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Gonadorelin for TRT and its clinical use for patients on testosterone replacement therapy.

Does Gonadorelin work as well as hCG?

NovaGenix Testosterone Replacement Therapy Many patients are asking the same question "Why did my doctor switch me from hCG to Gonadorelin?" The answer most likely is due to recent regulatory changes in compounding pharmacies and their ability to manufacture hCG, which is short for human chorionic gonadotropin. On March 23rd 2020, new rules went into place regarding the manufacturing of certain medications that are considered to be "biologics." hCG is among the medications concerned. Here is an explanation taken from the FDA website:"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 This transition affects compounding under sections 503A and 503B of the FD&C Act because, beginning on March 23, these transitioning biological products will not be eligible for the exemptions for compounded drugs under sections 503A and 503B of the FD&C Act.2"

Get prescribed HCG with your HRT protocol There are many clinics and physicians whom may be misinformed about the changes in FDA regulations and are telling patients that hCG is now "illegal" or no "longer available". Fortunately this is not the case, and there is still medicine available for the many men on TRT who cave come to rely on it as part of their HRT protocol. Many pharmacies are still getting brand name hCG like Pregnyl from Merck, for example but often the cost of brand name hcg is substantially more than from a compounding pharmacy. This is upsetting for the many patients that have been undergoing successful testosterone therapy protocols utilizing hCG only to be told they'll be taking a new medication. Taking a brand new medication certainly has risks as it's unknown how an individual may react, and certainly their may be concern as to how well it will work in replacing hCG. Many clinics are switching to Gonadorelin as a replacement for hCG and this has raised the question, "Does Gonadorelin work?"  Interestingly, the answer actually depends on your dose and protocol.

Studies have shown it to be effective in maintaining testicular functioning and size for both fertility and HRT treatments as hCG, however there's a catch. The issue with using Gonadorelin is that is has an 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. That's how long for it to be out of your system. 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 was necessary to achieve positive results in use on male subjects in an attempt to increase sperm production, testosterone production and maintain testicular functioning. So for these subjects, a needle was implanted inside the abdominal wall and medication was then administered by a 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 in order to remain active in the blood to show any real tangible results for men on low-T therapy. The problem we've been seeing from patients calling us for help from other clinics, is that many clinics/providers are prescribing gonadorelin the same way that they were writing prescriptions for hCG. The issue is that hCG has a half life of approximately 36 hours compared to gonadorelin's 2 to 20 minutes. In order to perform the same job as hCG, you would need a constant supply of gonadorelin pulsated into your bloodstream every 60-90 minutes 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. A similar clinical trial sponsored by Massachusetts General Hospital used a microinfusion pump which injected every 2 hours.  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 for testosterone therapy until the recent regulatory changes made it more difficult to fill hCG prescriptions.

Can I Still Get hCG?

Yes, Absolutely. There are many options available from reputable licensed US pharmacies. There are many online pharmacy websites which market and sell 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.  Our all inclusive programs include all medications, including testosterone, anastrozole and hCG. We provide convenient, affordable and effective treatments with a medical tam who specializes in Low-T therapy for men.Call or Text NovaGenix at 561-277-8260 or visit us online to learn more about our online Testosterone Replacement Therapy programs. 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 labs for free and total testosterone, estradiol, a PSA, CMP and CBC. If you need help getting bloodwork, we can assist with that as well. We can have you go to a LabCorp or Quest near you at your convenience and schedule a consult for Dr. Mackey to review the results. 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.

CLICK HERE TO FILL OUT AN ONLINE NEW PATIENT INTAKE FORM AND SCHEDULE A CONSULTATION FOR TRT

*ONLINE CONSULTS, ALL INCLUSIVE TRT PACKAGES WITH NO LONG TERM CONTRACTS OR SIGN UP FEES. ALL MEDICATION INCLUDED (TESTOSTERONE CYPIONATE,  ANASTROZOLE, HCG) SUPPLIES AND SHIPPING INCLUDED.

References1.https://www.fda.gov/drugs/human-drug-compounding/notice-compounders-changes-affect-compounding-march-23-20202. https://www.merckconnect.com/pregnyl/dosing-administration/3.https://en.wikipedia.org/wiki/Gonadorelin#:~:text=by%20the%20gonads.-,Pharmacokinetics,of%2010%20to%2040%20minutes.

4.Studying the Effects of 7 Days of Gonadotropin Releasing Hormone (GnRH) Treatment in Men With Hypogonadism   https://clinicaltrials.gov/ct2/show/NCT00493961

5. The Pulsatile Gonadorelin Pump Induces Earlier Spermatogenesis Than Cyclical Gonadotropin Therapy in Congenital Hypogonadotropic Hypogonadism MenLuyao Zhang,1 Ke Cai,1,* Yu Wang,1 Wen Ji,1 Zhen Cheng,1 Guanming Chen,1 and Zhihong Liao1https://www.otsuka.com.cn/en/index.php?c=article&id=245Directions to NovaGenix Anti-Aging 609 N. Hepburn ave Suite 106 Jupiter, Florida 33458https://www.google.com/maps/d/u/0/edit?mid=1WsElE9K_hgi-yq1S-6DMpBvZf2N5bV6T&usp=sharing