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Category Archives: Testosterone
Testosterone Replacement Therapy Market: An Insight on the Important Factors and Trends Influencing the Market – Online News Guru
Posted: October 17, 2019 at 8:42 pm
The globalmarket for testosterone replacement therapyis characterized by the presence of a large number of small and large scale manufacturers. All of the manufacturers have been steadfast in filling the meagre market gap in order to enhance their prospects of growth. Furthermore, research and development has been the central characteristic of al the market players operating in the global market.
In 2015, it was found that 80% of the total market share was held by the top five market vendors with AbbVie Inc. taking the lead. The large scale vendors are focusing on establishing an iconic brand for their product by resorting to rigorous marketing and advertising tactics. The smaller companies are expected to concentrate on capturing the local and regional markets to sustain themselves in the current scenario of stiff competition.
A negative implication for the leading market players in recent times has been the loss of patents for their products. This has not only plundered them of revenues but has also affected the workflow of these companies. The market players are expected to launch awareness campaigns about testosterone replacement therapies in order to educate and inform the consumers. Hence, the market for testosterone replacement therapies is expected to witness the emergence of several new trends and opportunities over the forthcoming years. Some of the key players in the global testosterone replacement therapy market include Bayer AG, Endo Pharmaceuticals, Inc., Novartis AG, and Allergen plc.
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The CAGR for theglobal testosterone replacement therapy marketis estimated to be -4.20% over the period between 2016 and 2024. The negative growth rate of the global market is expected to take the market value from US2.0 bn in 2015 to a decreased value of US$1.3 bn by 2024-end.
High Incidence of Hypogonadism to Drive Market Demand
Research studies suggest that around 30% of all men suffer from testosterone deficiency, which has driven demand within the global market for testosterone replacement therapy. Furthermore, the population demographic of men in the age range of 40-79 years is more likely to suffer from testosterone deficiency. The need for mutation or having an offspring amongst men in the aforementioned age range has driven demand within the global market. Moreover, the geriatric population has been on a rise, which underhandedly contributes to market growth. Several campaigns aimed at educating people about the benefits of testosterone replacement therapy have been an important propeller of demand within the global market. It is anticipated that more people suffering from testosterone deficiency would resort to these therapies over the coming years.
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Side Effects of Testosterone Replacement Therapy Could Obstruct Market Growth
Despite the rising awareness amongst the masses about the advantages of testosterone replacement therapies, the market growth is hindered by the apprehension of the people. The chances of developing metabolic disorders are higher in men who undergo testosterone replacement therapies. Furthermore, the risk of developing cardiovascular diseases also discourages people from resorting to testosterone replacement therapies. The FDA has also cautioned people about the use of such therapies by issuing strict warnings, which has further obstructed the growth of the global market.
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How to enjoy sex during the menopause – Yahoo News UK
Posted: October 17, 2019 at 8:42 pm
Many women battle hot flushes during the menopause. [Photo: Getty]
The menopause brings everything from hot flushes and night sweats to insomnia and mood swings.
But its affect on a womans sex life is less commonly discussed.
Going through the change often triggers vaginal dryness, which can make intercourse agonising.
Hormonal changes combined with sleepless nights and embarrassment over the middle age spread also puts many off being intimate.
With today marking World Menopause Day, Yahoo UK asks experts how women can continue to enjoy sex while going through the change.
Menopause usually strikes between 45 and 55, however, one in 100 women experience symptoms at under 40, NHS statistics show.
Most endure symptoms for around four years, but one in 10 battle the discomfort for up to 12 years.
While many blush at the thought of vaginal dryness, menopause specialist nurse Kathy Abernethy warns it is almost an inevitability.
Vaginal dryness comes about when the cells in the vagina change, she told Yahoo UK. The vagina is like a sponge; it gives during intercourse. Menopause makes it become rigid.
The uncomfortable symptom affects a womans day-to-day life, with many enduring pain and itching when they walk or exercise. When it comes to sex, vaginal dryness can be agonising.
It feels like sandpaper, Ms Abernethy said. You get a friction feeling when the penis should just glide in.
READ MORE: 10 of the best menopause relief products
While uncomfortable for all, gynaecologist Dr Michael Savvas warns young menopausal women may particularly suffer.
Hormone levels drop off more steeply in menopausal women under 40, he told Yahoo UK. Its unnatural for a young woman to have low oestrogen or testosterone.
While it may sound bleak, menopausal women do not have to wave goodbye to their sex lives.
It's important to communicate with your partner that its an issue, Ms Abernethy said.
Lots of women are suffering in silence. Sex is not an open conversation but men dont get it until theyre told.
Being open with your other half may also stop them blaming themselves, with many men feeling shunned when their partner turns down their advances, Ms Abernethy said.
When it comes to enjoying sex again, ramping up foreplay will not solve the problem.
READ MORE: Moody? Tired? Forgetful? You may be peri-menopausal even in your 30s!
Ms Abernethy recommends women opt for vaginal lubricants, which can be bought on the high street.
Some may also benefit from the hormonal replacement therapy (HRT) vaginal oestrogen, which can come as a pessary, cream or vaginal ring. Unlike other forms of HRT, vaginal oestrogen has not been linked to cancer or blood clots.
It is also only applied at the time of sex and doesnt enter the bloodstream, Ms Abernethy said.
Although both lubricants and vaginal HRT are effective, they do not cure vaginal dryness, with women relying on the treatments every time they have sex.
For the best results, it is important women seek help as soon as they experience discomfort.
Vaginal dryness doesnt get better on its own; treatment is required, Ms Abernethy said.
Eating a diet rich in plant-based oestrogen may also help. Speaking to Yahoo UK, Tania Adib - a consultant gynaceologist at The Medical Chambers Kensington - recommended chickpeas, nuts and seeds.
Limit your intake of alcohol as drinking over the safe recommended limit can lower oestrogen levels and lead to vaginal dryness as a result, she added.
While vaginal dryness stops some menopausal women being intimate, for others, a low sex drive means they simply do not want to.
Reduced libido affects lots of women, Ms Abernethy said.
Hormonal changes are often to blame, with testosterone, which gives a woman her sex drive, falling during the change.
It could also be caused by the ageing process, Ms Abernethy said. Women feel less sensual than they did when they were younger.
Menopause symptoms like insomnia also leave women exhausted and not in the mood. And relationships can get stale in middle age.
Hormonal changes and ageing also trigger abdominal weight gain, which often leaves women with low self esteem.
To get back in the mood, Ms Abernethy first recommends women make sex comfortable, via lubricants or other treatments.
Testosterone therapies can then help them feel more passionate. Testosterone is not licensed for use in women in the UK, however, doctors can give it off label.
READ MORE: The menopause timeline: What to expect from each stage
Doctors prescribe products licensed for men at a much reduced dose, Dr Savvas said.
When given appropriately, very few develop male characteristics, like facial hair, he added.
As well as getting women in the mood, testosterone may also help women enjoy intercourse.
Many report finding sex less pleasurable and finding it hard to orgasm, testosterone helps, Dr Savvas said.
Vaginal oestrogen aside, the medic also recommends often forms of HRT, like tablets, patches and implants.
The treatment has hit the headlines over the years after links to breast, ovarian and womb cancer.
According to Dr Savvas, however, HRT is extremely safe, particularly for those with no personal or family history of disease.
In early-onset menopause, HRT could even keep women healthy, he adds. Experiencing the change too soon can trigger osteoporosis and heart disease, with oestrogen being linked to both bone and cardiovascular health.
For some, their libido returns post-menopause, but Ms Abernethy stresses a womans attitude to ageing is important.
If youre hankering after a 20 year old's body, it's not going to happen, she said. You should accept your 50-year-old body is still hugely attractive to your partner.
To break down the stigma around sex during the menopause, Ms Abernethy urges people to discuss it more openly.
Menopause is a natural part of our lives, she said. It should be talked about.
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Reviewing AbbVie Inc. (ABBV)’s and Eli Lilly and Company (NYSE:LLY)’s results – MS Wkly
Posted: October 17, 2019 at 8:42 pm
This is a contrast between AbbVie Inc. (NYSE:ABBV) and Eli Lilly and Company (NYSE:LLY) based on their profitability, analyst recommendations, risk, dividends, institutional ownership, earnings and valuation. The two companies are Drug Manufacturers Major and they also compete with each other.
Valuation and Earnings
Table 1 shows gross revenue, earnings per share and valuation of the two companies. Eli Lilly and Company is observed to has lower earnings, but higher revenue than AbbVie Inc. When business has lower price-to-earnings means it is more affordable than its counterpart presently. AbbVie Inc. is trading at a lower price-to-earnings ratio than Eli Lilly and Company, indicating that it is presently more affordable of the two stocks.
Profitability
Table 2 provides AbbVie Inc. and Eli Lilly and Companys net margins, return on equity and return on assets.
Risk and Volatility
AbbVie Inc. has a beta of 0.92 and its 8.00% less volatile than Standard & Poors 500. Competitively, Eli Lilly and Companys beta is 0.18 which is 82.00% less volatile than Standard & Poors 500.
Liquidity
The Current Ratio and a Quick Ratio of AbbVie Inc. are 1 and 0.9. Competitively, Eli Lilly and Company has 1.1 and 0.8 for Current and Quick Ratio. Eli Lilly and Companys better ability to pay short and long-term obligations than AbbVie Inc.
Analyst Recommendations
The next table highlights the given recommendations and ratings for AbbVie Inc. and Eli Lilly and Company.
AbbVie Inc.s consensus target price is $80.75, while its potential upside is 7.47%. On the other hand, Eli Lilly and Companys potential upside is 19.24% and its consensus target price is $129.33. The information presented earlier suggests that Eli Lilly and Company looks more robust than AbbVie Inc. as far as analyst view.
Insider and Institutional Ownership
Roughly 71% of AbbVie Inc. shares are owned by institutional investors while 83.7% of Eli Lilly and Company are owned by institutional investors. Insiders owned roughly 0.1% of AbbVie Inc.s shares. Competitively, Eli Lilly and Company has 12.1% of its share owned by insiders.
Performance
Here are the Weekly, Monthly, Quarterly, Half Yearly, Yearly and YTD Performance of both pretenders.
For the past year AbbVie Inc.s stock price has bigger decline than Eli Lilly and Company.
Summary
On 11 of the 15 factors Eli Lilly and Company beats AbbVie Inc.
AbbVie Inc. discovers, develops, manufactures, and sells pharmaceutical products worldwide. The company offers HUMIRA, a biologic therapy administered as a subcutaneous injection to treat autoimmune diseases; IMBRUVICA, an oral therapy for the treatment of patients with chronic lymphocytic leukemia; and VIEKIRA PAK, an interferon-free therapy, with or without ribavirin, for the treatment of adults with genotype 1 chronic hepatitis C. It also provides Kaletra, an anti- human immunodeficiency virus(HIV)-1 medicine used with other anti-HIV-1 medications as a treatment that maintains viral suppression in HIV-1 patients; Norvir, a protease inhibitor indicated in combination with other antiretroviral agents to treat HIV-1; and Synagis to prevent RSV infection at-risk infants. In addition, the company offers AndroGel, a testosterone replacement therapy for males diagnosed with symptomatic low testosterone; Creon, a pancreatic enzyme therapy for exocrine pancreatic insufficiency; Synthroid to treat hypothyroidism; and Lupron, a product for the palliative treatment of prostate cancer, endometriosis, and central precocious puberty, as well as for the treatment of patients with anemia. Further, it provides Duopa and Duodopa, a levodopa-carbidopa intestinal gel to treat Parkinsons disease; Sevoflurane, an anesthesia product for human use; and ZINBRYTA, a subcutaneous treatment for relapsing forms of multiple sclerosis. The company sells its products to wholesalers, distributors, government agencies, health care facilities, specialty pharmacies, and independent retailers from its distribution centers and public warehouses. AbbVie Inc. has collaboration agreements with C2N Diagnostics; Calico Life Sciences LLC; Infinity Pharmaceuticals, Inc.; M2Gen; and Principia Biopharma Inc. The company was incorporated in 2012 and is based in North Chicago, Illinois.
Eli Lilly and Company discovers, develops, manufactures, and markets pharmaceutical products worldwide. It operates through two segments, Human Pharmaceutical Products and Animal Health Products. The company offers endocrinology products to treat diabetes; osteoporosis in postmenopausal women and men; human growth hormone deficiency and pediatric growth conditions; and testosterone deficiency. It also provides neuroscience products for the treatment of depressive disorders, diabetic peripheral neuropathic pain, anxiety disorders, fibromyalgia, and chronic musculoskeletal pain; schizophrenia; attention-deficit hyperactivity disorders; depressive, obsessive-compulsive, bulimia nervosa, and panic disorders; and positron emission tomography imaging of beta-amyloid neurotic plaques in adult brains. In addition, the company offers products to treat non-small cell lung, colorectal, head and neck, pancreatic, metastatic breast, ovarian, bladder, and metastatic gastric cancers, as well as malignant pleural mesothelioma; and cardiovascular products to treat erectile dysfunction and benign prostatic hyperplasia; and migraine headaches. Further, it provides animal health products, such as cattle feed additives; protein supplements for cows; leanness and performance enhancers for swine and cattle; antibiotics to treat respiratory and other diseases in cattle, swine, and poultry; anticoccidial agents for poultry; and chewable tablets that kill fleas and prevent flea infestations, and heartworm diseases, as well as controls intestinal parasite infections. Additionally, the company offers vaccinev to prevent Lyme disease, bronchial infections, rabies, and various infectious diseases in dogs, cats, and horses. It has collaboration agreements with Daiichi Sankyo Co., Ltd., Incyte Corporation, Pfizer Inc., AstraZeneca, William Sansum Diabetes Center, Purdue University, and Nektar Therapeutics. Eli Lilly and Company was founded in 1876 and is headquartered in Indianapolis, Indiana.
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Global Testosterone Replacement Therapy Market Growth Analysis, Forecasts to 2025: AbbVie, Endo International, Eli lilly, Pfizer, Actavis, Bayer – PR…
Posted: October 17, 2019 at 7:44 am
Report Testosterone Replacement Therapy covers all aspects of the "Testosterone Replacement Therapy Market". It provides basic market terminology and advanced analytical information in an understandable way that can be interpreted not just by a specialist but also a layman. One of the most important descriptions in this report is full information on the major key players AbbVie, Endo International, Eli lilly, Pfizer, Actavis (Allergan), Bayer, Novartis, Teva, Mylan, Upsher-Smith, Ferring Pharmaceuticals, Kyowa Kirin, Acerus Pharmaceuticals holding the market share. The information includes the company profile, annual turnover, the types of products and services they provide, income generation, which provide direction to businesses to take important steps.
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The market growth rate in around the globe can vary from region to region, for which the report presents the full analysis based on different geographic areas. Information on the technical tactics that are followed in the market, applications are provided exclusively in the Testosterone Replacement Therapy report. At the same time, the report provides data analyzed based on cost structure statistics for raw material collection, efficient product manufacturing, safe delivery, and overall after-sales costs.
The global Testosterone Replacement Therapy report also contains detailed information on important, less significant growth and limitation factors that significantly affect market growth. The strike of the global Testosterone Replacement Therapy market is mentioned in the part of those areas, It demonstrates various segments Gels, Injections, Patches, Other and sub-segments Hospitals, Clinics, Others of the global Testosterone Replacement Therapy market. The report also provides comprehensive information on the income of top market owners, their annual transactions, the stability of their actions and the strategies used to attract the activity. The report also highlights some of the rules and regulations that have been established by the governing bodies of some countries that can stimulate and restrict commercial activities in certain parts of the world.
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The information available in the Testosterone Replacement Therapy market summarized report provide customers with effective information that enables them to make effective decisions, which could lead to a significant expansion of the business in the future.
There are 15 Chapters to display the Global Testosterone Replacement Therapy market
Chapter 1, Definition, Specifications and Classification of Testosterone Replacement Therapy , Applications of Testosterone Replacement Therapy , Market Segment by Regions;Chapter 2, Manufacturing Cost Structure, Raw Material and Suppliers, Manufacturing Process, Industry Chain Structure;Chapter 3, Technical Data and Manufacturing Plants Analysis of Testosterone Replacement Therapy , Capacity and Commercial Production Date, Manufacturing Plants Distribution, R&D Status and Technology Source, Raw Materials Sources Analysis;Chapter 4, Overall Market Analysis, Capacity Analysis (Company Segment), Sales Analysis (Company Segment), Sales Price Analysis (Company Segment);Chapter 5 and 6, Regional Market Analysis that includes United States, China, Europe, Japan, Korea & Taiwan, Testosterone Replacement Therapy Segment Market Analysis (by Type);Chapter 7 and 8, The Testosterone Replacement Therapy Segment Market Analysis (by Application) Major Manufacturers Analysis of Testosterone Replacement Therapy ;Chapter 9, Market Trend Analysis, Regional Market Trend, Market Trend by Product Type Gels, Injections, Patches, Other, Market Trend by Application Hospitals, Clinics, Others;Chapter 10, Regional Marketing Type Analysis, International Trade Type Analysis, Supply Chain Analysis;Chapter 11, The Consumers Analysis of Global Testosterone Replacement Therapy ;Chapter 12, Testosterone Replacement Therapy Research Findings and Conclusion, Appendix, methodology and data source;Chapter 13, 14 and 15, Testosterone Replacement Therapy sales channel, distributors, traders, dealers, Research Findings and Conclusion, appendix and data source.
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Testosterone Replacement Therapy Market Examined in New Research Report – Midnight Stocks
Posted: October 16, 2019 at 4:49 pm
The globalTestosterone Replacement Therapy marketrides on the back of technology. As consumer focus shifts from access to comfort, players in the market for Testosterone Replacement Therapy are looking at new opportunities to capitalize on the potential. This exclusive report from Transparency Market Research will take you through an extensive analysis of every aspect in the Testosterone Replacement Therapy market that is critical for defining your success strategy. It offers prudent information on markets under currents, trends that will open new doors, factors that will remain important, challenges that need to be overcome, prevailing competition in the market, and the geographical landscape.
Based on a tested and proven research methodology, our research analysts bring to you fact-checked information. Besides presenting the current market figures, our analysts provide you with accurate forecasts that can be the game-changer for your winning strategies for tomorrow. On the other hand, our reports also offer tailor-made insights. Further, our reports are packed with experts viewpoints which are transcribed from interviews conducted by our analysts.
For every market, information on leading players can be the difference between success and failure, be it a prominent brand or not. Our reports cover every significant players in the global Testosterone Replacement Therapy market providing information about the company profile, products, winning strategies and market revenues. Not just that, TMR also provides information on the competitive landscape, helping you understand what impacted in one company being the market leader and others not. It also explains on the companies imperatives that define their success in the global market for Testosterone Replacement Therapy.
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Healthcare, unlike most industries, is typical of the region. Humans have multiple races and hence their genetic makeups are different. As a result, one condition has different impacts depending on the region. Therefore, information on how consumer requirements are different in regional landscape of the global Testosterone Replacement Therapy market is provided her in the report. Further, the economic capabilities of a country has a huge impact on healthcare infrastructure. TMRs report analysis the current economic scenario and also brings to you information on affordability during the coming years.
From market share to region-specific strategies, the report covers it all. At the same time, players in the Testosterone Replacement Therapy market who are looking to expand might want to assess the potential of a prospective region. Our reports can provide you with custom-made insights for specific regions in the global Testosterone Replacement Therapy market. The geographical analysis also covers regions-specific factors that could turn out to be hurdle for growth in the coming years.
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Hormone therapy clinics could be putting patients in danger – CBS News
Posted: October 15, 2019 at 8:44 pm
Medical clinics across the country are advertising a treatment some believe is a fountain of youth. They're selling hormone therapy as a way to make people look and feel younger. But a CBS News investigation finds this may be putting patients at risk.
Last year, at the age of 60, Cindy Kinder-Binge was rushed to a hospital in New Albany, Indiana, with a heart rate four times normal. Two months earlier, she had gone to the emergency room with palpitations.
"A cardiologist walks in and he said, 'Who put you on thyroid medicine?'" Kinder-Binge said.
She had been prescribed a thyroid hormone for menopausal symptoms like hot flashes, even though her thyroid blood levels were normal. She says her cardiologist had her stop taking the hormone because he believed it contributed to her irregular heartbeat.
She was treated by a nurse practitioner at a clinic called 25 Again. Hormone therapy is promoted as a way to help patients lose weight and feel younger. But a CBS News investigation found there are clinics across the country prescribing hormones like thyroid and testosterone to people with normal levels and it's not just 25 Again.
Ultrasound technician Leighann Decker is a former employee of an OB-GYN in Owensboro, Kentucky. The doctor Decker worked for prescribed testosterone to patients with normal testosterone levels looking to turn back the clock.
"More and more practitioners have tried to jump on board and when they've seen the profit that's being made from it. Of course, it's cash pay. It's easy money," Decker said.
The doctor in Kentucky and the practitioner in Indiana both attended seminars given by Dr. Neal Rouzier. He has been promoting hormone replacement therapy for decades and said he's trained thousands of clinicians around the world. During a 2016 deposition, he said he gives testosterone to patients even if their levels are normal.
"I don't care about the number. I treat patients. I treat symptoms," Rouzier said.
Some research suggests testosterone therapy may increase the risk of heart attack or stroke. In 2015, Rouzier dismissed that concern.
"There's thousands of articles to show protection against heart attacks," he said.But under oath, in that deposition, he was unable to point to any evidence that would back up his claim that his approach to testosterone therapy is safe.
"The problem is that there is no fountain of youth," said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic. Nissen is leading an FDA-mandated study to see if giving testosterone affects the risk of heart attack or stroke in men with low levels."There's no scientific basis for giving hormone therapy to people whose levels are already normal and there's lots of suggestions that it may actually be harmful," Nissen said.
Kinder-Binge is suing 25 Again. The company told CBS News the overall health of their patients is their priority and they make patients aware of any risks. Rouzier declined our request for an interview and did not respond to a list of written questions.
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Testosterone Replacement Therapy Market Overview, Analysis, Growth Opportunities and Forecast to 2025 – Pledge Times
Posted: October 11, 2019 at 10:51 am
The Testosterone Replacement Therapy market 2019 examines the global Testosterone Replacement Therapy market from a competitive outlook as well. Top Key Players of Testosterone Replacement Therapy are mentioned and a detailed competitive profile is presented for each of them.
The Global Testosterone Replacement Therapy report contains Market Revenue, Investment Opportunity, Market Features, Market Demand by Segment & Testosterone Replacement Therapy market Growth aspects. A wide variety of applications, Utilization ratio, Supply and demand analysis are also consist in the report. It shows manufacturing capacity, Testosterone Replacement Therapy Price during the Forecast period from 2019 to 2025. Testosterone Replacement Therapy Market by Key Players, Countries, Types and End Users, forecast to 2025 to its research database. This analysis is segmented on the bases of applications, types, technology and geography.
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Our research analysts also have taken significant account facets and landscape scenario like Testosterone Replacement Therapy industry market placement plan frame, and competitive atmosphere for providing a competitive analysis.
Eli lilly, Pfizer, Endo International, Actavis (Allergan), AbbVie, Novartis, Teva, Bayer, Kyowa Kirin, Mylan
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The Truth About Low Testosterone Levels, According to Experts – menshealth.com
Posted: October 11, 2019 at 10:51 am
Feeling tapped out. Foggy. Just not all that into sex. Gotta be your testosterone, ads would have you believe. And were believing it, too, with the number of T-supplement users tripling from the early 2000s through 2016.
Dont get us wrong: Testosterone is one critical hormone. Babies first encounter it in utero, when it triggers the differentiation of boys from girls. In puberty, it contributes to your bone growth and muscle mass, and continues to affect functions including your red-blood-cell production and mood stability.
But the message those ads are sending plays right into the economic and social anxieties men are facing. Its like when anti-anxiety meds such as Valium first came onto the scene, says urologist and MH advisor Elizabeth Kavaler, M.D. All these middle-aged women were addicted to Valium, because that was the solution to everything. Testosterone has become the new answer for a life of quiet desperation. More and more of us are feeling the exhaustion of uneasiness. We are being asked to do more with less. Were just trying to get through the day alive. Men think, Well, if I just get a little testosterone, Im going to feel great! Dr. Kavaler says. And thats not the case.
Theres so much information out there about Tmuch of it speculation and lorethat leads us to jump to conclusions about it. Men put all kinds of psychological weight on their testosterone numbera low one makes you think youre somehow less manly; a high one means youre basically LeBron Jamesand thats where we get things wrong. Theres little evidence for those stereotypes. Low doesnt automatically imply youre weak or retiring; high doesnt guarantee you muscles, aggressiveness, or MVP athletic performance.
A low number might not even be a low number for very long. It might just indicate that you havent been treating yourself very well. As long as your T is in the normal range, theres nothing about a high number thats better than a low one, or vice versa.
In the name of science and good journalism, I got my testosterone tested twice while writing this story. It put my assumptions up against a pretty big test, too (more on that later).
What do you really know about this famous hormone? Here, we break down the best and latest information to give you the clearest picture yet of what T means for you. And whether, maybe, you should be taking testosterone after all.
As many as 5 million men in the U.S. (generally older men) do actually have low levels of the hormone. To know if your testosterone is low, first see if you have any symptoms, which include: erectile problems, lack of energy (never feeling rested, no matter what you do; having a paunch; an AWOL libido (not just not wanting to have sex on a Thursday night after a crushing week, but lack of the kind of base-level sex drive wherein you get turned on by the sexy person you spot on the street, explains Tobias Kohler, M.D., of the Mayo Clinic).
With testosterone, as with life, normal is nuanced. And fraught (but shouldnt be). To get an accurate reading, you should have at least two tests, since testosterone is constantly in flux. It peaks in the morning, so if youre young and on a typical sleeping schedule, aim to be tested by 10:00 a.m. If youre over 50, it doesnt matter as much.
Be aware that your level can be affected by certain social factors and health habits. In the new book Testosterone: An Unauthorized Biography, scientists Rebecca M. Jordan-Young and Katrina Karkazis point out that T levels even respond to social factors like feedback. For instance, rugby players who watched video of good game plays and got positive feedback had up to a 50 percent increase in T compared with guys who were shown their mistakes and received critical assessments.
Resistance training can also give you a short-term boost in testosterone. Cardio doesnt elevate T levels as much in normal-weight men, says Jesse Mills, M.D., the director of the Mens Clinic at UCLA. But heres the thing: Jordan-Young and Karkazis dug through the research to find that T levels alone dont deserve the credit when it comes to an athletes performance. And cutting sleep short and taking multivitamins with biotin can push testosterone levels down (skip the vitamins for three days before testing).
So get your tests on days that are typical for you. And when you get your number, dont read too much into it. A T level of 264 to 916 nanograms per deciliter of blood is generally considered normal. If you are close to 264 and you feel fine, then youre no less healthy than a guy whose level is 700 and also feels fine. (Theres an exception to that, though: If your T level is below 300 and you have low-T symptoms, then docs would consider you in a low-T category)
Not reading into it is harder than it sounds. I got my first test at the tail end of a busy week. Id slept less than five hours the night before, then scrambled to the phlebotomist in a daze. My number: 287. Thats in the normal range, but just barely. I have no symptoms of low T, but it was hard to shake the feeling that there was something wrong with me, even though I know that normal is normal, no matter where it is in that range. Eleven days later, I was tested again. My number was 429. Why such a dramatic change? It might be because Id slept better and cut out my multivitamins.
Irrational or not, I felt like more of a man. The whole experience was a microcosm of our relationship with T. We act like its destiny, but its just biologyeasily misunderstood and more varied than we think.
The single best thing you can do to improve your level is be healthier. Avoid stress, get more sleep, and lose weightan enzyme in fat tissue converts testosterone to estrogen. Thats one reason flab can lower your T. Its also why overweight guys can develop man boobs, and why bodybuilders who juice can also develop man boobsthey dont have much fat, but theyve jacked their T levels so high that theres a lot of it available to be turned into estrogen. Thinking of T strictly as the male sex hormone oversimplifies the complex hormonal interactions that make our bodies work. Which is also why, if you can avoid it, you dont want to go with the needle-in-the-butt routine to raise your T.
But that might not work. If your level is low enough to warrant more aggressive treatment, your doctor can prescribe a drug that causes your pituitary to tell your gonads to make more testosterone. The typical choice is clomiphene citrate (Clomid), a common fertility drug for women. Using it doesnt exempt you from needing to get healthy, though, as it doesnt diminish the risk of losing T to bad sleep and a beer belly.
Then theres always testosterone-replacement therapy, which should be your last resort. (When you give your body T, it stops making its own, and theres no guarantee it can start again.) If, though, you and your doctor decide its the way to go, youve got options. You can try a testosterone replacement gel, a topical thats easy to use but can rub off on your partner or kids. There are pills, which are even easier to use than the gel and can deliver higher levels. Theres subcutaneous pellets, or rice-sized inserts that live directly under your skin. And then theres that needle in the butt, which can provide a major boost but is generally only used by docs who specialize in testosterone therapies.
Whatever you choose, be glad that weve moved past the early days of replacement therapies, like one in the 1920s that involved transplanting goat testicles into patients. Believe it or not, it didnt work, and it also didnt make anyone feel like more of a man.
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Global Testosterone Replacement Therapy Market Analysis, Growth, Demand & Forecast 2019-2026: Endo International, AbbVie, Eli lilly, Pfizer,…
Posted: October 11, 2019 at 10:51 am
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Global Testosterone Replacement Therapy Market Analysis, Growth, Demand & Forecast 2019-2026: Endo International, AbbVie, Eli lilly, Pfizer,...
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Mereo BioPharma And Leflutrozole In Hypogonadotropic Hypogonadism – Seeking Alpha
Posted: October 11, 2019 at 10:51 am
Introduction
Mereo BioPharma (MREO) is a British small-cap ($62M) biopharma developing therapeutics for rare disorders as well as endocrine and oncological diseases. MREO has a diverse pipeline including MPH-966 (alvelestat), BCT-197 (acumapimod), and OMP-305B83 (navicixizumab) for alpha-1 antitrypsin deficiency, chronic obstructive pulmonary disease, and ovarian cancer, respectively. The focus of this article is BGS-649 (leflutrozole), a drug asset licensed from Novartis (NVS) that is in clinical development for treating hypogonadotropic hypogonadism (Hypo-H).
Hypogonadism is a medical condition characterized by a deficiency in testosterone, the primary male circulating sex hormone synthesized in the gonads. Hypogonadism can present itself during fetal development, before puberty or during adulthood. Testosterone is important in the development and maturation of reproductive tissues. Symptomatic events of this disorder are decreased libido, impaired erectile function, muscle weakness, increased adiposity, depressed mood, and decreased vitality.
Hypogonadism can be triggered by a primary testicular disorder (hypergonadotropic; Hyper-H) whereas hypogonadotropic hypogonadism (Hypo-H) is a consequence of congenital or acquired diseases that affect the hypothalamus and/or the pituitary gland.
The hypothalamus (i.e. brain), pituitary (i.e. endocrine), and gonadal (i.e. reproductive) glands are all often known as hypothalamic-pituitary-gonadal axis because they all act in concert in the development and regulation of the reproductive and immune systems. Any alteration in this axis induces changes in the hormones produced by each gland that can affect their various local and systemic effects on the body. Hypo-H is frequently reported in metabolic disorders such as obesity, type 2 diabetes, and metabolic syndrome.
Men who present with Hyper-H do not respond to hormone replacement medication because the disorder is caused by primary testicular failure. Testosterone hormone replacement is the mainstay treatment for Hypo-H to normalize testosterone levels and restore fertility. Alternative options include gonadotropin therapy regimen to induce endogenous testosterone, aromatase inhibitors, and selective estrogen receptor modulators.
BGS-649 (leflutrozole) is a novel once-weekly oral aromatase inhibitor in clinical development as first-line therapy for the treatment of Hypo-H in obese men. The thesis is that BGS-649 normalizes testosterone levels by inhibiting aromatase and is, therefore, expected to improve the related conditions. The premise is that lower levels of testosterone in obese men with Hypo-H is driven by high levels of the aromatase enzyme in fat tissue which irreversibly converts testosterone into estradiol. Aromatase inhibitors are widely used therapeutically in breast cancer.
Clinical Data: A Phase 2b clinical trial of BGS-649 in 271 patients with Hypo-H achieved its primary clinical endpoint of total testosterone normalization:
in over 75% of subjects after 24 weeks of treatment, and in at least 90% of patients after 24 weeks at the two highest doses. All three doses met all secondary endpoints, including the improvement of testosterone luteinizing hormone (LH.) and follicle stimulating hormone (FSH.) levels. The exploratory endpoint of improvement in total motile sperm count was also met.
A safety extension study completed in 143 patients successfully demonstrated that none of the doses of BGS-649 met the lower bound (95% confidence interval) of the pre-specified safety criterion of a greater than 3% reduction in lumbar spine bone mineral density (BMD) after 48 weeks of treatment. The extension study also demonstrated normalization of testosterone in more than 90% of the patients at all three doses and maintenance of the effects on LH and FSH.
Individuals with Hypo-H lack or have low levels of gonadotropin-releasing hormone (GnRH.). GnRH is a peptide hormone secreted from the hypothalamus and stimulates gonadotropic cells in the anterior pituitary gland to release LH and FSH for normal gonad function including testosterone production by the testes. The observation that BGS-649 therapy was associated with normal FSH and LH levels in the Phase 2b study could suggest these patients also had GnRH levels normalized or elevated.
The prevalence of Hypo-H was estimated to be 1:10,000 to 1:86,000 individuals 20 years ago - meaning the prevalence could be higher due to increasing rates of obesity.
Upcoming catalytic events are:
Setrusumab for Osteogenesis Imperfecta (OI.)
12-month data from Phase 2b ASTEROID study in adult OI patients expected in Q4 2019. In May 2019, Mereo reported positive 6-month interim data from the fully-enrolled ASTEROID study. These data were accepted for a late-breaking oral presentation at the upcoming American Society for Bone and Mineral Research (ASBMR) 2019 Annual Meeting to be held from September 20-23 in Orlando, FL, USA. The Company expects to report 12-month topline data from the blinded portion of the study in Q4 2019. There are currently no FDA or EMA-approved treatments for OI.
Pivotal pediatric study ready in the EU and Canada. In addition to evaluating setrusumab in adult OI patients, Mereo's Paediatric Investigation Plan (PIP) has been approved by the EMA and a study design has been agreed for a pivotal registration trial in children. Mereo is also exploring an extension of the planned pivotal study into the U.S.
Alvelestat for Severe Alpha-1 Antitrypsin Deficiency (AATD.)
Enrollment continuing for the Phase 2 proof-of-concept study in severe AATD patients with topline data expected in mid-2020. If the results are positive, Mereo intends to commence a pivotal trial in the EU and the U.S. in AATD as soon as possible thereafter.
Investigator-sponsored clinical studies underway in AATD and also in bronchiolitis obliterans syndrome (BOS) as a result of graft-versus-host disease (GvHD) in patients undergoing hematopoietic stem cell transplantation (HSCT). BOS is an orphan disease characterized by inflammatory obstruction of the lung's tiniest airways and is the primary cause of death in patients who receive lung transplants. Based on the preliminary clinical data to-date, Mereo intends to investigate the use of alvelestat to treat patients with BOS following a lung transplant.
Partnering Discussions Continue for Broad Portfolio of Clinical-Stage Programs
Leflutrozole for Hypogonadotropic Hypogonadism .. Following the positive Phase 2b and six-month extension data reported in 2018, earlier this year Mereo held an advisory board to consider the future development strategy for leflutrozole, with a focus on the positive effects on semen parameters. Mereo has decided that future product development will focus on male fertility.
Acumapimod for Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) is Phase 3-ready following a successful Type B End of Phase 2 meeting with the FDA and agreed outline for a pivotal Phase 3 clinical trial program. Recently, a positive Scientific Advice Working Party (SAWP.) also took place with the EMA.
Navicixizumab for Advanced Platinum-Resistant Ovarian Cancer. In July 2019, Mereo held a successful Type B End of Phase 1 meeting with the FDA regarding a potential pathway for accelerated approval for navicixizumab for the treatment of patients with advanced ovarian cancer. Mereo and the FDA discussed, and agreed in principle, an outline for the design of a Phase 2 clinical trial that could potentially support the accelerated approval of navicixizumab in patients with ovarian cancer (including peritoneal or fallopian tube cancer) who have become resistant to prior therapies.
Etigilimab for Advanced Solid Tumors. Etigilimab has completed a Phase 1a/b trial of etigilimab, administered as either a single-agent or in combination with nivolumab, in patients with advanced or metastatic solid tumors.
The biggest risk is the low cash reserve. As highlighted above, MREO is seeking partnership agreements for some of its clinical programs. Partnership agreements would provide the financial stability needed to advance its clinical pipeline.
At the end of Q2/2019, it reported cash, cash equivalents, and short-term investments of $45.06M (after conversion from pounds sterling). Institutional ownership currently stands at 1.88%, with 43 institutional holders accounting for 1,805,180 total shares. Analysts recommend a buy with an average price target of $7.20.
CEO Dr. Denise Scots-Knight on the future:
Our team remains focused on advancing discussions with potential partners to help us further realize the value of these assets and we look forward to updating you regarding these discussions in the future. In addition to the progress have highlighted regarding our development programs, we also continue the build out of our senior Management Team and board of directors to ensure that we have the necessary expertise and are well positioned as our programs continue to advance.
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Mereo BioPharma And Leflutrozole In Hypogonadotropic Hypogonadism - Seeking Alpha
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