Thursday, January 21, 2021

Gonadorelin for men on TRT instead of hCG. Does it work?

Does gonadorelin work as a replacement for hCG?



Gonadorelin for Testosterone Replacement Therapy and its clinical use for patients as a substitute for human chorionic gonadotropin.


CLICK HERE TO LEARN ABOUT SWITCHING BACK TO TRT with hCG with NovaGenix

 Lately, we received calls from men inquiring if we still prescribe hCG because their current TRT clinic changed them from hCG to Gonadorelin.  We keep getting the same question, "Why did my doctor change my Rx from hCG to Gonadorelin?" The answer is probably due to recent regulatory changes by the FDA regarding compounding pharmacies and their ability to manufacture hCG, or human chorionic gonadotropin. On March 23rd 2020, the new rules went into place regarding the manufacturing of certain medications that are considered to be "biologics" Here is an explanation taken from the FDA website: (https://www.fda.gov/drugs/human-drug-compounding/notice-compounders-changes-affect-compounding-march-23-2020)

"A change to the law will impact compounding of certain products beginning on March 23, 2020. On that date, biological products that were approved under the Federal Food, Drug, and Cosmetic (FD&C) Act will transition to being licensed under the Public Health Service (PHS) Act.1"

    There are many patients now being told by their providers that hCG is now illegal or not available. This is not true, and there is still hCG commercially available for patients. Many large retail chain pharmacies are getting brand name hCG such as Pregnyl from Merck, for example. (https://www.merckconnect.com/pregnyl/dosing-administration/) Unfortunately the cost of brand name hcg is substantially more than from a compounding pharmacy despite being identical in chemical composition, strength and purity.  This has lead to many patients complaining of the additional costs and inconvenience after having been undergoing successful testosterone therapy protocols utilizing hCG, to now having to either pay much more for the same medication or be put on an entirely new medication. Many clinics are now switching to Gonadorelin to replace hCG which naturally raised the question, "Does Gonadorelin work as good as hCG?" We do not believe its a good substitute for TRT. Its not that it doesn't work...The problem is that it has been shown to work when patients were taking it constantly throughout the day, with an implanted pulsatile infusion pump. So the answer actually depends on your dose and protocol which doesn't factor in convenience for medication adherence. 

 The problem with Gonadorelin is its extremely short half life. The half life of a medication is the time that it takes half of the dose to be metabolized and eliminated from the blood stream. For Gonadorelin, the half life is between 2 and 10 minutes depending on how quickly a person metabolizes the medication and a terminal half life of 10-40 minutes. For this reason the administration route used during clinical applications which has been studied and published by using a portable infusion pump which can provide a pulsatile subcutaneous administration of the gonadorelin, which means a needle is implanted inside the abdominal wall and medication is administered by the pump every 90 minutes. In the published article, "The Pulsatile Gonadorelin Pump Induces Earlier Spermatogenesis Than Cyclical Gonadotropin Therapy in Congenital Hypogonadotropic Hypogonadism Men", the authors describe the administration route and protocol.

" In the PGP group, gonadorelin (a GnRH analog) was initially administered 10 μg every 90 min subcutaneously using a Hypophyseal Hormonal Infusion Pump (Microport, China). The needle was placed subcutaneously in the abdominal wall. The needle, reservoir, and connecting tube were changed every 3 days at home by the participants after having been given clear instructions. The dosage of gonadorelin was adjusted to maintain the normal serum levels of LH, FSH, and testosterone, which were monitored at each visit. Blood samples for the measurement of serum LH, FSH, and testosterone were taken 30 min after a pulsatile injection"

     So in the studies where Gonadorelin was effective, the usual dose given was 5 to 20 μg of gonadorelin pulsated by the infusion pump every 90 to 120 minutes. Now It's also available in a solution form for iv or subcutaneous injection and as a nasal spray, but that would require injections every hour and a half. The problem we've been seeing from patients from other clinics, is that many clinics/providers are prescribing gonadorelin the same way that they were hCG. The issue is that hCG has a half life of approximately 36 hours compared to gonadorelin's 2-20 minutes. In order to perform the same job as hCG, you would need a constant supply of gonadorelin and this makes it a very inconvenient medication for most TRT patients who would not want to give themselves 6-10 injections daily or be fitted with an infusion pump. Its why despite being around and available since 1978 under the brand name Factel, its never been used as an LH analogue over human chorionic gonadotropin until the recent regulatory changes. 




Can I Still Get hCG?

     Yes, Absolutely. There are many options available from reputable licensed US pharmacies. There are many online pharmacies which market medications, however they are illegal and lack the oversite and testing that US based accredited pharmacies undergo for purity and sterility of all medications they manufacture and distribute. If you would like for information on how to get started with TRT and hCG, we'd be happy to schedule an initial online consultation with our physician who can help you get tested, diagnosed and treated for Low T. NovaGenix can offer all inclusive TRT programs that are affordable, convenient and most importantly, effective. Call or text us at 561-277-8260 or visit us online to learn more about online TRT programs at NovaGenix. If you would like to set up a consultation, you can fill out our online new patient intake form and email us any blood work you may have to info@novagenix.org where we would like to see at a minimum free and total testosterone, estradiol, a PSA, CMP and CBC. If you need help getting labs, we can assist with that as well. Getting started is easy. Just  click the link below, fill out the form and once received, we'll reach out to help get you started.

Frequently Asked Questions Regarding Gonadorelin and hCG

 

1. Can HCG be prescribed if it is the patient's preference?

Yes, HCG can still be prescribed for patients as it is our preference due to it being a far better medication. Despite other clinics generally prescribing Gonadorelin, we prefer to utilize enclomiphene and hCG instead due to its effectiveness, but we recognize and respect our patient's choice in medications and will work with them whenever we can for the best patient outcome based on medication tolerance, legality, availability, results and medical necessity.

 

2. What is the cost difference between Gonadorelin and hCG?

Patients will typically spend an additional $40-50 per month for a therapeutic dose of Gonadorelin, while a therapeutic dose of HCG can cost $199 per month. It is important to note that the price and supply of hCG are not under our control. Because the supply of human chorionic gonadotropin is limited and the demand has increased, there may be temporary unavailability or price increases. hCG prices had increased after the FDA reclassified it as a biological compound restricting which compounding pharmacies could manufacture it.

 

3. What is the risk of running out of medication and experiencing changes in hormone levels with Gonadorelin?

Currently there is no regulatory interventions which could affect patients running out of Gonadorelin medication and experiencing changes in hormone levels. Patients can consistently receive refills without interruptions, ensuring they can maintain the benefits of testosterone replacement therapy (TRT).

 

4. Is it easy to find a pharmacy that can fill Gonadorelin prescriptions?

Yes, it is extremely easy to find a pharmacy that can fill Gonadorelin prescriptions for patients. We work with several, however we prefer to utilize our pharmacy partners for filling our patient’s prescriptions with superior medications such as enclomiphene and hCG first, as they are more effective than gonadorelin. At NovaGenix we send our patients Rx’s out to the pharmacy every 8 weeks so that they do not have to spend any time or energy in getting their prescriptions filled, as it is conveniently delivered to their doorstep with their other TRT medications.

 

5. How does Gonadorelin compare to HCG in terms of potential adverse effects?

Gonadorelin and hCG. HCG are both relatively safe and patients normally show no adverse effects. Both medications can cause redness and itching at the injection site, headaches and even mood swings but once again, these are fairly uncommon.

 

6. What are the physical symptoms associated with testicular shrinkage?

Testicular shrinkage can result in smaller testicles, a less full scrotum, and reduced ejaculate. These symptoms can make men feel less masculine and potent. IN some cases the testes may even have a dull ache which can be uncomfortable.

 

7. Why do we generally prescribe hCG instead of Gonadorelin?

We prescribe hCG instead of Gonadorelin primarily to prevent testicular shrinkage in older men who have already experienced it due to aging and to help men maintain fertility and natural testosterone production. hCG helps delay or reverse the ongoing shrinkage, addressing their physical symptoms better than Gonadorelin.

The Pulsatile Gonadorelin Pump Induces Earlier Spermatogenesis Than Cyclical Gonadotropin Therapy in Congenital Hypogonadotropic Hypogonadism Men

Luyao Zhang,1 Ke Cai,1,* Yu Wang,1 Wen Ji,1 Zhen Cheng,1 Guanming Chen,1 and Zhihong Liao1

https://www.otsuka.com.cn/en/index.php?c=article&id=245

https://www.google.com/maps/d/u/0/edit?mid=1WsElE9K_hgi-yq1S-6DMpBvZf2N5bV6T&usp=sharing

https://novagenix.org/clinics-that-prescribe-hcg/

https://www.google.com/maps/d/edit?mid=1Ex_R0hkW-_esQRPiWTAAzipIlpHmlmop&usp=sharing