Testosterone is often thought of as a man’s sex hormone contributing to muscle mass, improve sexual desire, performance, stamina and reducing. What people tend to overlook is the role testosterone plays in brain development, cognitive function, executive function and memory. In several studies men with low testosterone invariably perform below normal on tests for verbal fluency, visuospatial ability, memory, executive function and attention. Studies have shown that testosterone replacement in men with Low-T improve cognitive functions and memory recall. Testosterone has the following beneficial effects on the Brain: Mood Vitality Sexual Desire Social Behavior Communication Cognition Memory Problem Solving Creativity The Cognitive Function Trial of the Testosterone Trials is one of the largest placebo-controlled studies conducted to date of the effects of testosterone supplement and its effect on cognition in men with Low-T. The trial detected a clinically significant improvement in verbal and memory performance in men on testosterone supplementation. When testosterone is low, it can have a negative impact on a variety of cognitive functions, especially mood. When this happens, testosterone replacement therapy can help to improve cognitive functions and mood lability. However, testosterone therapy should not be considered as a primary way to treat conditions like depression. Testosterone asserts its effect on brain development before a male is born. While a in the womb, testosterone acts to masculinize the developing fetus which eventually leads to permanent male features. As men age, and testosterone levels fall, a few small studies have shown that there has been a decrease in visuospatial abilities and cognition over time. There has been speculation that testosterone therapy may improve the symptoms of dementia, but it is highly unlikely that the therapy could reverse the condition. Nevertheless, there is no doubt that normal testosterone levels have a positive impact on memory and other cognitive abilities. Many men also report an increased desire for sexual activity while receiving testosterone treatment and effect testosterone exerts on the brain. Men provided with testosterone replacement (TRT) usually will report having a better mood and better memory within 3-6 months after starting therapy. It is still not known if testosterone supplementation can prevent or slow down the effects of conditions such as Alzheimer’s or dementia; however, those who receive testosterone therapy do often see improvement in their energy levels and responsiveness. These types of clinical improvements are usually the benefits men obtain when on testosterone replacement therapy and desire. Men should always talk with their physician about their expectations of therapy and now understand that cognitive function may improve with therapy.

What is the cause for Testosterone increasing my hemoglobin levels? What is the best management option if my hematocrit and hemoglobin levels are high while on testosterone replacement therapy? What is Erythrocytosis? What Testosterone formulation has the greatest risk of elevating my hematocrit levels? Keywords: Erythrocytosis and Testosterone, Phlebotomy, Testosterone and VTE, Testosterone and Cardiovascular Risk, Testosterone and Stroke, Polycythemia and Testosterone Replacement, Hemoglobin and Hematocrit values on Testosterone, Testosterone therapy side effects, Testosterone Cypionate, Testosterone Undecanoate, , Testosterone Enanthate, Testosterone Pellets Hypogonadism (also known as low testosterone, testosterone deficiency or androgen deficiency) is defined as biochemically having a low testosterone level in combination with specific signs and symptoms. The treatment can be testosterone replacement therapy (TRT). Despite testosterone’s positive and beneficial effects on weight loss, lean muscle growth, decreased low-density lipoprotein (LDL), improved insulin resistance, improved cognition, decrease in waist circumference, improved libido and erectile function there are known risks of therapy. Risks of TRT include increases in estradiol levels, gynecomastia, and erythrocytosis. Erythrocytosis is an increase in red blood cell count that may impart a risk to the cardiovascular system. The following article will review TRT and erythrocytosis and treatment options. TRT induces an elevation in red blood cell count (RBC). An increase in RBC’s is referred to as erythrocytosis and polycythemia. The increase in RBC’s is measured by a laboratory measurement of hemoglobin (Hgb) and hematocrit (Hct) levels. Hemoglobin is a protein within red blood cells that carries oxygen. Hematocrit is the percentage or proportion of blood volume that is comprised of red blood cells. Blood volume is composed red blood cells, white blood cells, platelets and plasma. It is specifically the red blood cell component of total blood volume that is increased by TRT. Erythrocytosis and polycythemia should not be confused with Polycythemia Vera which is a type of cancer of the bone marrow resulting in an increase in all components of blood volume not only red blood cells. . Androgen Therapy and Erythrocytosis Androgen therapy has been used since the 1950’s to stimulate erythropoiesis in patients with low red blood cell volume secondary to a variety of medical conditions including iron deficiency anemia. Kennedy and Gilbertsen in 1957 demonstrated in an observation study of women with breast cancer treated with androgen therapy (100mg testosterone injections three times weekly), significant increases in red blood cell volume. While this regimen of testosterone is supra-physiologic in order to induce erythropoiesis, more standard dosing regimens by men today of 100mg testosterone injection weekly typically increases hemoglobin levels by only 10g/l. Increases in Hct and Hgb levels are often observed by 6 months on intramuscular injections of testosterone and 9 months when testosterone pellets are utilized. What is the risk of elevated hematocrit levels and increased red blood cell volume induced by testosterone therapy? Erythrocytosis is clinically diagnosed when the Hgb level is greater than 18.5g/dl and the Hct level is greater than 52%. When Hct levels rises above 52% the red blood cell volume of blood increases, leading to an increase in blood viscosity, reducing venous return and increase platelet adhesiveness. These blood conditions can lead to blood clot formation, stroke, cardiovascular risk and ischemia (1-3) The potential risk of erythrocytosis induced by testosterone therapy is the increase in blood viscosity and related ischemia (reduced blood flow) which may promote a thromboembolic event (also known as a blood clot or VTE/ Venothromboemoblism ). A blood clot can travel to your lung (known as a pulmonary embolism), a clot could form in your leg (known as a venous blood clot) or a blood clot can travel to your brain, resulting in a stroke. The increase in blood viscosity can also put a strain on your heart and cause ischemia to other parts of the body such as the brain. It should be noted that the direct relationship between TRT and an elevation in Hct and subsequent risk for VTE has not been investigated through prospective randomized clinical trials. Much of the data is retrospective and observational in nature, yet precautions are still recommended by many professional guideline statements from the endocrine and urologic societies. To Learn more about the risk of blood clot formation on testosterone therapy and FDA labeling click here. How does testosterone replacement therapy (TRT) cause an increase in red blood cell volume? What is the pathophysiology of TRT and elevated RBC’s? There are several different theories how TRT causes an increase in red blood cell volume. The first is testosterone’s ability to increase erythropoietin (EPO). EPO is a protein produced by the kidney and directly stimulates the bone marrow to make more red blood cells. It is hypothesized that testosterone stimulates EPO release from the kidney. Another mechanism for testosterone induced erythrocytosis centers around the suppression of hepcidin. Hepcidin regulates iron utilization in the body and iron is a key component of red blood cells. Bachman et al. theorized that testosterone causes suppression of hepcidin leading to an increase in iron absorption for erythrocytosis to occur. What type of testosterone formulation poses the greatest risk for erythrocytosis? Thera are a variety of testosterone replacement formulations including short and long acting intramuscular injections (Testosterone Cypionate, Testosterone Undecanoate, Testosterone Enanthate), Testosterone Pellets, Testosterone transdermal Cream/Gel, Nasal Testosterone and Oral Testosterone. Of these formulations, short acting IM testosterone injections have the highest incidence of erythrocytosis. The incidence of erythrocytosis secondary to testosterone injections approach 40-60%. Recent studies theorize that the large fluctuations in testosterone levels associated with IM injections is more supra-physiologic and causes a large spike in androgen levels resulting in increased hematocrit levels. This spike is less apparent with transdermal testosterone and testosterone pellets, where more steady state testosterone levels are achieved. Table 1 (4) : Testosterone Formulations & Erythrocytosis Percentage Testosterone Enanthate & Cypionate 66.7% Testosterone Undecanoate 7% Transdermal Testosterone (Testim ®, Androgel ® 1.62%) 12.8% Testosterone Pellets 35.1% What is the best treatment for erythrocytosis induced by testosterone replacement therapy? 5 main options for men on TRT who have elevated Hct levels. Interruption of TRT Phlebotomy Temporary reduction in dosage Must consider evaluation of cause of Hct/Hgb Consider changing testosterone delivery method to more stable/consistent delivery such as topical transdermal testosterone gel or cream. For patients who are on testosterone replacement therapy and a measured hematocrit (Hct) level is greater than 50% the following is recommended. A physician should consider withholding TRT until the etiology of the elevated Hct is investigated. The rise in Hct could be secondary to polycythemia vera, sleep apnea, high altitude or tobacco use among others. If the measured Hct level is greater than or equal to 54% this demands intervention. A patient can stop TRT and obtain further assessment, as recommended by the Endocrine Society Guidelines. Dose adjustments of testosterone can be optimally lowered. Second, and a more preferred method is phlebotomy. A patient can donate blood to remove excess red blood cell volume and continue on therapy after medical investigation. Phlebotomy and blood donation are often free in many states and provides a quick and cost-effective solution. 1. Guyton AC, Richardson TQ. Effect of hematocrit on venous return. Circ Res. 1961;9:157–64. 2. Hellem AJ, Borchgrevink CF, Ames SB. The role of red cells in hemostasis: the relation between hematocrit, bleeding time and platelet adhesiveness. Br J Haematol. 1961;7:42–50. 3. Wells RE, Jr, Merrill EW. Influence of flow properties of blood upon viscosity-hematocrit relationships. J Clin Invest. 1962;41:1591–8. 4. (Table 1) Samuel et al, Erythrocytosis Following Testosterone Therapy. Sex Med Rev. 2019 Jan1. 5. Nieschlag et al. Testosterone. Action. Deficiency. Substitution. Fourth Edition published 2012. Cambridge University Press.

Keywords: Deca, Nandrolone, Anavar, Oxandrolone, SARMS, Anabolic Steroids , Testosterone Cypionate, Anabolic Hormone, Androgenic Hormone. Nandrolone Decanoate, Deca-Durabolin, Nandrolone and ED, Nandrolone and Hair Loss, Androgenic Alopecia, Gynecomastia, Bodybuilding, Gym Athelete, Men's Health Testosterone is both an androgenic and anabolic steroid hormone. The androgenic effects of testosterone are associated with masculinization, such as deeper voice, facial hair, development of acne, and hair loss. We observe the androgenic effects of testosterone during puberty as boys mature into men. The androgenic effects of Testosterone are commonly not desired by men. The anabolic effect of testosterone is associated with skeletal muscle growth, weight loss, improved memory, cognitions, performance, stamina, increased utilization of protein. As testosterone replacement is becoming more prevalent in society so has the science behind the development of testosterone derivatives that lessen the androgenic effects of testosterone and enhance the anabolic affects. Selective Androgenic Receptor Modulators (SARMs) are an evolving class of anabolic hormones that have unique properties similar to testosterone without the androgenic effects and have role in men’s health. What does SARM stand for? Selective Androgen Receptor Modulator What are SARMS? A SARM is molecule that binds to an androgenic receptor and exerts a powerful effect on a target tissue such as skeletal muscle. A SARM can be taken orally or by intramuscular (IM) injection. SARMS are a modification of testosterone and have a greater anabolic effect on target tissue than androgenic affect. Anabolic effects are growth, preservation of lean muscle mass, nitrogen retention and weight loss among others. Androgenic effects are prostate growth, acne development and deepening of the voice among others. SARMS were developed in the 1940’s to promote the beneficial and wanted affects most men desire from taking testosterone and reduce unwanted androgenic adverse effects. This makes SARMS a unique and attractive therapeutic agent for the treatment of several clinical and medical conditions. As men age, lean muscle growth is lost resulting in muscle wasting, power and strength loss. Sarcopenia is the age-related loss of muscle mass and strength that can lead to disability and increased morbidity. This loss of muscle mass and strength reduces the body’s ability to prevent falls and reduces mobility, therefore the aging man becomes more fragile. SARMS are an anabolic medication used to combat aging muscle loss and fragility, aimed at promoting improved physical function and strength. While testosterone can be used to combat the signs of aging and improve lean muscle growth, supra-physiological doses can have unwanted side effects such as erythrocytosis and prostate growth leading to lower urinary tract symptoms. SARMS can achieve significant anabolic effects on muscle growth and muscle preservation at a much lower dose than testosterone and without the unwanted side effects. To learn more about testosterone and erythrocytosis click here To learn more about testosterone and lean muscle growth click here What is the difference between steroidal and non steroidal SARMS? Steroidal SARMS have the same chemical base structure, that of the testosterone steroid. All steroidal SARMS have the same testosterone base structure but the addition or subtraction of molecules to testosterone confers unique and therapeutic advantages. For instance, the addition of a 17-alpha alkyl group prevents the breakdown of testosterone and provides the steroid to be taken orally. However, this form of testosterone is not utilized given its effect on the liver (hepatoxicity). A new oral testosterone medication named JatenzoTM was recently approved by the FDA with minimal to no liver toxicity. Jatenzo™️ is not a SARM but a testosterone prodrug. It is comprised of a testosterone molecule with an attached long chain fatty acid. The testosterone molecule does not exert an effect until the body breaks the faty acid chain (i.e. prodrug). The long chain fatty acid allows Jatenzo™️ to be absorbed through the lymphatic intestinal pathway and confers protection from the liver. Non steroidal SARMS are currently in development, are not structurally comprised of the same structural base as testosterone and have may have different tissue specificity compared to steroidal SARMS. Much of the research of Non steroidal SARMS are not published and direct comparison to Steroid SARMS is unknown. What is Nandrolone Decanoate? Nandrolone Decanoate (often known as DECA, Deca-Durabolin, and 19-nortestosterone) is a steroidal SARM. It has the same chemical base structure as testosterone except for removal of the 19-methyl group. This small modification provides Nandrolone an increase in anabolic activity. When Nandrolone is broken down by 5 Alpha-Reductase it forms a less potent androgen compared to DHT (Dihydrotestosterone), called Dihydronandrolone. Dihydronandrolone is less aromatized into estrogen. Estrogen levels therefore do not rise as much with Nandrolone use compared to testosterone. As mentioned, Nandrolone does not get reduced into DHT which has potent effects on prostate growth and lower urinary tract symptoms. These factors make Nandrolone significantly different than testosterone and with higher androgenic potential. What is Nandrolone Decanoate Used for? Nandrolone has been well studied and available for several decades. Its primary indication for your use is prevent muscle wasting and improve anemia in patients with sarcopenia, renal failure, chronic obstructive pulmonary disease (COPD) and HIV. How is Nandrolone Decanoate delivered? Nandrolone bares many similarities to testosterone. Nandrolone is given as an intramuscular injection. It has a plasma half-life of approximately 8 days. But unlike testosterone, Nandrolone binds and interacts with androgen steroid receptors with more affinity (stronger) enhancing anabolic and myotrophic (muscle) activity. How does Nandrolone Decanoate different than Testosterone? Nandrolone has a much higher attraction to the androgen receptor when compared to testosterone. Nandrolone also had a greater effect on building and stimulating larger muscle mass than testosterone. Testosterone is broken down by 5 alpha- reductase into two components DHT and estradiol. DHT has unwanted side effects on the prostate (causing prostate growth) and hair follicle atrophy (androgenic alopecia / male pattern baldness). Nandrolone is also broken down by 5 alpha reductase, but into Dihydro-19-nortestosterone. This breakdown product has less activity and affinity for the prostate and hair follicle lending to less side effects, less androgenic alopecia, less urinary tract symptoms. Nandrolone and Muscle Growth Nandrolone is structurally similar to testosterone except for a simple removal of the 19-methyl group. This small structural change confers greater anabolic effects of the steroid hormone and less adverse unwanted androgenic effects. Testosterone has an anabolic to androgenic ratio of 1:1. This means it is able to build muscle and reduce waist circumference (anabolic effects) just as much as it stimulates prostate growth, hair loss and deepening of the voice (androgenic effects). Nandrolone, on the other hand, has an anabolic to androgenic ratio of 11:1. A significantly higher myotrophic/anabolic (muscle building) effect. The enhanced anabolic effect of Nandrolone minimizing the catabolic effect corticosteroids have during stress (stress hormones released during athletic activity). Second, Nandrolone enhances nitrogen retention and balance, improving protein utilization, reducing fatigue to enhance training abilities. Because of this amazing muscle building property of the hormone its use has been primarily in patients with anorexia, COPD, cachexia, chronic renal failure, HIV, and AIDS wasting syndrome. Nandrolone and Erectile Dysfunction (ED) Nandrolone will cause erectile dysfunction. The hypothesis for this side effect is Nandrolone’s ability to reduce natural testosterone and DHT production. This suppression of endogenous testosterone production by the testicles may lend to ED. In order to prevent ED with Nandrolone, concomitant use with testosterone will preserve erectile function. This addition of an in additional androgenic hormone in men who use nandrolone for alternative purposes is termed “stacking”. Stacking Nandrolone with Testosterone is a commonly used regimen for physique and bodybuilding athletes who use the medication alternatively and beyond it intended use. Nandrolone Use Among Bodybuilding Athletes and Gym Athletes According to studies, the prevalence of Nandrolone Decanoate usage among gym and bodybuilding athletes approaches 75%. The average duration of Nandrolone is approximately for 14 months with fluid retention, decreased testicular size and acne reported as the most common side effects. According to a study conducted in the United Kingdom of 4 gyms and 100 male steroids users 33% of men were professional bodybuilders and 67% recreational gym athletes. All users cycle was guided by their own experience or anecdotal evidence. Other medications, not a steroid hormone, used by men include Clenbuterol, Ephedrine, and L-thyroxine to improve protein deposition in muscle, training stimulation/performance and reduce subcutaneous fat respectively. Diuretics were found to be commonly also utilized in steroid users to reduce the unwanted effect of water retention. Anti-estrogen agents such as Tamoxifen and Arimidex were also utilized with cycles of steroid users. Physical signs prevalent in up to 1/3 of users in the study included the triad of acne, gynecomastia, and striae. Pan MM, Kovac JR. Beyond testosterone cypionate: evidence behind the use of nandrolone in male health and wellness. Transl Androl Urol 2016;5(2):213-219. doi: 10.21037/tau.2016.03.03 Evans, Nick. Gym and Tonic. Br Journal of Sports Medicine 1997;31:54-58

The difference between Testosterone Cypionate, Testosterone Propionate Testosterone Enanthate, Sustanon, & Testosterone Ester combinations explained. The history of Testosterone formulations The difference between IM Testosterone formulations and Testosterone Gels Androgel vs Testim Testosterone Gel, which one is better? Keywords: Testosterone Cypionate, Testosterone Propionate, Testosterone Enanthate, Androgel, Axiron, Testim, Fortesta, Testavan, Jatenzo, Natesto, Testosterone Cream, Nasal Testosterone, Oral Testosterone, Buccal Testosterone, Injectable Testosterone, Esterification, Androgen Ester, Testosterone Ester, Testosterone Undecanoate, 2% Testosterone Gel, Nebido, Aging, Androgens, Testosterone Replacement Therapy, Testosterone, Hormones. History of Testosterone Formulations Testosterone is the most important androgenic and anabolic hormone in men. Exogenous testosterone for the treatment of hypogonadism (Low-T) has been used since the 1940’s and testosterone is one of the most researched and studied medications. Furthermore, testosterone is one the oldest medications and has been demonstrated to be safe for clinical use. The aim of testosterone therapy as set forth in 1990 by the FDA, WHO and NIH: “the major goal of testosterone replacement therapy is to replace testosterone levels as close to physiological levels as possible” (World Health Organization 1992). Since testosterone’s first clinical use, methods have been developed to improve testosterone’s application, bioavailability and dosing regimen through a variety of testosterone formulations. The first testosterone formulation was developed in 1940 as subcutaneous implantable pellets. The pellets maintained a consistent level of testosterone and were long acting. The side effects of the pellets included having to be implanted by a physician, associated procedure pain and possible pellet extrusion. Today, Testopel is the most widely used implantable testosterone pellet. In the 1950’s intramuscular (IM) testosterone injections entered the market. IM testosterone injections provided patients the ease of at home use, often performed weekly and easy to administer. The undesired effects of IM testosterone injections are the large fluctuations in testosterone levels, injection site discomfort, and elevated risk for erythrocytosis. IM testosterone injections remain the most common formulation used today. In the 1980’s attempts to make testosterone an oral tablet was without success. Oral testosterone tablets while easy to administer caused significant liver toxicity and the tablets had be take almost three times daily. They were removed from the market, until recently with the approval of Jatenzo. Jatenzo is a new and novel oral testosterone tablet that bypasses liver metabolism and maintains consistent testosterone levels. In 1993 transdermal patches became available and were applied to the scrotum. The scrotal skin provides the highest rate of testosterone absorption, hence the reason for this location of the patch application. The patches were easy to use and apply but caused skin irritation, itching and discomfort and the patch was visible. By the year 2000, topical testosterone gels provided men an easy once a daily application that maintained steady state testosterone levels. The gel is clear and absorbs quickly with rapid onset. Drawbacks of testosterone gels include the possible transference to children or women. In 2014, a new nasal testosterone formulation, Natesto, provided men another option of therapy, yet the medication must be applied several times to each nostril throughout the day and can cause nasal irritation. There are a variety of testosterone formulations ranging from short and long acting IM injections, patches, gels, cream, pellets and oral tablets. How do these testosterone formulations compare, what is the difference and which one is most suitable for the hypogonadal male? Let’s discuss. Testosterone Esters Three approaches that have been used to make testosterone therapeutically effective in clinical use. 1) Provide various routes of administration 2) Chemical modification 3) Esterification in position 17 The most widely used form of testosterone is the intramuscular injection preparation of a testosterone ester. A testosterone ester is a modified version of the natural testosterone a body produces. Natural testosterone is known as unmodified testosterone. Unfortunately, unmodified testosterone cannot be injected on its own. Pure testosterone that the body produces cannot be utilized to increase testosterone levels in patients, it cannot be injected. Unmodified testosterone only has a half-life of 10 minutes. A medication’s half-life is the amount of time for the concentration of a medication to be reduced by the body 50%. On average is takes approximately 4-5 half-lives before a medication is eliminated from the body completely. If unmodified testosterone were to be injected it would be completely eliminated by the body in approximately 40-60 min (4-5 half-lives). A patient would have to inject testosterone almost every hour in order to maintain testosterone levels and this is not economical or practical. As thus, testosterone has been modified by a process called esterification. This process adds an addition side chain to testosterone prolonging its’ activity in the body. The acid used in esterification of testosterone is the name of the formulation used. For instance, Testosterone Enanthate is Testosterone esterified by enanthic acid. Testosterone Propionate is Testosterone esterified by propionic acid. As, thus modifications of testosterone have been performed to improve the testosterone’s half-life and delivery convenience of once a week dosing. Different acids add different length side chains to testosterone. The length and structure of the side chain added to testosterone determines testosterone's half-life. This explains how testosterone enanthate, testosterone propionate, testosterone cypionate and testosterone undecanoate all have different half-lives. Once injected into the body, esterified testosterone is slowly absorbed into the tissues before being rapidly converted to unmodified testosterone (i.e. the active form). It should be noted, that the testicles synthesize and secrete unmodified testosterone into circulation, this is termed endogenous testosterone. Modified testosterone, that which is injected, is called exogenous testosterone. Exogenous testosterone is modified by esterification as described earlier. When a patient takes a drug test endogenous versus exogenous testosterone can be determined because only exogenous testosterone is modified. Testosterone Ester and Plasma Half Life in Days testosterone propionate 0.8 testosterone enanthate 4.5 testosterone undecanoate 33.9 Testosterone Propionate Testosterone propionate has a very short half-life. After injection testosterone levels in the supraphysiological range are noticed at 14 hours. Testosterone levels are then seen below normal levels after 2 days. Most dosing regiments of this ester are 2-3 times per week. Because short-term kinetics, multi weekly administrations and large fluctuations of testosterone levels, testosterone propionate is not utilized for the testosterone replacement therapy in hypogonadal men. Testosterone Enanthate Testosterone Enanthate has a favorable plasma half-life. After injection supraphysiological levels of testosterone are experienced at 10 hours. Testosterone levels are sustained above normal until day 12. Testosterone Enanthate if often dosed once weekly given the prolonged half-life. After several once a week dosing, a steady state (stable) testosterone level is achieved. Testosterone Cypionate The pharmacokinetics of testosterone cypionate are comparable and similar to that of testosterone enanthate. Testosterone cypionate is the most commonly prescribed form of testosterone in the United States. Testosterone Ester Combinations Testosterone ester mixtures such as Testoviron and Sustanon are widely used for the treatment of men with hypogonadism (Low-T). The reason behind their use is provide a short acting testosterone ester for the beginning of the cycle combined with a long acting testosterone acting for the end of the cycle. These combination esters provide a more sustained and often times supraphysiological level of testosterone levels when utilized. Testosterone Undecanoate Testosterone Undecanoate is now utilized in the United States under the drug name Nebido (Aveed). Yet, testosterone undecanoate was initial formulated as oral therapy for hypogonadism in the 1970’s. It was not until 1991 that studies dissolving testosterone undecanoate in tea seed oil revealed the medication had a prolonged duration of action compared to other testosterone esters. Studies revealed that after injection of 1000mg of testosterone undecanoate mean serum testosterone levels could stay consistently above normal levels for 9 weeks. Testosterone undecanoate has since been reformulated and dissolved in castor oil and given its long duration of action, extended 10-week injection interval and achievement of steady state testosterone levels, this particular formula has become a popular treatment for men with hypogonadism. Testosterone undecanoate does require a loading does protocol of one injection to start. An addition IM injection at 4 weeks and then one IM injection every 10 weeks to maintain steady state testosterone levels. Testosterone Undecanoate (Aveed) currently must be given in a doctor’s office, clinic or hospital. After each injection a patient must wait in the doctors for 30 minutes to be observed for any post injection reaction. (Aveed) is only available through the Aveed Risk Evaluation and Mitigation Strategy (REMS) program. Oral Testosterone Oral testosterone therapy was historically considered a non-suitable form of testosterone replacement given the large doses that must be ingested in order to increase testosterone levels. These large doses were toxic to the liver and had unwanted side effects. Several attempts to improve testosterone’s oral bioavailability and prevent liver metabolism have been made. 17Alpha Methyltestosterone was one of the first oral testosterone substitutes but significant increases in liver enzymes and cholestasis prevented it widespread adaptation for use. This particular formulation was also found to induce liver tumors and it is no longer in use. In 1981 the medication was removed from the market. Fluoxymesterone & Mesterolone are other forms of oral testosterone no longer used today given liver toxicity and weak androgenic potential respectively. Recently, the FDA approve a new propriety form of testosterone undecanoate called Jatenzo. This new testosterone oral formulation is very unique given it’s the first FDA approved oral testosterone formulation approved in the United States to treat male hypogonadism. Jatenzo, unlike other testosterone formulations, is a prodrug. This means the medication is not activated until it is broken down by the body. Jatenzo is a combination of a testosterone molecule attached to a fatty acid. Jatenzo is absorbed preferentially in the intestinal lymphatic system after oral ingestion. This unique absorption method bypasses exposure and delivery of the medication to the liver, reducing liver toxicity. Jatenzo must be taken with food and is taken no less than twice daily. In clinical trials, in particular the inTUne Trial, reported 87% of men treated with Jatenzo achieved steady state and maintained physiological testosterone levels. Testosterone Gels & Creams & Patches Transdermal Testosterone (Androgel, Axiron, Testim, Fortesta) In 2000 Androgel ™ 1% became the first testosterone gel approved for use in the United States by the FDA. Androgel 1% is a colorless gel that contains 25 or 50mg of testosterone dissolved in 2.5 or 5g of gel. The gel dries in approximately 5 min after applied to the skin. Approximately 9-14% of the testosterone in the gel is available and active. After one hour of application testosterone levels have been shown to rise into the normal range. Androgel expanded its line to include a 1.62% testosterone gel strength in April of 2013. The difference between Androgel 1% and 1.62% is the strength of testosterone in each metered dose. Androgel 1% is no longer being manufactured. Testim was the second testosterone gel to enter the market. Testim is provided in small single use packets as opposed to a pump applicator. A study in 2008 reviewed the efficacy of changing testosterone gel preparations (Androgel or Testim) in hypogonadal men who fail to achieve a biochemical response to the initial gel selection. The study found that total and free serum testosterone levels increased significantly following a switch from Androgel to Testim and not vice versa. Testim has different (more enhanced) pharmacokinetic properties when compared to Androgel. This phenomenon is most likely explained by peak serum concentrations of total testosterone, free testosterone and dihydrotestosterone (DHT) are greater following Testim use then when compared to Androgel even with equivalent dosing. Testim provides a more enhanced absorption profile secondary to pentadecalactone used in the gel compared to Androgel. The most common reason men switch from Androgel to Testim is first scent (46%) followed by poor efficacy (30%). Men switching from Testim to Androgel did so most commonly because of the scent (92%). Fortesta and Axiron are both 2% topical testosterone gels, higher strength compared to Androgel and Fortesta. Axiron is applied under the arm pit, similar to a deodorant stick, while Fortesta is applied to the inner thighs. A new 2% testosterone gel called Testavan is very unique. The gel is very transparent and alcohol based. The amount of gel applied is significantly less than other brand names while still delivering the allocated strength of testosterone. In a controlled study, Testavan provided higher bioavailable testosterone and delivering more testosterone in a smaller amount of gel when compared to Androgel. Testosterone Patches The first testosterone patch, Androderm, was approved by the FDA for use in the United States in 1998. The patch is applied directly to the scrotum. Scrotal skin shows the highest absorption rate of a steroid compound compared to other bodily skin, as much as 40-fold higher absorption. In order to apply the patch, the hairs on the scrotum are shaved and clipped and patches are exchanged daily. Skin irritation and itching made testosterone patches less than desirable, but effective. Intramuscular Testosterone Injections compared to Transdermal Testosterone: Testosterone gel Pros More physiological testosterone level achieved Rapid Onset Flexibility in Dosing Cons Risk of secondary transference. Testosterone Injection Pros Less frequent administration Able to achieve supra-physiologic levels of Testosterone Less expensive compared to other formulations Cons Higher testosterone fluctuations Injection site reaction/ redness 1) ED Grober et al. Efficacy of changing testosterone gel preparations (Androgel or Testim) among sub optimally responsive hypogonadal men International Journal of Impotence Research (2008) 20, 213–217 2) Katherine A. Lyseng-Williamson, Testosterone 2% gel (Testavan®, Testarzon®) in adult male hypogonadism: a profile of its use, Drugs & Therapy Perspectives, 10.1007/s40267-019-00627-7, (2019). 3) Nieschlag et al. Testosterone Action, Deficiency, Substitution. Fourth Edition, Cambridge Medicine. 2012. 309- 330.

Keywords: Sarcopenia, Low-T and Muscle Cell Loss, Muscle Cell Fiber, Muscle Hypertrophy, Testosterone and Muscle Size, Androgen and Muscle Cell, Weight Loss, Metabolism, Androgen Receptor, Muscle Growth, Low Testosterone and Muscle Wasting and Fatigue, Weight Gain, Gaining Muscle on Testosterone, Physical Function and Testosterone, SARMS Men with low-testosterone (low-T) have decreased lean muscle mass compared to men with normal testosterone levels. The administration of testosterone to men with low-T results in an increase in lean muscle mass, muscle protein synthesis and enhanced fat cell (weight) loss. The increase in muscle mass secondary to testosterone administration was first thought to be universal for all skeletal muscle in the human body; however, studies have found that muscles in the body respond differently to testosterone replacement (TRT). The muscles of the upper back, shoulders, head, and arms were most those most affected by testosterone and seemingly increase in size. The muscle of the thigh were not found be affected by testosterone as much. The exact mechanism why certain muscles are affected by androgen administration is unclear, but could relate to the hypothesis of different androgen receptor phenotypes in different muscle groups. Further research into this receptor variability within skeletal muscles could illicit androgens that affect and grow particular muscles more so than others. Testosterone increases muscle mass by increasing the size of the muscle fibers (hypertrophy) and increasing muscle protein synthesis. Muscle fibers (myofibrils) are the structural component of a muscle. Within muscle fibers are androgen receptors. Androgen receptors are stimulated by testosterone. The administration of testosterone causes myofibrils to increase in number leading to an enlargement of the muscle cell and therefore muscle mass. In men with Low-T, it has been found that lack of testosterone causes myofibril dissolution (shrinkage) and loss of muscle cells, muscle size, and muscle mass. The mechanism by which testosterone promotes lean muscle mass and growth is by up-regulating myogenesis (muscle building). Testosterone is believed to cause nitrogen retention which may signal protein synthesis, promoting muscle and lean mass growth. An Increase in lean muscle mass will increase metabolism propagating the fat cell loss cycle. Low-T causes muscle cell loss. Testosterone is a necessary component for maintaining and building lean muscle mass. The actions of androgens to enhance muscle cell size is characterized as one of the anabolic components of testosterone. Testosterone has both anabolic and androgenic properties that we will now discuss. Anabolic potential refers to the ability of an androgen to increase muscle mass, decrease body fat, accelerate bone growth before epiphyseal plate closure and increase solid organ size. Androgenic potential attributes to increasing spermatogenesis, enlargement of genital size, and function, enhancing male body hair distribution, deepening of the voice and increasing sex drive. Androgenic properties of testosterone are those that boys experience during puberty and not desired by mature men on testosterone therapy. Many men desire testosterone replacement therapy (TRT) for the anabolic component fo the medication and not the androgenic component. The ratio fo anabolic to androgenic potential is 1:1. It is an equal ration. The development of medications such as Anavar (Oxandrolone) and Nandrolone (Deca) improved upon this ration by having an anabolic to androgenic potential of 10:1. Significantly more muscle building and weight loss enhancement compared to testosterone. May athletes and men who engage in strength-related endeavors use testosterone to increase performance and strength. A study published in the New England Journal of Medicine in 1996 by Bhasin et al. observed the effect of testosterone administration in normal men and its effect on behavior, muscle size, and strength. The study assigned 43 men to one of four groups: placebo injection with no exercise, testosterone injection with no exercise, placebo plus exercise, and testosterone injection plus exercise. The men received injections of testosterone or placebo weekly for 10 weeks. The men in the exercise groups performed standardized weight-lifting exercises three times weekly. Before and after the treatment period, fat-free mass was determined by underwater weighing, muscle size was measured by magnetic resonance imaging, and the strength of the arms and legs was assessed by bench-pressing and squatting exercises, respectively. The results of the study found that the combination of strength training and testosterone therapy produced the greatest increase in fat-free mass, muscle hypertrophy, and strength than any of the four groups studied. Many men today administer greater than physiological dosages of testosterone to increase performance and muscle size. Whether greater dosages truly lead to a heightened athletic performance or if a saturation model exists, continues to be investigated. Still, many athletes and men admit they feel enhanced performance and endurance while on testosterone replacement therapy, each patient response can be different. If we at look the Testosterone trials, one of the largest placebo- controlled, double blinded trials observing the effects of testosterone administration in men with low-T, men reported greater physical function. A meta-analysis by Skinner et. al, Muscular Response to testosterone replacement vary by administration route a systematic review and meta-analysis, concluded that TRT increases fat free mass, total body strength and upper and lower extremity strength when both a topical and injectable testosterone were administered. When comparing topical testosterone (gel) vs intramuscular testosterone delivery route, there were greater strength scores and greater physical functioning scores favoring the intramuscular route of administering testosterone. It is ideal for any man who is undertaking testosterone replacement therapy to incorporate an exercise and resistance training regimen into their everyday life, not only for the health benefits but to enhance the effects of testosterone therapy. Testosterone works synergistically with the addition of a workout regimen to provide faster results for improving strength, muscle size, and physique. For more information how selective androgenic receptor modulators (SARMS) can increase muscle size click here.

Keywords: HCG, Human Chorionic Gonadotropin, Raising Testosterone Naturally, Clomid, Clomiphene Citrate, Online HCG Therapy, Online Men’s HCG Clinic, Alternative to Testosterone, Testosterone Alternatives, Testosterone Supplementation Online, Low-T Online, HCG Online. Human Chorionic Gonadotropin (HCG) is a novel medication that can be used in men, off label, to enhance testosterone levels while maintaining fertility. According to the American Urology Association (AUA) a total testosterone level <300ng/dL should be utilized by clinicians as the threshold for diagnosing hypogonadism ( medical term for Low-T, Testosteron deficiency or Andropause ) and for the use of testosterone replacement. In men who have a testosterone level greater than 300, but are still symptomatic with signs such as decreased energy, libido, fatigue and weight gain the use of HCG can be an effective therapy. HCG is an analogue (identical) of Luteinizing Hormone (LH). LH is the primary signaling hormone produced by the pituitary gland that tells the testicles to make more testosterone. In effect, using HCG stimulates a man’s body to naturally up-regulate testosterone production. The benefit of HCG therapy are improving testosterone levels without using exogenous testosterone injections, less adverse events related to erythrocytosis and an application of therapy that is more comfortable than an intramuscular injection of testosterone cypionate. HCG is also used in hypogonadal men who are currently utilizing exogenous testosterone to maintain testicular size and reproductive potential. Younger men and mature fitness and bodybuilding athletes who use supra-physiological doses of testosterone often utilize HCG to combat the adverse effects of reduced testicular size and reduction in fertility. A small study by Madhusoodanan et al. looked reviewed the clinical charts of 37 men with presented with low libido, low energy, erectile dysfunction and insomnia and had a serum testosterone level > 300ng/DL. Men were given HCG for their condition and symptoms. HCG monotherapy improved testosterone levels by as much as 263 ng/DL (42.8%). Duration of HCG therapy was approximately 29 weeks and no adverse events or effects were noted. While improvement in symptoms was not the primary outcome study of this investigation, the use of HCG to raise testosterone levels was evident. A study by Sato Y. et al. reviewed the effects of androgen replacement therapy (HCG) and once a day tadalafil dosing to improve libido and energy in men. This is otherwise known as LOVE syndrome (Loss of Vigor and Energy). 78 patients with LOVE syndrome were recruited into the study and had normal testosterone and free testosterone values. Mean male age was 57.8. Patients were given tadalafil (Cialis ®) daily and 5000IU of HCG every 2 weeks. At 8 weeks symptoms were assessed. Results found improvement in sexual symptoms, especially spontaneous morning erections. Patients who had morning erections were found to have more pronounced vigor and libido during daily activity and more self-confidence. The use combination therapy of HCG with Clomid (clomiphene citrate) has been well studied as an option to improve testosterone levels. A prospective study by Habous M. et al, Clomiphene Citrate and Human Chorionic Gonadotropins are Good Alternative Therapy for Hypogonadal Men in Restoring Serum Testosterone and Improving Patient Symptoms, looked at 324 patients with Low-T. Patients were randomized into the following four groups: 1) Testosterone undecanoate 1000mg (Nebido) 2) Clomiphene Citrate 50mg tablets daily 3) HCG 5000IU twice weekly 4) Combination therapy Clomiphene Citrate and HCG 5000IU. All patients had physical examination, BMI calculated and lab tests performed at 1 month and 3 months. Mean patient age was 43. The largest testosterone increase was in Group 1 during the initial first month of therapy and the smallest rise in testosterone was in patients enlisted in group 3. Interestingly between 1-3 months the largest rise in testosterone was revealed in Group 3 (combination therapy of Clomid and HCG). HbgA1c (a marker of diabetic and glucose control) and body mass index (BMI) decreased in all groups during therapy. This small study supports prior studies and guidelines that HCG and Clomid, in combination, can be utilized as an alternative to testosterones supplementation and be as effective as testosterone therapy alone in some cases. To learn more about HCG Click Here.

The Future of ED Therapy & A Potential Cure Keywords: Penile Shockwave Therapy, ED, Erectile Dysfunction, Gainswave ®, P-shot ®, penile shockwave therapy side effects, LISWT, Psychogenic ED, Neurogenic ED, Vasculogenic ED , Iatrogenic ED, Low Intensity Shockwave Therapy, PDE5i, penile enlargement, penile suspensory ligament, men’s health clinic, men’s online ED therapy, Viagra, Cialis, Sildenafil, Tadalafil, Future ED therapy, Erectile Dysfunction (ED) Definition Erectile dysfunction (ED) is defined as a persistent inability to attain and maintain an erection sufficient to permit satisfactory sexual performance that often lasts for more than 6 months (NIH Consensus Conference, 1993). This is the definition for ED according to the NIH. It’s important to note that even if a man can achieve an erection in private, but can still not use it for satisfactory sexual activity that is defined as ED. Many men may be able to get an erection without a partner present, but if a man cannot use the erection for sexual activity he is defined as having ED. Also, note the word “persistent” in the medical definition of ED by the NIH. A man must not be able achieve an erection rigid enough for sexual activity on several accounts (defined as long as 6 months by the NIH), not just one time, in order to have the definition of ED. The American Urologic Association (AUA) definition of ED does not define a time period (ie. 6 months in NIH ED definition) to be defined as having ED. The AUA definition of ED states: ED is defined as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance. This is the most common definition of ED used today by urologists and medical practitioners. The ability to treat a patient for ED revolves around a man’s inability to have enjoyable and satisfactory (per his account) sexual activity. The principles of ED treatment are: 1) Restoring sexual enjoyment 2) Enhancing sexual function 3) Optimizing Quality of Life for both a man and his partner 4) Improving personal relationships What are the causes of ED? Erectile Dysfunction is one of the most common conditions in men above 40 years age. Approximately 100 million men worldwide have erectile dysfunction. The most common causes of erectile dysfunction are: 1) Hypertension 2) Cardiovascular Disease 3) Dyslipidemia 4) Diabetes Mellitus 5) Lifestyle Factors (lack of exercise, poor nutrition etc.) 6) Alcohol Use 7) Obesity 8) Physical inactivity 9) Smoking 10) Low-Testosterone levels What are the Different Types of ED? While there are a variety of conditions that cause ED, each condition effects the body differently (pathophysiology). As a urologist it is important not only to define the cause of ED but also identify the underlying pathophysiology. There are several underlying mechanisms that cause ED. They are: · Psychogenic ED · Neurogenic ED · Vasculogenic ED · Iatrogenic ED · Endocrine Causes a. Low-T b. Elevated Estrogen Levels c. Elevated SHBG Psychogenic ED Psychogenic ED is a non-organic mechanism that makes it difficult to achieve an erection. Psychogenic ED is a type of performance anxiety, an adrenaline mediated response. A man can get overly nervous, anxious or frightened during sex and not perform well during sexual activity. The surge of noradrenaline (a sympathetic hormone) activates the “fight or flight” response and arousal can be lost. Think of it as trying to have an erection while running from a bear, it just will not happen because you are freighted and nervous. Medical conditions such as anxiety, depression, and stress accompany psychogenic ED. Treatment revolves around reducing performance anxiety. Neurogenic ED Neurogenic erectile dysfunction is caused by a condition that effects nerve signaling to the corpora cavernosa. This can be secondary to spinal trauma, diabetes, lumbar disc disease, brain injury, radical pelvic surgery (radical prostatectomy). Typically, sacral lesions or neurologic insults in this area of the spinal cord result in ED. Nerve injury or reduced nerve function results in reduced Nitric Oxide (NO) release available to the smooth muscle of the penis. Lack of (NO) causes reduction and loss of smooth muscle cells in the penis and increased fibrosis in the penis causing venous leak resulting in ED. Treatments revolve around penile rehab and daily PDE5 inhibitors to improve penile blood flow. Patient’s with neurogenic ED can be ultra-sensitive to oral ED meds such as Viagra or Cialis or penile injections (ie. Trimix, Bimix, Alprostadil). Lowering the dose of medication usage in this subset of patients may be necessary. Vasculogenic ED An erection is a vascular phenomenon. In order for a man to achieve an erection, blood vessels and penile corpora cavernosa muscle must dilate to accommodate increase blood flow. Vasculogenic erectile dysfunction is a direct result of arterial insufficiency and/or arterial stenosis. Medical conditions such as obesity, hypertension, high cholesterol, diabetes can cause atherosclerosis, narrowing blood vessels and causing decreased blood vessel wall elasticity. In combination, these vascular changes reduce the ability of the penis to fill with blood during arousal lending to decreased rigidity, length and ultimately ED. Endocrine Causes It is well known that androgens, primarily testosterone, play a major role in penile development, physiology and health. Men with low testosterone levels can have erectile dysfunction. Androgen receptors in the corpora cavernosa (penile tissue) play an integral role in the erectile pathway. Androgens also are key to arousal and sexual desire which are integral to the erectile response to erotic stimuli. Several clinic studies have shown that castration in animals reduces androgen and testosterone levels, decreasing intracavernosal pressures. This low-pressure profile within the penile tissue is a direct result of reduced arterial inflow and altered veno-occlusion necessary for an erection to occur. What is penile shockwave for ED? Penile shockwave therapy for erectile dysfunction, also called low intensity shockwave therapy (LISWT) is a nonpainful, noninvasive therapy that can enhance erectile response, rigidity, sensation, break up penile plaques and improve response to oral ED meds. A shockwave is defined as an abrupt change in pressure produced by an object that travels faster than the speed of sound. The use of shockwave therapy in the field of medicine was first noticed during the second world war. The first identification of the effects of shockwaves on human tissue was when underwater bombs exploded causing nearby castaway lung tissues to be damaged despite no external signs of damage on the skin. In 1971 in Germany, shockwave forces were applied to breaking up kidney’s stones and gallbladder stones. Since the 1980’s shockwave therapy has been primarily utilized in the field of urology and cardiology to treat kidney stones and revitalize ischemic cardiac tissue respectively. It has not been until recently that the effects of shockwave therapy on penile tissues, at a significantly lower power, frequency and pulse rate, have been discovered to enhance blood flow and vasculogenisis to enhance erectile dysfunction. Penile shockwave therapy today utilizes a small handheld device that delivers small pulsatile shockwaves and pressure forces to the penile tissue. The therapy is not painful, requires no downtime, no adverse events and results can be experienced in less than weeks in according to some studies. . How does Penile shockwave therapy work? There are several different theories how penile shockwave therapy enhances penile erectile function. While all theories may differ in mechanism, they all point towards improving penile blood, improving vascular growth and renewal, improving nerve function and breaking down fibrotic tissue within the penis to enhance erectile function. The most prominent hypotheses behind shockwave therapy for the treatment of ED stems in part from the therapeutic uses of shockwave waves to induce angiogenesis (new blood vessel growth). When an ultrasound wave is in contact with specific cells, the mechanical vibration of the shockwave wave on the cells, can induce cell proliferation. Initial use of LISWT in other medical fields, saw the advantages of new blood vessel growth and tissue renewal when shockwave therapy was used to heal diabetic feet and damaged/ischemic cardiac tissues (heart cells). This theory is central to the improvement in vascular flow and erectile function after shockwave therapy has been applied. Several studies have observed increased smooth muscle cells and new vascular growth in corpora cavernosum tissue after shockwave therapy. A hypothesis by other clinical studies, focuses on improving neurogenic components of ED. Shockwave therapy has the potential to activate dormant Schwann cells (nerve cells) within the dorsal nerve of the penis, activation of endothelial cells and improve nitric oxide release to enhance vasodilation during erotic stimuli. For the treatment of Peyronies disease, a condition in which a fibrotic scar develops within the penis, causing ED, penile curvature, and pain with erection penile shockwave therapy has been utilized as nonstandard and investigational option. In this instance, shockwave therapy when applied to penile plaque may soften the plaque to assist in straightening the phallus and may cause an inflammatory reaction that can breakdown the plaque. Penile shockwave therapy has been studied extensively since 2010. Penile shockwave therapy for ED has been a European Urologic Association potential first line treatment for ED since 2013. LISWT is the only therapy available today that improves erectile function by potential treating the underlying physiology and may provide a cure for ED. Does penile shockwave therapy really work? Several clinical trials and studies have shown that penile shockwave therapy can work to improve erectile function. 60% men appear to achieve successful results from therapy as measured by IIEF scores with improved erectile response lasting up to and beyond 12 months. To date, there have been 11 randomized controlled studies investigating the effects of penile shockwave therapy on erectile function. Results are promising and under the right patient conditions, penile shockwave therapy can assist and improve erectile functional, blood flow, reduce penile pain and increase penile sensation. Penile Shockwave Therapy in men with ED non-responsive to oral ED Meds There have been several studies that investigated that use of penile shockwave therapy to improve a man’s response to ED meds such as Viagra or Cialis. Studies are encouraging and suggest that shockwave therapy could play a new role in the ED algorithm to enhance response to standard guideline therapies. Some studies have reported a 40% improvement in erectile functional in men utilizing Li-ESWT while on oral ED medication. What is GainsWave ® ? Gainswave ® as reported by the Urology Times is a “marketing organization that educates consumers and raises public awareness of low intensity shock wave therapy for erectile dysfunction”. Can penile shockwave therapy increase my penis length and size? Penile shockwave therapy at this time has not documented any increase in penile length. Some men who undergo penile shockwave therapy may report an increase penile size. This may be too due to an increase in blood flow with an erect phallus and not a true increase in size. Currently the treatment for improving penile length is penile extenders or incising the penile suspensory ligament. The penile suspensory ligament maintains an erection pointing up. Cutting this ligament does allow the penis to protrude more from the body but can also cause injury and possible penile anesthesia (numbness). Penile injectables and fillers have been used to increase penile girth but have complication rates and are not advised. Is penile shockwave therapy safe? According to several well published studies and clinicians there have been no reported negative impacts of penile shockwave therapy for the treatment of erectile dysfunction. Therapy is safe and can be effective in the right population of men who suffer from ED. How long does each therapy cycle? Each cycle of penile shockwave therapy is approximately 20-30 minutes in duration. After a numbing cream is applied to the phallus and allowed to sit for approximately 5 minutes, therapy is started. There is not standardized protocol for penile shockwave therapy. Providers currently use study protocols often consisting of 1-2 sessions per week.1500- 5000 shockwaves are applied to the corpora cavernosa and crus of the penis. Therapy can be delivered in a variety of ways depending on the shockwave machine utilized from a handheld device or fixed emitter. Who is a good candidate for penile shockwave therapy? At this time there are no guideline statements to identify the ideal patient for penile shockwave therapy. The American Urologic Association (AUA) in 2018 advised that therapy is still investigational. All patients who undergo penile shockwave therapy should know that this modality of therapy is not FDA approved and results, treatment protocols and side effects are not fully understood. However, penile shockwave results have been astounding and a novel therapy option for men with ED. Currently penile shockwave therapy is being and is best utilized for men in the following clinical situations: 1) Men with mild to moderate neurogenic or vasculogenic ED 2) Men who do not desire to be on Viagra or Cialis 3) Men who fail to achieve an erection on Viagra or Cialis 4) Men who desire to improve their erectile response, erectile size and rigidity while use oral ED meds 5) Men who have failed to respond to ED meds and do not desire penile injection therapy or MUSE ®. Penile shockwave therapy for Peyronies disease? Peyronies disease is a condition in which a penile plaque (fibrotic scar) develops within the penis and causes restriction of blood to the penis the impedes erectile function, may often cause pain and curvature of erection preventing intercourse. Shockwave therapy for Peyronies disease is still investigation but several well documented and published studies have seen excellent results with therapy to improve penile pain. Is penile shockwave therapy for erectile dysfunction FDA approved? Currently no penile shockwave therapy device is FDA approved. All patients who undergo low intensity penile shockwave therapy should be advised that therapy is investigational. How does long does shockwave therapy results last? The verdict is still pending, but consensus by many studies and patients is up to one year. Results are also dependent on the underlying cause of ED and patient health and comorbidities. Patients with mild to moderate ED and less medical conditions tend to have better and lasting results. What are the side effects of penile shockwave therapy for ED? According to statements made by the European Society of Sexual Medicine low intensity shockwave therapy for the treatment of erectile dysfunction is very well tolerated and is without clinically significant adverse side effects. When can I have sex after penile shockwave therapy for ED? Men can return to having normal sexual activity as soon as possible and during treatment. How much does shockwave therapy cost for ED? Penile Shockwave Therapy for ED can cost as much as 1000$-3000$ on average depending on the clinic and device used. While may clinics do offer this novel ED therapy, its use is still investigational. How long does penile shockwave therapy for ED take to perform? Therapy can take approximately 15-30 min. Patients often undergo 1-2 treatments per week for approx. 6-8 weeks. Although no therapy shockwave therapy protocol has been published or standardized this often a general rule. Will shockwave therapy improve my erectile response to ED meds? Approximately 40-50% of men do not respond to oral ED medications depending on the etiology of erectile dysfunction. Penile low intensity shockwave therapy (LISWT) can and has been utilized to enhance the response to oral ED meds in clinical studies (phosphodiesterase inhibitors- PDE5i). Can I have penile shockwave therapy for ED while on a blood thinner (anticoagulant)? Penile shockwave therapy is well tolerated and considered safe for patients on anti-coagulants. A study published in the journal of sexual medicine reviewed the treatment side effects of men undergoing low intensity shockwave therapy for vasculogenic ED. These men were also on anticoagulant therapy during the ED treatment. There were no reported adverse events and no patients reported any bleeding or bruising secondary to shockwave therapy while on antiplatelet medication. For more information about penile shockwave therapy and to find a trusted clinic that offers this novel ED therapy, speak with a REGENX Health provider today. Click Here.