter rest time between sets (1 minute rest outperforms 3 minutes rest) [9]. With the shorter rest time, women also get a large boost in HGH.

High-intensity interval training (HIIT) is another great option, especially if youre short on time or dont want to spend an hour in the gym for every workout. HIIT pushes you to your edge in minutes by using super intense exercise punctuated by brief rest. A full workout can take fewer than 20 minutes and leave you spent.

Rest and recovery is just as important as exercise, if not more so. Every time you do an intense workout, give yourself a minimum of 2 days to recuperate afterward, if not more. And dont mix exercise with sleep hacking. If youre exercising, get at least 8 hours of sleep every night. Your body uses it to rebuild, and you can throw your hormones out of whack if you dont rest up properly. Heres a more in-depth guide to Bulletproof weight training, complete with sample workouts.

Vitamin D and zinc are both essential to testosterone production. A year-long study looked at the vitamin D and testosterone levels of 2299 men. It found that men with vitamin D levels above 30 nmol/L had more testosterone and lower levels of sex hormone-binding globulin (SHBG). SHBG binds to hormones so your cells cant use them, and if you have too much of it, your testosterone levels drop [8]. Men with vitamin D deficiency had lower testosterone and higher SHBG levels.

The other interesting thing about the study: mens testosterone levels were lowest in March (at the end of winter) and highest in August (at the end of summer). Sunlight affects your vitamin D production, so you have seasonal dips and peaks. Get a blood test to check your levels, and if youre low, take a high-quality vitamin D3 supplement. If youre going to take D3, take vitamin K2 and vitamin A with it. The three work in sync, so you want them all to be balanced. Here are my dosage recommendations.

Take a look at your zinc levels while youre getting your vitamin D checked. Zinc deficiency can also cause low testosterone. If youre low on zinc, try eating more grass-fed red meat, and maybe a few oysters now and then. You can also take a zinc supplement the dose will depend on how deficient you are, if youre deficient at all.

Yes, seriously. Many deodorants, lotions, shampoos, conditioners, shaving creams, and other grooming products contain hormone disruptors. Check the labels on your toiletries for:

If youre using products that contain phthalates or parabens, ditch them in favor of natural options. Its especially important to use a good deodorant, because the pores in your armpits absorb chemicals easily.

And never, ever use antiperspirant deodorant. When you stop yourself from sweating, youre blocking your bodys natural detoxing system. Plus, most antiperspirants use aluminum to stop your sweat. Aluminum has possible links to dementia, especially Alzheimers [12]. Its also what causes yellow underarm stains.

Two natural deodorant brands that really work are Herban Cowboy and Fat Face, and EO makes excellent lotion, shampoo, and conditioner. I love Mother Dirt for bacteria-friendly shampoo and soap.

Professional-athlete-turned-biohacker Maximilian Gotzler gave a speech about boosting testosterone at the 2015 Bulletproof Conference. He started by leading the room through the Haka, a Maori war dance that New Zealands pro rugby team has made popular. The Pasadena Conference Center trembled as over 100 people shouted and stomped in unison. It was awesome.

It also had a purpose. It turns out posing in powerful stances causes your testosterone to increase within 20 minutes [13,14]. In those two studies, power posing for just a few minutes also dropped cortisol and boosted confidence. Its a great way to start your day, or to give yourself an edge before a job interview or a big presentation. They dont call it warrior pose for nothing!

Hacking your testosterone influences everything from body composition to energy levels to mood. Its easy to eat more butter; its hard to visit a doctor and get tested, but thats what I recommend: know your levels. If youre 25, youll know what your target is when youre 35. By the time youve noticed symptoms of low testosterone, its too late to get your normal measurements!

So enjoy this information, get some data, and try some upgrades! Have a great week and thanks for reading. And watch out for the boys if you have them.

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Read more:
What I Learned From Taking Testosterone For A Decade

Testosterone Replacement Therapy – My Anti Aging MD

* Results May Vary

At My Anti-Aging MD, we serve Arlington and Alexandria Virginia with testosterone replacement therapy. Give us a call to schedule a testing or just stop by to see if you are suffering from low testosterone levels. We offer 18 week cycles of testosterone replacement therapy via self injections at home. Our program is physician supervised for your health and safety and you are only required to visit our office for the initial consultation.

Although it is normal for testosterone levels to drop as men age, low testosterone can affect a mans health. The rush of new testosterone in puberty builds muscle and bone, deepens the voice, and revs up the sex drive.In matured men, testosterone is the main hormone that gives men a healthy libido, builds muscle mass and helps maintain energy levels.

Testosterone levels decline steadily after age 30. The decline is relatively small, at an average rate of about 1% to 2% percent per year. By middle age and older, all men experience decline in testosterone, but only a small percentage of men do something about it!

Low testosterone is defined as less than 300 nanograms per deciliter of blood. The symptoms of low testosterone include low sex drive, erectile dysfunction, mood problems, fatigue, and sleep disturbances. Of all men with below-normal testosterone levels, about one-half to two-thirds report symptoms.

Unlike a womans menopause, when estrogen levels plummet over months to very low levels, mens andropause is a gradual decline of testosterone levels over years. The effects of low testosterone can be insidious, even go unnoticed.

Some men with low testosterone levels have symptoms without recognizing them; for example, you may still have a sex drive, but not realize how much it has declined. Men with symptoms of low testosterone can have significant impairment in quality of life and ultimately sex drive. Current medical thinking is that these men should be treated with testosterone replacement.

Low testosterone can be replaced by using a daily skin gel, patches worn on the skin, orally disintegrating tablets, or injections. The general recommendations are to raise the blood testosterone level only into the normal range.

* Results May Vary

My Anti-Aging MD specializes in medically supervised HGH Therapy, Hormone Replacement Therapy (HRT) and Testosterone Therapy treatments that employ the latest advancements in treatment protocols.

Starting around age 30 hormones decline and individuals may experience symptoms of a low testosterone. If so you may be a good candidate for hormone replacement therapy.

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Hormone Replacement

Read more from the original source:
Testosterone Replacement Therapy - My Anti Aging MD

Myth about Testosterone Replacement and Prostate Cancer – page 2

The Memorial Sloan Kettering Experience

I was still giddy when I decided to look up the article detailing the experience of testosterone administration to men with metastatic disease from the Memorial Sloan Kettering Cancer Institute, published in 1981 by the urologic giant of his day, Willet Whitmore, and his colleague, Jackson Fowler. The short summary of the paper was quite damning. Over a course of eighteen years, fifty-two men with metastatic disease had undergone treatment with daily T injections, usually as a last-gasp treatment for their cancer. Of these fifty-two men, forty-five had experienced an unfavorable response, most within the first month of treatment.

This seemed pretty grim. Maybe Huggins had been right after all, despite basing his conclusions on a solitary patient. But then I discovered something equally shocking in the fine print of this article. Of the fifty-two men studied, all but four had already been treated with castration or estrogen treatment to lower testosterone. And of these four previously untreated men, one had an early, unspecified unfavorable response, while the remaining three men continued to receive daily T injections for 52, 55, and 310 days without apparent negative effects. In fact, one of these men was reported to have had a favorable response to T administration.

Drs. Fowler and Whitmore were impressed by the difference in outcomes for the untreated group of four men compared with the men who had already undergone hormonal treatment to lower testosterone. To explain the lack of negative effects on the untreated men, the authors postulated the following: Normal endogenous testosterone levels may be sufficient to cause near maximal stimulation of prostatic tumors. In other words, raising testosterone levels beyond the normal range did not seem to cause any increased cancer growth, even in men with metastatic disease!

This important concept was lost in the headline of the study, which clearly indicated that giving testosterone to men with prostate cancer was associated with rapid onset of negative consequences in most men. One had to read the article closely to learn that the headline applied only to men who had been previously castrated. Although this article has been cited for many years as evidence that T administration causes rapid and near-universal growth of prostate cancer (PCa), the authors in fact clearly made the point that the worrisome effects of T administration did not appear to occur in their small group of men without prior hormonal treatment.

It had been an amazing day in the library, which had long since turned to night. My head was spinning, but I wanted to tackle the last hurdle, the problem of testosterone flare. In the early 1980s, medications were developed to replace the need for surgical removal of the testicles for men with advanced prostate cancer. These medications are called LHRH agonists, and they continue to be used to this day. LHRH injections cause T concentrations to increase by 50 percent or more for seven to ten days, after which testosterone levels fall rapidly to castrate levels. This transient rise in testosterone is called testosterone flare.

Not long after LHRH agonists began to be used, there were reports of complications occurring after men began these treatments, and these complications were attributed to testosterone flare causing rapid growth of prostate cancer. These complications included the inability to urinate, worsening of bone pain, or, in the most tragic cases, paralysis due to collapse of a vertebra in which the cancer had eaten away the bone. As a result, for the last twenty years, it has been routine to add medications to block testosterone flare when starting a patient on treatment with LHRH agonists.

That night in the basement of Countway Library, I pulled all the original studies I could find of LHRH agonists, as well as reports of bad outcomes due to the flare. As I read, two things became apparent. First, many of the bad outcomes attributed to testosterone flare occurred a month or more after initiation of treatment. This meant that these complications occurred not when testosterone levels were high, but when testosterone levels had already dropped for some time to castrate levels.

Second, out of the substantial literature on LHRH agonists and prostate cancer, I could find only two articles that actually measured and reported PSA levels during the time of the testosterone flare. And here was the kicker: both articles showed absolutely no change in mean PSA values during the time of the testosterone flare! Curiously, neither article so much as mentioned this result.

PSA is an excellent indicator of prostate cancer growth. The fact that PSA did not rise in these men during the testosterone flare strongly suggested that the cancers did not grow during this time. Perhaps the complications attributed to testosterone flare were nothing more than the cancer progression that would have happened without any treatment at all.

It had been quite a day and night in the Countway Library. I left with my head spinning and a feeling that I had stumbled onto something very important. It was like the childrens story The Emperors New Clotheswe see what we want to see. And for two-thirds of a century, it had been assumed that raising testosterone increased prostate cancer growth. But maybe the emperor was naked.

Even in men with metastatic disease, there was no evidence I could find that raising testosterone made prostate cancer grow more than it would have anyway. Shockingly, the very publications cited so regularly to demonstrate a dangerous relationship between testosterone and prostate cancer contained evidence that this was not true.

Still, I was worried, because there was a bothersome unresolved paradox to explain. For decades, the storyline was that lowering testosterone levels caused prostate cancer to shrink away and raising testosterone levels caused it grow. The second part of this story was now seriously in doubt, yet the first part was obviously correct. In my own practice, I had seen the beneficial effects of lowering testosterone levels many times over in men with advanced prostate cancer. This part of Dr. Hugginss work was indisputable. But if lowering testosterone levels caused these cancers to shrink, how was it possible that raising testosterone levels did not cause the cancers to grow? This was a paradox that needed to be solved if physicians were to accept the possibility that testosterone therapy may not increase the risk of prostate cancer.

The answer turns out to be not all that complicated. All the reports of testosterone causing rapid growth of prostate cancer occurred in men who already had extremely low testosterone levels, due to castration or estrogen treatment. Once we get beyond the near-castrate range, it is hard to find any evidence that changes in T concentrations matter at all to prostate cancer. This is essentially what Drs. Fowler and Whitmore described in their 1981 article when they suggested that near maximal growth of prostate cancer is provided by naturally occurring T concentrations.

The experimental proof of this concept was provided by a landmark article published in 2006 using much more sophisticated means. In this study by Leonard Marks and colleagues, men with low testosterone received injections of testosterone or a placebo every two weeks for a total of six months. At the beginning and end of the study, measurements of testosterone and DHT (the more active form of testosterone within prostate tissue) were obtained from the blood and also from the prostate itself. The results showed that although blood concentrations of testosterone and DHT rose substantially in the T injection group, as expected, the concentration of testosterone and DHT within the prostate itself did not change at all and was similar to the group that received placebo injections. In addition, biochemical markers of prostate cell growth also did not change with T injections.

This study showed in elegant fashion that raising testosterone levels in the blood did not raise testosterone levels within the prostate. It is as if once the prostate has been exposed to enough testosterone, any additional testosterone is treated as excess and does not accumulate in the prostate. In technical terms, we say the prostate has been saturated with regard to testosterone. And it is this saturation that resolves the paradox of testosterone and prostate cancer.

Saturation explains the paradox in this way. At very low levels of T, near the castrate range, prostate growth is very sensitive to changes in T concentration. Thus, severely lowering testosterone will definitely cause prostate cancer to shrink; adding testosterone back will cause the cancer to regrow. However, once we get above the point where the prostate is saturated with testosterone, adding more testosterone will have little, if any, further impact on prostate cancer growth. Experimental studies suggest the concentration at which this saturation occurs is quite low.

In other words, the old analogy I learned in training was false. Testosterone is not like food for a hungry tumor. Instead, a much better analogy is, Testosterone is like water for a thirsty tumor. Once the thirst has been satisfied, prostate tumors have no use for additional testosterone. And the vast majority of men with low testosterone appear to have prostates that are not particularly thirsty.

I no longer fear that giving a man testosterone therapy will make a hidden prostate cancer grow or put him at increased risk of developing prostate cancer down the road. My real concern now is that men with low testosterone are at an increased risk of already having prostate cancer.

When my colleagues and I published our results in 1996 from prostate biopsies in men with low testosterone and PSA of 4.0 ng/mL or less, the 14 percent cancer rate was several times higher than any published series of men with normal PSA. In 2006, Dr. Rhoden and I published a larger study of prostate biopsies performed in 345 men. The cancer rate of 15 percent in this group was very similar to the first study. But whereas the cancer rate in 1996 was much higher than anything published to that date in men with PSA of 4.0 ng/mL or less, in 2006 the perspective had changed due to an important study called the Prostate Cancer Prevention Trial.

In that study, the cancer rate among men with a PSA of 4.0 ng/mL or less was also 15 percent. Because this value is identical to what we had found in our patients with low testosterone, it was suggested that the cancer rate in men with low testosterone is the same as the normal populationneither higher nor lower. However, the average age of men in our study was a decade younger than the men studied in the Prostate Cancer Prevention Trial (fifty-nine versus sixty-nine years). Almost half the men in the other study were seventy years or older, and age is the greatest risk factor we know for prostate cancer. The way I look at these numbers is that men with low testosterone have a cancer rate as high as men with normal T who are a decade older.

More importantly, in our study of 345 men, we found that the degree of testosterone deficiency correlated with the degree of cancer risk. Men whose testosterone levels were in the bottom third of the group were twice as likely to have cancer diagnosed on biopsy as men in the upper third. This finding adds to the concern that low testosterone is a risk factor for prostate cancer.

There is now additional data from around the world associating low testosterone and worrisome features of prostate cancer. For example, low testosterone is associated with more aggressive tumors. In addition, men with low testosterone appear to have a more advanced stage of disease at the time of surgical treatment.

Whereas I originally began to perform prostate biopsies in men with low testosterone because I was worried that treatment might cause a hidden cancer to grow, I now perform biopsies in these men because I am concerned they might have an increased risk of cancer. This risk is approximately one in seven for men with PSA values less than 4 ng/mL.

Because prostate cancer tends to be curable when caught early, I feel Ive done these men a service by finding their cancers before they have an abnormal PSA or DRE. With todays ability to monitor men with prostate cancer, not all of these men will necessarily require treatment. But the ones who have evidence of more aggressive tumors should definitely have an advantage by having their diagnosis made early.

For over sixty-five years, there has been a fear that testosterone therapy will cause new prostate cancers to arise or hidden ones to grow. Although no large-scale studies have yet been performed to provide a definitive verdict on the safety of testosterone therapy, it is quite remarkable to discover that the long-standing fear about testosterone and prostate cancer has little scientific support. The old concepts, taken as gospel, do not stand up to critical examination. I believe the best summary about the risk of prostate cancer from testosterone therapy, based on published evidence at the time this book is written, is as follows:

Low blood levels of testosterone do not protect against prostate cancer and, indeed, may increase the risk.

High blood levels of testosterone do not increase the risk of prostate cancer.

Treatment with testosterone does not increase the risk of prostate cancer, even among men who are already at high risk for it.

In men who do have metastatic prostate cancer and who have been given treatment that drops their blood levels of testosterone to near zero, starting treatment with testosterone (or stopping treatment that has lowered their testosterone to near zero) might increase the risk that residual cancer will again start to grow.

Prostate cancer with infiltration into bladder, lymph nodes, and urethra.

One of the most important and reassuring studies regarding testosterone and prostate cancer was an article published in the Journal of the National Cancer Institute in 2008, in which the authors of eighteen separate studies from around the world pooled their data regarding the likelihood of developing prostate cancer based on concentrations of various hormones, including testosterone. This enormous study included more than 3,000 men with prostate cancer and more than 6,000 men without prostate cancer, who served as controls in the study. No relationship was found between prostate cancer and any of the hormones studied, including total testosterone, free testosterone, or other minor androgens. In an accompanying editorial, Dr. Carpenter and colleagues from the University of North Carolina School of Public Health suggest scientists finally move beyond the long-believed but unsupported view that high testosterone is a risk for prostate cancer.

More and more physicians are coming around to recognize that testosterone therapy is not a true risk for prostate cancer, but it can take many years to alter established beliefs. Dont be surprised if your own doctor still raises this issue with you if you are considering testosterone therapy. If he objects to treating you for that reason, you should refer him to the article above, or one of the other review articles listed in the References at the back of this book. Even better, have him read this chapter!

Q. Im fifty-three years old and Ive been on testosterone therapy for two years, with good results. However, my father was diagnosed with prostate cancer at age seventy-five. Does this mean I need to stop testosterone?

A. There is a familial form of prostate cancer, but only in families in which prostate cancer occurs at age sixty-five or younger. Even in those families where a family member develops cancer at a young age, this does not necessarily mean that every other male in the family will develop cancer. Men with a family history of prostate cancer should be sure to have a yearly PSA and prostate exam. There is no need to discontinue testosterone treatment.

Q. My physician started me on testosterone, but I never had a prostate biopsy. I am sixty-four years old. Was this a mistake?

A. Because there is no evidence that testosterone treatment increases the risk of prostate cancer, it is fine to begin therapy as long as your PSA and DRE are normal. My own practice is to recommend prostate biopsy in men with low testosterone because our published data indicate there is an increased risk that cancer is already present in men with low testosterone, but this is by no means a standard recommendation yet among physicians.

Q. Why do you perform prostate biopsies on men with low testosterone if you dont feel that testosterone treatment will make a hidden cancer grow?

A. Because so many men with prostate cancer will not die from it, even without treatment, there is a fair amount of controversy over how aggressive to be in making the diagnosis. My perspective is that it is worth knowing the diagnosis, whether or not one chooses to be treated immediately. And because low testosterone seems to represent a small but definite increased risk, I feel that biopsy in men over fifty with low testosterone is worthwhile.

Q. A man in my bowling league was started on testosterone treatment and then developed prostate cancer one year later. Doesnt that show that testosterone is risky for prostate cancer?

A. If the wife of this man had switched to a new type of laundry detergent before the cancer was diagnosed, would we assume the cancer was caused by the detergent? Of course not. But we are predisposed to believe that testosterone therapy causes prostate cancer, so it is easy to hear a story like this and assume that testosterone therapy caused the cancer. Prostate cancer and testosterone therapy are both common in the United States, and both tend to occur in the same age range, so there will always be stories of men developing cancer some time after beginning testosterone therapy. If testosterone really made prostate cancers grow, then we should see high rates of cancer among men who start testosterone therapy. But we dont. Its false logic.

Q. Isnt it true that all men would eventually get prostate cancer if they lived long enough? If so, why does it even matter if testosterone were to increase the risk of something that is inevitable anyway?

A. Men do get prostate cancer at an increasingly high rate as they age. And it is true that most men diagnosed with prostate cancer would never have a moments trouble from it, even if it were left untreated, because most of these cancers grow so slowly that other medical conditions eventually become more troublesome. Yet for those with more aggressive forms of prostate cancer, the danger is very real. The challenge is to identify men at risk, because even high-grade prostate cancer is curable when caught early.

Q. It took more than thirty years for scientists to learn that hormones were dangerous for women and caused breast cancer. Isnt it possible well eventually find out the same is true for testosterone and prostate cancer?

Abraham Morgentaler, MD

A. The fear that hormone therapy is dangerous in women is currently being reevaluated, and it appears to not be as dangerous as was originally proclaimed. More to the point, it is critical to understand that men are not women and that testosterone is not estrogen. Anyone, particularly a scientist, must always allow for the possibility that new information will one day change current views. But after so much research over so many decades, there is little reason to believe that testosterone therapy poses a major risk for prostate cancer. As a medical student once said to me, If testosterone is really so dangerous for prostate cancer, why is it so hard to show it?

Abraham Morgentaler, MD, is an associate clinical professor of urology at Harvard Medical School, and is the founder of Mens Health Boston, a center focusing on sexual and reproductive health for men. He is the author of a number of popular books including The Male Body and The Viagra Myth.

Excerpted with permission from Testosterone for Life: Recharge Your Sex Drive, Muscle Mass, Energy and Overall Health by Abraham Morgentaler, MD, FACS. Published by McGraw-Hill.

If you have any questions on the scientific content of this article, please call a Life Extension Wellness Specialist at 1-800-226-2370.

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Myth about Testosterone Replacement and Prostate Cancer - page 2

The Definitive Testosterone Replacement Therapy MANual …

Praise for The Definitive Testosterone Replacement MANual

"Inspiring is Jay's knowledge of hormone replacement and human physiology, which surpasses that of many of my medical colleagues. This he brings to you the reader in the pages of his much-needed and timely opus. Open your eyes, read and digest Jay's words. This book is the chapter that I was scared to write."

Brett Osborn, MD Diplomate, American Board of Neurological Surgery Diplomate, American Academy of Anti-Aging Medicine CSCS, National Strength and Conditioning Association, Author of Get Serious, A Neurosurgeon's Guide To Optimal Health and Fitness

"The Definitive Testosterone Replacement MANual presents practical information about the best ways to maximize benefits and minimize side effects of testosterone replacement therapy. It accomplishes this goal in the most visually appealing way I have ever seen in this field. This book makes for an enjoyable and highly empowering read for any man who wants to take charge of his health and quality of life."

Nelson Vergel CEO, ExcelMale.com and DiscountedLabs.com, Author of Testosterone A Man's Guide: Practical Tips For Boosting Physical, Mental and Sexual Vitality

Is your sex drive at its peak, or has it diminished? Is your enthusiasm for life lessening?

Healthy testosterone levels are not only a physical state of prime health, but a mental state of positive wellness and aggression.

A man with low testosterone will experience not only a physical decline, but also a diminished quality of life.

Testosterone is often misrepresented by the media at large as inciting "hostility", or its effects are reduced down to building muscle only, and its portrayed as being detrimental to health. Nothing could be further from the truth. Comprehensive clinical evidence has unequivocally demonstrated that healthy testosterone levels not only slow the aging process and improve physical markers of health, but that they also reduce the possibility of degenerative disease, and by extension vastly improve quality of life.

Men NEED Optimal Testosterone Levels to age powerfully and live to their maximum potential.

The Definitive Testosterone Replacement Therapy MANual is the first book of its kind covering not only the therapeutic practice and application of TRT, but the historical, sociological, and biological issues that inform its usage.

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Testosterone Replacement: Options for Treatment Have …

The first thing to understand about testosterone replacement is that oral testosterone (pills taken by mouth) doesnt really work because it is broken down so quickly by the liver. The solution to this problem involves patches, gels, shots, and even nasal sprays. Here are your options, with some new players in the game.

Androderm patches are meant to be worn on the arm or torso. Androderm patches deliver approximately 5 mg of testosterone per 24 hours and result in normal testosterone levels in the majority of hypogonadal men. These have been around for a while.

Four testosterone gels are available: AndroGel, Testim, Fortesta, and Axiron.

The option of intramuscular injections is a good one, though it requires office visits. Injections are usually given one shot of 100 mg, once a week for 12 weeks. Regimens of 300 mg every three weeks and 400 mg every four weeks can also be used. An advantage of the shots for men is the freedom from daily administration of a gel or patch, while the disadvantages are the need for a shot of an oily solution every one to three weeks.

Natestois the first nasaltestosteronegel approved in the United States for the treatment of male hypogonadism andtestosteronedeficiency.Natestois a metered-dose pump applicator that places the gel into the nostrils.

The good thing?Because this gel is applied inside of the nostril, there is little chance of transferringtestosteroneto women or children who come into close physical contact with the person using the intranasal gel. That can occur with the gels and patches used on the skin.

There are some disadvantages.Some men wont like that it needs to be used three times daily. People with allergies or underlying nasal or sinus problems also may not likeNatestoas a runny nose, sore throatand sinusitis are among the most common side effects.

Thoughts?

Dr. O.

Most options for testosterone replacement are considered Tier 2 drugs by many insurance plans, though they may fall under higher copays or may not be covered with some plans. Androderm patches and all gel options run about $550-$600 per month or per prescription (for 30 patches or one container of gel). Testosterone shots are significantly less expensive, with generic versions sometimes available for as little as $20 per dose.

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Testosterone replacement can affect sex drive, osteoporosis | To … – STLtoday.com

Dear Dr. Roach I am a 67-year-old male in fair to good health (more good than fair, really). In a recent column, you mentioned that a good testosterone level for a man taking a replacement would be between 500-600 ng/dl.

In November 2016, I was tested for my testosterone level. At the time, I was (and still am) suffering from a low sex drive and erectile dysfunction. My level was 290 ng/dl. The reference range my primary care doctor bases his judgment on has an acceptable range from 193-950 ng/dl; hence he said my level was low normal.

When looking at the symptoms of low testosterone, I noted that I have at least four symptoms: low sex drive, ED (for which I have already been treated with a prosthetic implant), loss of body hair (especially my legs) and, most notably, osteoporosis (for which I take alendronate sodium, 70 mg weekly). I was diagnosed in November.

I also am being treated for depression and anxiety disorder, and have been since 2001. I dont know if this is related to my testosterone level.

Should I talk to my doctor about the disparity Ive found in reference ranges? Should I be seeking treatment for the low testosterone? J.P.P.

Answer I think you definitely should speak to your primary care physician. You also might benefit from a discussion with a urologist or endocrinologist with experience in treating men with testosterone replacement.

When we look at normal testosterone levels by age, we find that older men have lower normal levels; however, given your symptoms and result, I certainly would think a trial of testosterone would be appropriate. I must say that I am surprised that you had an implant placed without a trial of testosterone first. I also am surprised you were treated for osteoporosis without a trial of testosterone replacement, which has been shown to improve bone density in men with low testosterone levels (one study treated men with a testosterone level below 350; another if they were below 320). Low libido and erectile dysfunction both frequently respond to testosterone replacement: Some men get benefit in their mood as well. You sound to me like an excellent candidate for testosterone replacement.

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 request an order form of available health newsletters at 628 Virginia Drive, Orlando, Fla. 32803. Health newsletters may be ordered from rbmamall.com.

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MY EPIC FAIL + I NEED QUESTIONS for New Q A Series! (Please Thx!)
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Testosterone Replacement Therapy – Testosterone Treatment

Testosterone is a major sex hormone produced in the testes of men. The pituitary gland is responsible for controlling the production of testosterone hormone. In the testes, luteinizing hormone binds to receptors on Leydig cells; this stimulates production and secretion of testosterone. Testosterone helps to develop the primary and secondary sexual characteristics in males. Development of sex organs, deeper voice, muscle mass, and facial hair all result from the sufficient production of this hormone. Testosterone deficiency as happens with age needs effective testosterone treatment.

Along with the development of sexual features, testosterone hormone also controls the following actions in a body:

With age, testosterone production declines, thus disturbing overall body functioning. Low levels of testosterone hormone lead to a condition termed as hypogonadism that can be treated with testosterone replacement therapy. Hypogonadism can be divided into two categories depending on the occurrence of pathology.

Primary Hypogonadism: It occurs at testicular level with high release of follicle stimulating hormone (FSH), luteinizing hormone (LH), and low release of testosterone.

Secondary Hypogonadism: It occurs at pituitary hypothalamic level with low or in some cases normal release of luteinizing hormone and follicle stimulating hormone along with low levels of testosterone hormone.

Testosterone replacement therapy effectively works to improve upon the conditions of primary and secondary hypogonadism.

Along with aging, there are some other factors that contribute toward low testosterone production and make a man go for testosterone treatment.

Deficient testosterone hormone levels can lead to many undesirable symptoms, like poor libido, lack of vitality, erectile dysfunction, declining muscle mass, osteoporosis, loss of body hair, depression, lower blood hemoglobin, memory loss, poor concentration, mood swings, mild anemia, disturbed cholesterol profile and a decrease in cognitive function that effects all of your activities. Testosterone therapy is the only possible way to cope with testosterone deficiency.

Before start of the testosterone treatment, there should be the right detection of the hormone deficiency. If you consult an expert doctor for testosterone therapy, he may prescribe you the blood test in the morning because testosterone levels are at peak during that time.

We, at Nationwide Synergy Inc, provide patients with best available options to treat their hormone deficiency.

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Antares’ Xyosted Is One Of The Best Testosterone Replacement Therapies Available – Seeking Alpha

Image Source: Health Journals

Antares Pharmaceuticals' (ATRS) XYOSTED may be one of the best testosterone therapies available when evaluated against competitors such as Aveed, Depo-Testosterone, Delatestryl, and Testopel. Considering the sector has decade-old generics priced at $25/mo., management should be praised for its efforts to grow XYOSTED scripts to over 7,000/mo., and its revenues by 100% Y/Y despite a $550/unit pricing. Overall, this results in the company trading for merely 2.5x FY 2020 EV/Sales in terms of valuation, making the stock a strong buy.

In its earnings report early November, ATRS saw its bottom line improve by 182% Y/Y and posted a profit of $0.01 per share. Its annual guidance increased by 10% to $115 million for FY 2019. Revenues were also up sharply, growing by over 100% Y/Y with 46.5% of its growth coming from the launch of XYOSTED (subcutaneous testosterone enanthate injection) indicated for testosterone replacement therapy in hypogonadal men.

Source: Bloomberg Terminal/Symphony HealthCare Solutions

Much of this organic growth can be directly attributed to XYOSTED's prescription count. Based on data from 2 leading competitors, TRX for TRT grew nearly 200% YTD. Nearly 58% of this increase can be attributed to XYOSTED, which saw its prescription count balloon to over 7,000 units/mo.

The drug is currently priced at ~$550/unit retail, and is largely in-line with ATRS's revenue figures when multiplied by monthly prescription count. Whilst a simple calculation, this is fantastic news for ATRS as a drug's list price is usually at a premium to its net price due to bulk discounts and negotiations with pharmacy benefit managers. A lack of pricing differential in the case of XYOSTED indicates and reiterates its significant value proposition for patients.

Currently, XYOSTED's major competitors in the TRT market include Aveed, Depo-Testosterone, Delatestryl, and Testopel. Each and every single one of these drugs possesses disadvantages which puts XYOSTED in the spotlight when competing against sector players.

For starters, 90% of hypogonadal patients taking XYOSTED saw their testosterone levels return to normal (300 to 1100 ng/dl) after 12 weeks. There were no abuse-related adverse events reported in its clinical trials, as no single patient had witnessed testosterone levels spike beyond 1500 ng/dl. Furthermore, while its label indicates XYOSTED may be linked to major adverse cardiovascular events, medical literature have debunked this hypothesis. While the FDA has cited 4 studies suggesting an increased risk of heart disease post TRT, over 100 studies have reported reduced CV risk with higher endogenous testosterone concentration.

All combined, this gives XYOSTED a definitive advantage against standard TRT, some of which are decades old and cost just $25 per month retail. One such competitor is Delatestryl, which only has a minimum efficacy of 72% in normalizing testosterone levels and is suffering from supply shortages.

Another generic, Testopel, is not performing so well either. The drug was approved in 1972, but saw various hurdles related to its pharmaceutical parameters and was not marketed until 2008. In follow-up studies, 100% of patients who took the drug saw their testosterone levels normalize after 4 weeks, but this metric dropped to just 31.8% after 16 weeks of treatment.

As for Aveed and Depo-Testosterone, these are currently the most prominent competitors to XYOSTED. However, even these drugs have their fair share of drawbacks. Patients taking Aveed and Depo-Testosterone have reported severe fluctuations in mood/libido, and serious risks of anaphylaxis respectively.

As shareholders should see, XYOSTED possesses one of the best clinical profiles out of all sector players. It's superb efficacy, low prevalence of serious adverse events, and negligible risks of abuse makes it a leading candidate in a total addressable market estimated to be worth $2.2 billion in FY2018.

On the other hand, there continues to be over 10 new cases of testosterone deficiency per 1000 persons per annum. It is now estimated 2.1% to 12.8% of middle aged men have this condition. As a result, the CAGR of the total addressable market for its treatment isn't likely to decline any time soon.

With an annual run rate of $46 million in XYOSTED revenues, the drug has captured approximately 2.1% of the TRT TAM 1 year after launch, and is growing at +100% annually. In a past article, the author was critical of management for paying themselves nearly $6.4 million in annual share-based compensation and salaries while revenues stagnated at the $40 million mark. However, ATRS's leadership should now be applauded for their ability to grow sales of XYOSTED in a hypercompetitive market filled with generic competition.

Currently, the company has an enterprise value of ~$600 million and possesses negligible debt. While the company is expensive in terms of backward-looking metrics, the future is rather bright for ATRS. In terms of valuation, the company is trading at 10x EV/TTM Sales, but is only priced at 5x FY 2019 EV/Sales, and is valued as little as 2.5x FY 2020 EV/Sales. 10x spot revenues is not an expensive premium to pay for a company growing its sales at 100%. Hence, Investors interested in small-cap biotech should consider ATRS as an enticing growth stock.

Disclosure: I am/we are long ATRS. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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Antares' Xyosted Is One Of The Best Testosterone Replacement Therapies Available - Seeking Alpha

Reclaim Your Energy and Sex Drive | Testosterone …

Reclaim Your Energy and Sex Drive Reclaim Your Youthful Energy and Sex Drive!

Low testosterone levels commonly known as Low T, Hypogonadism & Andropause . . . find a doctor. The condition can produce devastating symptoms that include dramatically reduced sex drive, weight gain and a loss of energy and enthusiasm just to name a few.

Just because lower testosterone is associated with natural aging doesnt mean you have to accept a lower quality of life. To reduce or even eliminate the debilitating symptoms of Low T, Dr. Lionel Bissoon evaluates and treats the condition in both men and women.

Although low levels of testosterone are often associated with older men, testosterone levels begin naturally declining at about age 30. It should come as no surprise, therefore, that even younger people can be candidates for testosterone replacement therapy.

One of the first symptoms of lower testosterone is a decrease in libido. Reduced sex drive is a sign that there isnt enough testosterone present in the circulating blood. Unfortunately, patients with decreased libido and other Low T symptoms are often told by physicians that their testosterone falls within normal levels for their age group, and are sometimes denied testosterone replacement treatment.

Theres just one problem with this diagnosis: the difference between high and low normal is significant. Because of this, many men experience low-testosterone symptoms when their testosterone level falls below 50% of the median range for their age group.

Dr. Bissoons approach is to evaluate patients symptoms as well as their blood test results to determine who will benefit from testosterone replacement therapy. In other words, Dr. Bissoon listens to his patients to ensure they live healthier, happier lives.

Testosterone replacement treatment can produce transformative results, assuming there are no other underlying medical problems. Thus, Dr. Bissoon will perform a complete medical evaluation to assess your testosterone (and other hormone) levels.

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Choosing Wisely: Aytu BioScience vs. Lipocine – GuruFocus.com – GuruFocus.com

Both Aytu BioScience (AYTUD) and Lipocine Inc. (NASDAQ:LPCN) are advancing novel testosterone replacement therapies, but when placed side by side, which stock may make investors pumped for joy?

The testosterone replacement therapy market is a hot sector with companies focused on grabbing as much of the estimated $2 billion market as they can. Two emerging companies, in particular, are focused on delivering shareholders both near- and long-term value propositions by advancing their unique TRT products, one of which has recently hit the market. While several large pharmaceuticals are well entrenched in the TRT market already, their products, like AbbVie's (NYSE:ABBV) AndroGel, Eli Lilly's (NYSE:LLY) Axiron and Endo International's (NASDAQ:ENDP) Fortesta, are plagued with the most severe of Food and Drug Administration (FDA) warnings the dreaded Black Box warning. Thus, with the market opportunity open to treatments that may provide a better solution without the known risks of currently marketed TRT products, let's place two peer competitors side by side to determine the chances of either taking a bite out of the current market potential.

Is Aytu BioScience the 'wise choice?'

Although Aytu BioScience experienced a tough month in August, likely attributable to the recent capital raise, the company has never been stronger from a clinical and marketing perspective. Now that the split is old news and with shares trading above $3.70, the distractions of the past month may soon get replaced with investor optimism about the company's lead TRT product, Natesto.

Natesto has the potential to become a game changer in the TRT market. Although Aytu is marketing with a much smaller budget than those with already approved therapies on the market, at some point investors believe that wisdom will soon replace big pharma muscle, making Natesto the TRT of choice for prescribing physicians. And, when looking at published clinical data, the case for a market-leading Natesto should not be cast off as pure fodder. In fact, when comparing Natesto to Lipocine's pipeline TRT, Tlando, as well as to a host of other big-name drugs, Natesto has demonstrated statistically better efficacy and appears to be a safer and more effective treatment than most TRT products currently on the market.

Keeping the focus only on both companies' TRT products, other promising Aytu pipeline products won't get considered. Investors should not discount the value inherent to the Aytu pipeline consisting of a male infertility product MiOXSYS and a female sexual wellness product Fiera that like Natesto may offer significant and compelling market advantages. OK, so what about Natesto's bid to be best in class?

First off, Natesto is the only nasally administered TRT on the market. And, while some investors may not understand the significance of that issue, users of the product will. Being nasally administered helps to alleviate inadvertent transfer of testosterone, provides consistent and efficient dosing and offers significant convenience over topically applied products. Because of these advantages, Natesto is the only currently marketed FDA-approved topical TRT product not labeled with the severe FDA-required Black Box warning. Those safety and convenience issues are just the tip of the iceberg in the advantages column; there is more to Natesto to justify its place in the $2 billion TRT market.

It's no accident that Natesto has been called the potential best-in-class therapy on the market. Coming off its recent spike of over 300% in new prescription volume, Natesto is grabbing the attention of physicians due to the proven effectiveness of the product, which also leaves behind the severe side effects for patients. The differentiating factors are apparent; Natesto reduces or eliminates the potential for accidental transfer and does not require a man taking the product to quarantine himself from a female or child while the product is applied.

Additionally, being a hands-free application, Natesto offers consistent dosing in a measured treatment, and that's an important issue since excessive intake of testosterone is not necessarily a good thing for patients. Of perhaps greater importance, though, is that Natesto does not significantly reduce levels of LH and FSH hormones in the body, which has caused side effects in patients (including reducing sperm count and decreasing testicle size) who use products like AndroGel, Axiron, Fortesta and injectable products. Not only does Natesto maintain proper hormone levels in patients, but it also eliminates the potential for users getting hooked on testosterone treatments to maintain healthy testosterone levels. Natesto excels in other areas of concern as well, demonstrating a better safety profile over long-acting gels and injections that have been shown to increase hematocrit concentrations in the patient. That is, the treatments make the patient's blood thicker, which may lead to stroke and cardiac-related complications in patients. From a safety perspective, Natesto is best in class, but what about the efficacy?

The safety profile is significant, but it's how Natesto performs that is the real story. Marketed as "testosterone in seconds," Natesto is now the first and only FDA-approved intranasal TRT on the market. In a clinical trial, the majority of patients achieved statistically significant improvement in each of the five domains of erectile function. In most cases, the effect on normalizing erectile function occurred within the first 30 days of treatment. In addition to the benefits mentioned, 70% of men in the Natesto pivotal trial said they would switch from their current TRT to treatment with Natesto. Thus, no surprise that Natesto has seen a sharp trend higher in new prescription rates, with new authorizations for the product doubling since May. Also, 90% of men taking Natesto get their testosterone levels back to "normal," which is higher than other TRTs. And most men taking Natesto see their moods improve as soon as 30 days from starting treatment. The market is estimated to stand at approximately $2 billion currently, and if Aytu maintains the current trend, even a 10% market penetration can return over $200 million in new revenues.

Now that Aytu has roughly only 4 million shares outstanding, a revenue spike of that magnitude would most likely cause a disproportionate rise in company market cap, which currently reflects anemic value considering this potentially game-changing product. Adding in the potential of Aytu's other marketed products, the company may be a very wise choice for investors seeking long-term value and probability for share price appreciation.

Is Lipocine the 'wise choice?'

Lipocince is developing a testosterone product called Tlando. Although the product is not yet on the market, Lipocine is the closest peer to Aytu from a market perspective. Lipocine is taking a different approach for Tlando, testing an orally administered dose of testosterone, which the company plans to submit to the FDA for approval in the coming months. Investors need to know that the FDA has already denied the application for Tlando once, but Lipocine is preparing to try for approval once again, relying on similar data from the original rejected application.

A potential drawback for the oral administration of Tlando is that patients will be required to keep a consistent diet, maintaining certain fat content and calorie intake. And this is the case for each dosing. If patients fail to adhere to specific dietary requirements, patients are unlikely to see a meaningful rise in testosterone levels, which would be a huge problem and a potential marketing nightmare for the product. A significantly more adverse scenario is that during the company's FDA studies, a handful of men reached testosterone levels of over 2500 ng/dl, which is both extremely high and dangerous.

In addition to potential FDA problems looming for Tlando, the company itself said in a press release that LPCN 1021 (Tlando) only "generally met" the prespecified per dose secondary endpoints for twice daily oral administration. In layman's terms, the product either meets the endpoint or it doesn't, and when the company itself publishes mixed messages, investors should pay close attention. Also important to note is that the FDA will be highly unappeased if men being treated by Tlando exceed the 2500 ng/dl level, making the chances for approval unlikely. And to add insult to potential misery, as far as the FDA is concerned, when endpoints are "generally met," product support is unlikely. The FDA's words, not mine.

The biggest issue for Tlando compared to Natesto, though, is that when placed side by side, Tlando does not get as many men to normal testosterone levels. Company-sponsored studies demonstrate a significant edge in benefit from Natesto with 90% of males reaching normal testosterone levels, compared to just 70% of patients reaching normal testosterone levels when using Tlando. The FDA has made it known that at least 75% of men taking the testosterone product must reach normal T levels so it is difficult to understand how the FDA would even approve Tlando. Additionally, with Tlando known to produce dangerously high testosterone concentrations in some men, the road to approval may be far tougher than even the most optimistic investor may be willing to admit.

The 'wisest choice?'

Comparing the two, Aytu emerges as a clear "wise choice" for investors wanting exposure to the multibillion-dollar TRT market. Interestingly, Lipocine has a current market cap of roughly $75 million compared to Aytu's approximately $15 million market cap. From both a product and valuation standpoint, the opportunity for growth is substantial in the Aytu BioScience camp, particularly when you consider that there is no regulatory risk for Aytu. The product is already on the market and growing rapidly. Although a slim chance exists for approval for Tlando, the product would most likely be met with considerable marketing difficulties. Conversely, with Aytu's Natesto already approved and marketed, the promise again lay squarely in the Aytu potential.

Now that the TRT comparisons are noted, it's fair to factor in both Aytu's and Lipocine's additional pipeline opportunities. While a slight opportunity may have existed for Lipocine to present itself in a better light, the company is yet to produce an impressive clinical statistic. Thus, the clear advantages still weigh heavily in Aytu's favor, solidifying its position as the better of the two. With a pipeline focused on making use of a combined market opportunity of more than $11 million in the bank following its recent capital raise, in this case, Aytu BioScience is the superior choice for investors looking to "choose wisely."

This article was originally featured on CNA Finance.

Disclosure: The author has no positions in any stock mentioned in this article.

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