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Compounded Medications in Testosterone Replacement Therapy

Author Devante Delbrune covers Compounded Medications in Testosterone Replacement Therapy on BackTable Urology

Devante Delbrune • Aug 3, 2023 • 361 hits

Compounding medication has rapidly progressed patient focused medical therapy, enhancing both patient satisfaction and efficacy of treatment. The use of compounded medications has high utility for urologic patients receiving testosterone replacement therapy (TRT). With compounding medication, these patients have access to customizable dosages along with a variety of routes of administration, including intramuscular (IM) injections, subcutaneous (SubQ) injections, and dermal creams. Patients who receive TRT may wish to preserve fertility and will therefore receive additional treatments of human chorionic gonadotropin (HCG), followed by follicle-stimulating hormone (FSH) therapy. While these treatments are relatively safe, it is imperative that providers prescribing the medication thoroughly review the pharmaceutical manufacturer to ensure proper quality and efficacy. Dr. Grand, Dr. Schneider, & Dr. Silva discuss compounded testosterone, compounded HCG, and more in this article.

This article features excerpts from the BackTable Urology Podcast. We’ve provided the highlight reel in this article, but you can listen to the full podcast below.

The BackTable Urology Brief

• Testosterone can be injected SubQ, a method favored by many due to its ease of application and the potential for more stable testosterone levels.

• The use of compounded testosterone injections in grape seed oil allows for IM or SubQ administration.

• Compounded testosterone creams can offer higher concentrations of testosterone, providing more effective dosing compared to commercially available products.

• Fertility concerns necessitate the use of compounded HCG and FSH in addition to testosterone.

• Protocols may differ based on individual needs. Urologist Dr. Jordan Grant typically starts with 500 international units (IUs) of HCG and 150 IUs of FSH three times a week.

• It's important to ask a compounding pharmacy about their frequency of product batch testing and sterility and endotoxin testing protocols.

• The Certificate of Analysis is a critical document that reveals the quality of the active pharmaceutical ingredients used in the medication.

Compounded Testoterone Replacement Therapy Drawing

Table of Contents

(1) Patient-Centered Strategies for Testosterone Replacement

(2) Compounded HCG Use and Fertility Considerations in TRT

(3) Elevating Patient Care with Compounded Medications: Behind the Scenes

Patient-Centered Strategies for Testosterone Replacement

Dr. Jordan Grant is a board certified urologist currently utilizing compounded medications in Paris, TX. In Dr. Grant’s practice he utilizes a practical perspective on testosterone replacement therapy (TRT), based on a patient-centric philosophy. This philosophy allows for more liberal use of TRT with dosing based on patient symptoms and free testosterone levels as opposed to strictly relying on total testosterone levels. Compounded testosterone can be delivered via IM injection, SubQ injection, or compounded creams. SubQ delivery requires more frequent dosing (2-3 times weekly) but has less tissue trauma and is easier to titrate to various testosterone levels as compared to IM. Both compounded testosterone injections methods utilize the addition of grapeseed oil to assist with proper viscosity of the medication. The delivery method of choice is typically based on patient preference, however, compounded testosterone creams are recommended if the patient has difficulty administering injections, such as forgetting to perform injections or associated skin rashes. Along with TRT, the patient may be offered compounded HCG and even FSH for fertility maintenance.

[Dr. Jordan Grant]
I'm probably more liberal than most urologists when it comes to this, just mainly based on being a patient myself and seeing guys who fit the bill when it comes to the symptoms, even though their numbers may look fine. I also check free testosterone. I know it's not really part of the guidelines or it wasn't at one time, even though the studies use free testosterone. I check both. If I see somebody in single digit, I convert everything to nanograms per deciliter and I see them as single-digit free T, which a lot of these guys are and they have symptoms. I have no problem treating them. I would talk about doing a trial of TRT. I think that's a reasonable thing to do. A lot of these guys, if they're honest with themselves, three months in, they don't feel any better, it's like, "You're probably not running your natural production three months in." We have ways to rebound that if we need to.

[...]

Fertility, again, I don't know if you were going to touch on that, but that's a big part of what I do, is maintenance of fertility. I don't rip guys off their testosterone. If they have zero sperm counts, we'll add HCG. If that doesn't do the trick, we'll add FSH along with it. I've just been amazed with Revive how affordable their HCG and FSH are and they work.

[Dr. Jose Silva]
Prior to going to HCG, let me ask, in terms of the compounded testosterone, are you using the testosterone cream? Are you using testosterone injections? How do you decide what to offer the patient?

[Dr. Jordan Grant]
Usually, if they've never been on anything, because a lot of guys I see are coming from other places where they've been mishandled and we'll try to dial things in, a lot of times they're already happy with what they're doing. They just want to tweak it. If they're a newbie, the first time I say injections, if they cringe and say, "I hate needles," I say, "Let's try cream." There's nothing wrong with cream. I've done both. A lot of guys coming in already have that in their head. They already know what they want to do. Then others, I say, "If you hate needles, let's try cream first. It doesn't work for everybody. Not everybody absorbs it great." Or if they just end up hating it, I've got some guys that are like, "I just can't remember to do it. I don't get that," because it's like brushing your teeth, but, "Hey, you forget, then go back to injections." We teach them how to do shots.

It's really just personal preference or based on maybe a few other things where they just don't feel right. Some guys just don't do well with injections. They still have the brain fog or they have skin outbreaks. Again, you're injecting preservatives and some people's body just don't like that. A lot of times, their skin clears up, their brain fog lifts. I can't explain it, but I definitely see it.

[Aaron Schneider, Pharm D]
To speak to the compounding aspect there, you know what, we make our testosterone injectable with grape seed oil, because of the viscosity. The reason for that is to allow us the option of either dosing IM or SubQ. Most of our patients today actually use testosterone SubQ. We found that the optimal level is actually the benefit of stabilizing the testosterone level above that minimum threshold is easier to achieve in more frequent doses SubQ rather than your once-weekly dose IM. Splitting that typical IM dose across two injections or three you see a baseline level that avoids a lot of the crash at the end of their therapy before they dose again and allows the patient to have a better baseline.

We send supplies and depending on the providers' recommendation and prescription SubQ three times a week, or twice a week. We found that early the need for education is important, because it's a little bit difficult of a draw.

Once they get used to it, it's such an easier injection. You're not dealing with the soreness, perhaps tissue tear not knowing how to dose with a 1CC syringe, trying to pick an area to dose. It's a lot more pleasant, but we do have options, creams, and other testosterone options are available. We're about to launch an oral dose as well with testosterone decanoate.

[Dr. Jose Silva]
The SubQ, it's in the forearm or where do you inject?

[Aaron Schneider, Pharm D]
It's wherever they feel doing it, honestly. A lot of guys use their abdomen and it's 50/50. Some guys love it and some guys get welts and things. Again, it's person-specific, and then obviously water-based stuff is SubQ.

Listen to the Full Podcast

Integrating Compounding Into Your Practice with Dr. Jordan Grant and Aaron Schneider, PharmD on the BackTable Urology Podcast)
Ep 87 Integrating Compounding Into Your Practice with Dr. Jordan Grant and Aaron Schneider, PharmD
00:00 / 01:04

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Compounded HCG Use and Fertility Considerations in TRT

Patients undergoing TRT who desire to maintain fertility may be given HCG therapy. There is often a misconception that patients must be prescribed HCG in conjunction with testosterone, but this is ultimately based on patient goals or preferences. Compounded HCG maintains high efficacy in preserving fertility, but for patients unresponsive, Dr. Grant will add treatment with FSH. To dose these medications, Dr. Grants utilizes his own protocol of 500 international units (IUs) of HCG three times a week and 150 IUs of FSH. The dosing is adjustable according to patient side effects and tolerance. It is imperative that when beginning treatment, patients have frequent lab checks and follow-up to check for drug absorption and hormonal response.

[Dr. Jose Silva]
I think that's all to be done, I mean, our scope. Thanks for the explanation and it was great. Jordan, in terms of your decision to start a patient with HCG, you talk about fertility, keeping that fertility. Does the patient give you any setback, because you're doing HCG? Right now I don't think that the patients know all the dilemma with HCG, right?

[Dr. Jordan Grant]
Well, a lot of mine did. A lot of guys that I inherited the last few years came from other places that were told, a lot of these, I'm not going to knock the telemed places at all, but they're told they have to take HCG with their testosterone. A lot of these guys came to me from these other places where they're already on it. Then when a certain big compounder in Texas was unable to compound HCG anymore, which is where most of these guys were getting it, because that's where their clinics got it, they freaked out. It was a nightmare at first and I know REVIVE got hammered for a bit with the orders for HCG. They caught up quick. It may have been a month or something I told guys, "Hey, we just can't get it right now." We had to do just like a vial at a time at first for fertility only. It wasn't like, "Yes, you just want to take it to keep your testicles larger. Sorry guys, you got to--" we try to really triage it just for fertility purposes.

Now like I said, I'm not a stickler where like, oh you have to be on HCG when you're on TRT, I just don't. There's a lot of guys that don't feel, they feel worse when they start HCG and not better. That's a patient preference thing. Then obviously for fertility it's kind of a no-brainer. Like if you want to try and maintain, we got to do some HCG and then they have to know that's not permanent either. It will still be a slow decrease in the sperm count, usually over time it's just not as quick. Then that's where FSH comes in.

[Dr. Jose Silva]
What do you do for a patient that has low T and wants to keep the fertility? What your protocol?

[Dr. Jordan Grant]
I keep them on their testosterone and if it's a fertility, if it's like they're really freaking out and they're, we get a semen analysis obviously, and if it's zero. I get them started on HCG FSH right away at the same time and I do, I don't know, go crazy with the HCG. I know there's some protocols, like I know Dr. Lip Shield's protocol, he has different ones for his patients and some of the HCG doses are crazy high. I understand that I'm trying to limit side effects while still get the job done. I'll usually do like 500 IUs of HCG three times a week to start, and I do 150 IUs FSH three times a week and you could probably actually get by with 75 of FSH. I think that's what they used to do with HMG with 75, but I just go for 150. It's just one I made it up and it seems to work so far.
[...]
When we start somebody on testosterone, let's say if they're on cream, I'll get labs at three or four weeks just to make sure they're not wasting their time on it, because I don't want them to pay for it if they don't absorb it. Injections, we do it at six weeks and then typically six months after that. Once they're "dialed in," personally, I like just once a year on their testosterone labs. Usually they're getting more than that with their PCPs anyway. If they want to check them more frequently, they can.
A lot of my guys and what I do is try to talk them off the ledge, because they're over anxious about lab work all the time. They come in with their spreadsheets and they've got labs every two months and they're-- I used to be that guy so I understand it, but it almost paralyzes you, because you're so focused on numbers, you're not as much focused on symptom resolution. I'm not as big of a stickler for frequent labs as long as everything else is smooth, say whether or not having issues. Obviously if you're dose suggesting or whatever, then labs will come in more handy.

[Dr. Jose Silva]
Is there a unique compounding formulation you prescribe in your practice? For example, if you ask something specific, do you call Aaron, "Hey, I want this formulation" and he prepares? How does that work?

[Dr. Jordan Grant]
Not really. I haven't had to go anything that specific. I know that if I needed to, they would though. I know they can do those and I think they do that. Aaron, you can speak to this more with like, if you're trying to get a special ratio of thyroid hormone, things like that, you can titrate T3, T4 to different ratios.

[Aaron Schneider, Pharm D]
We have the ability to do custom formulations. Over the years, since 2016, working in this space supporting urologists, we have a formulary that we really work off of that probably offers the solutions to 90% of urologists. It's not common that we get corresponding requests for unique formulations, but we can make them. Trimix, we have eight formulations today and that service is the greater need. We can even do intra urethral gel. Really that product is great for someone segueing into an injection, because honestly the injections are what works. For a patient who's just really having a hard time using a needle for that particular purpose, the injections or the gel can help benefit that patient at least interim until we transition to something that's really the most effective option for them in the future, but yes, unique formulations are definitely available.

Elevating Patient Care with Compounded Medications: Behind the Scenes

Overall, the benefits of compounded medications are met with equal risks, particularly when utilized with HCG. Current trending stigma surrounding compounded HCG treatments includes the narrative that the compound is not natural. Additionally, HCG is used for various controversial treatments including weight loss and has side effects, such as water retention. While there are risks with administration of all medications, it is important to discuss with pharmacies their sterility, endotoxin, and potency testing of the compounds. These tests provide information on the quality of the product, as there is a high degree of variation between pharmaceutical compound manufacturing. Dr. Grant states that as a minimum standard of care, providers should require that manufactures provide their documentation, such as a Certificate of Analysis, documenting their active ingredients. This transparency helps to increase both patient safety and efficacy.

[Dr. Jose Silva]
Jordan, at some point, going back to HCG, did you that there was a liability by using the compounding pharmacy?

[Dr. Jordan Grant]
I do what's right for the patient in my mind, I see no issues using compounding. I know there's stigma. I guess the stigma, and I didn't keep up with the stigma about the HCG diet. I think that's where a lot of this came from and people poo-pooed that. I'm like, nobody seemed to look into the HCG diet, realize people were eating 500 calories a day and starving themselves and that's why they were, you know what I mean? They just, "Oh, HCG, and then who knows what else they were doing?" Obviously, everything can have an effect that you don't want. HCG is one of those guys who complain of water retention and other kinds of weird things.

It's just the that it's going to happen when you're injecting a compound into your body that is like HCG it just is what it is. It's not LH, it's not identical necessarily, and it's not made like we make it naturally. Same with testosterone. I always tell that to guys, we are giving this artificially so it's not the same, but we try to get you feeling good. Anyway, that's the sidebar, but no, I have no issues using HCG, I've never thought twice about it using compounded.

[Aaron Schneider, Pharm D]
If you're working with a pharmacy make sure that they're providing you the opportunity to discuss what type of sterility testing are they doing on their products? What type of batch testing, how frequent do they test the products, how frequent do they do endotoxin testing? That's not just sterility, sterility is just a basis of knowing that it's sterile. Endotoxin testing will tell you that even a sterile product could cause a reaction locally due to potential bacterial contamination that maybe are non-infected. That's also a step that's important in a sterile-produced product. Then potency testing and how frequently they do potency of batches, and in addition to that certificates of analysis, I think those are really your basis for knowing that that particular pharmacy has some form of quality system in place.

Your certificate of analysis is a copy that I would at least ask for as a baseline, which is the quality of the product that they are using, the quality of the active pharmaceutical ingredient they are using in the medication that you are prescribing to your patient. That tells you the high degree of quality, the assay of the chemical. You really want that to be at 95% or higher. Most of our products are at 98 to 99, which is above the FDA's minimum threshold. The additional steps would be asking for a copy of a sterility test, at least to know that they're doing that type of testing and a copy of their latest endotoxin testing to ensure that they're going beyond just sterility.

Then potency would be just an addition to say, Hey, we know that this is going to be effective, because they have a good formulation that doesn't lag in potency. Even if your certificate of analysis shows the product is of high quality, if your formulation doesn't yield the potency that produces the desired effect or potency that represents the dose of that labeled product, you're not going to get the outcome you want. It's important to know those things and know the facility you're working with does those types of testing.

[Dr. Jordan Grant]
I see a lot of variability in testosterone lab levels in the same patient on some of the local-- This isn't just here. These are guys that are using it all over the place. They'll get a lab test. It's like there's nothing in there. It's nice to have a bigger compounding pharmacy that is batch testing, is doing all this stuff to ensure that it's done the right way every single time, because you don't want to get a bad batch of your testosterone cream and feel like crap for a month. I know.

[Aaron Schneider, Pharm D]
You'll get variability across some compounding pharmacies if, in fact, maybe they're making their own cream base and that cream base may not be compatible with that active ingredient and therefore it doesn't absorb correctly or with a trophy base, if it doesn't match the material or active's ability to absorb correctly, it may impact the product to actually achieve the desired effect or dose. It may have nothing to do with the active, but the formulation will matter.

Podcast Contributors

Dr. Jordan Grant discusses Integrating Compounding Into Your Practice on the BackTable 87 Podcast

Dr. Jordan Grant

Dr. Jordan Grant is a practicing urologist in Paris, Texas.

Aaron Schneider, PharmD discusses Integrating Compounding Into Your Practice on the BackTable 87 Podcast

Aaron Schneider, PharmD

Dr. Aaron Schnieder is a pharmacist and co-founder of ReviveRX.

Dr. Jose Silva discusses Integrating Compounding Into Your Practice on the BackTable 87 Podcast

Dr. Jose Silva

Dr. Jose Silva is a board certified urologist practicing in Central Florida.

Cite This Podcast

BackTable, LLC (Producer). (2023, March 15). Ep. 87 – Integrating Compounding Into Your Practice [Audio podcast]. Retrieved from https://www.backtable.com

Disclaimer: The Materials available on BackTable.com are for informational and educational purposes only and are not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The opinions expressed by participants of the BackTable Podcast belong solely to the participants, and do not necessarily reflect the views of BackTable.

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