← BETTER! with Dr. Stephanie Estima | Strength, Body Composition & Perimenopause
BETTER! with Dr. Stephanie Estima | Strength, Body Composition & Perimenopause
Saving Marriages & Bedroom Comebacks: Midlife Women on Testosterone with Shalin Shah
01:05:52
Your husband can get testosterone therapy by sneezing in his doctor's general direction, but you're told it's "just aging" and here's an SSRI. Shalin Shah is here to blow up every myth about testosterone and women's health—because spoiler alert: that brain fog, disappearing muscle, and stubborn belly fat might not be a "you" problem, it's a hormone problem. Watch the full episode at https://youtu.be/7Kf5orCNH-g
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- [00:01]
Shailen Shah
What's really misunderstood or not understood at all is that there's a testosterone receptor on every organ in the body. So this does affect your brain, your cardiovascular system, your bone health, your muscle health. Yes. Your libido, mitochondrial biogenesis, or oxidative stress. These are things that affect your mitochondria and effectively how healthy your cells are. And downstream, what does that mean for your overall body? So big picture is that testosterone has a role all across your.
- [00:33]
Dr. Stephanie Esteema
Hello, fam. Welcome to another episode of better with Dr. Stephanie. It's me, your host, Dr. Stephanie Esteema. Today we are talking all about testosterone replacement therapy for women. Now, certainly we are going to talk about this for men because it's very well established in the literature. But if you are someone who is experiencing brain fog, you used to be able to make decisions and now you feel like you are a former shell, you are a shell of your former self. If you are finding that you're not able to make your squat anymore or your deadlift numbers, your strength in the gym is starting to deteriorate. Despite doing all the right things or things like sleep, you notice that your sleep is trash no matter what you do. And you have all the sleep hygiene dialed in. This is going to be a conversation for you. My guest today is Shalin Shah. He is the chief executive officer at Marius Pharmaceuticals where he led the development and the FDA approval of oral testosterone called Kaiserrex. This is the first oral testosterone therapy for men with low testosterone due to medical conditions. Now keep in mind that we talk a lot about off label use of testosterone for females in this conversation because as of this recording in North America, currently there are no approved products for testosterone in women. So a lot of our conversation is around the off label use and how to do that. I understand that we now have in Australia and yay, the United Kingdom, we have products that are available for females. But as of this recording in North America, we are still working on it. So a lot of our conversation is, okay, what does the body of evidence suggest around men, around metabolism, around libido, around muscle mass, around cognitive function? And how can we extrapolate that and apply it to our women? Should the physicians who are listening to this show decide to use this product or any other testosterone product off label? So this is going to be important for you as a consumer to learn about some of the clinical signs and symptoms of low testosterone in your own life and also how to bridge this conversation with your primary care physician. Because there are a lot of myths around testosterone that still perseverate today around cardiovascular risk, around prostate cancer risk, certainly in men. And we talk about all of these in the studies that have really been shown to, to sort of myth bust, if you will. So I hope that you take a lot out of this conversation. I certainly did. And without further delay, please enjoy my conversation with Shailen Shah. A new year means a new chance to invest in yourself. And for most of us, that involves the gym. But let me tell you, cannot out train low energy. It starts deeper than that. The good news is that more energy starts with one simple daily habit. Matapure gummies are the first ever longevity gummies that support your cellular energy so that you feel strong, clear and vibrant all day, all week, all month and all year long. They're the only clinically proven urolithin, a gummy that helps renew your cell's powerhouses so that you can show up as your best self every single decade. Urolithin A helps with your cellular energy, which means it gives your cells more power to fuel your day. It supports steady, sustained energy, which means that it helps your body turn stress into usable energy, which thank goodness for that because I'm finally putting my stress to good use. And it also helps with strength. Clinical studies show that urolithin A supports muscle strength and function. Think of it as charging your internal batteries every single day. Your body makes less energy with this, helps bring it back. Don't let another year go by feeling less than your best. Grab 35% off of your one month subscription of Mitopure Gummies at timeline.com better35 that's T I M E L I N E.com B E T-T-E R and the numbers 3 and 5 to grab your 35% off while the offer lasts.
- [04:39]
Dr. Stephanie
All right, Shalin, welcome to the show. I'm happy to have you here today.
- [04:42]
Shailen Shah
Thanks for having me. Pleasure to be here.
- [04:44]
Dr. Stephanie
We are going to be talking about testosterone in women, which is potentially a very spicy, you know, controversial topic. And I think I want to start off by helping the audience understand, especially when they're in the context of speaking with their physician, what is the fundamental misunderstanding around the role of, of testosterone in the female body. And I think maybe for as a ground rule we can talk about the role of testosterone in men as well and then as a comparative, the analog for the misunderstanding around the role of testosterone in the female body.
- [05:19]
Shailen Shah
So yeah, the easy place to start is on the male side because, you know, folks barely even consider it a female hormone today, even though it absolutely is Right. Testosterone is a male and female hormone, just like estrogen is a female and male hormone. Same thing. So on the male side, it's often pigeonholed in terms of muscle building because of all the history around steroids and sports. Or it's really sexual health. Right. That this is going to make guys sort of, you know, just. Just drive to crazy levels of, you know, sexual activity or something like that, which is. Which is far from the case. But what's really misunderstood or not understood at all is that there's an androgen receptor or a testosterone receptor on every organ in the body. So this does affect your brain, your cardiovascular system, your bone health, your muscle health. Yes. Your libido. And even all the way down to the cellular level, mitochondria, which is becoming more and more, you know, discussed today and understood, you know, mitochondrial biogenesis or oxidative stress. These are things that affect your mitochondria and effectively, how healthy your cells are. And downstream, what does that mean for your overall body? So big picture is that testosterone has a role all across your body. It is not a single category. And that really is very similar on the female side as well. Yes, our bodies are different. They do function slightly differently. But at large, a lot of those parameters that you see on the male side are equally happening on the female side as well.
- [06:53]
Dr. Stephanie
Yeah. And to your point, I think we phenotypically ascribe estrogen as the female hormone testosterone. We often say, oh, this is the male hormone, but we have more testosterone in our bodies than we have estrogen. Even if you just look at the way that we measure a T, it's usually like nanograms per deciliter. Estrogen's like picograms per milliliter. So even there, there's like an order of like, three. You know, it's like 10 to the minus. Oh, my goodness, is that like minus 12 and then 10 to the minus 15. So there's like orders of magnitude more testosterone in the female body. Certainly when we compare men to women, we're gonna have, you know, like 10 to 20 times less tea than men. But this is one of the. Especially in the menopause and the perimenopause conversation now with the Women's Health Initiative essentially denying women hormone therapy for the better part of 20 years, I think that that conversation is now swinging to the other direction. But the most often in that MHT or HRT conversation is progesterone and estrogen. And, like, do you have a uterus? Then you're going to use this, and if you don't have a uterus, then you're going to use that, et cetera. And I think that the testosterone piece of HRT is often left out. So maybe you can talk to us a little bit about some of the clinical signs and symptoms. Again, male. And then I'd like you to carve out for female. For our female listeners, what are some of the clinical signs and symptoms of low testosterone.
- [08:17]
Shailen Shah
So some of the first things that show up on the male side, which unfortunately still get dismissed as general aging often, but it is, it is around energy, feeling. That afternoon drag is certainly one of the main ones that show up in the male side. And you also see things like sexual dysfunction, that loss of libido that does happen, the inability to put on muscle mass. Right. So all the positive aspects of the therapy often do manifest as the symptoms. The inability to burn fat. So these things are pretty common on the male side, but they're equally common on the female side too. Right. And I think, you know, as. As most of your listeners will. Will know.
- [08:55]
Dr. Stephanie
Right.
- [08:56]
Shailen Shah
Even the body comp. I think that's. That's probably one of the. The first things that the female sees too. Right.
- [09:01]
Dr. Stephanie
Biggest frustration.
- [09:02]
Shailen Shah
Yeah, you're working. You're working, eating, hitting the gym, but you're not seeing those results. It's often a hormonal imbalance, and it doesn't have the underlying fuels to make the changes that would have otherwise occurred if you were in a hormonal balance.
- [09:16]
Dr. Stephanie
Talk to me about sleep and cognitive function, because again, like, you hit the nail on the head with the body composition. That is probably the most common thing that I'll hear from women. It's like, I don't know what it is. I'm not like, I'm doing literally the same thing I was doing when I was 35, and now I'm 45 and my waist is disappearing. I'm accumulating belly fat at a. At a rate that I'm unhappy with. Clothes are not fitting the way that they used to. So body composition 1. Sleep is the other early sign. I find a lot of women will, you know, turn 42 and then it's like. And I can't sleep.
- [09:46]
Dr. Stephanie Esteema
So talk to us about sleep, how.
- [09:49]
Dr. Stephanie
Testosterone might influence sleep drive and sleep pressure. And then also I'd like to talk about brain function and cognitive function as well as.
- [09:57]
Shailen Shah
So I'll start on even the cognitive function. So, yeah, these are the receptors across the brain. So again, on the male side and female side, this is actually one of the Interesting things, actually, if you look at a lot of the Alzheimer's data as well. So you can look at tau protein accumulation and if you look at low testosterone patients at older levels and you'll see higher tau protein accumulations, full stop. Right. So I think there are clearly neural activity levels that are happening with appropriate testosterone levels and effectively fueling that cognitive function. And same thing on the sleep side. And I've heard this anecdotally. Do we. We don't actually have, in terms of Kaiser Track's data on it yet, but I've heard anecdotally from patients within weeks of starting therapy that sleep is markedly different. And I thought that was pretty outstanding or resounding, if you will, that you can see those kind of impacts and how quickly that they manifest on that male side, but again, equally translating to the female side. And now you have wearables. I think that's another beauty that you can kind of put into this equation is you can really understand what those impacts are in a short amount of time, whether that is on rem, primarily REM sleep and deep sleep sleep.
- [11:16]
Dr. Stephanie
Yeah, I know that for men it's, it's a little bit more cut and dry. Right. So it's like, yeah, I started taking testosterone and I'm sleeping better and I'm making, you know, better decisions. I feel like that brain fog has lifted. But this is again, another very common.
- [11:31]
Dr. Stephanie Esteema
It's hard to tease out when you're.
- [11:32]
Dr. Stephanie
In it because it's such a slow and gradual decline. It's almost like you habituate to the.
- [11:36]
Dr. Stephanie Esteema
You know, to the new normal. And we're.
- [11:38]
Dr. Stephanie
Yeah, it's your new normal.
- [11:39]
Dr. Stephanie Esteema
Exactly.
- [11:40]
Dr. Stephanie
So one of the, one of the challenges, I think, and maybe we can talk a little bit about testing and looking at levels of free testosterone and shbg, sex hormone binding globulin, what those mean and how we might, as a male or a female, because I know it's a little bit different, figure out what the right level of testosterone is for us.
- [12:01]
Dr. Stephanie Esteema
So talk to us a little bit.
- [12:02]
Dr. Stephanie
About the mechanisms in terms of what's happening when t gets lower, what happens to shbg, sex hormone binding globulin, and then what are some of the ranges that we want to be considering for both a male patient. I know there's a huge variability here. And then as. As well for a female patient.
- [12:19]
Shailen Shah
So I think diagnostics is, is certainly the, the best place to start and something that we advocate a lot more for. I mean, again, blood panels, standard blood panels don't include Testosterone today, even though it is in, in a lot of instances, the single most telling biomarker you can draw on. Right. Because you're taking a look into your cardiovascular function, your inflammation, your glucose metabolism, your insulin sensitivity and so on. But, but in terms of what we would test, it would start relatively simple. You can look at your total testosterone, you have to look at your free testosterone, you have to look at your shbg. Because again, ultimately I think that's where the conversation is really going to go is free testosterone and shbg. Both on male and females, we see elevated male side. As you get older, females often have elevated SHBGs because of historical birth control use. Right. That drives these levels much higher. We do like to look at LH and fsh. I think there's a really interesting paradigm shift that's happening, happening with daily oral testosterone and your diurnal rhythm and what's happening then the impacts on LH and fsh. So those are some of the common things that you should certainly be testing for. But again, I think free testosterone is going to take the lion's share of the conversation if you go forward because that is what is actually available for your body to use and bind to receptors.
- [13:42]
Dr. Stephanie Esteema
Yeah.
- [13:43]
Dr. Stephanie
And this, you know, when we're looking at this from a female perspective, this is where I think that added layer of complexity comes in because as of this recording, as of today, there's only an approved product, I think in Australia. And then I think you mentioned that the UK they just approved a testosterone product for females.
- [13:59]
Dr. Stephanie Esteema
So.
- [14:00]
Dr. Stephanie
And the only way, if you are in North America at this point to get access to testosterone as a woman is to have a physician who's willing.
- [14:08]
Dr. Stephanie Esteema
To prescribe it for you off label.
- [14:10]
Dr. Stephanie
And certainly there are, but the only indicated, you know, on label, if you will reason that a woman might qualify to get testosterone right now is hyposexual desire disorder. So I think that there's, and you mentioned before, testosterone for muscle mass and libido for men, which is, which is wonderful. But I think that we have to also be thinking as clinicians and I think just as the healthcare system as a whole, if you're on, if you are assuming a, assuming a heterosexual couple, okay. If you are just treating one half of the couple. So if you have, you know, a 45 year old male or 55 year old male who is being treated, treated.
- [14:52]
Dr. Stephanie Esteema
For ED or low T or whatever.
- [14:53]
Dr. Stephanie
It is, he's on TRT and he's ready to go and he's like, you know, the, you Know, the penis is happy, right. Like, he's ready to kind of, like, you know, put it to use. But then on the other side, you have a woman who has declining testosterone and some of the other reproductive hormones. You know, that's a.
- [15:08]
Dr. Stephanie Esteema
That's a. That's a disaster.
- [15:10]
Shailen Shah
Big mismatch. And honestly, you're almost exasperating it. Right. Like, if you're already this off, generally. Right. And then you go even further in that direction if it's a. Again, a male is being put on testosterone, for example, and the female's not being treated, I think, yeah, these are train wrecks. And you have to treat both couples. And we see, you know, we see that in with a lot of the clinicians that we deal with. The wives are often in the practice, in the appointments with the males, and they become patients then instantly, because they say, okay, what about me? And then, yes, luckily, a lot of the sexual health doctors are able to treat both. But, yeah, it's an incredibly important sort of equation that can't be ignored. And, yeah, frankly, I think there has to be a lot more education on it so you don't have this train wreck for couples, full stop.
- [15:58]
Dr. Stephanie
I remember a friend of mine who was saying that they went on a menopause cruise or something, and there was a divorce lawyer there, and she was saying something to the effect of, you know, I literally think I would be.
- [16:09]
Dr. Stephanie Esteema
Out of a job, like, because of.
- [16:11]
Dr. Stephanie
The lack of access to hormones for women for the last 20 or so years since the WTI, I would literally.
- [16:17]
Dr. Stephanie Esteema
Be out of a job.
- [16:18]
Dr. Stephanie
Like, there's so much divorce that happens in midlife, and part of it, I think, certainly can be traced back to the mismatch that we're. That we're describing. Right.
- [16:27]
Dr. Stephanie Esteema
So we are able to, you know.
- [16:29]
Dr. Stephanie
A male walks into a physician's office, and he has a full suite of options available to him in terms of treating a variety of, you know, whether it's sexual disorders or just generally hormone optimization.
- [16:39]
Shailen Shah
Right.
- [16:39]
Dr. Stephanie
And I think that most women, you know, just want to have the option to age like men. You know, it's like, I just want to have a suite of options available to me, and I can make an informed decision with my primary healthcare provider to age well in the same way that we've afforded our beautiful men.
- [16:57]
Shailen Shah
No, I. I totally agree. And I've seen it sort of firsthand, right. Like, I. Look, men have it easy in comparison, and I've seen in my own household, right. How hormones have changed and how that affects, you know, downstream it's not just, it's just not just mood, right. It's overall health and even things when you look at like female gut health versus male gut health. And there are differences there. So, yeah, I'm a full supporter of that. And I think that's where the education really has to come in because women need more. It gets a more complex system, right. So you have to get into these greater details, but then you need providers that can go and help the journey. And I'm starting to see it a little bit. Honestly, I've heard from, from a lot of females that I've spoken to that now they're, you know, gynecologists or someone may recommend, like, please go see a functional doctor because I can't do this. Right. And I think that that actually does, as much as that's not necessarily helpful. That's the first time that I've started to hear that and kind of mark a shift to realize or recognize that the females or the female system needs more support and, you know, the tools need to be addressed. So again, I think that's progress. I think, you know, shows like this, obviously educating and, you know, you asked a question around the normal range, for example, right? Like helping people understand where they should be or what's optimal too. Because normal has been sort of decimated if you think about it, right? If you look at the male normal range, which is wider, it's just continued to come down and down over the years and decades now. And now, you know, a lot of lab reference systems even have as low as like 268. 250 is normal, right. When this used to be 400, right. And that's so, you know, again, then you get thrown into the bucket that says, okay, everything looks good, can't help you. Right? Or insurance is not going to cover it. You're going to have to look somewhere else. I think we have to reframe that. Normal people need to understand what's that, you know, optimal for them. And that's why testing is important earlier and earlier because I may be say, 500, 600 is my normal at, I don't know, 25, 30. Then when I'm 50, I know that's probably where I need to be at to be optimal. Somebody might need to be a thousand because that's what they were when they were younger. So it's really important to be able to allow diagnostics and like history to be tracked appropriately.
- [19:17]
Dr. Stephanie
One of the things that hormone therapy, at least I hear a lot of the clinicians who are, who are dosing and prescribing and managing patients with hrt, particularly females, is that they are not necessarily looking at labs, but they are looking at the patient's symptomatology.
- [19:34]
Dr. Stephanie Esteema
Right.
- [19:35]
Dr. Stephanie
So does she feel brain foggy? Is she forgetting things? Are we starting to see vasomotor, you know, signs and symptoms? But to your point, I think that there's something to be said, especially when, you know, air quotes, we're gonna say normal. I think that the better word is maybe common.
- [19:52]
Dr. Stephanie Esteema
Right.
- [19:52]
Dr. Stephanie
So as we are starting to see.
- [19:54]
Dr. Stephanie Esteema
Over the several decades, we've started to.
- [19:56]
Dr. Stephanie
See these numbers as you alluded to, get lower and lower and lower. And we have huge ranges now like you were saying, like 300 to, you.
- [20:04]
Dr. Stephanie Esteema
Know, 1200 nanograms per decibel.
- [20:07]
Dr. Stephanie
That's an incredibly large range. So it is very important for, for men, I'm referencing for men, I think for. So, so there is value in understanding.
- [20:16]
Dr. Stephanie Esteema
If you are able to, if you.
- [20:18]
Dr. Stephanie
Are a young person or if you have a young person in your life that you love and care about, maybe encouraging them when they are in their 20s to have some kind of, that would be ideal to have some kind of baseline when you're like 25ish, and.
- [20:31]
Dr. Stephanie Esteema
Then you can sort of track that.
- [20:32]
Dr. Stephanie
Over the arc of that person's life.
- [20:35]
Dr. Stephanie Esteema
But I did have a question around.
- [20:37]
Dr. Stephanie
What you think may be happening to testosterone levels in general. Like I was saying, I had Shauna Swan on the, on the show and she was saying like 2 point something percent decline in testosterone per year, which is for, and she was referring to men, which I think is petrifying. I think that that's, you know, you know, there's comments that you can make on the future of the human race if we continue to see declines like that. What do you think are some of the contributing factors to this persistent and almost predictable at this point, lowering of testosterone levels in men?
- [21:12]
Shailen Shah
It's, it from, from our perspective, it's, it's generally two, two sides here. You have a lifestyle component that is, that is driving this lower level of testostero testosterone, but you also have an environmental component. And I think there are some underlying similarities there or cross currents, if you will. I mean again, we are, you know, generally unhealthy lifestyles and sedentary is driving, you know, higher levels of obesity and our inactivity levels are, you know, higher than ever per se. So that drives, again, that does have an effect on your, on your hormone production. There's also a lot of environmental factors though. If you think about our food or microplastics or things that are in the water, in that sense, these are all pretty much part of society. I don't think you can try to remove some of these. I mean even fragrances, right? For the longest time, frankly, I don't work alone anymore because I would not put on a fragrance on my body or the skin, the lotions and the soaps. All of these things have the chemicals that have penetrated our body, right? These are all endocrine disruptors and, and it's very hard to get those out. That's literally sort of being ingrained and retranscripted into our genetic code. So you can do some of it. I think a big one that I think is the intersection of the lifestyle and environmental is sleep and screens. This has become so embedded in our culture, our society, whatever it is. So I don't blame the folks that are up at midnight and 1am like scrolling, that's just become. Our brains have been rewired by technology and our bodies don't know how to handle that. Right. So I think there is a component that is you can take control of and try and correct, but you can't. It's difficult to do all of that. And I think that is massively affecting our hormone production.
- [23:04]
Dr. Stephanie Esteema
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- [24:20]
Dr. Stephanie
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- [24:23]
Dr. Stephanie Esteema
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- [24:42]
Dr. Stephanie
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- [24:45]
Dr. Stephanie Esteema
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- [25:39]
Dr. Stephanie
This do you think that there are ways for us to reliably increase our own natural levels of T, male or female?
- [25:49]
Shailen Shah
I think so. Short answer is yes. Longer answer is a little complicated in the sense that can you lose 10 to 20% of your body weight and see some increases in your T levels? Yes. But these are often, you know, to the tune of 50100 points potentially, which again really may only put you at that lower end of normal, if that at all. So there are lifestyle improvements that you can do, but you have to also look at again those signs and symptomology that we talked about earlier. So if you don't have the energy, it's going to be difficult for you to be less sedentary, like to do the things that you need to do. You need to get into a virtuous cycle. And I'm not saying testosterone is the cure all by any means, but if say you're able to restore your testosterone levels and you do have better energy and you do end up going in the gym three, four days a week, better than zero. And even by that nature, you start eating better because you're more encouraged, you're doing things in a positive fashion. And again, that's why I use the upward spiral or virtuous cycle. And maybe after one, two years, you are in a much better metabolic place. And naturally your T levels could be higher. Could you stop therapy? Absolutely. But first get there. I think that's really the point, that we need to use the tools in our toolbox to get there. Not everything is this. I don't know, let's call it a willpower. If you have the willpower, you can make it happen and that's it. Like, I don't think that's fair to the general population to expect that.
- [27:23]
Dr. Stephanie
It's very similar to GLP1s as well.
- [27:26]
Dr. Stephanie Esteema
Right.
- [27:26]
Dr. Stephanie
There's still a stigma, I think, around GLP1s feeling like you're cheating, feeling like you're not doing the right thing. But it gives you that energy. Right. It also gives you that dopaminer, like almost that. Like that boost of energy and drive to actually do the right things that you have to be doing. I like you. I think I'm. And redirect me here if I'm wrong, but I think that you have to marry both of those things. This is where we have, like, a marriage of, you know, pharmacology and lifestyle. Like the two things, you can't just take, you know, testosterone and think that you're going to grow glutes and shoulders and whatever else you want to, you know, whatever you want to do, you still have to put in the work. But it's going to help create. It's going to help you overcome that inertia that would otherwise preclude you from doing the things that, you know that you should be doing.
- [28:10]
Shailen Shah
Absolutely. No, it's a synergistic thing. And I think you can include, yes, foundational health items such as, you know, diet, sleep, stress, exercise, and then above that sits hormones, and you have to optimize those. And that kind of works as a positive feedback loop. And yeah, same with GLP1s. Throw GLP1s in the mix. You know, testosterone is often. Can be an important component of that because, say you want to talk about lean muscle mass, Right. How do you preserve this? You know, yes, you need to have the appropriate strength training, the appropriate nutrition and protein intake. But again, an anabolic component certainly is. I think this is the future of G. I mean, that's why companies are already chasing muscle preservation in the terms, in terms of GLP1s with myostatin inhibitors, which frankly haven't worked out yet, and other components. But that is really the future. Especially if you think about an aging population that's at risk of like sarcopenia and frailty, hip fractures, etc, muscle. Is that currency? You know, I'm sure you, you know, we, we run in the same circles where a lot of people are talking how important that is. Even if you look at longevity conversation, it's going to boil down to strength, VO2 max and body composition. Yep, it's, it's, it is sort of as simple as that. So what are the interventions that are driving those kind of outcomes? But one thing I think is important to know is things like with testosterone, we are always advocating for physiologic doses. Right. Whether that's male or female. And that's important to remember in the sense that again, I'm going to pick on GLP1s a little bit. At these really high doses of GLP1s, you have often, you have like four times the amount of, of typical GLP1 crossing the blood brain barrier. Right. Like, we can't advocate for something like that in testosterone where you're at running at four times super physiological levels. Like, we are just talking about physiological levels and replacing what the body doesn't have. We're not manipulating genes on or off in that sense. We're really just replacing. And that's why the safety profile is at physiologic doses really clean, because the body knows exactly what to do with it. It's not sent into overdrive and figuring out how to compensate in different directions. It's relatively straightforward.
- [30:29]
Dr. Stephanie
And what about any concerns? And this is more of a specific, female specific question around virilization. So I've certainly this podcast, we talk a lot about fitness and health, muscle building and cardio. Like the audience like, oh, there she goes again, talking about sprinting and VO2 max and deadlifting and all the things. But especially, you know, and I competed many, many years ago. But in the bodybuilding world, in physique competitors, even today, if you look at bikini, like all the girls, like, as beautiful as they are, they're all in gear, what is the concern or risk, potential risk with something? When we are, when we are looking at physiological doses, do we have concerns around virilization? When I say that, you know, for those of you that might not be familiar with that, that might be things like changes in your voice, that might be like bone. Like you, you'll see women with very pronounced mandibles. You might even see growth of the clitoris. Right. So you'll see an enlargement of the clitoris. So what are some are, is that.
- [31:29]
Dr. Stephanie Esteema
A risk with some of the doses.
- [31:31]
Dr. Stephanie
That we're talking about if this were to be used off label for women?
- [31:37]
Shailen Shah
So again, generally female testosterone is dosed at one tenth the dose of a male. Right. And I think where this conversation or this sort of side effect issues really stem is when that isn't one tenth of a dose. And again, frankly, this stems from a lot of pellet therapy today. Right. That's a major, major modality that is used in females. And the levels are often super physiologic. And the problem is not necessarily always super physiologic levels if they are basically pulsatile and temporary. Right. So, so if they were coming, you know, hitting a peak during the day and coming back down during the same day, that would be one thing. But often on pellet therapy, you're on, you have a super physiologic level for an extended period of time.
- [32:25]
Dr. Stephanie
Months.
- [32:25]
Shailen Shah
Yeah, exactly, exactly. And unfortunately it's sort of being sold to women. Right. And they hear stories about why, you know, their friends feel so good, so they obviously get on. But then you're in, once you're, once that pellet's in there, it's not coming out for these three, four months. So that's really when you see these side effects peak more often if you're at physiologic doses. And again, we're going to do the work for this. We just announced our female advisory board this morning and we're going to start our clinical trial specifically designed for female and to drive an FDA approved product. But I do not think at physiologic doses you are going to see anywhere close to the side effect profiles that you do regarding pellets.
- [33:09]
Dr. Stephanie
Well, let's actually talk about the different modes of delivery. So you, you know, we've talked a.
- [33:13]
Dr. Stephanie Esteema
Little bit about oral.
- [33:13]
Dr. Stephanie
I think that it's important for us to sort of set the stage here because when we used to think about oral testosterone, this was very much hepatotoxic, so it was very much toxic to the liver. You've mentioned pellets. Let's actually talk about some of the different modes of delivery that's available for testosterone right now, on label or off. And then maybe why Kaisertrex is, is it's an, or it's an oral testosterone, if I'm correct.
- [33:36]
Dr. Stephanie Esteema
Oral testosterone, it's oral.
- [33:37]
Dr. Stephanie
So why is this not hepatotoxic so.
- [33:40]
Shailen Shah
I'll just quickly address that. So Kazotrex is designed to be lymphatically absorbed, so it goes through the small intestine and is absorbed there. This is, this is a unique formulation that we've developed and that's really why it drives down the path that it does. You do have to take it with food to activate the lymphatics. But that can be any sort of fat content, meal, whether it's low fat, medium fat, et cetera, versus some fat. Yeah, just some fat. Older versions of oral testosterone. Yes. Were liver toxic or required high amounts of fat, like 50 grams of fat with a meal to drive absorption. And yes, we all know that that's not realistic. So the delivery system is unique and novel and I think that's what's going to drive and that's what drives its efficacy in terms of the modalities. And happy to talk about both sides. Right. Injections are quite common on the male side. Gels were used a decent amount when it was a branded product and marketed. But gels have a lot of their own issues, whether it's transference, risk to others, whether it's actual absorption issues or in absorption, I should say. So that's really not too common these days. Pellets exist for both male and females. Again, I think it's used more on the female side because injections are not that common for females. It's mainly creams or pellets.
- [35:04]
Dr. Stephanie
Well, the creams also have, I think you mentioned it very briefly, their own. Like if you have children and you put some. Even if you put on your thigh or something and then you're wearing. But if it's on your hands, it's still on your hands at some trace and you're picking up your kids and you know, then there's gonna be that transference that you. That you mentioned. Which we also want to avoid.
- [35:22]
Shailen Shah
Exactly. So on the male products, there's a. There's a black box for transference to others. Right. So it just doesn't exist because there's no female product. They have nowhere to put that. Warning the compounders, compounding creams don't have to put that. But yeah, no, it's an absolute issue. I get. I've seen it firsthand and it's. It's between. Especially if you talk about your audience. Right. We're on the go. You don't have. You put this cream on, you gotta wait 30 minutes for it to dry or you're putting your clothes on top of it or whatnot. It doesn't fit into routines. But then also you just have variable absorption. So you don't know what you're gonna get versus again, yes, an injection. You're gonna get pretty much a steady blood level. Likely go super physiologic on Kaisertrex. We see if you're taking it appropriately, you're gonna see a more consistent daily level.
- [36:16]
Dr. Stephanie
Well, let's talk about that. How do we first maybe describe the circadian rhythm of testosterone? And then I would like to also overlay that with the infraredian rhythm of testosterone for women. So whenever we talk about testosterone, it's always like, highest in the morning, and then it sort of falls out, which is very. Which is very true. And then there's, you know, women also have this beautiful overlay of our menstrual.
- [36:39]
Dr. Stephanie Esteema
Cycle for the better part of, you know, 40 or so years where we.
- [36:43]
Dr. Stephanie
See peaks of testosterone at certain points in the menstrual cycle.
- [36:47]
Dr. Stephanie Esteema
So how.
- [36:47]
Dr. Stephanie
And I know, you know, you just announced that you're working and developing on a female product, female specific product. How does that change the production of testosterone? Whether you are a male taking Kaisertrex or a female taking the female dosage, the female product, once it's ready. And how does that. Maybe I'll say, honor the. The normal rhythm of the way testosterone is actually utilized in the male and female body or produced, I should say, in the male and female body.
- [37:15]
Shailen Shah
Yeah. So like most of the things in the conversation. Right. Male side is relatively easy. You know, like you say we peak in the morning and then decline throughout the day. So, you know, Kaisertrex effectively mimics that same, you know, diurnal rhythm. And at the end of the day, when. When it's, you know, let's call it flush from the body, that's. That's where we see interesting data around. Like, let's say LH and fsh, which don't go to zero on in our data because the hypothesis is the pituitary goes back to work. Right. It's at the end of the day, it's saying, okay, there's no exogenous testosterone here. Let's get to work, and let's produce what we can. And so we don't.
- [37:49]
Dr. Stephanie
There's no negative feedback loop that's like, hey, stop producing this. We have so much of it.
- [37:53]
Shailen Shah
Exactly. So it's not 100% negative feedback loop. Maybe it's 50%. Right. But the factory, we like to use the analogy that, that the factory is still working. You maybe turned off some equipment, some workers home, but you're still working versus in often injection therapy, that factory is completely closed. All the machines are off, all the workers are home. So on the female side, and this, to be fair, is going to be naturally part of the research and program. From the majority of our clinical discussions thus far, we've seen standardized dosing across the cycle or across that month. So, you know, females are getting back up into a normal range, which they would again, sort of typically have, but that doesn't get modified for time of month.
- [38:44]
Dr. Stephanie
So cyclically you're not like progesterone sometimes is often dosed cyclically. If you're still menstruating and you figure out if you've ovulated or not, you take progesterone for the, you know, the luteal phase of the cycle and then you stop once you start bleeding again. But for testosterone, you would not do that. It would just be a consistent dose daily.
- [39:01]
Shailen Shah
Based on what we've seen, again, I think this also stems back to, you know, yes. Do you have the ability to do that because you have an oral daily capsule, but because peaks are transient, you can, you can really dose to a level that you feel good with throughout the entire time. Because I think it actually stems down then to compliance and consistency. Right. Like, what's the best therapy is something that you can be compliant and consistent with. So if I can tell you, look, you're taking one capsule or two capsules every morning, period, I think that's, that's better than saying, okay, for this time you're taking two and then you're going to take three, or you're going to take it Monday, Wednesday, Friday or every other day. Right. Once you start introducing different sort of dosing schemes, although they could be ideal from a pure physiologic perspective. I don't know if they translate to real world clinical life and enough delta where you want to modify them.
- [39:59]
Dr. Stephanie
Right? Yeah, I mean, I think when you start, when, I think you start adding in different layers of complexity, as you're saying, like, your compliance is going to go down. It's like, should I take one today.
- [40:08]
Dr. Stephanie Esteema
Or two or three? I'm not sure.
- [40:10]
Dr. Stephanie
So I'm just not going to do it.
- [40:11]
Dr. Stephanie Esteema
Right.
- [40:11]
Dr. Stephanie
And then you start missing days or it's tough, Right.
- [40:14]
Shailen Shah
I mean, even, like, I'm not the most compliant patient. Right. But even if I look at my supplement routine, when I start adding in, like, okay, I gotta take this one 15 minutes before the meal, some are 15 minutes after the meal. I, I, you know, this one needs to be Taken at lunch versus evening. Like I struggle myself.
- [40:32]
Dr. Stephanie
I don't even take my electrolytes at the same. At the right time. So like typically you should take electrolytes in the morning. I end up forgetting about it until the evening. I'm like, oh, you know what?
- [40:39]
Shailen Shah
I should probably have some rehydrate.
- [40:41]
Dr. Stephanie Esteema
Yeah, I should probably rehydrate.
- [40:42]
Dr. Stephanie
Yeah. And it's like I never do it at the ideal time, but I'm at least doing it on a d. A daily basis. So there's some kind of ritualization which I think is at the, at the bare minimum what you can ask for the public from the public at large.
- [40:54]
Shailen Shah
Right. So I. And again, I think like as this conversation evolves, I think we're really in the first inning of where hormone therapy is sort of. It's, it's, it's actually a renaissance because I think it was there, you know, pre. Whi. And. And growing and then, you know, hit its. Hit its, you know, these roadblocks. But I think so, so that's why I call it we're in a renaissance. But we will continue to pair these things back and get to more and more personalization as we go. And I think that's where the things like the free tea conversations come back and what you're aiming for specifically. But right now I think we're advocating for better diagnostics or more frequent diagnostics. And the ability to treat like that's more than half the battle right now is convincing. I guess let's call it traditional medicine that this should not be ignored.
- [41:41]
Dr. Stephanie
Yeah.
- [41:43]
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- [43:05]
Dr. Stephanie
Yeah, there's a lot of myths around testosterone. There's a lot of. In the same way that people think estrogen, you know, take estrogen therapy, you're going to get bre cancer. I think the same is true. You can say testosterone, you might go to a traditional doctor who's maybe not up to, up to snuff on the latest science, might say, oh, it's cardiovascular disease or prostate if you're a male, you know.
- [43:23]
Dr. Stephanie Esteema
So talk to us a little bit.
- [43:24]
Dr. Stephanie
About some of the myths because I really want to arm the listeners with maybe talking points that they might approach.
- [43:30]
Dr. Stephanie Esteema
Their pcp, their primary care provider with.
- [43:33]
Dr. Stephanie
In terms of how to gently direct or redirect misinformation around testosterone.
- [43:38]
Shailen Shah
Testosterone, yes. Two of the biggest ones, as you mentioned rightfully, are cardiovascular risk. And, and this really started to come into the picture around 2013, 2014. They actually changed the labels on testosterone products and, and you know, effectively, you know, sort of shut it down, if you will. Right. So cardiovascular risk, which then fast forward to ten years later. The FDA did mandate what was the largest randomized placebo control study around cardiovascular risk and testosterone therapy that was called the Traverse trial and that read out in June of 23. Simple conclusion. Testosterone therapy does not increase the risk of cardiovascular events, period. And actually in the data, there were, there were less CV events in the testosterone arm than the placebo arm. Right. So I think actually where the conversation is going to go is how understanding testosterone's role in, in cardiovascular health, because if you actually look at endothelial function improves on testosterone therapy. So that's where I think it's going. But again, firmly that, that myth still perpetuates today, despite that study. It's going to take, usually they say it takes 10 years for these things to be fixed. I think it, it should be faster given the day and age of information that we're in. But yeah, that's, that's certainly extremely damaging. And then the second, which is a long time myth for testosterone, is that testosterone causes prostate cancer on the male side. Right. And this actually originally stemmed from there was a study, it was like 1940, there were three patients, one was a female so that's out. And then there were two guys, older males.
- [45:18]
Dr. Stephanie
Nice.
- [45:19]
Dr. Stephanie Esteema
Yeah.
- [45:20]
Shailen Shah
The end was two people.
- [45:21]
Dr. Stephanie
Two.
- [45:22]
Shailen Shah
And one guy got prostate cancer. Right. Like old men do. So I think that's been firmly shown. There's saturation models to show after a certain level of testosterone level, there's no impact on the prostate. I mean, a simple way to look at it is like, prostate cancer. Young guys who have high levels of testosterone. What's the incident rate of prostate cancer versus old guys who have low testosterone?
- [45:48]
Dr. Stephanie
Yeah, it's the same. It's the same comment with breast cancer. It's like, when are you more. More likely to have breast cancer as a young woman or an older woman? It's an older woman. When the. When your levels of estrogen are lower.
- [45:58]
Shailen Shah
And there's been studies on both sides. So, like, we've. We've seen interesting data around testosterone therapy, reducing incidence of prostate cancer and actually colorectal cancer. And I think some of that data exists even on the breast cancer side.
- [46:15]
Dr. Stephanie
Yeah, that's super. It's.
- [46:16]
Dr. Stephanie Esteema
It's like super cool stuff.
- [46:18]
Dr. Stephanie
And also it's frustrating because, you know, you said it's about 10 years. I'd actually counter and say it's probably closer to 20. You know, whatever. What we're seeing in the literature usually starts to get out into clinical practice.
- [46:29]
Dr. Stephanie Esteema
At a delayed rate of like, two decades.
- [46:32]
Dr. Stephanie
Unfortunately, like now, we're only now being like, you know what, this wh. Thing.
- [46:35]
Shailen Shah
Yeah, maybe so. It's so scary, honestly. Right. Because you, again, the lay patient, really doesn't have a clue. So you're going in.
- [46:42]
Dr. Stephanie Esteema
Right.
- [46:43]
Shailen Shah
And again, this is nothing against doctors. Right. I think the system is. Has set them up where, you know. Yeah, that's how it works. Right. Like, it's. How do you even. Guidelines. Right. I mean, I know this. Speaking to people from guidelines and whatnot, like how rigid they can be or how unwilling, even with new data, they will be, to move the needle. And this is bureaucracy. This is liability risk. There's so many things that are not medicine that make their way into this decision making, and ultimately, unfortunately, patients are the losers. Then.
- [47:19]
Dr. Stephanie
Yeah, let's talk a little bit about. I want to get back to dosage and maybe also monitoring in terms of sort of dispelling some of the worry around testosterone. So you've mentioned one or two pills, you know, taken in the morning, and then. Is there a second. Is there. Is it for women or maybe for men? Maybe it's easier to answer it for men and then carve out the female Answer, what does the dosage look like? What might that look like as of now, where someone might be prescribing it, a physician might be prescribing it off label. And then the second question or the follow up there is what are some of the monitoring, what are some of the symptoms that a woman or men.
- [47:59]
Dr. Stephanie Esteema
Need to be looking for to report back to their, their doctor?
- [48:03]
Dr. Stephanie
So for example, with estrogen or progesterone, actually, we want to look for any new bleeding, vaginal bleeding, we want to be watching that and reporting that back to our doctor. So we can monitor it to figure out if the dosing is right, if they need to monitor it or change it, et cetera. So same question, dosage for T and then also monitoring for potential side effects.
- [48:26]
Shailen Shah
So dosage on the male side for Kaisertrex is our most common doses are 300mg bid or 400mg bid. So you are taking this twice a day? Day two capsules twice a day. And then in terms of monitoring, I'd.
- [48:41]
Dr. Stephanie
Say so 150 and 200 each capsule.
- [48:44]
Shailen Shah
Yeah, the capsules are 150 milligrams size and 200 milligram size. Correct. It's like a fish oil capsule. Right. Because again, it's a soft gel, it's not a pill per se. But in terms of the monitoring, it's twofold blood work. Right. What are you checking in terms of again, you obviously can check the levels, but that's really more of a symptomatic thing. And if you feel good, then that's what clinicians are mostly monitoring. But safety, you'll look at a big one. Here is hematocrit. So on the male side, so that's your red blood count. And often on injections, historically on injections that could run high. Right. There's data that looks at even 66% of patients on injection therapy have elevated hematocrit levels. And that's definitely been a concern for providers historically. And I think a major reason why.
- [49:31]
Dr. Stephanie
Is that transient when you first start?
- [49:33]
Shailen Shah
It's not necessarily transient, especially again, if you think about supraphysiologic levels for an extended period of time on Kaisertrex, that that hematocrit is sub 2%, that would have an elevated level. So I think that's really something. And again, it's an important point to monitor regardless. But I think that's helping shift the paradigm in terms of providers and especially primary care providers who are thinking, thinking, hey, can I come back to this space and what are the risks. So that's important. Again, on the male side we like to check LH and FSH as well to see what the activity levels are there. And then you look at psa. Right. That's again going back to the prostate debate. You're always checking that because again what the data would show is testosterone can actually help identify an underlying cancer that's there. So that's actually, you know, I think that's also part of the misnomer there is that it's causing it, but it's actually helping expose that and you know, speak to enough clinicians. There will be a similar story there on the female side. Switching over there. Again, the doses for females are generally 1/10 in our development program. What we are going to aim at is somewhere between a 20 and 60 milligram dose. Again, this is titratable because again everybody's different and how they respond. But I think on the, you're mainly going to be looking at symptom relief for females from a monitoring perspective. Yeah, you want to monitor that the levels are not shooting too high but a lot of these side effects and actually I'll go back to the mail first in a second. The side effects are often self reported. Right. If you see something like, you know, yes, unwanted hair growth or deepening of the void, voice or hair. Right. These are often, you may have sensitivities to androgens at certain levels but often dose dependent activities. So titrations are really important. Again, impellets don't let you do that properly. So titrations are really important. Again, back to the male side. When I look at, you know, what are the doctors that we deal with monitoring from a symptomatic perspective. Yes, they'll report how they're feeling and so forth. But some of the ones that will say, hey look, maybe we need to make a dose adjustment often come down to like mood, anxiety, irritability. Right. Those are not common by any means but can be triggered. Testosterone can trigger them at the wrong doses.
- [52:01]
Dr. Stephanie
I think. It's also one of the things I think is important to also carve out here. When you're looking at blood work for women, you don't necessarily have to have low table to get on. Like if to get on testosterone therapy, I think that that's important and I think that would be true for men as well. I think that it is really important to think about the clinical representation of the patient. So if the patient feels like I have brain fog, I can't remember things, I have, you know, I'm walking around in this haze, I can't make decisions. I'm noticing my, I'm losing my strength. So I was able to squat, you know, I don't know what, whatever £150. And now I can't make that weight anymore. More and even, yeah, libido for women, certainly, if you're noticing, you know, I love my husband or I love my partner and I just like he's ready to go and I'm just not. I think that these are all very, very important considerations. And so when you're looking for blood work for women, I think it's also, and maybe I'd love for you to maybe expand on this, that you don't.
- [52:57]
Dr. Stephanie Esteema
Necessarily have to have low T to.
- [53:00]
Dr. Stephanie
Get on testosterone therapy. You just can't have like super physiological levels of T. And hey, like I want more, you know.
- [53:07]
Shailen Shah
Exactly. No, I think that's fair. And we see that mirrored on the male side too. Again because the ranges are so wide and what is actually appropriate for an individual varies. So there's, you know, it's an optimization piece to a certain degree. But again, like you said, what best example is on the male side I'll still use. And before I go back to the female side, we love our men.
- [53:26]
Dr. Stephanie
Yes, we love men.
- [53:27]
Shailen Shah
It's just easy to kind of like. But it's what's nice is that like it does translate. I don't think it has to be. Again, this is not just for us but like clinicians kind of hearing this, this, you know, often our board certified urologist or PCBs or endocrinologists that we're working with, they'll say, look, under a certain level, maybe it's 400 nanograms per deciliter. They'll say, look, you can try, yeah, let's try this and let's see how you do. There's no harm because you may see these improvements because yeah, you might need to be at 800 or 1,000 nanograms per deciliter. Just because again, you're not technically low T doesn't mean you're not going to benefit from therapy if you're already at 1,000. And maybe that's not the solution, but I think the same thing is going to happen for the female side. We just need more providers speaking about it, willing to try a therapy that is not harmful. Right. And say, okay, let me give you this trial and see how you do and go from there. Right. Because again, if it's transient peaks, they're coming down throughout the day, you don't have side effects. Why not? Right. And I think we have safety data to show even higher levels of testosterone not being harmful.
- [54:43]
Dr. Stephanie Esteema
Yeah.
- [54:43]
Dr. Stephanie
And it's the transient peaks, I think that is sort of critical to this conversation. It's not like the pellet where you have consistent levels for three or four months, as we were discussing earlier. It's like you're taking something, it's metabolized in the body, it reaches this peak and then there's a trough. Right. So it's like you have it, it's up and it's down and it's that these physiological levels, it's not like we're giving women like 300. It's like you're not like you're dosing them at 300. You know, you're giving them, you know, I wrote, I was just making notes as you've been talking like 20, 20 to 60. Like I've seen, I've had labs come back and I've had, you know, when you sort of reading the, like the patient value and then like what they consider normal. Like I've seen, I've seen labs where zero is considered normal. And it's like this is, this is wrong. Like zero is not, is not acceptable. It's not an acceptable level for t in a woman.
- [55:31]
Shailen Shah
Right, Absolutely. Yeah. And I think providers have to get comfortable. And the ones that do see clinically patients day in and day out and see the outcomes and monitor the safety and so forth, they know this. Right. You just need the broader. It's just, you know, unfortunately for patients, it's like finding a needle in a haystack. Right. Finding that good provider that can take care of them.
- [55:53]
Dr. Stephanie
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Dr. Stephanie Esteema
Coffee, but you really have to choose the right one to make sure that.
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Dr. Stephanie
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Dr. Stephanie
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- [57:16]
Dr. Stephanie
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Dr. Stephanie Esteema
So how do we talk to our providers?
- [57:19]
Dr. Stephanie
Because this is a, this is a big problem. I think I hear this in the United States. This is a big problem in Canada as well. Now. They're two slightly different systems in the United States. I think there's a little bit more. I don't know if the word is permission, but that's the word I can think of right now. It's like, it's like if I don't like what this doctor's telling me, I'm gonna go and find another provider. Right. But in Canada, because there is, and I will say this, being a Canadian now, I'm very blessed. I have just the best, like, my MD is like my, my friend, like, wonderful, wonderful relationship with her. But many people don't have that.
- [57:51]
Shailen Shah
It's, it's sort of spawned, for better or worse, like an alternative system. Right. Obviously, in the US we have a lot of functional medicine doctors, we have a lot of concierge doctors and so forth. In Canada, I've definitely seen even telehealth rising. Right. In the last couple years.
- [58:03]
Dr. Stephanie
There's a lot of telehealth in Canada.
- [58:05]
Dr. Stephanie Esteema
Yes.
- [58:05]
Shailen Shah
Yeah. So it's just like, again, these wouldn't exist, honestly, if patients didn't need them. So I think they're good. Right. And they're helping progress the dialogue and giving people, you know, there's enough information online. Right. To kind of arm the patient. But it really depends on how willing is your physician to hear this. Right. And I've heard that. And this has honestly happened to people other us personally, all the way from pediatrics through. Right. Our own personal care. When we bring up topics or research or studies, because we spend the time and bring it up to the physician, you'll know very quickly, like, are they open to this? Are they going to dismiss you? Right. And yeah, like you mentioned, maybe it's easier to sort of fire and find a new provider here in the US But I think the same. I'm sure Canada will sort of catch up in the sense that these alternative channels and not alternative in a weird way, in that sense just, just outside of the government pay system will continue to sprout and serve patients, you know, really well.
- [59:06]
Dr. Stephanie
Are there other forms of testosterone right now that are similar in their delivery, like this lymphatic absorption that we've been talking about with Kaiser Tracks that are available to market right now? And is it available in the United States only? Is it, where, where can, where can patients, if they're looking for it, where can they find it?
- [59:25]
Shailen Shah
Right, so there is another oral on the market here in the U.S. but the approach is very different. Right. Kaisertrex has gone out sort of counterintuitively on a cash basis because that was the best way to get access for people to get access rather than our insurer, our payers and PBMs. When a new drug comes to market, the first move is to block it. Right. Not available, too expensive and so forth. So I think we're the most accessible drug by far here in the US in terms of oral testosterone. And you know, again we've, our approach is just different. That's why we're out educating kind of every day talking about the therapy. You know, all boats will rise. But I think Kaisertrex is sort of synonymous with oral testosterone. We are actually probably by this time the time this airs, this should be approved in Canada. So we have Canadian approval underway, we have UK approval underway. Way we're looking at multiple Asian markets today and the Middle East. So we are rapidly bringing Kaisertrex around the world.
- [60:26]
Dr. Stephanie
And as of this recording we just have a male version. But certainly a physician can decide to say, hey, we can, we can try this off label. You're mentioning before for currently right now there's like 150, like 150 and 200 pills. So how would, how would someone.
- [60:42]
Shailen Shah
There's also 100 milligram capsule pill.
- [60:44]
Dr. Stephanie
Oh, there's 100 mgs as well. Okay.
- [60:46]
Shailen Shah
Yeah, we just, it's not used to too much because again you can replicate it with the 200 milligram. So it simplifies patient.
- [60:52]
Dr. Stephanie
So you might be just cutting that in half. If you're a woman, you might be just like splitting it in half.
- [60:56]
Shailen Shah
I can't tell you that, I can't tell you what to do.
- [60:59]
Dr. Stephanie Esteema
If someone were to, if someone were to, theoretically, if there was an off.
- [61:03]
Dr. Stephanie
Label prescription, they would take the lowest dosage and then split it up.
- [61:07]
Shailen Shah
So we're gonna, again, our trials are gonna aim for this 20 to 60 milligram zone. We think that will will deliver the proper levels for females.
- [61:18]
Dr. Stephanie
Yes, I like the CYA answer there.
- [61:21]
Dr. Stephanie Esteema
That's great.
- [61:21]
Dr. Stephanie
Like the COVID your ass answer. Okay, so I'd like knuckle out a lot of things.
- [61:25]
Shailen Shah
There's some things I will definitely get in trouble for.
- [61:28]
Dr. Stephanie
Okay. So no, no, that's completely fair. Certainly we want to be abiding by the prescriber rules and the regulatory bodies and all of that. So I completely respect that and I ask it because I know that there are a lot of physicians in Canada and the state states that, that use testosterone products that are designed for men off label for their female patients. So that's me just.
- [61:49]
Shailen Shah
Yeah, no, absolutely. It happens every day. Right. So I think that's totally fair. But yeah, we're really excited about at least putting these into trials and producing the data. I'm sure there will be posters, abstracts, et cetera that show just the efficacy and safety. Right. I think it's been much needed. We have a good hunch on this work and frankly it's just an unmet need. Right, that's the way to put it. There's an unmet need.
- [62:16]
Dr. Stephanie
And do you have an estimated project timeline for the female product that we were talking about?
- [62:23]
Shailen Shah
So I would like to complete phase three trials in 27.
- [62:30]
Dr. Stephanie
Okay, great. Well I hope that you'll come back in 27 when if you've gone through all the phases, you've gone through all the hoops that the FDA and Health Canada and everybody's going to put you through. Love to have you back on to talk about that product if and when it comes to market. Because I think that as we've been saying there's a, there's a big need for women and I think what you're doing in terms of educating just around testosterone in general, like what it does physio, like what does it do in the human body, like you know, sex agnostic and then we can layer on some of these nuances for the male and female body. I mean I don't see a lot of pharmaceutical companies doing that, which I think is, is commendable. So I think that yeah, this has been fantastic. So I know, I've been to your website, I know that there's telehealth providers.
- [63:13]
Dr. Stephanie Esteema
That are list that are listed there.
- [63:15]
Dr. Stephanie
So for people who have access, who may be in the States right now, where can people find, if they, is.
- [63:21]
Dr. Stephanie Esteema
It telehealth providers or can you go.
- [63:23]
Dr. Stephanie
Into your doctor's office and say hey, I want Kaiser. Like how does it, how does it work? If People are.
- [63:27]
Shailen Shah
Couple ways. I mean, again, you can absolutely go to your doctor's office and request it. I don't, you know, depending on how familiar they are or not. Right. That will drive that discussion. But if you go to our website, kaisertreks.com, you can find either. Yeah, you can find a provider brick and mortar that you can go and see and if makes sense, can get on therapy or. Yes, we have telehealth providers as well that are covering 50 states across this country. Yeah, I anticipate we'll have Canada early in 26 as well. But you can go on there, find one that fits sort of your, let's call it ethos. Right. We have longevity providers through traditional kind of more simple, streamlined HRT providers. And so there's, there's a mix for, for everybody depending on what your goals are. But yeah, it's. We, our goal is access. At the end of the day, it's education and access and we want to reduce barriers to, to therapy.
- [64:18]
Dr. Stephanie
Fantastic. Thank you so much for your time today. This has been phenomenal and wonderfully informative and we will make sure that all of those links that we talked about are in the show notes. So make sure if you're listening, you can go to the show notes and find a provider if you are in the States right now or 26 if you're in Canada. And then I'm assured that there's going to be a rollout in the UK and Europe and you know, the common, you know, Australia and all the places.
- [64:38]
Dr. Stephanie Esteema
Shortly thereafter as well.
- [64:39]
Dr. Stephanie
So thank you so much, Shalin. This has been absolutely wonderful.
- [64:42]
Shailen Shah
Thank you for having me. Stephanie, it's been a pleasure.
- [64:46]
Dr. Stephanie Esteema
Hello my friends. Welcome to the after party where I tell you exactly what I thought of this episode. And I think when we are talking about this episode in particular, I think it is very clear that there is just not enough information about testosterone for women. That was maybe the biggest, biggest through line that I got from our conversation. So certainly men, we love men. We love men. Right. I'm raising men, I'm married to. And we love men, but they are easier to study. They have been studied more extensively. Don't have a menstrual cycle, don't go through perimenopause and menopause andropause, not the same thing. And so we're just kind of guessing with women when it comes to hormone replacement therapy. And I think this is where clinicians who are using HRTs and testosterone will be included in that off label really are the pioneers that are paving the way for women to just have the opportunity to age in the way that men are given the opportunity to. So I mentioned this, you know, kind of early in our conversation, where it's like, you know, men have, like, a whole suite of options available to them for any, you know, erectile dysfunction or low T or whatever. They have 10, 20, maybe 30 different products available to them. And women, we got, you know, we got none. We got none. So I think that all women are really asking for is like, can we just age like our male counterparts? And so I thought that this conversation was important to bring to the table and have it, because we have this CEO of this pharmaceutical company who is creating a product for men. It's available for men right now, and now is looking at creating a product for females. And I think that this is going to be super duper important. My hope is by the time that this. This podcast airs, that we are either very close to having this available in all the countries that we talked about. So certainly it's available now in the United States. But my hope is for my Canadians who are always listening and, like, what about me? That it'll be available for you, too, or very shortly thereafter. So a couple things that I really liked in terms of what we talked about is that testosterone is not just for libido. And this is, again, coming back to this. Like, the only reason as a woman, as of today, that you can get tr testosterone replacement therapy is for hyposexual desire disorder. So it's not just a libido thing. And if you are certainly in a committed couple, that we definitely want to be treating both sides of the equation. We can't just treat the penis and ignore the vagina. Right. We want to be thinking about both the male and the female. But I loved how he talked about this idea that testosterone is not just a reproductive hormone. It's not just about libido, but we have androgen receptors. So androgens, testosterone being a part of that, are all over the body. They're on the heart, they're in the brain, they're on the lungs, certainly in the muscle. And so there is this profound effect that testosterone has systemically in the body. And he even mentioned it briefly when he was talking about the capacity for testosterone to influence mitochondrial biogenesis. So the production of new cells that are going to create energy and also to reduce oxidative stress, that is one of the big markers of aging is that inflamma.
- [68:02]
Dr. Stephanie
Aging.
- [68:03]
Dr. Stephanie Esteema
Right. So that infla, like those inflammatory markers as we age just get higher and higher and higher and, and testosterone can help to quell that can help to sort of pull that back. So love that part of the conversation. I also like the, the, the looking at our lab markers as a nice baseline. I think that if you are able to, if you don't have to fight with your doctor to get some type of baseline in terms of your total testosterone free testosterone and shbg, I think that that would be absolutely wonderful for.
- [68:31]
Dr. Stephanie
You if you were smart enough or.
- [68:33]
Dr. Stephanie Esteema
Able, you know, able enough had the access to get it when you were in your 20s, 20s phenom. And if you were not able to try to get something now because then you'll be able to triangulate that with symptoms should they get worse. So I thought that was really fantastic. I also thought that the looking for some of the signs and symptoms of super physiological levels or if you're having a bad reaction to testosterone was important. Again all been studied in men. We don't have a ton of data on women but generally for women, women that viralization piece. So looking for the deepening of the voice, looking for excess hair, let's say around the chin and chest like that Hertz, the development like the acceleration of bone density. Often for women we tend to see it not always, but tend to see it in the mandible. We all see it in the shoulders too. And then that, that clitoral enlargement as well. So looking out for that. He also mentioned hematocrit for men men and I actually loved that he said that testosterone is sort of myth busting a little bit around this fallacy that testosterone is one of the causatives or corollaries with cardiovascular disease. So really talking about how testosterone in fact does the opposite. It looks like it improves endothelial function so the ability of the lining of our arteries to expand and contract. And then in the case of men, men it looks as like as well when we are able to. When, when a man is on testosterone therapy doesn't cause prostate cancer cancer but can actually help to uncover maybe a hidden silently growing tumor, whether it's been benign or malignant on the prostate. So I thought that these were also very, very good. I loved that they are announcing that they are now looking at a female specific product which should be available. You know, we were, I think we were talking about this in the. When we stopped recording or maybe it was on the recording. I can't. Sometime in 2027 they're looking to complete. Oh no, no, it was on the recording, completing phase three trials in 2027, which I think is very, very exciting. It's like, we're doing it, fam.
- [70:38]
Dr. Stephanie
You know, it's like we're.
- [70:39]
Dr. Stephanie Esteema
We're making progress and people are listening to these needs. So I thought that that was really fantastic. And I will certainly be watching this pharmaceutical company in particular, as they are expanding beyond the United States. United States to the worldwide consumers, which, you know, it's not just that we love our Americans, but certainly Americans need help, but so do North Americans, so do Europeans, so do, you know, Middle east people in the Middle east, et cetera. So I'm very much looking forward to the. The development of this product for, specifically for women. And, you know, you can kind of tell every time I pushed him, like, tell me about the women, he's like, well, it's like, we don't really know, but this is my best guess. So my hope is that we'll start to fill in those gaps with the research, research that that Kaisertrex or that Mary's Pharmaceuticals is. Is conducting over the next several years. So I hope that you found this informative, maybe something exciting to look forward to in terms of your own health journey. Let me know in the comments if you are going to be leaving a comment on Apple or Spotify. We read them all. And until next time, I bid you adieu. All right, all right. I hope you enjoyed today's episode and and I must give you the obligatory legal and medical disclaimer here. This podcast, Better with Dr. Stephanie, is for general information only and the advice recommendations we discuss do not replace medicine, chiropractic or any other primary healthcare provider's advice, treatment or care in the consumption of this podcast. There is no doctor patient relationship that has been formed and the use and implementation of the information discussed are at the sole discretion of the listener. The information and opinions shared on this podcast are not intended to be a substitute for primary care diagnosis or treatment. In other words, guys, be smart about this. Take it with a grain of salt. Take this information to your primary healthcare provider and have a discussion with him or her her to make the best choice. That is for you. Remember, I am a doctor, but I am not your doctor and these conversations are meant for educational purposes only.