Jasen Bruce

Jasen Bruce

Another method of administering testosterone is through transdermal absorption. Testosterone is available as a transdermal delivery system (TDS) in various concentrations for topical application. Testosterone is purchased in raw form (testosterone base) by compounding pharmacies and drug manufactures to be used to create various testosterone products. A specific concentration of testosterone base is then added to a transdermal delivery system either in the form of an alcohol-based gel or transdermal cream. A patient can apply a measured amount of the gel or cream to the skin where a small amount of the hormone penetrates through the skin, absorbing into circulation. When applied on a daily basis, topical testosterone provides 24-hour duration of action, which naturally mimics the rise and fall of testosterone throughout the day.

Types of transdermal delivery systems

Transdermal delivery systems are self-contained dosage forms that, when applied to unbroken skin, are designed to deliver the drug(s) through the skin to systemic circulation. TDS works by diffusion. The drug diffuses from the carrier through the skin into general circulation. Transdermal testosterone products are available in different types of TDS. The most common types of delivery systems used for hormones are in the form of a gel, lotion, cream, or patch. Although each type of delivery system has a different appearance and texture, all of them are designed to deliver the highest concentration of active ingredient deep into the dermis. There are transdermal creams and gels that are also designed to deliver multiple active ingredients at one time. A compounded hormone combination cream is an example of a multi-drug transdermal delivery system (ie. Testosterone 10%+DHEA 10% topical cream). Compounding pharmacies have the ability to compound testosterone using different delivery systems depending on which one is best for the patient. Manufactured brand-name transdermal testosterone products are available only as either a gel or transdermal patch.

Common transdermal testosterone delivery systems

Compounding pharmacies usually carry a variety of TDS bases that can be used to make a transdermal hormone. Many pharmacies manufacture their own TDS formulas and even make improvements to existing base formulas available at the pharmacy supplier. Here is a list of common TDS bases used in transdermal hormone products including testosterone.

Lipoderm®- Transdermal cream base that is designed to deliver multiple medications or hormones through the skin.

HRT Cream base-An oil-in-water emulsion developed for use as a topical or vaginal delivery system in Hormone Replacement Therapy. Primarily used for women, this versatile base can also be used for men. It's highly absorbent and is specially designed with an emollient to help soften skin. Alternatively, this base can be used in a wide variety of other medicated topical applications.

Versabase®- Cosmetic transdermal cream base that is designed to deliver fast absorption of medication. Due to its moisturizing effects on the skin, Versabase ® can be used for both cosmetic and pharmaceutical application.

Hydro-Alcohol Gel-Alcohol is used to solubilize the skin to allow for diffusion of the hormone. Hydro-alcohol gels dry faster than transdermal creams, but can also cause drying of the skin and irritation at the site of application.

All types of TDS listed are available at compounding pharmacies.

Transdermal Testosterone Absorption

Absorption can vary between individuals who apply transdermal testosterone to the skin. The standard measurement of predicted absorption used by compounding pharmacists is at 10%. Roughly 10% of the total dosage of topically applied hormone will penetrate the skin. This means that for every 100mg of testosterone applied only 10mg will actually be absorbed through the skin. Depending on the individual sometimes less is absorbed, therefore it is important to follow up with laboratory testing so that the testosterone dose might be titrated to maximize transdermal absorption.

Men require a daily supply of 7mg-10mg of testosterone to achieve a physiological level in the upper-quartile and to reverse the symptoms of hypogonadism. Using compounded transdermal testosterone appears to be more effective than brand name (manufactured) transdermal testosterone products (Androgel, Testim, etc) for a few reasons. Higher concentrations of testosterone can be achieved in a compounded transdermal. Common strengths found in compounded topical testosterone products range between 5%-20% testosterone. 5% equals a 50mg/ml concentration of testosterone; 7% equals 70mg/ml; 10% equals 100mg/ml; etc. The highest concentration available for most transdermal hormone creams and gels is 20%, or 200mg/ml. More than 20% concentration may result in poor distribution of the testosterone, ‘clumping’ of the ingredients, and reduced absorption of the medication. Most male patients respond best to dosages between 5%-20% applied topically to reach 5mg-10mg absorption. Another reason compounded transdermal testosterone might more effective is due to the ability to provide patients a transdermal delivery system that works best for them. For example, cream based delivery systems apply better to skin in sensitive areas, such as the scrotum or inner thighs. Using an alcohol based gel in these areas can irritate the skin, therefore using a compounded cream is preferred. Some patients who do not experience skin irritation may like the consistency and faster rate of absorption found in gels. Compounding pharmacies can compound either a gel or cream depending on what the prescription calls for. If the type of delivery system is not specified on the prescription, the pharmacy will usually default to either a cream or gel base.

Available transdermal delivery systems for testosterone

Common brand name testosterone products on the market include AndroGel® from AbbVie and Testim® from Endo Pharmaceuticals. AndroGel® is a very expensive, low dose 1% (10mg/ml), testosterone product on the market since July 2000, which provides a safe, alcohol based gel containing testosterone in low physiologic doses. Due to the low concentration, larger amounts are required for adequate testosterone replacement in men. Testim®, released in 2004, seems to have slightly better absorption rate than AndroGel, making it more efficient, but it also has a low concentration of testosterone (1%) therefore the increased absorption rate may not provide significant elevation of total testosterone. Patients have also reported a slight musky odor after applying Testim®. Clinical trials have also proven that testosterone patch called Androderm®, developed by Watson pharmaceuticals in 1985, is another safe form of testosterone replacement. Androderm® is available in two strengths, as either a 2mg or 4mg transdermal patch. Due to the low strength, two patches are often needed to adequately restore testosterone. Patients who use testosterone patches have reported negative experiences including problems with the patch falling off, often when they are physically active. Patients have also reported skin irritation including a rash at the site where the patch is applied. Testosterone is also available at compounding pharmacies who specialize in hormone preparations. Compounding pharmacies have the ability customize topically applied testosterone into different strengths and combinations using a variety of transdermal delivery systems (Lipoderm, HRT, Versabase, alcohol gel). Compounding pharmacies can be used to prescribe a higher concentrated transdermal testosterone which will allow enough of the hormone to be absorbed to maintain a good physiologic level of total testosterone. In addition, testosterone can be compounded using a custom delivery system which will result in minimal skin reactions. Lipoderm, Versabase, and HRT base are delivery systems that can provide maximum bio-availability and penetration of active ingredients while minimizing skin irritation that can occur with alcohol-based gels or transdermal patches.

The higher-dose compounded testosterone creams containing 5% to 20% testosterone have been available by physician’s prescription from any compounding pharmacy specializing in hormone preparations. The cost for compounded testosterone creams are far less expensive than 1% AndroGel® Likewise, cheaper generic alternatives to can be compounded by many pharmacists. A low dose dihydrotestosterone, DHT gel, labeled Andactrim™, also from Solvay, has been available in Europe for almost a decade. Doctors who specialize in bio-identical hormone replacement therapy have been using cream and gel delivery of female hormones for decades.

Compounded testosterone creams create more physiologic testosterone levels, skin reactions are minimal and short-term discontinuation of therapy is possible due to the longer half-life of up to 25 hours. Scrotal application is also convenient and discrete while theoretically producing more DHT than when applied to other locations on the body.

Transdermal containers

There are different containers that can be used to dispense transdermal hormones. Dispensing syringes of various sizes are commonly used for hormone gels and creams. The hormone is dispensed by depressing the plunger until a measured dose releases from the syringe. Plastic or glass jars can also be used to store medicated transdermal gels and creams. The jar may come with a measuring spoon or the patient can use their finger to apply an estimated amount of hormone. Another common dispensing container is called “Topi-Click”, which looks like a deodorant container. The patient twists the dial at the bottom of the container to dispense a measured dose of transdermal hormone out of the opening at the top. 1 twist (click) of the dial equals 1/4ml of medication. Other containers might be available depending on the pharmacy. If the prescription does not request a specific type of container, then the compounding pharmacy will usually default to one of the more commonly used containers.

For more information of Topical Transdermal Delivery Systems go to: http://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/transdermalStimArticle.pdf

Transdermal Testosterone Compounded transdermal testosterone cream in a Topi-Click container

Compounded injectable testosterone medications like cypionate are presently being pushed out of the market.

Compounding pharmacies provide a low cost alternative to standard and more expensive manufactured brand name medications. In the case of testosterone, compounding pharmacies are able to obtain the FDA approved raw material to compound testosterone into strengths, solutions, forms, and combinations not available on the market. Testosterone Cypionate is not under a patent, and is available as a raw material to be compounded as a sterile injectable in various custom strengths.

Technically, a compounding pharmacy is not supposed to compound a drug in the same strength and form already available as a brand name. Since Testosterone Cypionate is available as a brand name (Pfizer, Watson, etc) in 10ml 200mg/ml form, many compounders alter the finished product to justify compounding it. For example they may offer it in a different strength, volume, or as a combination drug.

Similar to the lack of enforcement regarding the compounding of Sildenafil (Viagra), the compounding of Testosterone Cypionate 200mg/ml at 10ml is not enforced due to the fact this particular medication has been around for a long time, is cheap to produce, and was not a potential profit generator for big pharmaceutical companies until the recent rise in TRT availability and marketing. In addition, it is also difficult to enforce this rule when a drug is compounded in a sterile injectable due to the compounders ability to subtly change the finished product by using different oils (like grapeseed instead of more common cottonseed), altering the strength (250mg/ml instead of 200mg/ml), or even combining different esters not available on the market as a brand (ex. Cypionate 80%/Propionate 20%).

Instead of being able to enforce patent violations, another method is being used to stop the compounding of Testosterone Cypionate. Through the continued establishment of redundant regulatory obstacles a compounder must go through to produce a sterile injectable, it is becoming more expensive to make sterile compounds including injectable testosterones. To seize on the fast growing market big pharmaceutical brands like Pfizer's Depot Testosterone are reducing their prices to become more competitive in order to gain the very high volume of residual sales generated from the prescribing of long term TRT. In addition, more generics are becoming available at a low price. To provide cost comparison, the AWP for Depot Testosterone is roughly $122. The AWP for Westward generic Test Cyp 200mg/ml 10ml is roughly $112 (as of March 2016). Note that there is only a $10 difference between the brand and generic, when typically the gap is far greater. The retail price for compounded Testosterone Cypionate 200mg/ml 10ml is typically around $50, more or less depending on the particular compounders volume and overhead. The wholesale price (what Walgreens pays for it before selling to you) of Depot Testosterone 200mg/ml 10ml is $46 while wholesale for Westward is roughly $41. You can see by this comparison that the gap in price between brand and generic is closing, while the cost to compound this same medication is increasing due to continued layers of regulation designed to limit the compounding industry. In recent weeks, the FDA has been visiting sterile compounders to specifically request samples of their compounded testosterone cypionate to test using their own lab to confirm sterility, potency, and endotoxin content. Remember, this is in addition to the already required FDA approved third party testing that a compounder must send each batch through before dispensing to a patient. So basically the FDA is re-testing a medication that that has already passed approval from a FDA-approved third party lab. They are hunting for anything to be used as ammunition against compounders at this point. Third party testing is required on top of the compounding pharmacies own in-house testing, which must also be completed and documented using FDA approved methods. The high cost for third party batch testing contributes to the increased cost to compound testosterone cypionate. At this time I will not mention the additional layers of costs added to establish beyond use dating as now required for compounders. Also not to mention the scheduling of testosterone as a controlled substance which creates more costs for both pharmacists and doctors to prescribe and dispense it.

This stuff is important because what is occurring behind the scenes will possibly result in limiting availability of testosterone cypionate (and many other medications) on the market resulting in increased price and decreased access to these medications.

The removal of blood for health purposes has been practiced for several thousand years. Across many societies the act of “bloodletting”, or removal of blood, was thought to cure a multitude of ailments. Ancient Egyptians (circa 1000 BC) believed that occasionally self- sacrificing some blood improved spirituality and cured the body of any illness present. Other ancient societies like the Myan’s encouraged bloodletting for religious purposes.

Throughout the advancement of our understanding of how the human body works we slowly realized that getting rid of blood does not cure all illnesses, however there is a benefit from this procedure under specific circumstances.

Today we call the procedure of removing excess red blood cells Therapeutic Phlebotomy, which is the treatment of choice for blood disorders in which the removal of red blood cells and/or iron is needed to manage disease symptoms and reduce complications.

Polycythemia’ is one of the more common conditions effectively treated using therapeutic phlebotomy. Polycythemia is an excessive production of red blood cells. With polycythemia the blood becomes very viscous or "sticky," making it harder for the heart to pump. High blood pressure, strokes and heart attacks can occur in left untreated. People with polycythemia usually experience fatigue, weakness, headaches, and hypertension. Polycythemia is a symptom which occurs with a variety of known and sometimes unknown origins.

Here are just some examples of known origins of polycythemia;

• Heavy smoking • Dehydration • High levels of stress • Lung diseases or disorder • Certain medications and drugs • Exposure to high altitudes • Too much Testosterone (see below) • Obesity

Testosterone (TRT) & Elevated Red Blood Cell Production- Polycythemia

Some men and woman are genetically prone to getting polycythemia, and more commonly people have poor lifestyle choices which result in too many blood cells (smoking, for example). The association between testosterone replacement therapy (TRT) and polycythemia has been reported for the past few years as the use of testosterone replacement has become more common. In addition to increasing muscle and sex drive, testosterone can increase the body's production of red blood cells. This hematopoietic (blood-building) effect could be a good thing for those with mild anemia.

Most men on Testosterone Replacement Therapy who are being properly monitored by an experienced TRT doctor do not experience polycythemia. Women taking testosterone typically do not have to worry about polycythemia resulting from the testosterone itself due to being prescribed a much lower dosage of testosterone than men (Read more about Testosterone in Women-make clickable to: http://defymedical.com/blog/item/18-testosterone-replacement-for-women-too ) For those patients who do experience elevated red blood cells it can be effectively reversed with a therapeutic phlebotomy where typically one pint or blood is removed and discarded. This could also be done by volunteering for a blood donation in which one pint is usually taken. Doctors may prescribe a therapeutic phlebotomy every 8-12 weeks for patients with persistent polycythemia, or more frequently until the red blood cells return to normal.

Once the phlebotomy (or donation) is complete many patients immediately feel better and high blood pressure returns to normal. People who suffer from chronic polycythemia may need routine therapeutic phlebotomies to keep red blood cells within a consistent healthy range.

Testing Hematocrit Is Important for Patients on TRT

Follow up blood testing is required at least twice per year for any patient receiving hormone and testosterone medications. One of the reasons follow up testing is important is to monitor red blood cells including one of its primary components called hematocrit. The test that measures your blood cells including hematocrit is called the Complete Blood Count or CBC.

An experienced TRT doctor will make sure blood cells and hematocrit are maintained within a healthy normal range and will correlate test results with your testosterone levels and lifestyle factors, making adjustments to medications if needed along with ordering a Therapeutic phlebotomy if hematocrit becomes too high.

Here is a very informative article which explains polycythemia caused by TRT and how to effectively manage it

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How to Manage High Red Blood Cells Caused By TRT

http://www.defymedical.com/resources/health-articles/308-how-to-manage-polycythemia-caused-by-testosterone-replacement-therapy

Other Possible Health Benefits

Therapeutic Phlebotomy can be an important new method of treatment for some patients, especially for people who suffer from hypertension (high blood pressure). A small study conducted by Immanuel Hospital in Berlin found that therapeutic phlebotomy caused a marked decrease in both blood pressure and “bad” cholesterol levels. This latest study was prompted by earlier research which suggested regular blood donors have lower cholesterol and reduced risk of heart problems and stroke.

Defy Medical patients who receive therapeutic phlebotomy for the treatment of high hematocrit and high blood pressure have been observed to have an immediate decrease of blood pressure, returning to a normal range. Other studies show that diabetics had better blood sugar control when they had blood regularly removed.

Improved Well-Being

Although anecdotal, almost every patient who completes a therapeutic phlebotomy at Defy Medical has reported an increase in energy and well-being during the days following the treatment.

Defy Medical Offers Therapeutic Phlebotomy at our Tampa Clinic

During your treatment you will receive:

• Hematocrit test administered before treatment- Immediate results • Blood pressure and examination before and after treatment • Therapeutic Phlebotomy performed by our Registered Nurse • Q&A discussion during treatment with experienced clinician • No wait time • One-on-one care during treatment • Appointment Reminders when routine treatments are needed • Average time for treatment: 1 hour

Further reading

How to Manage Polycythemia Caused by Testosterone Replacement Therapy (TRT) by Nelson Vergel: http://www.defymedical.com/resources/health-articles/308-how-to-manage-polycythemia-caused-by-testosterone-replacement-therapy

With the ever increasing price of the brand “Armour Thyroid”, which is a popular thyroid medication we prescribe, I wanted to take a moment to explain the different thyroid medications. We have options for our patients which are a better cost and it is important for you to understand the differences in medication in order to both save money and more importantly receive proper treatment.

The thyroid consists of two hormones known as triiodothyronine (or T3) and its prohormone thyroxine (or T4). In conventional medicine many patients diagnosed with hypothyroidism are only prescribed Synthroid (Levothyroxine or synthetic T4) by itself. T4 is a prohormone which must convert to the active T3 hormone for the body to properly respond. T3 is the bioactive thyroid hormone. Some people have an issue converting T4 into T3 and therefore still experience symptoms of hypothyroidism despite showing normal T4 levels. Achieving optimal T3 levels is an important outcome necessary for the effective treatment of hypothyroidism and related symptoms.

Alternatively, patients can be prescribed a compounded combination of T3 and T4 to treat hypothyroidism. There are two types of T3 and T4 medications available at our compounding pharmacy; Desiccated T3/T4 combinations and ‘synthetic’ T3/T4 combinations. Desiccated thyroid is what people consider ‘natural’ or ‘bio’ thyroid. This is because desiccated thyroid is extracted from animal thyroid gland tissue. The most common and the type we use is extracted specifically from porcine (pig) tissue, which is believed to be most similar to a human. “Armour” thyroid is a brand name for desiccated thyroid. Desiccated porcine thyroid and Armour thyroid are one in the same.

Synthetic thyroid medications come in the form of Levothyroxine (T4) and Liothyronine sodium (T3). Technically even desiccated thyroid, despite being known as natural, still goes through a synthesis in a lab in order to be manufactured into a usp raw material to be used in a tablet or capsule. Common brand names for synthetic versions are “Cytomel (liothyronine)” and “Synthroid (levothyroxine)”.

Both desiccated and synthetic T3 and T4 are available as a compounded generic at most compounding pharmacies. Compounded thyroid is much cheaper than using the brand name thyroids like Armour. Remember, Desiccated is the same thing as Armour- Armour is just a brand name for generic porcine desiccated thyroid. When it comes to compounded ‘synthetic’ (liothyronine/levothyroxine) thyroid, pharmacists can customize the ratio of T3 and T4 therefore allowing the doctors to adjust the dosage to the smallest detail based upon individual patient response. Desiccated thyroid is only available in specific ratios. The nice thing about compounded thyroid medications is that both T3 and T4 are combined in a single capsule whereas the brand name comes in only liothyronine (Cytomel) or levothyroxine (Synthroid) individually as a tablet and can be more expensive.

There is a place for both types of thyroid combination medications. Some patients respond well to desiccated thyroid while others need a combination of liothyronine sodium t3/levothyroxine t4 to respond to treatment. For example, desiccated and Armour thyroid comes in a pre-determined ratio of T3 and T4, usually 4:1 ratio of T4 to T3. As mentioned above, compounded liothyronine sodium/levothyroxine combination can be customized which some patients may need. Another example of why someone may respond to one over the other; since Desiccated thyroid is 4:1 ratio of T4 to T3 and humans are generally 11:1, there may be some who do not respond to desiccated and need liothyronine sodium t3 and levothyroxine t4 at a specific ratio to restore thyroid levels successfully.

There are many patients who respond very well to desiccated thyroid and therefore prefer to have the more ‘natural’ form. Medically, both are found to be safe long term when properly administered and monitored by a trained doctor. Therefore, the preferred type to use depends on what works best for the patient.

Sarcopenia is defined as the loss of muscle, fat free mass (FFM), and loss of strength experienced by men and women as they age. This is usually coupled with an increase in body fat. This change in our body resulting partly from a decline in testosterone and GH levels results in an increased risk for injury and also metabolic disease. Testosterone plays a role in restoring glycogen and increasing nitrogen in muscle tissue; both processes are important for the maintenance of muscle. When testosterone declines so does the ability to support muscle.

Men and women start Testosterone Replacement Therapy (TRT) for different reasons, all commonly diagnosed as having some degree of hypogonadism with symptoms. One thing is certain, TRT will help slow down (prevent) sarcopenia during the aging process. When low testosterone is properly restored in older men and women with existing sarcopenia they can experience a reversal of symptoms and improved quality of life. Incorporating strength training and a high protein/low glycemic diet will result in the opposite of sacropenia- a decrease in body fat with an increase in muscle and strength.

A paper titled "Anabolic Interventions for Age-Associated Sarcopenia" discusses how sarcopenia is influenced by hormones, nutrition, and excersise. The authors examine some clinical data regarding specific hormones, nutritional supplements and their effect on body composition. The full paper in PDF is available for free in the Defy Medical clinical study archive- Contact us to receive access. The paper was written in 1999 and since then there has been more data collected regarding the anabolic effects of testosterone on body composition.

Preventing and Reversing Sarcopenia can prolong lifespan

Interestingly, another paper shows that people who have more muscle and less fat live longer lives. Not to mention a better quality of life. The study is titled "Muscle Mass Index As a Predictor of Longevity in Older Adults" and is also available for free by requesting a copy.

" Aging is associated with significant reductions in fat free mass, and an increase in adiposity. The principal component of the decline in fat free mass is a decrease in muscle mass due to a reduction in muscle protein content and synthesis rates. The loss of FFM is associated with loss of muscle strength and function and with increased disability and mortality (6). The body composition changes in old age are multifactorial and may be related to the concomitant changes in hormone production, protein turnover, and disuse atrophy. The evidence to support the use of testosterone or GH supplementation in age-related sarcopenia is only beginning to be presented"

"The age-associated changes in body composition result from lower levels of anabolic hormones, neuromuscular alterations, and a general decline in muscle protein turnover (1–3). The frailty of old age has emerged as an important public health problem because it impairs mobility and quality of life and increases the risk of falls and the use of health care resources (4–6). Therefore, recent years have witnessed a growing interest in the use of anabolic interventions for augmenting muscle mass and function in older men"

One of the most frustrating things for a guy on testosterone replacement therapy is when the pharmacy cannot refill medication due to it being on "back order". Back-order can of course mean many things, and since pharmacies sometimes fail to explain to the patient what is happening I thought I would post my understanding of what may be occurring, what to expect, and what to do. Things change rapidly within the US pharmaceutical pipeline resulting in limited access to some medications. This article is meant to provide a better understanding of the situation when specific medications are temporarily not available at the pharmacy.

One might wonder how a common medication like "testosterone cypionate" can all of a sudden be unavailable at the pharmacy.

Medication shortages can indeed happen even with common medications. The shortage can occur at different levels within the pipeline that delivers medications from the supplier to the pharmacy shelf. Where this shortage occurs will determine how many people are affected. I will briefly explain how the pipeline works. Drug manufacturers who make "brand name" drugs and compounding pharmacies who create customized generic drugs both purchase drugs in raw form from an FDA approved supplier. Once a drug is made into a finished product by the manufacture or compounder, it then must pass a series of regulatory protocols which include testing before becoming available to patients through a pharmacy.

So when it comes to raw material suppliers, if just one large supplier has a problem leading to a shortage of a specific raw material than it will certainly affect many pharmacies across the US who will be unable to obtain it from that supplier. Sometimes the shortage can affect all suppliers who carry that drug, or sometimes there is only one (or few) supplier who carries a particular drug- like testosterone esters. This can result in a nationwide shortage of a medication.

For example, there could be a delay with the supplier of the raw materials needed to make test cypionate which would mean that no pharmacy or manufacturer could obtain the needed ingredient to make a finished product. A delay can occur for a variety of reasons, including inability to pass an FDA inspection resulting in temporary or even permanent suspension. Usually there is enough stock left on the pharmacy shelf to be used while the shortage is resolved. Smaller pharmacies may not have stock and will be out completely so you would need to call around to see if another pharmacy may have your medication available.

Shortages can also occur down the chain at the pharmacy level- maybe the pharmacy simply forgot to order their supply or they underestimated the amount needed. Usually this level of shortage can be resolved in a day or two. Also at the pharmacy level, particularly compounders, there are different regulations including USP 797 which governs how injectable testosterone (and all injectables) are made. USP 800 which requires HCG and testosterone to be made in a separate negative flow "clean room" which some compounding pharmacies do not have. If the drug does not pass every test while being compounded or manufactured then it will be discarded instead of dispensed, causing a temporary delay as another batch is made. Another delay that may occur when obtaining your medication is the result of the additional steps needed to procure and fill a controlled substance. Dont forget that testosterone (and HCG in many states) is considered a controlled substance. All of these regulations are controlled by state and federal agencies who can pass legislation that limits access to certain medications. Any of this can cause a delay or lead to a shortage of testosterone or hcg.

I have wintessed an entire batch of test cypionate thrown out because it's potency was higher than the strength listed on the label. This caused the pharmacy to place test cyp on back order for 48 hours until they catch up on making more. The worst I have experienced while working at the pharmacy in 2009 is when compounded testosterone enanthate was on back order for 6 months before becoming available for most pharmacies to dispense again. In this case the shortage occurred at the supplier, reason unknown. I dont see this happening with cypionate as its very common in the US, but shortages may still occur for various reasons.

Brand name HCG is commonly in shortage at retail pharmacies as of 2015. Due to lack of insurance coverage and high price, men are much better off obtaining their HCG from a compounding pharmacy. Compounded HCG is less than half the price and rarely on back order at compounding pharmacies.

Suppliers and pharmacies usually work fast to resolve any delay unless it has to do with policy change or regulatory violation

What to do if your pharmacy is out of testosterone cypionate?

Contact other local pharmacies first to see if they have any in stock. Do not hesitate to ask them why there may be a shortage, but don't expect an answer because often they may not even know

Contact compounding pharmacies who supply injectable testosterones. Even if the compounder does not take insurance, they will charge you an affordable price. Paying for it is much better than missing your injection.

If the issue is related to a specific type of testosterone, like 'cypionate', you can then ask if another ester like 'enanthate' is available. Enanthate is close enough to cyp that you could substitute it if needed. Remember, you will have to get your doctor to 'okay' the change to enanthate first. Testosterone enanthate is usually available at retail pharmacies in 200mg/ml X 5ml bottles. It is also compounded at some pharmacies.

If there is ever an injectable testosterone apocalypse and no injectable versions are available (which should never happen), you can always temporarily change to a topical gel + HCG to maintain. Again, there many different brands/generics injectable testosterones that such a full shortage would be rare. At least there are options

If you ever find HCG on backorder at compounding pharmacies just sit tight, it will become available again soon. As stated before, I have never seen HCG in short supply on the compounding side and if there ever was a shortage it was only for a day or so.

Part of the high level of service Defy Medical strives towards for our patients includes maintaining communication with our pharmacies in order to prepare for any upcoming changes and requirements. This ensures that we can continue providing affordable access to these medications to our patients no matter where they happen to live.

Click here to view full article titled "Testosterone needs estrogen's help to inhibit depression" by Professor Mohamed Kabbaj from Florida State University College of Medicine.

http://www.defymedical.com/video-education/health-articles/332-testosterone-needs-estrogens-help-to-inhibit-depression

Article commentary by Jasen Bruce

Men and women on testosterone replacement therapy who previously suffered from low testosterone and depression already understand the positive effect that testosterone has on their mood. A study led by Rupert Lanzenberger from the Vienna Medical University Department of Psychiatry and Psychotherapy has demonstrated for the first time worldwide that testosterone increases the number of serotonin transporters (proteins) in the human brain. Serotonin is a neurotransmitter that plays an important role in maintaining positive mood and emotional well-being. There are many more studies which demonstrate the relationship between the sex hormone testosterone, depression, and positive mood. Maintaining adequate levels of testosterone is shown to reduce the occurrence of depression. The presentation titled “Testosterone needs Estrogen's help to inhibit Depression “by Professor Mohamed Kabbaj interestingly shows that both estrogen and testosterone work together to alleviate depression and anxiety. In both men and women, some testosterone converts to estrogen. In men, this is the primary source of estrogen. In women, estrogen is also produced in the ovaries. The article indicates that the actual conversion of testosterone to estrogen in the brain is necessary for anti-depressant and anti-anxiety effects. This research will hopefully help patients suffering from depression obtain better access to hormone testing and proper treatments when certain hormones are found to be too low

The only statement I do not agree with is regarding the “need” to synthesize a drug which acts like testosterone due to the fear of “numerous side effects” associated with testosterone. Of course those of us who read the latest evidence know that the “numerous side effects” result from improper prescribing of testosterone and the lack of proper monitoring. Testosterone replacement therapy correctly administered and monitored by an experienced doctor has very low risk and long term health benefits. Why take a hormone already identical to what the body produces and alter it to produce a drug? I believe the efforts would be better spent educating more doctors on how to properly monitor testosterone replacement therapy after diagnosing low testosterone. Although this study is done on men, we know the effects are equally beneficial in women. Article excerpt: “Maybe in the future, when we are trying to develop an antidepressant that works in low-testosterone males, we can target some of the mechanisms by which testosterone acts, since it has numerous side effects,” he said. Testosterone acts on many receptors and pathways in the brain, so the challenge is to come up with a drug that provides only the effect you want.” Referenced: http://www.defymedical.com/video-education...-rfp69hrv-dpuf

"...the male sex hormone testosterone also affects our mood and emotions, as well as our libido -- and in a positive way."

Friday, 17 April 2015 19:49

Testosterone Replacement for Women too

Testosterone is often mistakenly defined as a hormone that is important for men only. Studies and practical obervation has shown that testosterone is a very important hormone for women too.

Women experience a rapid decline in sex hormones such as estradiol and testosterone while aging. Other important hormones that can decline with age or illness include those produced by the adrenal and thyroid glands. Although women produce a much lower amount of testosterone than men, this decline is noticed throughout the whole body. Research has shown that testosterone is responsible for a women’s sexual desire and responsiveness, mood, sense of well-being and mental acuity. The Women’s Health Institute at the University of New Jersey suggests that androgens (testosterone) play a significant role in affecting pre-menopausal and post-menopausal symptoms and quality of life

As it does in men, testosterone supports bone density and muscle tissue. Increased bone density is critical because of the increased risk of osteoporosis women face as they age. Women produce their testosterone in the ovaries and adrenal glands and typically lose 70 percent of the hormone by the age of 40. This decrease can cause most, if not all the effects listed above. Some other effects of low testosterone in women include increased risk of cardiovascular disease (Med. Suisse Romande2003 Mar) and increased risk of Alzheimer’s (Cell mol Life Sci. 2005 Feb). A simple blood test through a physician can determine the level of testosterone in the body and therefore can detect a deficiency.

The best testosterone range for men to maintain health and quality of life has been established. Men appear to respond optimally when the total testsoterone level is greater than 550ng/dl. Improvments can be experienced when testosterone is maintained in the upper-end of the established range, roughly between 650ng/dl-1100ng/dl. Just like men, women have testosterone level that should be maintained within a specific range in order for the hormone to support the functions in which it is reponsible. Clinical focus on testosterone in women has been lacking therefore we must rely on the data that is presently available. In addition to clinical studies, we also have years of observing clinical practice within the emerging feild of "hormone replacement therapies" in which re-trained doctors provide compounded bio-identical hormone medications to treat women for hormone deficiencies inclduing testosterone. Many of the most experienced doctors have established the best range for Total Testosterone levels in women to be between 45ng/dl-120ng/dl, depending on other factors including symptom response and other hormone biomarkers. I have no doubt that women can experience the same health and physical benefits as men by maintaining optimal testosterone levels with the assistance of a trained doctor.

Supplementing with the adrenal hormone ''DHEA' can be useful for improving testosterone levels in women. If this does not work, there are other methods of testosterone administration. The therapy of choice is a topical cream applied in a very small amount to the skin. The hormone is absorbed through the skin and into the blood stream. Injections and pellets are also available to restore deficient testosterone. Just a small amount of this hormone will make a big impact on women’s quality of life.

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A recent study of a male population explores the relationship between testosterone and erectile function. As suspected, higher levels of testosterone equals a better erection and improved sex drive. This study also helps to explain the different types of blood tests used to check testosterone, and why it is important for men and women to have more than just the total testosterone checked (also known as serum testosterone).

The study observed over 700 men from a specific population (population-based study) and established a correlation between a man’s testosterone level and his erectile function. The men in the study were followed for a period of 4 years and were selected to participate after receiving a comprehensive survey and baseline examination designed to narrow down the participants. Erectile function was determined by having each participant complete the widely used IIEF erectile function questionnaire in addition to blood testing. The men had to have been “in a stable sexual relationship for at least 6 months” at the time of the study. Their IIEF results helped to quantify their level of erectile dysfunction (ED) into three categories; none, mild, and moderate to severe (ED).

You can take the IIEF erectile function questionnaire used in this study by clicking the link below. What is your IIEF erectile function score? http://defymedical.com/services/sexual-health/326 Results will generate a score that can be used to recommend the next clinical step towards treatment.

The blood tests performed in the study include measurements of total testosterone, free testosterone, bio-available testosterone, and a protein called sex hormone binding globulin (SHBG). Many men (and women) along with their primary care doctors focus on just total testosterone, which measures the total sum of both bound and unbound testosterone. There is a difference between bound and unbound testosterone. Your body cannot use all of the testosterone measured in a total testosterone test. SHBG is a protein which can attach to testosterone very tightly which prevents testosterone from entering your cells. Any testosterone attached to SHBG would be considered bound, which the body cannot use. The level of SHBG was tested along with testosterone in this study. There are other proteins which can also bind to the testosterone molecule, such as albumin. Albumin does not bind as tightly as SHBG and therefore can quickly become unbound so that testosterone can be used by your cells. Free testosterone describes the testosterone which is not bound by any proteins and is available to be immediately used. Bio-available testosterone is a measurement of both free testosterone and also testosterone bound to albumin which, as mentioned, is easily separated so that the testosterone becomes available for use (free) when needed. Your body can use bio-available testosterone but it cannot use testosterone bound by SHBG.

This study explored the relationship between testosterone, our primary sex hormone, and erectile function. The conclusion showed a clear cause-effect relationship between the two. This is important to know since erectile dysfunction (ED) “is a worldwide disorder that affects millions of men” and has a negative influence on quality of life. If this relationship is not understood then ED treatments can fail for many men without understanding why. For example, PDE-5 inhibitors (Viagra, Cialis, Levitra) are commonly prescribed medications to treat ED. They work by inhibiting the enzyme (PDE-5) that prevents nitric oxide from relaxing the spongy erectile tissue in the penis (corpus cavernosum). Nitric oxide is released in the penis when a man is sexually aroused. Studies show that PDE-5 inhibitors like Viagra work more efficiently when there is a sufficient amount of testosterone present. These medications are more likely to fail if a man has low testosterone. Interestingly there is a positive relationship between testosterone and nitric oxide. Aging men who are experiencing ED should request to have a testosterone blood test to see if low testosterone, or more specifically low free-testosterone is the cause. The study came to the conclusion that “men with low free testosterone and high SHBG were at the highest risk of ED”. Remember, free testosterone is not bound by proteins and can be immediately used to support an erection and improve overall sexual performance.

This study emphasizes why it is important to always blood test both total and free testosterone. It can be additionally beneficial for some men experiencing poor erectile function to also blood test sex hormone binding globulin (SHBG), and Dihydrotestosterone (DHT)-an androgenic byproduct of testosterone. Androgens are shown to help maintain healthy erectile function in aging men (Testosterone is also an androgen). Testosterone in a younger man plays a role in the development of sex organs and male characteristics, such as the voice deepening and increase in body hair. After these tasks have been completed testosterone continues to play a role in the maintenance of erectile function and sex drive in aging men.

There can be many factors leading to erectile dysfunction but amongst all the causes it was common to find a deficiency or insufficiency of testosterone. It is important to first check testosterone levels when experiencing ED. Testosterone replacement therapy can be prescribed by a trained doctor to help restore low levels but first you must determine if your low testosterone may be caused by lifestyle habits, such as alcohol or drug use, or by disease. Restoring testosterone to a good level can help improve your erectile performance and libido.

To download the full study as a PDF for free please visit our clinical study library by clicking on the link below. The study is listed under the title “Sex Hormones Predict the Incidence of Erectile Dysfunction: From a Population-Based Prospective Cohort Study (FAMHES)”. You can also email jasen@defymedical to request a PDF copy.

Clinical study library: http://defymedical.com/resources/clinical-studies/24-testosterone-replacement-therapy

Reference: Luo, Y., Zhang, H., Liao, M., Tang, Q., Huang, Y., Xie, J., Tang, Y., Tan, A., Gao, Y., Lu, Z., Yao, Z., Jiang, Y., Lin, X., Wu, C., Yang, X. and Mo, Z. (2015), Sex Hormones Predict the Incidence of Erectile Dysfunction: From a Population-Based Prospective Cohort Study (FAMHES). Journal of Sexual Medicine. doi: 10.1111/jsm.12854

Other references used:

The role of testosterone in erectile function and dysfunction. L. Gooren, MD, PhD, Available online 7 September 2006

Combining Testosterone and PDE5 Inhibitors in Erectile Dysfunction: Basic Rationale and Clinical Evidences. Emanuela A. Greco, Giovanni Spera, Antonio Aversa. Department of Medical Pathophysiology, University of Rome “La Sapienza”, 00161 Rome, Italy. Available online 13 July 2006

This study found that maintaining testosterone levels above 550ng actually reduced cardiac disease risk. Note that they tested estradiol levels, which was lacking in the inaccurate study recently published. In addition, they found negative correlation between testosterone levels are type 2 diabetes risk. This study was done over 5 years and analyzed all kinds of markers, including SHBG.

High Serum Testosterone Is Associated with Reduced Risk of Cardiovascular Events in Elderly Men

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