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Category : Low T

Getting Testosterone Down To The ‘T’ – Qrius

We place unreasonable trust in biological explanations of male behaviour. Nowhere is this truer than with testosterone. Contemporary pundits invoke the hormone nicknamed T to prove points about maleness and masculinity, to show how different men and women are, and to explain why some men (presumably those with more T) have greater libidos. Yet, despite the mythic properties popularly associated with T, in every rigorous scientific study to date there is no significant correlation in healthy men between levels of T and sexual desire.

Beginning in the 1990s and really picking up steam in the 2000s, sales of testosterone replacement therapies (TRTs) went from practically zero to over $5 billion annually in 2018. This was either because there was a sudden outbreak of Low T when a major medical epidemic was finally recognised, or because T became marketed as a wonder drug for men thrown into a panic when they learned that their T levels declined 1 per cent annually after they hit 30.

The answer is not that mens bodies changed or that Low T was horribly underdiagnosed before but that, in the minds of many, T became nothing short of a magic male molecule that could cure men of declining energy and sexual desire as they aged.

Whats more, many have been taught that, if you want to know what causes some men to be aggressive, you just test their T levels, right? Actually, wrong: the science doesnt support this conclusion either. Some of the famous early studies linking T and aggression were conducted on prison populations and were used effectively to prove that higher levels of T were found in some men (read: darker-skinned men), which explained why they were more violent, which explained why they had to be imprisoned in disproportionate numbers. The methodological flaws in these studies took decades to unravel, and new rigorous research showing little relation between T and aggression (except at very high or very low levels) is just now reaching the general public.

Whats more, it turns out that T is not just one thing (a sex hormone) with one purpose (male reproduction). T is also essential in the development of embryos, muscles, female as well as male brains, and red blood cells. Depending on a range of biological, environmental and social factors, its influence is varied or negligible.

Robert Sapolsky, a neuroscientist at Stanford University in California, compiled a table showing that there were only 24 scientific articles on T and aggression 1970-80, but there were more than 1,000 in the decade of the 2010s. New discoveries about aggression and T? No, actually, although there were new findings in this period showing the importance of T in promoting ovulation. There is also a difference between correlation and cause (T levels and aggression, for example, provide a classic chicken-egg challenge). As leading experts on hormones have shown us for years, for the vast majority of men, its impossible to predict who will be aggressive based on their T level, just as if you find an aggressive man (or woman, for that matter), you cant predict their T level.

Testosterone is a molecule that was mislabelled almost 100 years ago as a sex hormone, because (some things never change) scientists were looking for definitive biological differences between men and women, and T was supposed to unlock the mysteries of innate masculinity. T is important for mens brains, biceps and that other word for testicles, and it is essential to female bodies. And, for the record, (T level) size doesnt necessarily mean anything: sometimes, the mere presence of T is more important than the quantity of the hormone. Sort of like starting a car, you just need fuel, whether its two gallons or 200. T doesnt always create differences between men and women, or between men. To top it all off, there is even evidence that men who report changes after taking T supplements are just as likely reporting placebo effects as anything else.

Still, we continue to imbue T with supernatural powers. In 2018, a US Supreme Court seat hung in the balance. The issues at the confirmation hearings came to focus on male sexual violence against women. Thorough description and analysis were needed. Writers pro and con casually dropped in the T-word to describe, denounce or defend the past behaviour of Justice Brett Kavanaugh: one commentator in Forbes wrote about testosterone-induced gang rapes; another, interviewed on CNN, asked: But were talking about a 17-year-old boy in high school with testosterone running high. Tell me, what boy hasnt done this in high school?; and a third, in a column in The New York Times, wrote: Thats him riding a wave of testosterone and booze

And it is unlikely that many readers questioned the hormonal logic of Christine Lagarde, then chair of the International Monetary Fund, when she asserted that the economic collapse in 2008 was due in part to too many males in charge of the financial sector: I honestly think that there should never be too much testosterone in one room.

You can find T employed as a biomarker to explain (and sometimes excuse) male behaviour in articles and speeches every day. Poetic licence, one might say. Just a punchy way to talk about leaving males in charge. Yet when we raise T as significant in any way to explain male behaviour, we can inadvertently excuse male behaviour as somehow beyond the ability of actual men to control. Casual appeals to biological masculinity imply that patriarchal relationships are rooted in nature.

When we normalise the idea that T runs through all high-school boys, and that this explains why rape occurs, we have crossed from euphemism to offering men impunity to sexually assault women by offering them the defence not guilty, by reason of hormones.

Invoking mens biology to explain their behaviour too often ends up absolving their actions. When we bandy about terms such as T or Y chromosomes, it helps to spread the idea that men are controlled by their bodies. Thinking that hormones and genes can explain why boys will be boys lets men off the hook for all manner of sins. If you believe that T says something meaningful about how men act and think, youre fooling yourself. Men behave the way they do because culture allows it, not because biology requires it.

No one could seriously argue that biology is solely responsible for determining what it means to be a man. But words such as testosterone and Y chromosomes slip into our descriptions of mens activities, as if they explain more than they actually do. T doesnt govern mens aggression and sexuality. And its a shame we dont hear as much about the research showing that higher levels of T in men just as easily correlate with generosity as with aggression. But generosity is less a stereotypically male virtue, and this would spoil the story about mens inherent aggressiveness, especially manly mens aggressiveness. And this has a profound impact on what men and women think about mens natural inclinations.

We need to keep talking about toxic masculinity and the patriarchy. Theyre real and theyre pernicious. And we also need new ways of talking about men, maleness and masculinity that get us out of the trap of thinking that mens biology is their destiny. As it turns out, when we sift through the placebo effects and biobabble, T is not a magic male molecule at all but rather as the researchers Rebecca Jordan-Young and Katrina Karkazis argue in their book Testosterone (2019) a social molecule.

Regardless of what you call it, testosterone is too often used as an excuse for letting men off the hook and justifying male privilege.

Matthew Gutmann

This article was originally published at Aeon and has been republished under Creative Commons.

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Getting Testosterone Down To The 'T' - Qrius

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Indiana Regenerative Medicine Institute Offers Innovative Approaches in Regenerative Medicine, Hormone Replacement and Pain Management – Carmel…

February 2020

Are you looking for a health care provider who offers innovative alternatives and a customized approach to your health issues? Indiana Regenerative Medicine Institute (IRMI) believes in offering specialized alternatives to health care. Its medical team, headed by Doctor of Chiropractic Preston Peachee, utilizes the latest developments in regenerative medicine, hormone replacement and pain management.

Dr. Peachee is a native of Jasper, Indiana. He graduatedfrom Logan College of Chiropractic and has been in practice since 2003. Hisareas of specialty include patients with chronic and severe back, neck andjoint pain as well as other complex neurological conditions.

Dr. Peachee has earned a reputation as an innovative thinkeras well as a compassionate practitioner who brings his wide expertise andexperience to the Greater Indianapolis area. His ability to help those in needof regenerative medicine, neuropathy pain relief, low testosterone or otherphysical ailments, such as back pain or fibromyalgia, makes him not only uniquebut highly sought-after.

A key member of the IRMI team is Leann Emery, FNP. Emery isa family nurse practitioner with more than 20 years of experience in hormonereplacement and alternative pain management. Emery provides optimal patientcare through personal consultations and assessments to identify her patientsspecific health needs. She was rated in the top 10% of providers in the U.S.with patient satisfaction.

Regenerative medicine is making huge leaps in our understanding of the human body, and it is offering real, possible treatments that would have seemed like science fiction a few short years ago, according to IRMI. Most patients we see have tried other more traditional treatments and have either not gotten any better or have gotten even worse. Unfortunately, a lot of people we see depend on multiple medications per day to try and function but still are not happy with how they feel or how they live their lives. It is unfortunately the nature of deteriorating and degenerative joints, they will get worse with time, and generally the pain increases as well.

Depending on the injury, Dr. Peachee will often combinelaser therapy with the regenerative medicine protocols to improve the outcomesand try and speed the recovery process.

We offer mesenchymal stem cell therapy, Dr. Peachee said. With the combination of laser therapy, mesenchymal stem cell therapy is incredibly effective for rotator cuff problems and treating knee pain. Eighty percent of our stem patients are dealing with knee pain or Osteoarthritis. Osteoarthritis-or O.A. of the knee- is a huge problem for a lot of people, and we get great results from these therapies. Most people can even avoidknee surgery.

Dr. Peachee recently introduced hormone treatments for low testosterone. Family Nurse Practitioner Leann Emery has been doing [hormone] treatments for 20 years, and that area of medicine became a natural fit for IRMI.

I have several patients who were seeking this type ofcaremany who are police officers and firefighterswho couldnt find thetherapy and individualized care and attention that they needed.

Dr. Peachee explained that low T treatments help patients with unique and even complicated cases of Erectile Dysfunction (E.D.). Most people seek us out for treatment because they are tired, worn out, stressed out and just simply lack the energy they used to have.

We are able to fill a niche with patients who hadcomplicated cases that were not responding well with their primary careproviders or other places, Dr. Peachee shared. We have a patient who hasstruggled for a long time with fertility issues but has done very well [withtreatments], and we just got good news that he and his wife are expecting aftertrying for a really long time. So, he is really enthused about that.

The typical candidates for low T treatments, according toDr. Peachee, are men who feel worn out, are lethargic and have lost theirzest for life.

Our patients dont have the same pep that they had 10 or20 years ago, Dr. Peachee stated. They struggle getting up in the morning andmight be struggling in the afternoon after having six cups of coffee or threeRed Bulls just to get through the day. We have a lot of people that want to getback into the gym and get the maximum benefit of their workouts. We can helpthem improve their overall health and energy so that they can enjoyrecreational activities like working out or practice with the Little Leaguewith their kids. Many times we hear from spouses, friends and family how muchbetter they feel and that they seem happier and get more out of life again.

It goes without saying that proper hormonal balance canimprove a patients personal relationships as well and improve the overallmental health of a patient by reducing stress, anxiety and depression oftencaused by symptoms related to low testosterone levels.

We focus on injectable [low T] treatments because we canmodify the dosage and give more frequent doses to keep our patients at a levelthats going to give them the maximum benefit and improvement for theirconditions, Dr. Peachee explained.

With the modern changes in medicine over the last 20 and 50years, were helping people to live a lot longer and adding 20 to 30 years totheir lives, but we have not given them an improved quality of life as theyage. By working with their hormones and getting them in balance, their qualityof life becomes way better, and were seeing a positive improvement for manypeople with these treatments.

Patients suffering from severe disc injuries, such a bulgingor herniated disc or discs, or who suffer from degenerative disc disease mayhave undergone treatment from chiropractors or have seen physical therapistsbefore coming to Indiana Regenerative Medicine Institute.

Our typical patient who comes in for this type of treatmenthas seen other therapists or chiropractors but hasnt found lasting relief,Dr. Peachee said. Many of our patients want to get off the rollercoaster ofopioids and pain medications. They are looking for a solution without narcoticsand risk of addiction or other possible negative side effects of narcoticsand/or surgery. We are generally able to alleviate the pain in 90% of patientsand are able to keep them from having surgery or from taking addictivemedications.

Laser therapy allows Dr. Peachee to work on the damaged tissue so that it can heal, and the method reduces inflammation and swelling in a way that traditional treatments cannot.

Its an innovative new therapy within the last decade thatallows us to do some amazing things, Dr. Peachee stated. We perform ourprocedures in our office and have several different devices for the specificneeds and issues of our patients. For instance, we have a unique device forpeople with knee pain that can help the majority of our patients walk betterand live more pain-free. We get a phenomenal outcome with this procedure.

One of the other major differentiators that sets IndianaRegenerative Medicine Institute apart from other offices and clinics is thatthey are advocates for their patients, especially when it comes to dealing withtheir patients insurance providers.

A lot of our low T patients are able to get their insurancecarriers to cover the services so that it doesnt cost them as much out ofpocket for the care they seek, Dr. Peachee said. Weve partnered with abilling company that has helped us to be able to navigate the craziness of ourmodern insurance companies, and by doing so, were able to keep the cost downfor a lot of patients. Not every insurance plan will cover this type of care,but a lot of them will. When its possible and ethical, we do whatever we canto benefit our patients to help keep the cost low. I have spent a lot of freetime writing letters on behalf of our patients. We go above and beyond with ourservice and care of our patients.

The Indiana Regenerative Medicine Institute team will make housecalls or come to a patients place of work when the situation calls for thatlevel of care.

We will go and draw blood for blood work, bring medications and even do exams in some situations, Dr. Peachee said. As I mentioned before, we see a lot of police officers and firemen all over the statefrom Mishawaka to South Bend and all over Indiana. We go once a month to see these patients at their departments and stations so that we see them all in one day versus making 10 to 15 guys drive hours to come in to see us. Its a service we can offer because we are a small clinic and we are focused on that one-on-one patient attention and relationship building. We have great relationships with our patients, and thats something that we work very hard at.

Building trust and transparency is crucial to the success ofhis practice, Dr. Peachee emphasized. The trust that we build with ourpatients is crucial to not only the success of the practice but to thepatients outcomes. And not just with hormone therapy but also with ournonsurgical spinal decompression patients. These are patients with significant discinjuries, and we need them to tell us everything we need to know so we can givemore accurate and complete care for a better outcome.

I would say to anybody if you have any doubts or reservations to take some of the burden and some of the anxiety out of the equation and schedule an initial consultationabsolutely free of charge, Dr. Peachee encouraged.

Dont put off living your best life any longer. Visit Indiana Regenerative Medicine Institutes website at indianaregen.com or call (317) 653-4503 for more information about its services and specialized treatments and schedule your free consultationtoday!

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Indiana Regenerative Medicine Institute Offers Innovative Approaches in Regenerative Medicine, Hormone Replacement and Pain Management - Carmel...

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Low Testosterone – Symptoms & Treatment | Everyday Health

Low testosterone levels, or "low T," can affect men and women alike.

Testosterone, the primary sex hormone in men, is produced mainly in the testicles, and causes men to develop a deep voice, large muscles, and body hair.

Testosterone is also essential for the production of sperm.

When levels of testosterone fall known as low testosterone or "low T" it can have a profound effect on men, both physically and psychologically.

Normal levels of testosterone in healthy men range from about 300 nanograms per deciliter (ng/dL) up to 1,000 ng/dL, according to Medline Plus.

The normal range is broad and varies by age. In older men, the lower end of "normal" may be lower than in younger men.

Levels of testosterone in the male body rise during and after puberty, then gradually decrease after age 30.

This gradual lowering of testosterone is sometimes referred to as andropause or male menopause.

Testosterone levels may also be lower in men with hypogonadism, a condition in which the body is unable to produce normal amounts of testosterone.

Hypogonadism can occur because of a problem with the testicles or with the pituitary gland, which controls the testicles.

Obesity, having medical conditions such as autoimmune diseases or type 2 diabetes, or using drugs including alcohol or opioids, can also contribute to low levels of testosterone.

Women also produce testosterone, although much less than men: A normal testosterone level in women is 15 to 70 ng/dL according to Medline Plus.

In women, testosterone is produced in the ovaries and the adrenal glands.

Similar to men, low T in women can be caused by a variety of medical conditions as well as by advancing age.

In the years leading up to menopause, women normally experience a drop in testosterone levels.

Low levels in women may be associated with decreased libido, low energy, and depressed mood.

There is some evidence that testosterone replacement therapy can increase sex drive and help with other sexual problems in some women.

But the long-term safety of this treatment is unknown, and some experts say it may raise the risk of breast cancer, though there has yet to be conclusive evidence.

Currently, testosterone preparations are not approved for use in women by the Food and Drug Administration (FDA).

Male hypogonadism may be present from birth or may develop later in life as a consequence of injury or infection.

In infants, symptoms of hypogonadism include:

In boys around the age of puberty, symptoms include:

In men, symptoms of hypogonadism include:

As the level of testosterone in the body decreases with age, men may also experience:

However, these symptoms are nonspecific, meaning they can be caused by many factors, not just low testosterone.

Male hypogonadism is diagnosed based on symptoms, blood tests of testosterone level, and other lab tests, as needed.

It's typicallytreated with testosterone replacement therapy and other therapies, depending on what's causing low T.

In men who are obese, or who have an underlying medical condition such as diabetes that can contribute to low T, losing weight or managing the underlying condition often causes testosterone levels to normalize.

In recent years, many advertising dollars have been spent on promoting testosterone replacement therapy to middle-aged men experiencing such symptoms as fatigue and low libido.

Whether treating such men with testosterone is safe or appropriate, however, is a matter of some controversy. Some doctors are strongly in favor of it, while others are much more cautious.

Learn More About Low Testosterone Causes

Learn More About Low Testosterone Symptoms

Learn More About Low Testosterone Treatment

Learn More About Low Testosterone In Women

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Low Testosterone - Symptoms & Treatment | Everyday Health

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Lost revenue from low T fares must be recouped – Boston Herald

For those questioning how free for all policies espoused by progressive leaders on and off the presidential campaign trail would work in the real world, look no further than our own MBTA.

As the Boston Herald reported, the Ts Fiscal and Management Control Board met in December, and among the items on its agenda (besides the transit agencys expanding budget deficit) was discussion of means-tested fares, as in discounts for low-income riders.

We cant keep talking about this for years and years, board Vice Chairwoman Monica Tibbits-Nutt said. The community has been patient.

For those struggling to get by, T fares can take a big chunk out of the day-to-day budget, and the call for relief is understandable.

The Ts been studying the logistics, and this week revealed that an income-based MBTA fares option could boost ridership substantially. The bad news: It would cost the agency tens of millions of dollars in revenue.

Much depends on who would qualify for the lower fares, depending on where the income threshold would be set. Letting those who earn twice the federal poverty level ($26,200 for a family of four) qualify would bring in roughly 50,000 to 90,000 new commuters to the bus and subway every year, MBTA Deputy Director of Policy and Strategic Planning Lynsey Heffernan told the FMCB.

And those riders would cause the T to forgo between $23.3 million and $42.3 million in revenue each year.

The MBTA is spending on a lot of things, such as increased inspections and quality-control measures, in the wake of last years devastating report by a safety review panel. At the December meeting, the T said its budget was likely to run a $42.2 million deficit. Thats with riders paying their regular fares.

Gov. Charlie Bakers $18 billion transportation bond bill, meanwhile, has moved before the House Ways and Means Committee. Among the features: money for MBTA improvements, regional transit authority electrification and additional funding for the South Coast Rail and Green Line Extension projects, already underway.

The MBTA needs to make safety improvements, finish rail and subway projects and advance transportation options for Bay Staters outside of the Greater Boston area. That takes money, and Baker has put together a plan for borrowing it.

The House is rolling out its own transportation plan, one that may include a gas tax.

Inevitably, the proposal to institute an income-based MBTA fare system and lose revenue collides with efforts to borrow or raise revenue to maintain and bolster safety and advance capital improvements.

Which brings us to a key flaw in so many free for all proposals: There are many needs to be met, all of them come with costs, and revenue is not in inexhaustible supply.

Does one halt plans for regional transit authorities to pay for low-income fares in Greater Boston? Or put new buses and trains on hold, despite the rise in ridership such a fare program would initiate?And as many of the capital improvements are under the aegis of helping the environment by getting public transportation to more people, does one dial back the green agenda to assist low-income residents?

Or will someone hit the default switch and call for a tax hike to cover the tab? It takes little imagination to envision the reaction to that.

In the real world, even reducing costs can come at a high price, and when resources have to stretch to cover many needs, triage is a crucial part of the decision-making process.

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Low T Therapy Market 2020-2027 Worldwide Analysis and Prediction by Leading Players: AbbVie, Endo International, Eli Lilly, Pfizer – News Parents

Low T Therapy Market: Evaluation, Epidemiology & Market Forecast 2027

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A snapshot on the marketed and pipeline emerging drugs, along with comprehensive insight on emerging treatments based on their safety & efficacy results, mechanism of action, route of administration, therapeutic potential, regulatory success, launch dates, and other factors. This section also covers latest news which includes agreements and collaborations, approvals, patent details and other major breakthroughs.

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Market forecast specifically base on Y- o -Y growth rate. Data projection and future performance of each segment is scrutinize based on key aspects produced from primary and secondary research result. Thus, data projection exhibits the assumption on how the market performs under microeconomic and macroeconomic parameters. Our market forecasting technique represents strategic conclusions which can play a crucial role for our clients in making strategic marketing plans.

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This segment provides the country-specific information, along with historical and current patient pool and forecasts for prevalent/ incident cases, as well as diagnosed and treatable patient particulars.

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This segment of the report focuses on Important Key Questions: What is the size of the total & addressable market for Low T Therapy? This question will help and give you answers whether the market is big enough to be interested in your business. Admissible and detailed patient sagmentations provided for each and every Indication, enabling to evaluate the commercial potential of the market.

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Key Leaders in Low T Therapy industry, developing new products to meet the unique needs according to demands, technology and market trends. Such innovations ranging from new product designs, utilization of novel materials that could ameliorate existent fallibility. Such activities will support the strong development of this industry, augmenting the market growth.

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Research methodology is succeeded by combining special industry knowledge and in-country research encounters. We employ data interrogation methodologies to generate new and meaningful analyses and insights. The research method uses extencive use of secondary sources, paid database platforms to pinpoint and collect needed information, that is very useful to gain knowledge on technical, commercial and market-oriented aspects.

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Aytu BioScience to Report Fiscal Q2 FY 2020 Results and Business Update – Yahoo Finance

ENGLEWOOD, CO / ACCESSWIRE / February 6, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, today announced that the company will present its operational results for the quarter ended December 31, 2019 on February 13, 2020, at 4:30 p.m. ET. The company will review accomplishments from the quarter and provide an overview of its business and growth strategy.

Conference Call Information

1- 844-602-0380 (toll-free)

1- 862-298-0970 (international)

The webcast will be accessible live and archived on Aytu BioScience's website, within the Investors section under Events & Presentations, at aytubio.com, for 90 days.

A replay of the call will be available for fourteen days. Access the replay by calling 1-877-481-4010 (toll-free) and using the replay access code 57940.

About Aytu BioScience, Inc.

Aytu BioScience is a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the effects of the business combination of Aytu and the Commercial Portfolio and the previously announced, but not yet consummated, merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, the failure to obtain the required votes of Innovus' shareholders or Aytu's shareholders to approve the Merger and related matters, the risk that a condition to closing of the Merger may not be satisfied, that either party may terminate the merger agreement or that the closing of the Merger might be delayed or not occur at all, the price per share utilized in the formula for the initial $8 million merger consideration in the Merger may not be reflective of the current market price of Aytu's common stock on the closing date, potential adverse reactions or changes to business or employee relationships, including those resulting from the announcement or completion of the Merger, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

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The Signs a Testosterone Booster is Needed – Science Times

Staff ReporterJan 22, 2020 07:57 PM EST

As people age, their bodies start to change. This includes issues related to hormones. One of the most common hormonal issues that men face has to do with low testosterone, also called low T. As a common male health issue, there are many people who would like help addressing this issue. For those who would like to learn more, read more about testo boosters and some of the signs of low T.

One of the most common signs that someone has low levels of testosterone is sexual dysfunction. Testosterone is the main male sex hormone and controls factors such as libido and the ability to both achieve and sustain an erection that is suitable for intercourse. When someone has low levels of testosterone, they are going to notice issues with their reproductive system. Men will notice that they just don't "feel" like having sex. Their libido has dropped due to a lack of testosterone. They will also notice that they don't have spontaneous erections like they used to. This can be incredibly frustrating and can lead to serious mental health issues. Therefore, the issues of low testosterone need to be addressed.

Next, men with low testosterone are going to notice that they don't have as much lean muscle mass as they used to. Testosterone plays a key role in someone's ability to put on lean muscle by working out. Even though someone puts in the hours at the gym and eats a healthy, well-balanced diet, they just can't seem to put on the same amount of lean muscle they used to. One of the possible reasons why is that someone has low testosterone. Testosterone is required for the body to respond to the stimulus produced by working out regularly. Without testosterone, lean muscle is not going to stick.

In addition, another common sign of low testosterone is hair loss. Testosterone is responsible for keeping hair follicles healthy and full. If someone has low levels of testosterone, people may notice bald spots starting to appear on the scalp. Hair may also fall out when someone uses a comb or brush. Finally, men may also notice more hair on the floor of the shower. Addressing low testosterone can help someone prevent hair loss.

Finally, one of the most important signs of low testosterone is reduced bone mass. Bones are made up of a calcium network that gives bones their strength and durability. Without testosterone, the bones are going to start to weaken. While this might lead to pain and discomfort, it may also cause someone to be more susceptible to bone fractures. This presents a serious health complication that might land someone in the hospital. In order to avoid this, those who have low testosterone need to make sure this problem is treated.

Anyone who thinks they might have low testosterone should know that there are treatment options available. This comes in the form of testosterone boosters. This is a great way for someone to restore their testosterone levels back to normal. Then, they can enjoy life just as they did during their younger years.

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The Signs a Testosterone Booster is Needed - Science Times

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New Guideline for Testosterone Treatment in Men With ‘Low T’ – Medscape

The American College of Physicians (ACP) has released new clinical guidelines providing practical recommendations for testosterone therapy in adult men with age-related low testosterone.

The evidence-based recommendations target all clinicians and werepublished online January 6 in Annals of Internal Medicine, highlighting data from a systematic review of evidence on the efficacy and safety of testosterone treatment in adult men with age-related low testosterone.

Serum testosterone levels drop as men age, starting in their mid-30s, and approximately 20% of American men older than 60 years have low testosterone.

However, no widely accepted testosterone threshold level exists that represents a measure below which symptoms of androgen deficiency and adverse health outcomes occur.

In addition, the role of testosterone therapy in managing this patient population is controversial.

"The purpose of this American College of Physicians (ACP) guideline is to present recommendations based on the best available evidence on the benefits, harms, and costs of testosterone treatment in adult men with age-related low testosterone," write Amir Qaseem, MD, PhD, MHA, from the American College of Physicians, Philadelphia, Pennsylvania, and colleagues.

"This guideline does not address screening or diagnosis of hypogonadism or monitoring of testosterone levels," the authors note.

In particular, the recommendations suggest that clinicians should initiate testosterone treatment in these patients only to help them improve their sexual function.

According to the authors, moderate-certainty evidence from seven trials involving testosterone treatment in adult men with age-related low testosterone showed a small improvement in global sexual function, whereas low-certainty evidence from seven trials showed a small improvement in erectile function.

By contrast, the guideline emphasizes that clinicians should avoid prescribing testosterone treatment for any other concern in this population. Available evidence demonstrates little to no improvement in physical function, depressive symptoms, energy and vitality, or cognition among these men after receiving testosterone treatment, the authors stress.

ACP recommends that clinicians should reassess men's symptoms within 12 months of testosterone treatment initiation, with regular re-evaluations during subsequent follow up. Clinicians should discontinue treatment in men if sexual function fails to improve.

The guideline also recommends using intramuscular formulations of testosterone treatment for this patient population instead of transdermal ones, because intramuscular formulations cost less and have similar clinical effectiveness and harms.

"The annual cost in 2016 per beneficiary for TRT [testosterone replacement therapy] was $2135.32 for the transdermal and $156.24 for the intramuscular formulation, according to paid pharmaceutical claims provided in the 2016 Medicare Part D Drug Claims data," the authors write.

In an accompanying editorial, E. Victor Adlin, MD, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, notes that these new ACP guidelines mostly mirror those recently proposed by both the Endocrine Society and the American Urological Association.

However, he predicts that many clinicians will question the ACP's recommendation to favor use of intramuscular over transdermal formulations of testosterone.

Although Adlin acknowledges the lower cost of intramuscular preparations as a major consideration, he explains that "the need for an intramuscular injection every 1 to 4 weeks is a potential barrier to adherence, and some patients require visits to a health care facility for the injections, which may add to the expense."

Fluctuating blood testosterone levels after each injection may also result in irregular symptom relief and difficulty achieving the desired blood level, he adds. "Individual preference may vary widely in the choice of testosterone therapy."

Overall, Adlin stresses that a patientclinician discussion should serve as the foundation for starting testosterone therapy in men with age-related low testosterone, with the patient playing a central role in treatment decision making.

This guideline was developed with financial support from the American College of Physicians' operating budget. Study author Carrie Horwitch reports serving as a fiduciary officer for the Washington State Medical Association. Jennifer S. Lin, a member of the ACP Clinical Guidelines Committee, reports being an employee of Kaiser Permanente. Robert McLean, another member of the committee, reports being an employee of Northeast Medical Group. The remaining authors and the editorialist have disclosed no relevant financial relationships.

Ann Intern Med. Published online January 6, 2020. Full text, Editorial

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New Guideline for Testosterone Treatment in Men With 'Low T' - Medscape

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Expert Insights on Osteoporosis From the ACR/ARP 2019 Annual Meeting – Rheumatology Advisor

The Great Debate at the 2019 ACR/ARP Annual Meeting addressed the issue of whether anabolic therapies are appropriate as first-line treatment for glucocorticoid-induced osteoporosis (GIO). The risk is usually defined based on previous fracture history, low T-score, and the presence of multiple risk factors for fracture including smoking, alcohol, or low body weight. Kenneth Saag, MD, presented the pro side while Mary Beth Humphrey, MD, PhD, presented the con side of using anabolic agents for GIO.

Audience members were surveyed on their opinion, with 60% of participants indicating their preference for using anabolic agents including teriparatide as first-line therapy for GIO. It was interesting to see this audience response, as certainly those advocating the use of teriparatide won. I was actually surprised the margin wasnt even greater for the pro side, because clearly anabolic drugs are superior to any antiresorptive agents for fracture protection in high-risk patients, with better bone efficacy data.

The main problem is that there have been no head-to-head trials conducted with fracture reduction as a primary end point for GIO. Several trials have shown bone mineral density (BMD) differences between drugs. Dr Saag noted in his presentation that research has found statistically significantly fewer fractures in patients taking teriparatide, but again, the fracture rate was not indicated as a primary end point in the design of the clinical trial. There also may never be a head-to-head trial for various drugs in GIO, the main reason being obviously the cost of conducting such trials.

Dr Humphrey indicated that patient preference, satisfaction, and adherence should also be taken into account when debating whether anabolic agents should be given to a patient at high risk for GIO, suggesting that some patients will not elect to receive medication delivered by injection. In general, patients dont want an injection when they can be prescribed a pill. From my point of view, the conversation should then shift to which is the best and most effective drug given your risk factors. From there we usually can come to a consensus that may include an anabolic agent. As for medication adherence, a patient who has a history of vertebral fracture and back pain may be more likely to be adherent than someone who is asymptomatic.

What I have found to be the larger issue, not only for payers but also patients, is the cost of the anabolic agents, especially for patients with Medicare who are dealing with the donut hole: those who are unable to use copay cards available to other patients with commercial insurance.

From a pathophysiologic perspective, I like to refer back to studies referenced in the past that point to the foundational effect of an anabolic. Researchers studied the effects of alendronate vs romosozumab in postmenopausal women with osteoporosis in the ARCH trial (Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis, ClinicalTrials.gov Identifier: NCT01631214). This trial found that patients who were treated with romosozumab for 1 year followed by alendronate had a significantly lower risk of fracture compared with patients treated with alendronate alone. The fracture rate in people who had taken romosozumab in the first year was significantly less because of the foundational effect of the drug. The process consists of laying down new bone and then consolidating that new bone formation. That is what we have always had to consider, and this speaks to Dr Humphreys point that you do need to continue on an oral bisphosphonate after romosozumab to consolidate the bone after treatment with an anabolic. I like to tell my patients that this process of building bone is like a spring: first you expand the spring, then you have to prevent bounce back to the set point.

Dr Saag mentioned that he was not advocating anabolic agents as first-line treatment for every patient; these agents should be reserved for high-risk patients. I absolutely agree with him. We do not want to give teriparatide, abaloparatide, or romosozumab to everyone. In some patients, oral bisphosphonates are perfectly appropriate, such as those patients taking steroids.

Another point that was mentioned during the Great Debate was the risk for osteosarcoma, which was mainly derived from rat toxicology data using Fischer rats with open epiphyses their entire lives. The incidence of osteosarcoma was found to be markedly higher at baseline compared with humans. However, this osteosarcoma risk was noted by researchers; a registry was started to examine this link, and a drug length use limitation is imposed with some drugs. The registry is still insufficiently powered, so we are not yet certain that there is no relationship between the drugs and the risk for osteosarcoma. Thus far, various tumor registries in the United States have looked at the incidence of osteosarcoma with teriparatide use and no increased signal has been found.

Currently use of romosozumab is limited to 1 year because the effect tends to wane after 12 months. This is probably because the effect on osteoblasts is so potent that it depletes the osteoblast, and after a year there is nothing left to do. After 1 year, romosozumab becomes an expensive antiresorptive drug. What is further notable is the lack of information on the label about retreatment, as well as the lack of further guidelines about retreatment.

The current gaps in preventing glucocorticoid-induced osteoporosis are similar to those present in preventing postmenopausal osteoporosis. The number of people in whom bone density is being measured and who are being diagnosed with osteoporosis is decreasing. I think some patients may be risk averse because of the issues related to atypical femur fractures and osteonecrosis of the jaw. I think physicians may also be too busy to elevate this issue, even though mortality after hip fracture in women is 20% after one year and in men its 40%.

More broadly speaking apart from GIO, I believe the biggest game changer in osteoporosis research being presented is romosozumab. We now have a new anabolic agent that works differently than teriparatide as a signaling pathway drug. STUCTURE (An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women; ClinicalTrials.gov Identifier: NCT01796301) studied the effect of 1 year of treatment with romosozumab compared with teriparatide on total hip BMD in postmenopausal women with osteoporosis who were previously treated with bisphosphonate therapy. The investigators found a dramatic increase in BMD with romosozumab therapy compared with teriparatide. Importantly, they also conducted finite element analysis at the hip that showed increased hip strength with romosozumab. Given these data, I believe this is the biggest story right now in osteoporosis.

Disclosure: Dr Deal is a speaker and consultant for Radius and Amgen.

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Expert Insights on Osteoporosis From the ACR/ARP 2019 Annual Meeting - Rheumatology Advisor

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8 Awful Things That Happen to You After You Turn 30 (And What You Can Do to Stop Them) – Mandatory

A lot of things in life get better after you turn 30. Unfortunately, your testosterone level isnt one of them. Testosterone peaks during adolescence and young adulthood, but as men age, this manliest of hormones begins to drop by one percent each year beginning at age 30, and the decline affects your body and brain in myriad ways. Were going to unpack the eight unfortunate effects of low T, but just because biology has it in for you and your masculinity doesnt mean you have to take these changes lying down. (In fact, lying down may be one of the worst things you could do.) There are strategies to combat plummeting T levels, and were going to help you figure out which ones might work for you.

To be blunt, testosterone is what makes you want to fuck. As T decreases in your system, you may find the urge to mate is less intense. Suddenly, you can take sex or leave it. Youd rather binge watch a good show, eat a bucket of fried chicken, and fall asleep in your recliner than swipe through Tindr looking for your next one-night stand.

What you can do: Get moving! Exercise pumps blood throughout your body, cock and balls included. Indulge your fantasy life (yes, this means all the porn, but it could also include erotic reading and role-playing with your partner). Build anticipation by planning a date night and getting excited about the sex it will inevitably involve; make a playlist, set the scene, take a long shower and primp beforehand.

The most disturbing side effect of low T is the inability to get (or keep) it up. Suddenly, your once rock-hard, go-all-night member is acting like a lazy stoner. While the occasional dick disappointment is nothing to be concerned about, if your cock is failing to crow on a regular basis, its time to call in the professionals.

What you can do: They make drugs for this, and for good reason. Viagra is just one of the options for medically-induced erections you can discuss with your doctor. If boner pills dont work, testosterone replacement therapy may also be necessary.

Testosterone is what gives muscles that pumped-up look. As your T dips, your muscles deflate, and what was once high and tight is now soft and saggy.

What you can do: Make sure your exercise routine incorporates cardio and strength training. Either of those alone wont be enough. You need them both. Get more sleep so that when its time to hit the gym, youre raring to go. Recover with high-protein foods to give your muscles a boost. You can also talk to your doctor about whether testosterone supplementation is right for you.

Its so unfair. Youre not even a dad but youve been cursed with dad bod. Blame low T. Beyond the aesthetic of a fuller shape, though, the real danger in weight gain (no matter what the cause) is that it increases your risk of Type 2 diabetes, heart disease, and some cancers.

What you can do: Theres no shortcut here. You have to lose weight. And to do that, youll have to burn more calories than you consume. This means cutting out any empty calories and replacing them with healthy foods in addition to exercising. If youre already athletic, now is the time to step up your exertion and work out harder. Seek out a trainer if you need some ideas on how to make that happen.

Low T can mess with your sleep at night, leaving you drowsy and unmotivated by day. You might feel like youre dragging a giant sandbag previously known as your body around. Your usual get-up-and-go is more like crawl-into-a-hole-and-sleep-until-spring.

What you can do: Were going to sound like a broken record, but here goes: exercise! It seems counterintuitive, but by expending energy, youll gain more oomph. Low energy also means its time to tweak your diet and make sure that youre fueling your body with high-quality calories from whole, healthy foods, not processed ones purchased at the gas station or drive-thru window.

Feeling anywhere from mildly blue to downright depressed is common when testosterone levels start to dwindle. You may also feel irritable or experience mood swings.

What you can do: Youve heard it before, but it bears repeating: exercise and diet are crucial in mediating your mood. Yoga and meditation can help you find your Zen. Therapy can be a beneficial way to unload your feelings without taking them out on your loved ones. Antidepressants may also be warranted if your depression is severe and/or persistent.

If only this meant we forgot all our former fuckups, that ex we cant stop obsessing about, and how little our boss appreciates us! Unfortunately, low T means your brain is like Teflon: new information slides right off and doesnt get stored as reliably as it used to. You forget what room the morning meeting is in, what the new guys name is, or the cross streets of that restaurant you wanted to check out at lunch.

What you can do: A daily meditation practice can help the brain maximize its memory storage space. If meditation puts you to sleep, no worries; naps are good for your brain, too. Some studies show that caffeine, berries, and chewing gum may improve memory functioning. Play brain games like sudoku and crosswords to keep your grey matter in tip-top shape. Finally, be proactive: if you're likely to forget something, write it down or set an alert on your phone.

Low T levels means your hair on your head and your face falls out easier. It sucks, though the one upside is if you have a hairy back (or other unflattering hairy areas), they, too, might just resolve themselves. Hello, dolphin bod!

What you can do: Try Rogaine. Look into laser treatments. Spring for a surgical follicle hair transplant. Or say fuck it and shave your head. (Its badass and plenty of ladies love the look.)

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8 Awful Things That Happen to You After You Turn 30 (And What You Can Do to Stop Them) - Mandatory

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