Archive for the ‘Hypogonadism’ Category

Global Male Hypogonadism Market Analysis to 2025 is a specialized and in-depth study of the Male Hypogonadism industry with a focus on the global market trend. The report aims to provide an overview of global Male Hypogonadism Market with detailed market segmentation by product/application and geography. Male Hypogonadism Market report covers the present and past market scenarios, market development patterns, and is likely to proceed with a continuing development over the forecast period.

Some of the key players of Male Hypogonadism Market:Astrazeneca Plc., Eli Lilly and Company Ltd., Allergan Plc., Merck & Co. Inc., AbbVie Inc., Laboratories Genevrier, Teva Pharmaceutical Industries Ltd., Ferring, Endo International Plc., Finox Biotech, Bayer AG, IBSA Institut Biochimque

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The Global Male Hypogonadism Market research report offers an in-depth analysis of the global market, providing relevant information for the new market entrants or well-established players. Some of the key strategies employed by leading key players operating in the market and their impact analysis have been included in this research report.

Market Analysis by

The report provides a detailed overview of the industry including both qualitative and quantitative information. It provides overview and forecast of the global Male Hypogonadism market based on product and application. It also provides market size and forecast till 2025 for overall Male Hypogonadism market with respect to five major regions, namely; North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South America (SAM), which is later sub-segmented by respective countries and segments.

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The report evaluates market dynamics effecting the market during the forecast period i.e., drivers, restraints, opportunities, and future trend and provides exhaustive analysis for all five regions.

Fundamentals of Table of Content:

1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Players Covered1.4 Market Analysis by Type1.5 Market by Application1.6 Study Objectives1.7 Years Considered

2 Global Growth Trends2.1 Male Hypogonadism Market Size2.2 Male Hypogonadism Growth Trends by Regions2.3 Industry Trends

3 Market Share by Key Players3.1 Male Hypogonadism Market Size by Manufacturers3.2 Male Hypogonadism Key Players Head office and Area Served3.3 Key Players Male Hypogonadism Product/Solution/Service3.4 Date of Enter into Male Hypogonadism Market3.5 Mergers & Acquisitions, Expansion Plans

4 Breakdown Data by Product4.1 Global Male Hypogonadism Sales by Product4.2 Global Male Hypogonadism Revenue by Product4.3 Male Hypogonadism Price by Product

5 Breakdown Data by End User5.1 Overview5.2 Global Male Hypogonadism Breakdown Data by End User

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Progressive Report On Male Hypogonadism Market By Growth, Demand & Opportunities & Forecast To 2025 | Astrazeneca Plc., Eli Lilly and Company...

Global Male Hypogonadism Market 2020 is analyzed in details, to provide accurate and useful insights and market data that players can perform strong growth in the future. Experts and Male Hypogonadism industry analysts, which makes it legitimate and dependable compile the analysis. Readers have a thorough inspection of historical and futuristic Male Hypogonadism market scenarios to have a good understanding of other issues that are important with the market competition. The report offers Male Hypogonadism information on key players, key sections, market dynamics and assorted niches. It is a complete collection of Male Hypogonadism research and in-depth analysis of the market.

Global Male Hypogonadism market trends provide a basic summary of the including definitions, classes, applications and industry chain analysis. The Male Hypogonadism market analysis is provided for the international markets, including key regions, development status, competitive landscape, and development trends. Plans and policies are discussed, as well as cost structures are analyzed and processes. This Male Hypogonadism report also claims ingestion, demand and supply figures, cost, price, revenue and gross margins.

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Key Players Mentioned at the Male Hypogonadism Market Trends Report:

Male Hypogonadism Market: Segmentation

The report gives a breakdown of the Male Hypogonadism market sections, focusing on potential market size, market share and their CAGR for future growth. The industry is divided by product type, application and region. Each segment in these types is the subject of comprehensive Male Hypogonadism research to familiarize yourself with its growth prospects and key trends. The segmental analysis is essential to identify the most important growth factors of a sector. The Male Hypogonadism report offers specific details on market development and demand for applications and products that players may concentrate on their industrial growth.

On the end-users/applications basis, the Male Hypogonadism report concentrates on the status and prognosis for revenue quantity, important applications market share and growth rate for each application, including

On the basis of types, this report shows the revenue quantity, revenue (USD), Male Hypogonadism market share and growth rate, largely split into

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Male Hypogonadism Market: Regional analysis includes:

Global Male Hypogonadism Market Report Structure at a Brief:

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Male Hypogonadism Market 2020: Insights and Regional Forecast to 2026 TRUX Route Management Systems, Soft-Pak, Cairn Applications, 21st Century...

Complete study of the global Testosterone Cypionate market is carried out by the analysts in this report, taking into consideration key factors like drivers, challenges, recent trends, opportunities, advancements, and competitive landscape. This report offers a clear understanding of the present as well as future scenario of the global Testosterone Cypionate industry. Research techniques like PESTLE and Porters Five Forces analysis have been deployed by the researchers. They have also provided accurate data on Testosterone Cypionate production, capacity, price, cost, margin, and revenue to help the players gain a clear understanding into the overall existing and future market situation.

Key companies operating in the global Testosterone Cypionate market include _Pfizer, Cipla, Sun Pharmaceutical, Teva, Perrigo, Hikma Pharmaceuticals

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Segmental Analysis

The report has classified the global Testosterone Cypionate industry into segments including product type and application. Every segment is evaluated based on growth rate and share. Besides, the analysts have studied the potential regions that may prove rewarding for the Testosterone Cypionate manufcaturers in the coming years. The regional analysis includes reliable predictions on value and volume, thereby helping market players to gain deep insights into the overall Testosterone Cypionate industry.

Global Testosterone Cypionate Market Segment By Type:

, 200 mg/mL, 100 mg/mL

Global Testosterone Cypionate Market Segment By Application:

Primary hypogonadism, Hypogonadotropic hypogonadism, Late-onset hypogonadism Global Testosterone Cypionate

Competitive Landscape

It is important for every market participant to be familiar with the competitive scenario in the global Testosterone Cypionate industry. In order to fulfil the requirements, the industry analysts have evaluated the strategic activities of the competitors to help the key players strengthen their foothold in the market and increase their competitiveness.

Key companies operating in the global Testosterone Cypionate market include _Pfizer, Cipla, Sun Pharmaceutical, Teva, Perrigo, Hikma Pharmaceuticals

Key questions answered in the report:

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TOC

Table of Contents 1 Testosterone Cypionate Market Overview1.1 Product Overview and Scope of Testosterone Cypionate1.2 Testosterone Cypionate Segment by Type1.2.1 Global Testosterone Cypionate Sales Growth Rate Comparison by Type (2021-2026)1.2.2 200 mg/mL1.2.3 100 mg/mL1.3 Testosterone Cypionate Segment by Application1.3.1 Testosterone Cypionate Sales Comparison by Application: 2020 VS 20261.3.2 Primary hypogonadism1.3.3 Hypogonadotropic hypogonadism1.3.4 Late-onset hypogonadism1.4 Global Testosterone Cypionate Market Size Estimates and Forecasts1.4.1 Global Testosterone Cypionate Revenue 2015-20261.4.2 Global Testosterone Cypionate Sales 2015-20261.4.3 Testosterone Cypionate Market Size by Region: 2020 Versus 2026 2 Global Testosterone Cypionate Market Competition by Manufacturers2.1 Global Testosterone Cypionate Sales Market Share by Manufacturers (2015-2020)2.2 Global Testosterone Cypionate Revenue Share by Manufacturers (2015-2020)2.3 Global Testosterone Cypionate Average Price by Manufacturers (2015-2020)2.4 Manufacturers Testosterone Cypionate Manufacturing Sites, Area Served, Product Type2.5 Testosterone Cypionate Market Competitive Situation and Trends2.5.1 Testosterone Cypionate Market Concentration Rate2.5.2 Global Top 5 and Top 10 Players Market Share by Revenue2.5.3 Market Share by Company Type (Tier 1, Tier 2 and Tier 3)2.6 Manufacturers Mergers & Acquisitions, Expansion Plans2.7 Primary Interviews with Key Testosterone Cypionate Players (Opinion Leaders) 3 Testosterone Cypionate Retrospective Market Scenario by Region3.1 Global Testosterone Cypionate Retrospective Market Scenario in Sales by Region: 2015-20203.2 Global Testosterone Cypionate Retrospective Market Scenario in Revenue by Region: 2015-20203.3 North America Testosterone Cypionate Market Facts & Figures by Country3.3.1 North America Testosterone Cypionate Sales by Country3.3.2 North America Testosterone Cypionate Sales by Country3.3.3 U.S.3.3.4 Canada3.4 Europe Testosterone Cypionate Market Facts & Figures by Country3.4.1 Europe Testosterone Cypionate Sales by Country3.4.2 Europe Testosterone Cypionate Sales by Country3.4.3 Germany3.4.4 France3.4.5 U.K.3.4.6 Italy3.4.7 Russia3.5 Asia Pacific Testosterone Cypionate Market Facts & Figures by Region3.5.1 Asia Pacific Testosterone Cypionate Sales by Region3.5.2 Asia Pacific Testosterone Cypionate Sales by Region3.5.3 China3.5.4 Japan3.5.5 South Korea3.5.6 India3.5.7 Australia3.5.8 Taiwan3.5.9 Indonesia3.5.10 Thailand3.5.11 Malaysia3.5.12 Philippines3.5.13 Vietnam3.6 Latin America Testosterone Cypionate Market Facts & Figures by Country3.6.1 Latin America Testosterone Cypionate Sales by Country3.6.2 Latin America Testosterone Cypionate Sales by Country3.6.3 Mexico3.6.3 Brazil3.6.3 Argentina3.7 Middle East and Africa Testosterone Cypionate Market Facts & Figures by Country3.7.1 Middle East and Africa Testosterone Cypionate Sales by Country3.7.2 Middle East and Africa Testosterone Cypionate Sales by Country3.7.3 Turkey3.7.4 Saudi Arabia3.7.5 U.A.E 4 Global Testosterone Cypionate Historic Market Analysis by Type4.1 Global Testosterone Cypionate Sales Market Share by Type (2015-2020)4.2 Global Testosterone Cypionate Revenue Market Share by Type (2015-2020)4.3 Global Testosterone Cypionate Price Market Share by Type (2015-2020)4.4 Global Testosterone Cypionate Market Share by Price Tier (2015-2020): Low-End, Mid-Range and High-End 5 Global Testosterone Cypionate Historic Market Analysis by Application5.1 Global Testosterone Cypionate Sales Market Share by Application (2015-2020)5.2 Global Testosterone Cypionate Revenue Market Share by Application (2015-2020)5.3 Global Testosterone Cypionate Price by Application (2015-2020) 6 Company Profiles and Key Figures in Testosterone Cypionate Business6.1 Pfizer6.1.1 Corporation Information6.1.2 Pfizer Description, Business Overview and Total Revenue6.1.3 Pfizer Testosterone Cypionate Sales, Revenue and Gross Margin (2015-2020)6.1.4 Pfizer Products Offered6.1.5 Pfizer Recent Development6.2 Cipla6.2.1 Cipla Testosterone Cypionate Production Sites and Area Served6.2.2 Cipla Description, Business Overview and Total Revenue6.2.3 Cipla Testosterone Cypionate Sales, Revenue and Gross Margin (2015-2020)6.2.4 Cipla Products Offered6.2.5 Cipla Recent Development6.3 Sun Pharmaceutical6.3.1 Sun Pharmaceutical Testosterone Cypionate Production Sites and Area Served6.3.2 Sun Pharmaceutical Description, Business Overview and Total Revenue6.3.3 Sun Pharmaceutical Testosterone Cypionate Sales, Revenue and Gross Margin (2015-2020)6.3.4 Sun Pharmaceutical Products Offered6.3.5 Sun Pharmaceutical Recent Development6.4 Teva6.4.1 Teva Testosterone Cypionate Production Sites and Area Served6.4.2 Teva Description, Business Overview and Total Revenue6.4.3 Teva Testosterone Cypionate Sales, Revenue and Gross Margin (2015-2020)6.4.4 Teva Products Offered6.4.5 Teva Recent Development6.5 Perrigo6.5.1 Perrigo Testosterone Cypionate Production Sites and Area Served6.5.2 Perrigo Description, Business Overview and Total Revenue6.5.3 Perrigo Testosterone Cypionate Sales, Revenue and Gross Margin (2015-2020)6.5.4 Perrigo Products Offered6.5.5 Perrigo Recent Development6.6 Hikma Pharmaceuticals6.6.1 Hikma Pharmaceuticals Testosterone Cypionate Production Sites and Area Served6.6.2 Hikma Pharmaceuticals Description, Business Overview and Total Revenue6.6.3 Hikma Pharmaceuticals Testosterone Cypionate Sales, Revenue and Gross Margin (2015-2020)6.6.4 Hikma Pharmaceuticals Products Offered6.6.5 Hikma Pharmaceuticals Recent Development 7 Testosterone Cypionate Manufacturing Cost Analysis7.1 Testosterone Cypionate Key Raw Materials Analysis7.1.1 Key Raw Materials7.1.2 Key Raw Materials Price Trend7.1.3 Key Suppliers of Raw Materials7.2 Proportion of Manufacturing Cost Structure7.3 Manufacturing Process Analysis of Testosterone Cypionate7.4 Testosterone Cypionate Industrial Chain Analysis 8 Marketing Channel, Distributors and Customers8.1 Marketing Channel8.2 Testosterone Cypionate Distributors List8.3 Testosterone Cypionate Customers 9 Market Dynamics9.1 Market Trends9.2 Opportunities and Drivers9.3 Challenges9.4 Porters Five Forces Analysis 10 Global Market Forecast10.1 Global Testosterone Cypionate Market Estimates and Projections by Type10.1.1 Global Forecasted Sales of Testosterone Cypionate by Type (2021-2026)10.1.2 Global Forecasted Revenue of Testosterone Cypionate by Type (2021-2026)10.2 Testosterone Cypionate Market Estimates and Projections by Application10.2.1 Global Forecasted Sales of Testosterone Cypionate by Application (2021-2026)10.2.2 Global Forecasted Revenue of Testosterone Cypionate by Application (2021-2026)10.3 Testosterone Cypionate Market Estimates and Projections by Region10.3.1 Global Forecasted Sales of Testosterone Cypionate by Region (2021-2026)10.3.2 Global Forecasted Revenue of Testosterone Cypionate by Region (2021-2026)10.4 North America Testosterone Cypionate Estimates and Projections (2021-2026)10.5 Europe Testosterone Cypionate Estimates and Projections (2021-2026)10.6 Asia Pacific Testosterone Cypionate Estimates and Projections (2021-2026)10.7 Latin America Testosterone Cypionate Estimates and Projections (2021-2026)10.8 Middle East and Africa Testosterone Cypionate Estimates and Projections (2021-2026) 11 Research Finding and Conclusion 12 Methodology and Data Source12.1 Methodology/Research Approach12.1.1 Research Programs/Design12.1.2 Market Size Estimation12.1.3 Market Breakdown and Data Triangulation12.2 Data Source12.2.1 Secondary Sources12.2.2 Primary Sources12.3 Author List12.4 Disclaimer*

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Testosterone Cypionate Market Size, Key Trends, Challenges and Standardization, Research, Key Players, Economic Impact and Forecast to 2026|Pfizer,...

ENGLEWOOD, CO / ACCESSWIRE / April 13, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today the launch of Regoxidine, an over-the-counter foam formulation of minoxidil available for use by both men and women. Regoxidine is indicated for hair treatment and regrowth and is available through the company's recently acquired, wholly-owned subsidiary Innovus Pharmaceuticals. Regoxidine is a branded alternative to hair regrowth treatment Rogaine.

Regoxidine is available for purchase through the product's website regoxidine.com. The product is also available through its Beyond Human marketing and sales platform and through Amazon. Over 11 million Americans purchased and used hair regrowth products in 2019.

Regoxidine for Men and Regoxidine for Women are the second and third FDA-approved, over-the-counter drugs Innovus Pharmaceuticals has launched to date following the launch of FlutiCare (fluticasone propionate 50 mcg nasal spray) in 2017. FlutiCare is indicated to treat nasal and allergy-related symptoms.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "We are excited about the launch of Regoxidine OTC and the expansion of our consumer health product portfolio. Regoxidine represents the first consumer product launch since completing the merger between Aytu and Innovus, and the consumer health team will continue its focus on developing and launching new products that address large segments of consumers. Through the expansion of the over-the-counter product portfolio, and the growth of our existing prescription and consumer healthcare products, we anticipate continued revenue growth with strong contribution from both of Aytu's business segments, expected to accelerate our path to profitability."

About Regoxidine 5% Minoxidil Foam for Men and Women

Regoxidine is a topical foam containing 5% minoxidil that is approved by the FDA as a hair regrowth treatment and is used to grow hair on the top of the scalp. The active ingredient is 5% minoxidil and is comparable to the Rogaine* line of similar products from Johnson & Johnson. The product comes in a 60g canister and will be sold as a 90-day supply for men and as a 120-day supply for women. Regoxidine is available as a foam for men and women.

The American Hair Loss Association (AHLA) reported that more than 95% of hair loss is caused by androgenetic alopecia. Also, approximately 35 million men and 21 million women 35 years of age and older experience hair loss. The 5% minoxidil market segment of the hair regrowth treatment market is projected to grow more than 4.5% annually through 2024. According to Global Market Insights the US market is valued at $0.5 billion with approximately 50 million retail units sold. The 5% foam products are the newest means of minoxidil delivery and are proven to be more effective against androgenic alopecia among men than other minoxidil formulations.

For more information visit http://www.regoxidine.com

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage 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 recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Story continues

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the Company's proprietary Beyond Human marketing and sales platform.

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 and visit innovuspharma.com to learn about the Company's consumer healthcare products.

Forward-Looking Statement

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: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 IgG/IgM Rapid Test, shipping delays and their impact on our ability to introduce the COVID-19 IgG/IgM Rapid Test, our ability to enforce our exclusive rights to distribute the COVID-19 IgG/IgM Rapid Test in the jurisdictions set forth in the distribution agreement, the ability of the COVID-19 IgG/IgM Rapid Test to accurately and reliably test for COVID-19, the manufacture of the COVID-19 IgG/IgM Rapid Test's ability to manufacture such testing kits on a high volume scale, manufacturing problems or delays related to the COVID-19 IgG/IgM Rapid Test, our ability to satisfy any labelling conditions or other FDA or other regulatory conditions to sell the COVID-19 IgG/IgM Rapid Test Kit, the ability to obtain a sufficient number of COVID-19 IgG/IgM Rapid Test kits to meet demand if any, the demand or lack thereof for the COVID-19 IgG/IgM Rapid Test Kit, effects of the business combination of Aytu and the Commercial Portfolio and the recently completed 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, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, 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.

*Rogaine is a trademark of Johnson & Johnson.

CONTACT:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

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Aytu BioScience Consumer Health Subsidiary Launches Regoxidine(R), an FDA Approved Hair Regrowth Treatment Foam that Contains 5% Minoxidil and Targets...

Hypergonadism is a condition in which your gonads overproduce hormones. Gonads are your reproductive glands. In men, gonads are the testes. In women, theyre the ovaries. As a result of hypergonadism, you can end up with higher-than-normal levels of testosterone and estrogen.

Hypergonadism is less common than hypogonadism. Hypogonadism is another term for abnormally low hormone production in the gonads.

Hypergonadism and hypogonadism are both treatable. However, depending on when they appear, they can affect puberty, fertility, and other issues related to development and reproductive health.

Hypergonadism that develops prior to puberty can lead to precocious puberty. Precocious puberty is the early and rapid onset of changes related to sexual maturity. Hypergonadism is one of several possible causes of precocious puberty.

In boys and girls, hypergonadism can bring on:

Some symptoms of hypergonadism and precocious puberty are unique to each sex.

In girls, hypergonadism can cause:

In boys, hypergonadism can cause:

Hormonal treatments aimed at slowing the onset of puberty can be effective, and may help to make for a more normal adolescence.

Doctors cant always diagnose the cause of precocious puberty. Some conditions that are associated with it include:

In mild cases of hypergonadism prior to puberty, the onset of physical and mood changes may not be abnormally early or significant enough to cause any psychological or long-term physical complications.

If hypergonadism develops after puberty, men may face early hair loss and women may have some facial hair growth.

The underlying cause of hypergonadism is often never identified. When the cause of is unknown, its known as idiopathic hypergonadism.

There are several health conditions that are known to cause hypergonadism. Some of them include:

Youre at a higher risk of hypergonadism if you use anabolic steroids. Thats because those supplements can lead to abnormally high levels of testosterone and other androgens (male sex hormones) as well as estrogen, a female sex hormone.

Aside from acne and other physical changes, such as facial hair on women and more breast tissue in men, hypergonadism can cause some more serious complications.

Hypergonadism can interfere with regular menstrual cycles. That can make it difficult for women to become pregnant.

Men may also have fertility challenges, especially if their hypogonadism was caused by anabolic steroid use. Anabolic steroids can affect testicular health, including reducing the production of sperm.

Generally, the complications associated with hypergonadism are related to the underlying cause. Treating the cause may help reduce symptoms and complications brought on by hypergonadism.

If you notice precocious puberty in your child or physical changes in yourself that may be related to hormonal abnormalities, discuss your concerns with a doctor.

If hypergonadism is suspected, your doctor may order a blood test to see if hormone levels are unusually elevated. Additional tests might include a pelvic ultrasound to get a more detailed view of the adrenal glands and other parts, such as the ovaries (for women). Brain imaging may be done to look for tumors of the pituitary gland.

Treating hypergonadism is difficult. The goal is to reduce hormone levels, which is more difficult than trying to increase hormone levels.

The hormonal treatments that are administered for hypergonadism include a combination of hormones tailored to your particular levels. This can be a slow process. It may take some time to find the right mix of hormones at the right dosages.

If a specific cause can be diagnosed, then treatment will also focus on caring for that condition. If a gland has a tumor, for instance, it may be necessary to surgically remove the tumor. If the cause is severe underactive thyroid, you may be prescribed strong doses of thyroid medication to help restore healthier body chemistry.

Hypergonadism, unlike hypogonadism, is a rare condition, often triggered by a more serious health problem. Treating that underlying cause and working with your doctor to help balance out your hormone levels may help you avoid or at least reduce hypergonadism complications.

One important key is to see a doctor as soon as you suspect that there may be hormone-related problems. An earlier start to hormone treatment may mean a faster resolution.

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Hypergonadism: Symptoms, Causes, Treatment, and More

Talk to anyone whose been around for a few decades, and youll usually hear that life gets sweeter with age. Even with the inevitable slowdown that starts in your 30s, your best years can still be ahead.

Perhaps youve noticed that slowdown: If you become fatigued more easily than you used to, your mind isnt as sharp, or your libido is on the decline, it could be because of low testosterone.

As you grow, your brain periodically produces signal hormones responsible for stimulating testosterone production, according to Vital4Men. Testosterone is the main hormone responsible for the growth and development of male sex organs, muscle mass, and bone density. It also gives you energy and affects your mood.

When testosterone reaches an acceptable range, brain signals slow down, which allows your testosterone to lower. However, that decrease could lead to testicular problems at this stage. This low level of testosterone production is called hypogonadism.

Signs you may have low testosterone

The symptoms of low testosterone or hypogonadism include the following:

You may not think that you have low testosterone if you ignore symptoms or simply attribute them to aging. Unfortunately, hoping these issues will go away on their own wont work and, in fact, you may notice they just get worse.

Your testosterone levels will likely continue to decline over time and the severity of your symptoms will most likely continue to increase, Vital4Men says.

However, if you pay attention, the good news is that low testosterone is treatable, so you can feel like yourself again and look forward to the years ahead.

One of the best treatments is testosterone replacement therapy.

What is testosterone replacement therapy?

Testosterone replacement therapy can improve the symptoms of low testosterone. Doctors may prescribe testosterone through injections, gels, patches, surgically implanted pellets, or oral options to improve hormone levels.

The treatment process is simple. For example, when you visit Vital4men, the medical professionals will perform a blood test to determine if you are an eligible candidate for testosterone replacement therapy, and youll receive your results within a few days.

If your testosterone levels fall outside the normal range, you may be a candidate for treatment. Your doctor will go over potential side effects to determine if testosterone replacement therapy is the right option.

At the viTal4men clinic, we treat low testosterone levels with testosterone replacement therapy to get you back to your optimum level, the company says. We are a complete mens wellness center.

The clinic will support you through the entire process. The best part, though, is the results. While your outcome will be individual, there are many potential benefits to testosterone replacement therapy:

If youre experiencing any of the symptoms of low testosterone, dont give up hope. Visit Vital4Men for more information and to schedule a free testosterone level test.

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What is testosterone replacement therapy, and do you need it - KTAR.com

Greater alcohol consumption is associated with lower serum bone formation markers in patients living with HIV (PLWHIV) with substance use disorder, according to study results published in Alcoholism: Clinical and Experimental Research.

Previous studies have established that low bone mass is common and fracture risk is increased for PLWHIV. Several factors may contribute to the low bone density, including the effect of HIV itself, low body mass index, hypogonadism, liver disease, and smoking and alcohol consumption.

As limited data are available on alcohol consumption and bone turnover markers, the goal of the current study was to investigate the association between alcohol consumption and bone turnover markers, specifically serum C-terminal telopeptide of type 1 collagen (CTX) and procollagen type 1 N-terminal propeptide (P1NP), in PLWHIV with substance use disorder.

The study cohort included 233 patients, and after exclusion of 35 due to fracture in the preceding year or missing data, the final sample was 198 individuals (median age, 50 years; 38% women). Almost all patients (93%) were prescribed antiretroviral medication, and most (72%) had HIV viral load suppression.

Approximately half (48%) of the study cohort met criteria for both current alcohol and drug dependence. At baseline and 12-month follow-up, the mean daily number of drinks was 1.93 and 1.51, respectively; mean number of heavy drinking days was 4.65 and 3.25, respectively.

Higher average number of drinks/day was significantly associated with lower P1NP (=-1.09; 95% CI, -1.94 to -0.23 per each additional drink). Bone formation was lower in patients who drank on 20 days in the past month (P1NP, -15.45 ng/mL; 95% CI, -26.23 to -4.67) compared with those who did not. Furthermore, a higher number of heavy drinking days was associated with lower bone formation (=-0.58, 95% CI, -1.05 to -0.12 per additional heavy drinking day).

There was a significant association between a phosphatidylethanol level 8 ng/mL and lower P1NP. In addition, an increase in mean drinks per day over 12 months was associated with a nonsignificant decrease in bone formation (=-1.14; 95% CI, -2.40 to 0.12; P =.08 per each additional drink).

As for the effect of change in alcohol consumption over time, the researchers reported that neither change in the number of heavy drinking days nor change in whether a participant had alcohol use on 20 days in a month was significantly associated with bone formation.

There were no significant associations between alcohol consumption and bone resorption.

The researchers acknowledged several study limitations, including that alcohol use was measured only during the 30 days before each study interview and not throughout the follow-up. Data were also missing on nadir CD4 levels and other markers to assess bone formation, and there was no HIV-uninfected comparator group.

Information about low [bone turnover markers] may provide motivation for [PLWHIV] to reduce alcohol use and mitigate risks related to abnormal bone metabolism, concluded the researchers.

Follow @EndoAdvisor

Reference

Kim TW, Ventura AS, Winter MR, et al. Alcohol and bone turnover markers among people living with HIV and substance use disorder [published online March 2, 2020]. Alcohol Clin Exp Res. doi:10.1111/acer.14303

This article originally appeared on Endocrinology Advisor

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Alcohol Consumption Linked to Lower Bone Formation Markers in Patients With HIV - Infectious Disease Advisor

Commercial Distribution of First 100,000 Tests to Commence Upon Receipt of Inbound Product Shipment

ENGLEWOOD, CO / ACCESSWIRE / March 23, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that it has received confirmation from the U.S. Food and Drug Administration (FDA) that the company may begin distribution of its Coronavirus Disease 2019 ("COVID-2019") IgG/IgM Rapid Test throughout the United States. The COVID-19 IgG/IgM Rapid Test is intended for professional use and delivers results between 2 and 10 minutes at the point-of-care.

Aytu expects delivery of its first shipment of 100,000 tests this week. The Company has been in discussions with healthcare distributors, healthcare institutions, medical practices, and government agencies and is working quickly to begin distribution into the U.S. healthcare supply chain.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "We are moving as quickly as we can to bring the COVID-19 IgG/IgM Rapid Test to the U.S. professional medical community. With product now in transit to our warehouse in Colorado we're optimistic that we can have test kits ready for sale in the very near term. In the two short weeks since signing our distribution agreement, we have ordered our first 100,000 tests and have received confirmation from FDA that we may begin distribution. We are optimistic that we're now just days away from placing these COVID-19 test kits into the hands of healthcare professionals."

The COVID-19 IgG/IgM Rapid Test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has been validated in a 126 patient clinical trial and is CE marked.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage 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 recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has been validated in a 113 patient clinical trial and has received CE marking.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

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 and visit innovuspharma.com to learn about the company's consumer healthcare products.

Story continues

Forward-Looking Statement

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: market and other conditions, the completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of net proceeds from the registered direct offering, the regulatory and commercial risks associated with introducing the COVID-19 Rapid Test, effects of the business combination of Aytu and the Commercial Portfolio and the recently completed 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, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, 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.

Contact for Media and Investors:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

Contact for COVID-19 IgG/IgM Rapid Test-Related Inquiries:COVID-19@aytubio.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/582030/Aytu-BioScience-Submits-Notice-of-Commercialization-to-the-FDA-Allowing-for-Companys-Distribution-of-its-2-10-Minute-COVID-19-IgGIgM-Point-of-Care-Rapid-Test

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Aytu BioScience Submits Notice of Commercialization to the FDA, Allowing for Company's Distribution of its 2-10 Minute COVID-19 IgG/IgM Point-of-Care...

Company Expects to Seek Regulatory Clearance Under Health Canada and COFEPRIS Expedited Clearance Procedures

ENGLEWOOD, CO / ACCESSWIRE / March 19, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that it extended its distribution right to commercialize the clinically validated and commercially used coronavirus 2019 (COVID-19) IgG/IgM Rapid Test. The test has been licensed from L.B. Resources, Limited (a Hong Kong Corporation). The COVID-19 IgG/IgM Rapid Test is intended for professional use and delivers clinical results between 2 and 10 minutes at the point-of-care. This amendment expands Aytu's commercial rights and grants Aytu the right to distribute and commercialize the COVID-19 test in North America, specifically including the United States, Canada and Mexico.

The Company expects to pursue expedited regulatory clearance of the product with Health Canada and COFEPRIS (Comisin Federal para la Proteccin contra Riesgos Sanitarios), the regulatory agencies in Canada and Mexico, respectively.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "We have to be progressive in doing our part in combatting the spread of the COVID-19 virus. We need to ensure that screening is available across North America and providing broad access to screening tests has to be among our highest priorities as we collectively fight the coronavirus outbreak. With COVID-19 now designated as a global pandemic, we believe we should expand our efforts to assist healthcare providers with faster point-of-care detection."

The COVID-19 IgG/IgM Rapid Test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has been validated in a 113 patient clinical trial and is CE marked.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage 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 recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has been validated in a 113 patient clinical trial and has received CE marking.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

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 and visit innovuspharma.com to learn about the company's consumer healthcare products.

Story continues

Forward-Looking Statement

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: market and other conditions, the completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of net proceeds from the registered direct offering, the regulatory and commercial risks associated with introducing the COVID-19 Rapid Test, effects of the business combination of Aytu and the Commercial Portfolio and the recently completed 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, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, 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.

Contact for Media and Investors:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/581543/Aytu-BioScience-Expands-Its-Distribution-Rights-for-Coronavirus-2019-COVID-19-Point-of-Care-Rapid-Test-to-Canada-and-Mexico

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Aytu BioScience Expands Its Distribution Rights for Coronavirus 2019 (COVID-19) Point-of-Care Rapid Test to Canada and Mexico - Yahoo Finance

Financing to speed commercialization of the only FDA-approved oral treatment of its kind for testosterone deficiency1,2

NORTHBROOK, Ill., March 16, 2020 (GLOBE NEWSWIRE) -- Clarus Therapeutics, Inc., a commercial mens health specialty pharmaceutical company, announced today that it has completed a senior debt financing of up to $75M. Morgan Stanley & Co. LLC acted as sole placement agent for the transaction.

Clarus will use the proceeds from this financing to accelerate the commercialization strategy and launch for JATENZO (testosterone undecanoate) capsules, CIII, the first and only FDA-approved oral softgel testosterone replacement therapy for the treatment of men with hypogonadism due to certain medical conditions. This additional investment builds on an exceptional year for the company, which includes hiring multiple key executives and making JATENZO available for patients.

We are thrilled to have this investment as we bring JATENZO to market, said Dr. Robert Dudley, Chief Executive Officer of Clarus Therapeutics, Inc. We can now fully implement JATENZOs commercialization strategy and move Clarus closer to profitability.

About HypogonadismHypogonadism, also known as testosterone deficiency, is a condition in men in which the body does not produce enough testosterone.3 Only those men who are symptomatic and have consistently low results on a reliable testosterone assay should be offered testosterone replacement therapy, according to current treatment guidelines from both the Endocrine Society and the American Urological Association.3,4 Treatment is meant to induce and maintain secondary sex characteristics and improve clinical symptoms associated with testosterone deficiency.4About Clarus Therapeutics, Inc.Clarus is a men's specialty pharmaceutical company developing and commercializing JATENZO, a product protected by patents issued in the United States and in other major pharmaceutical markets around the world. Clarus owns the worldwide, royalty-free commercialization rights for JATENZO.For more information, please visit:www.clarustherapeutics.com.

About JATENZO JATENZO is the first and only FDA-approved oral testosterone undecanoate for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).1,2

JATENZOs proprietary formulation is built around testosterone undecanoatea testosterone prodrug that the body converts to testosterone. In the JATENZO pivotal inTUne (investigational testosterone undecanoate) clinical trial, 87 percent of hypogonadal men treated with JATENZO achieved a mean total testosterone concentration in the eugonadal range at the end of treatment.1 The efficacy and safety of JATENZO was evaluated in 166 adult, hypogonadal males in a 4-month, open-label study. The primary endpoint was the percentage of patients with mean plasma total testosterone concentration (Cavg) over 24 hours within the normal eugonadal range on the final pharmacokinetic visit of the study.

INDICATIONJATENZO (testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

Limitation of use

Safety and efficacy of JATENZO in males less than 18 years old have not been established.

IMPORTANT SAFETY INFORMATION

WARNING: INCREASES IN BLOOD PRESSURE

CONTRAINDICATIONS

JATENZO is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate, in women who are pregnant, in men with a known hypersensitivity to JATENZO or its ingredients, or in men with hypogonadal conditions that are not associated with structural or genetic etiologies as JATENZO has not been established for these conditions and there is a risk of increased blood pressure with JATENZO that can increase the risk of MACE.

WARNINGS AND PRECAUTIONS

ADVERSE EVENTS

The most common adverse events of JATENZO (incidence 2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

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The safety and efficacy of JATENZO in pediatric patients less than 18 years old have not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses.

There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing JATENZO to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. There is insufficient long-term safety data in geriatric patients utilizing JATENZO to assess the potentially increased risk of cardiovascular disease and prostate cancer.

Please click here for full Prescribing Information, including BOXED WARNING on increases in blood pressure.

Media ContactAmir KhanPhone: (212) 462-8767Email: Amir.Khan@Syneoshealth.com

1JATENZO (testosterone undecanoate) [prescribing information]. Clarus Therapeutics, Inc.

2US Food & Drug Administration. FDA Approved Drug Products. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206089. Accessed October 1, 2019.

3Bhasin S, et al. J Clin Endocrinol Metab. 2018;103(5):1715-1744.

4Mulhall JP, et al. J Urol. 2018;200(2):423-432.

2020 Clarus Therapeutics, Inc. All rights reserved.

JATENZO is a registered trademark of Clarus Therapeutics, Inc.

COR-US-0038 03/2020

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CLARUS THERAPEUTICS ANNOUNCES FINANCING TO SUPPORT THE COMMERCIAL LAUNCH AND AVAILABILITY OF JATENZO (TESTOSTERONE UNDECANOATE) CAPSULES, CIII FOR THE...

Greater alcohol consumption is associated with lower serum bone formation markers in patients living with HIV (PLWHIV) with substance use disorder, according to study results published in Alcoholism: Clinical and Experimental Research.

Previous studies have established that low bone mass is common and fracture risk is increased for PLWHIV. Several factors may contribute to the low bone density, including the effect of HIV itself, low body mass index, hypogonadism, liver disease, and smoking and alcohol consumption.

As limited data are available on alcohol consumption and bone turnover markers, the goal of the current study was to investigate the association between alcohol consumption and bone turnover markers, specifically serum C-terminal telopeptide of type 1 collagen (CTX) and procollagen type 1 N-terminal propeptide (P1NP), in PLWHIV with substance use disorder.

The study cohort included 233 patients, and after exclusion of 35 due to fracture in the preceding year or missing data, the final sample was 198 individuals (median age, 50 years; 38% women). Almost all patients (93%) were prescribed antiretroviral medication, and most (72%) had HIV viral load suppression.

Approximately half (48%) of the study cohort met criteria for both current alcohol and drug dependence. At baseline and 12-month follow-up, the mean daily number of drinks was 1.93 and 1.51, respectively; mean number of heavy drinking days was 4.65 and 3.25, respectively.

Higher average number of drinks/day was significantly associated with lower P1NP (=-1.09; 95% CI, -1.94 to -0.23 per each additional drink). Bone formation was lower in patients who drank on 20 days in the past month (P1NP, -15.45 ng/mL; 95% CI, -26.23 to -4.67) compared with those who did not. Furthermore, a higher number of heavy drinking days was associated with lower bone formation (=-0.58, 95% CI, -1.05 to -0.12 per additional heavy drinking day).

There was a significant association between a phosphatidylethanol level 8 ng/mL and lower P1NP. In addition, an increase in mean drinks per day over 12 months was associated with a nonsignificant decrease in bone formation (=-1.14; 95% CI, -2.40 to 0.12; P =.08 per each additional drink).

As for the effect of change in alcohol consumption over time, the researchers reported that neither change in the number of heavy drinking days nor change in whether a participant had alcohol use on 20 days in a month was significantly associated with bone formation.

There were no significant associations between alcohol consumption and bone resorption.

The researchers acknowledged several study limitations, including that alcohol use was measured only during the 30 days before each study interview and not throughout the follow-up. Data were also missing on nadir CD4 levels and other markers to assess bone formation, and there was no HIV-uninfected comparator group.

Information about low [bone turnover markers] may provide motivation for [PLWHIV] to reduce alcohol use and mitigate risks related to abnormal bone metabolism, concluded the researchers.

Follow @EndoAdvisor

Reference

Kim TW, Ventura AS, Winter MR, et al. Alcohol and bone turnover markers among people living with HIV and substance use disorder [published online March 2, 2020]. Alcohol Clin Exp Res. doi:10.1111/acer.14303

Originally posted here:
Alcohol Consumption Linked to Lower Bone Formation Markers in Patients With HIV - Endocrinology Advisor

Updated FDA Policy Likely Enables Near-Term Availability of COVID-19 Test in the U.S.

ENGLEWOOD, CO / ACCESSWIRE / March 17, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that the company intends to expedite the U.S. launch of its recently licensed COVID-19 IgG/IgM Point-of-Care Rapid Test in light of yesterday's updated FDA policy on coronavirus diagnostic testing.

On March 16, 2020 the FDA announced, "as part of our ongoing and aggressive commitment to address the coronavirus outbreak, the FDA updated a policy originally issued on Feb. 29 on diagnostic testing for coronavirus (COVID-19) in order to achieve more rapid testing capacity in the U.S. We believe the unprecedented policy set forth in today's updated guidance, which addresses laboratories and commercial manufacturers, will help address these urgent public health concerns by helping to expand the number and variety of diagnostic tests..." Further, the agency made recommendations specifically for test developers stating that "the FDA does not intend to object to the distribution and use of serology tests to identify antibodies to SARS-CoV-2 where the test has been validated" and other labeling conditions are satisfied.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "While we are still working with FDA on making the COVID-19 Rapid Test available, we believe that this updated policy may enable near-term availability of our recently-licensed point-of-care test. During this public health emergency, we are working tirelessly to satisfy all requirements in order to make the test available to the professional medical community as soon as possible." Disbrow also commented that, "We have already gotten confirmation from the manufacturer that our initial supply is being shipped and is expected to arrive in the U.S. very soon."

The company will continue to provide updates about the near-term availability of the COVID-19 test.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage 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 recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

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 and visit innovuspharma.com to learn about the company's consumer healthcare products.

Forward-Looking Statement

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 regulatory and commercial risks associated with introducing the COVID-19 Rapid Test, 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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Aytu BioScience Announces Acceleration of U.S. Availability of COVID-19 IgG/IgM Rapid Test Based on Updated FDA Policy - Yahoo Finance

NATIONAL HARBOR, Maryland Long-term opioid use in men is linked to a significantly increased risk for hypogonadism, new research suggests.

Findings from a retrospective case-control study show that men who used long-acting opioids on a long-term basis had close to a 1.5-fold increased risk of developing the condition. Moreover, for every increase in 100 maximum morphine equivalent daily dose (MEDD), there was a 44% increase in risk.

Dr Natalie Hanks

Hypogonadism, a condition in which little or no testosterone is produced by the testes, puts men at risk for infertility and osteoporosis, but such adverse endocrine effects of long-term opioid use are frequently unrecognized, study investigator Natalie Hanks, MD, Ochsner Clinical School, University of Queensland University Medical Center, New Orleans, Louisiana, told Medscape Medical News.

The findings were presented here at the American Academy of Pain Medicine (AAPM) 2020 Annual Meeting.

The investigators note that opioid-induced androgen deficiency (OPIAD) can be detrimental to patients' quality of life as well as to the healthcare system.

The investigators examined the dose-response relationship between opioids and hypogonadism to shed more light on future diagnosis and management of OPIAD.

The researchers analyzed data from 357 men aged 1880 years with long-term opioid use, defined as using opioids continuously for longer than 3 months.

Exclusion criteria included the following: a diagnosis of hypogonadism prior to initiation of long-term opioid use; a history of Klinefelter syndrome, a rare genetic condition in which a male is born with an extra copy of the X chromosome; other chromosomal abnormalities; cryptorchidism; varicocele; myotonic dystrophy; mumps; radiotherapy to the testes; testicular torsion; long-term corticosteroid use; prostate cancer; or an endocrine disorder.

In total, 95 long-term opioid users had hypogonadism and served as case patients; 263 long-term opioid users did not have hypogonadism and served as control patients.

Case patients were matched to control patients by age, race, and body mass index in a 1:4 ratio. MEDD data were collected from electronic health records.

The prevalence of hypogonadism varied with MEDD dose. It was 15.6% for MEDD <100; 27.1% for MEDD 100199; 41.5% for MEDD 200299, 35.7% for MEDD 300499; and 50% for MEDD 500800.

Interestingly, for 14 patients, the estimated probability of hypogonadism plateaued in the MEDD 500800 range.

The results also showed a significant linear association between maximum MEDD and the odds of developing hypogonadism with long-term use of long-acting opioids (odds ratio, 1.44; 95% confidence interval, 1.16 1.78) by 100 units' difference in maximum MEDD.

"I feel as if hypogonadism is often overlooked or forgotten among all of the other side effects that go along with opioid use," Hanks said. "Our findings require replication in other clinical settings, but our results do suggest that we should start to look for signs of hypogonadism and opioid-induced androgen deficiency in this population and try to diagnose and treat it promptly."

Commenting on the findings for Medscape Medical News, Robert Bolash, MD, Cleveland Clinic, in Ohio, said the study provides important information about an often ignored side effect of long-term opioid use.

Dr Robert Bolash

This "well-matched control trial was conducted in a sizeable cohort and shows a thought-provoking dose-response curve," said Bolash.

"The relationship appears to be nonlinear, with particular hazard at low and moderate doses, then a plateau at high-dose therapy ranges. It would be interesting to see if duration of therapy was similarly hazardous or if dose was the primary driver of this endocrine dysfunction," he added.

Bolash also said the study is an important reminder about this important side effect of long-term opioid used.

"Contemporary pain physicians often consider the respiratory depressant and gastrointestinal side effects of this class of therapy, and may need to revisit the notable challenges that opioids can impart on the endocrine side effects as well," he noted.

Hanks and Bolash report no relevant financial relationships.

American Academy of Pain Medicine (AAPM) 2020 Annual Meeting: Abstract LB015. Presented February 27, 2020.

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Long-term Opioid Use in Men Linked to Hypogonadism - Medscape

Latest Report on Hormone Replacement Therapeutics Market size | Segment by Applications (Menopause, Hypothyroidism, Growth Hormone Deficiency, Male Hypogonadism and Other Diseases), by Type (Estrogen Hormone, Growth Hormone, Thyroid Hormone and Testosterone Hormone), Regional Outlook Opportunity, Market Demand, New Latest Trends, Hormone Replacement Therapeutics Market Share & Revenue by Manufacturers, Leading Companies Profiles, 2026. Analyzes current market size and upcoming Few years growth of this industry.

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Hormone Replacement Therapeutics Market Share, By Product Analysis, Application, End-Use, Regional Outlook, Competitive Strategies & Forecast up...

The Male Hypogonadism Market report embarks with industry overview which interprets value chain structure, industrial environment along with regional analysis, application, market size, and forecast. It provides overall Analysis of Male Hypogonadism Market industry structure, types, applications, regions, competitors and forecast period from 2020-2026. It also determines investment opportunities and probable threats in the industry based on an intelligent analysis. Moreover, the report serves an inclusive analysis of this market by volume and value.

This report focuses on the Global Male Hypogonadism Market trends, future forecast, growth opportunity, key market and key players. The study objectives are to present the Male Hypogonadism development in North America, Europe, China, Japan, Southeast Asia, India and Central & South America.

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Topmost List manufacturers/ Key player/ Economy by Business Leaders Leading Players of Male Hypogonadism Market Are:Astrazeneca Plc.Merck& Co. Inc.Laboratories GenevrierAllergan Plc.Endo International Plc.FerringAnd More

In market segmentation by types of Male Hypogonadism, the report covers:Testosterone Replacement TherapyGonadotropin-Releasing Hormones Therapy

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Male Hypogonadism Market Segment by Regions, regional analysis covers:North America (USA, Canada, and Mexico)Europe (Germany, France, UK, Russia, and Italy)Asia-Pacific -(China, Japan, Korea, India, and Southeast Asia)South America (Brazil, Argentina, Columbia etc.)The Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria, and South Africa).

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Male Hypogonadism Market Historic Data (2015-2019):

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Global Male Hypogonadism Market Size |Incredible Possibilities and Growth Analysis and Forecast To 2026 | Astrazeneca Plc., Merck& Co. Inc.,...

The Global Testosterone Gel Market report provides a holistic evaluation of the market for the forecast period (20192026). The report comprises of various segments as well an analysis of the trends and factors that are playing a substantial role in the market. These factors; the market dynamics, involves the drivers, restraints, opportunities and challenges through which the impact of these factors in the market are outlined. The drivers and restraints are intrinsic factors whereas opportunities and challenges are extrinsic factors of the market. The Global Testosterone Gel Market study provides an outlook on the development of market in terms of revenue throughout the prognosis period.

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Global Testosterone Gel Market: Scope of the Report This report provides an all-inclusive environment of the analysis for the Global Testosterone Gel Market . The market estimates provided in the report are the result of in-depth secondary research, primary interviews and in-house expert reviews. These market estimates have been considered by studying the impact of various social, political and economic factors along with the current market dynamics affecting the Global Testosterone Gel Market growth.

Along with the market overview, which comprises of the market dynamics the chapter includes a Porters Five Forces analysis which explains the five forces: namely buyers bargaining power, suppliers bargaining power, threat of new entrants, threat of substitutes, and degree of competition in the Global Testosterone Gel Market. It explains the various participants, such as system integrators, intermediaries and end-users within the ecosystem of the market. The report also focuses on the competitive landscape of the Global Testosterone Gel Market.

Global Testosterone Gel Market: Competitive Landscape The market analysis entails a section solely dedicated for major players in the Global Testosterone Gel Market wherein our analysts provide an insight to the financial statements of all the major players along with its key developments product benchmarking and SWOT analysis. The company profile section also includes a business overview and financial information. The companies that are provided in this section can be customized according to the clients requirements.

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Testosterone Gel Market can be segmented into Product Types as 0.010.0162

Testosterone Gel Market can be segmented into Applications as Primary hypogonadismHypogonadotropic hypogonadismLate-onset hypogonadism

Testosterone Gel Market: Regional analysis includes: Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia) Europe (Turkey, Germany, Russia UK, Italy, France, etc.) North America (United States, Mexico, and Canada.) South America (Brazil etc.) The Middle East and Africa (GCC Countries and Egypt.)

Major Players included in this report are as follows AbbVieTevaPerrigoEndo PharmaceuticalsAcerus PharmaceuticalsLupinDr. Reddys LaboratoriesUpsher-Smith Laboratories

Global Testosterone Gel Market: Research Methodology The research methodology is a combination of primary research secondary research and expert panel reviews. Secondary research includes sources such as press releases company annual reports and research papers related to the industry. Other sources include industry magazines, trade journals, government websites and associations were can also be reviewed for gathering precise data on opportunities for business expansions in Global Testosterone Gel Market.

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Global Testosterone Gel Market Insight Growth Analysis on Volume, Revenue and Forecast to 2019-2026 - 3rd Watch News

Analystview market insights has added a new report titled,Hormone Replacement Therapy (HRT) Market research report provided by Analystview market insights is a complete study of the Global Hormone Replacement Therapy (HRT) Market in its vast database of research reports.The report presents a comprehensive scenario of the market so as to calculate the market size, based on the way of study, synthesis, and summation of data from multiple sources. The global , which covers all the necessary information required by new market entrants as well as the existing players to gain a deeper insight into the market.

The report offers a complete company profiling of leading players competing in the global Hormone Replacement Therapy (HRT) market with high focus on share, gross margin, net profit, sales, product portfolio, new applications, recent developments, and several other factors. It also throws light on the vendor landscape to help players become aware of future competitive changes in the global Hormone Replacement Therapy (HRT) market.

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The main company in this survey is: Amgen, Inc., Novo Nordisk, Eli Lily, Abbott, and Genentech

By the Replacement therapy, the market is primarily split into : Estrogen, Human Growth Hormone, Testosterone, Thyroid,

By the Route of Administration, the market is primarily split into : Parenteral, Oral, Transdermal, Other,

By the Disease, the market is primarily split into : Male Hypogonadism, Menopause, Hypothyroidism, Growth Hormone Deficiency, Others,

Regional Market Analysis

This is one of the most valuable portions of the research study that helps readers to gain a quick understanding of the advancement of the global Hormone Replacement Therapy (HRT) markets in different parts of the world. The regional analysis provided in the report can be a powerful tool that market players can use to increase their presence in the global Hormone Replacement Therapy (HRT) markets. Each geographical market studied in the report is analyzed on the basis of crucial factors such as gross margin, market share, production, price, consumption, and CAGR.

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An in-depth study of the Global Hormone Replacement Therapy (HRT) Market, including a complete evaluation of the parent market. A thorough analysis of the market providing a complete understanding of the market size and its commercial landscape. Hormone Replacement Therapy (HRT) market evaluation by upstream and downstream raw materials, present market dynamics, and subsequent consumer analysis. Analysis providing the driving and restraining factors of the Global Hormone Replacement Therapy (HRT) Market and its impact on the global industry. A thorough understanding of Hormone Replacement Therapy (HRT) industry plans that are now increasingly being adopted by leading private businesses. Value chain analysis of the market, providing a clear understanding of the key intermediaries involved, and their individual roles at every phase of the value chain. Porters five forces analysis of the market, elaborating the efficiency of purchasers and sellers to develop efficient growth strategies. Competitive landscape analysis, highlighting the leading competitors in the market so as to understand the strategies adopted by them.

Table of Contents

Overview: Includes product scope, highlights of segment analysis, and Hormone Replacement Therapy (HRT) market size forecast.Competition Includes production, revenue, and average price shares by manufacturers and sheds light on competitive situations and trends.Regional Production: Focuses on production, revenue, price, and gross margin of regional Hormone Replacement Therapy (HRT) markets.Consumption: Focuses on regional consumption in different parts of the world.Research Findings and Conclusion: Tells what the analysts make of this research study and the global Hormone Replacement Therapy (HRT) and includes valuable suggestions for achieving market success.

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Hormone Replacement Therapy (HRT) Market to Witness Promising Growth Opportunities During 20202025 with Top Leading Players Amgen, Inc., Novo Nordisk,...

The Global Steroids Market is expected to grow at a CAGR of XX% during the forecast period, 2017-2025.Increase in geriatric population drives the androgens and anabolic steroids market, as older men are more prone to hypogonadism. Additionally, rise in obesity in men propels the global androgens and anabolic steroids market.

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The increasing poor health status especially in the developing countries is projected to fuel the growth of the market during the forecast period. Moreover, rise in government initiatives for better health care is attributed to the growth of the global androgens and anabolic steroids market.This report analyses the future prospects of Global Steroids Market.

Development policies and plans are discussed as well as manufacturing processes and cost structures are also analyzed. This report also states import/export consumption, supply and demand Figures, cost, price, revenue and gross margins.

Complete report on Steroids Industry spread across 114 pages, profiling 09 companies and supported with tables and figures. Enquire for more at https://www.orianresearch.com/enquiry-before-buying/484751

Top Key Companies Analyzed in Global Steroids Market are PFIZER Novartis Merck Sanofi Johnson And Johnson GSK Astrazeneca Cipla Sumitomo

Key benefit of this report: This report provides current market trends and future growth expectations. This report examines the market size and changing competitive dynamics It covers information regarding key drivers, challenges or restraining market growth It provides a five-year forecast assessed on the basis market value chain, porters five forces, and supply chain management. Market factor analysis delivers treasured information regarding the possible purchasers and suppliers and understanding the stakeholders involved. This report incorporates data regarding companies and business decision by having complete insights on the markets and by creating in depth analysis of market segments.

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Major Points Covered in Table of Contents:1. Executive Summary2. Demographic Overview3. Research Methodology4. Premium Insights5. Market Overview6. Market Factor Analysis7. Market Segment by Types8. Market Segment by Application9. Market Segment by Routes of Administration10. Market Segment by End User11 Market Segment by Regions12 Market Trends & Competitive Analysis

13 Company ProfilesAuthor ListDisclosure SectionResearch MethodologyData Source

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Steroids Market Size 2019: Global Industry Share, Types, Applications, Top Key Players, Demand Analysis and 2025 Forecast Report - News Times

MedicalResearch.com Interview with:

Robert E. Dudley, Ph.D.Chairman, Chief Executive Officer and PresidentClarus Therapeutics

Dr. Dudley discusses the recent announcement that Clarus Therapeutics, Inc. has launched JATENZO (testosterone undecanoate) capsules for the treatment of appropriate men with testosterone deficiency (hypogonadism):

MedicalResearch.com: What is the background for this announcement?

Response: JATENZOis the first and only oral softgel testosterone undecanoate and the first oral testosterone product approved by the U.S. FDA in more than 60 years.JATENZO is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

The launch of JATENZO means that physicians and men living with testosterone deficiency due to genetic or structural abnormalities finally have a safe and effective oral testosterone replacement therapy. We are proud to commercially launch this unique oral formulation to healthcare providers and the appropriate patients who they treat. JATENZO is now available at pharmacies across the country.

MedicalResearch.com: What are the main findings of the underlying studies?

Response: JATENZO was evaluated in a Phase 3 pivotal trial among 166 adult, hypogonadal men in a 4-month, open-label study with a topical testosterone comparator arm. The starting dose was 237 mg twice daily (BID) with meals. Dose adjustments (minimum 158 mg BID; maximum 396 mg BID) were made roughly 3 and 7 weeks after initiation of JATENZO based on average circulating testosterone concentration levels. 87% of JATENZO patients reached testosterone levels within the normal eugonadal range at the end of the study; peak testosterone levels were in close alignment with FDA targets.

Across all Phase 2 and Phase 3 trials combined, the safety of JATENZO has been evaluated in 569 patients who were treated with JATENZO for up to two (2) years. Liver toxicity was not observed with JATENZO in clinical trials.

Mild gastrointestinal adverse events observed with JATENZO were transient, manageable and did not lead to discontinuation.Decreased HDL cholesterol and increased hematocrit were associated with JATENZO use but did not lead to discontinuation of JATENZO. Only three of the 166 patients (1.8%) in the 4-month study experienced adverse reactions that led to premature discontinuation from the study, including rash (n=1) and headache (n=2). JATENZO was associated with an increase in systolic blood pressure. A boxed warning about the potential risks associated with elevated blood pressure appears on JATENZO labeling. Patients on JATENZO should have their blood pressure monitored.

Among the 569 patients who received JATENZO in all Phase 2 and 3 trials combined, the following adverse reactions were reported in >2% of patients: polycythemia, diarrhea, dyspepsia, eructation (i.e., burping), peripheral edema, nausea, increased hematocrit, headache, prostatomegaly (i.e., enlarged prostate), and hypertension.

MedicalResearch.com: How doesJATENZO differ from other treatments for testosterone deficiency?

Response: The launch of JATENZO is an important step forward in testosterone replacement therapy. The only other oral testosterone replacement therapy product ever approved by the FDA is methyltestosterone (an alkylated androgen) that has been associated with serious liver toxicity and is rarely, if ever, used today. Because JATENZO is formulated as a lipophilic prodrug, it bypasses the first-pass hepatic metabolism. No liver toxicity-related events were observed in clinical studies of JATENZO including in patients who took JATENZO at higher doses than recommended in current product labeling for two (2) years.

We believe JATENZO addresses a long-standing need for a safe and effective oral testosterone replacement product that meets current day FDA safety and efficacy standards. JATENZO enters a market where the vast majority of hypogonadal men are treated with injectable or topical testosterone products. JATENZO avoids administration challenges seen with these non-oral treatments it presents no injection site pain, no transfer risk, no mess, no skin irritation and no surgical procedure. Therefore, we believe a significant number of hypogonadal men will prefer JATENZO as an alternative to other forms of testosterone therapy.

MedicalResearch.com: How are men tested to determine ifJATENZO therapy is appropriate for them?

Response: According to the American Urological Association and Endocrine Society clinical guidelines, diagnosis of hypogonadism is determined by both the identification of symptoms and/or signs consistent with hypogonadism and blood test measurement of low morning total serum testosterone concentration (defined as <300 ng/dL, on two separate days). Healthcare providers should assess each patient individually for the appropriateness of JATENZO to treat their clinical hypogonadism.

MedicalResearch.com: What else should readers take away from your report?

Response: Clinical hypogonadism can be more complex than most people realize and left untreated, can have a profound negative impact for the individual. Men with the symptoms of hypogonadism have a real medical need that deserves appropriate diagnosis and treatment.

Any disclosures?

Pleaseclick herefor full Prescribing Information, including BOXED WARNING on increases in blood pressure.

Citation:

CLARUS THERAPEUTICS ANNOUNCES COMMERCIAL LAUNCH AND AVAILABILITY OF JATENZO (TESTOSTERONE UNDECANOATE) CAPSULES, CIII FOR THE TREATMENT OF HYPOGONADISM

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Feb 19, 2020 @ 12:05 pm

The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.

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Clarus Therapeutics Lauches JATENZO - Oral Testosterone Replacement Therapy - MedicalResearch.com

6 Serious Health Conditions Linked To Erectile Dysfunction

There is a connection between ED and dementia, heart disease, and other diseases.

We frequently think of erectile dysfunction as a minor consequence or side effect of getting older, and that makes sense. After all, some data show that more than half of all men ages 40 to 70 have some form of erectile dysfunction. But did you know that having difficulty getting or maintaining an erection could also be a sign of other health difficulties?

Here are six diseases linked to erectile dysfunction:

1.Stroke and Heart Attack

Erectile Dysfunction is one of the earliest symptoms of blockage in arteries, which could start to a stroke or heart attack, A Heart Attack happens when blood flow to a portion of the heart is blocked, normally by a blood clot. The damage to the heart tissue normally is made by a blocked coronary artery, which then prevents oxygen from getting to the tissue muscle of the heart. A heart attack is the most common cause of death in the US. There have been many new studies showing a relationship between erectile dysfunction and a heart condition.

A stroke occurs when a blood vein feeding the brain gets clogged or bursts. He points out that the arteries which supply the penis get blocked first because they are smaller that also within 20 and 30 percent of men who have Erectile Dysfunction have some form of unknown heart disease or blockage in their blood veins if they also have at least two other risk factors for developing a heart condition. So if you are a smoker with ED and high cholesterol, for example, you might want to ask your physician to check out your heart, too.

2.Coronary Artery Disease (CAD)

Coronary artery disease occurs when some important blood veins that provide your heart with blood, oxygen, and nutrients (coronary arteries) become injured or diseased. Cholesterol-containing deposits in your veins and infection are usually to blame for coronary artery disease. Coronary artery disease (CAD) is the most common sign of heart disorder. It is the leading cause of death in the United States in both men and women.

Diseased arteries can also be an important symptom of another heart disease later on in life. One research shows having ED under the age of 45 is a major risk factor for CAD. While CAD can cause stroke and heart attack, it can also lead to heart failure and abnormal pulse. According to your physicians, presently understand that theres a link between erectile dysfunction and the lining of the blood veins, called the endothelium.

The endothelium tells the blood veins when to contract and relax, he says. The endothelium can become damaged from something like stress and tobacco usage, making it more difficult for the insulation to function accurately and for blood to reach the penis because the blood veins providing the penis are unable to relax.

3.Diabetes

Diabetes is a disease that occurs when your blood glucose, also called blood sugar, is too high. Blood glucose is your main source of power and comes from the meals you eat. Diabetes has one of the most devastating influences on erectile Dysfunction for two reasons: Not only does it affect blood flow, but it also affects the nerves.

Men among with diabetes are four to six times more hopeful to develop erectile dysfunction. Diabetes can also start to strokes and heart attacks disease.

4.Dementia

Dementia is a common term applied to explain many signs of the cognitive drop, such as forgetfulness. It is a sign of various underlying disorders and brain diseases According to a 2015 research, men among erectile dysfunction are 1.69 times more possible to improve dementia than men who dont have Erectile Dysfunction.

While this research shows a relationship among erectile dysfunction and dementia, it does not truly show that dementia causes of erectile dysfunctionor vice versa. But now, there is not sufficient research to say for sure whether one causes the other. But still, he faces out that the two diseases often have some of the related risk factorslike atherosclerosis, elevated cholesterol, and diabetes, etc.

5.Prostate cancer

Prostate disease is cancer that happens in the prostate a small walnut-shaped gland in men that produces the seminal liquid that nourishes and transports sperm. This is a difficult one: When it comes to prostate cancer, two situations are occurring. Having prostate cancer it does not cause of Erectile Dysfunction, but the treatments used to fight cancerlike surgery or radiation can. He says surgery is the most frequent cause of Erectile Dysfunction in men who have prostate cancer. Aurogra 100 medicine can also help to cure Erectile Dysfunction.

When a prostate is killed, the nerves can get damaged, resulting in erectile dysfunction, he describes. Tissues and blood veins destroyed by radiation can also cause Erectile Dysfunction. It is the second-leading disease of cancer deaths for men in the U.S. About 1 in 8 men will be diagnosed with prostate cancer in their lifetime. This year, approximately 191,000 men will be diagnosed with prostate disease.

6.Liver disease

The more complicated the liver disorder, the more serious your odds for and the importance of Erectile Dysfunction. One research shows that Erectile Dysfunction was more prevalent in people with early-stage hepatitis C-induced liver cirrhosis than people who had a chronic hepatitis B infection.

Damaged liver function in men can result in erectile dysfunction or hypogonadism or both. We examined whether existing donor liver transplantation (LDLT) results in an increase in male sexual function.

Patients with liver disorder have raised SHBG (sex hormone-binding globulin) and less albumin, and thats a bad thingbecause [these proteins decrease your free testosterone levels, and not only can low testosterone kill your sex drive, but it also makes it more challenging to achieve an erection. Also, alcohol abuse can cause the liver disorder. That men need to limit their alcohol intake.

What you can do

Approximately 75 percent of men who have Erectile Dysfunction does not try for treatment. But they are researches that show that erectile dysfunction can be entirely changed with diet and exercise. While medicines like sildenafil (Viagra), Suhagra 100, Aurogra, Fildena, tadalafil (Cialis), can treat ED, they cannot cure it.

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6 Serious Health Conditions Linked To Erectile Dysfunction - The African Exponent

The study on the Male Hypogonadism Market Research delivers a profound comprehension of the market dynamics like drivers, the challenges, trends, and opportunities. The analysis further elaborates on the micro and macro-economic facets which can be predicted to shape the increase of the Male Hypogonadism Market through the forecast period (2019-2029).

The study elucidates the crucial indexes of Male Hypogonadism Market expansion which contains a comprehensive analysis of CAGR development this value series, and Porters Five Forces Analysis. This data may enable readers to realize the growth parameters of this industry that is Male Hypogonadism .

Analytical Insights Contained from the Male Hypogonadism Market Report

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Male Hypogonadism Market Segmentation Assessment

The increase prospects of this marketplace in several Regions are examined in the report together with details like political, the regulatory frame, and financial prognosis of each region.

Trends and Opportunities

The top driver of the male hypogonadism market includes rising prevalence of testosterone deficiency among men, increasing infertility rates, and increasing awareness among individuals about hypogonadism treatment due to awareness drives organized by several governments across the world. Moreover, high risk of hypogonadism among the geriatric population with obesity and diabetes, and increasing prevalence of chronic disorders among the geriatrics are further expected to boost the markets growth.

However, factors such as high side effects of testosterone products are challenging the growth of testosterone replacement therapy market. Top players in the market are focused on research and development to introduce newer products with fewer or negligible side effects and improved results. For example, LPCN 1111, a product which is under development from Lipocine Inc., is a newer testosterone prodrug that utilizes Lipral technology for enhanced systemic absorption and for enhanced solubility of testosterone. Nevertheless, technological advancements are anticipated to extend new opportunities to the markets growth.

Global Male Hypogonadism Market: Regional Overview

The global male Hypogonadism market can be analyzed with respect to the regional segments of North America, Asia Pacific, Europe, Latin America, and the Middle East and Africa. North America held the majority share of the global market in the recent past and is expected to retain its dominant position in the near future. This is mainly due to the rise in the number of individuals suffering from primary and secondary conditions of hypogonadism, and rising awareness among individuals about treatment options for the condition. Moreover, the presence of ultra-modern healthcare infrastructure and increasing popularity of technologically advanced products are expected to offer new opportunities for top players in this market. The region is closely followed by Europe.

Asia Pacific is expected to offer lucrative opportunities to this market due to the modernization of the healthcare infrastructure in the emerging economies of India and China and the increasing awareness about the treatment for the condition. In Asia Pacific, the increasing prevalence of hypogonadism and infertility rates along with the rising geriatric population base with diabetes and obesity are propelling the growth of this market. China, Taiwan, and Malaysia are some of the countries that display the highest rate of male hypogonadism.

Major Companies Mentioned in Report

Some of the key players in the male Hypogonadism market include AbbVie Inc., Astrazeneca plc, Eli Lilly and Company Ltd., Merck & Co. Inc., SA, Finox Biotech, Laboratories Genevrier, Teva Pharmaceutical Industries Ltd., Allergan plc, Bayer AG, Endo International plc, IBSA Institut Biochimque, and Ferring.

Key players are focused on product approval for growth considerations and to cater to the changing demand of the industry. The introduction of innovative and technologically advanced products is also the focus of key players to increase their market share and for serving patients in a better manner.

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Male Hypogonadism to Witness Growth Acceleration During 2018 2028 - Redhill Local Councillors

Latest Research Report on Male Hypogonadism Therapy Market size | Industry Segment by Applications (Hospitals, Drugstores and Others), by Type (Parenteral, Transdermal, Oral and Others), Regional Outlook, Market Demand, Latest Trends, Male Hypogonadism Therapy Industry Growth, Share & Revenue by Manufacturers, Company Profiles, Forecasts 2025.Analyzes current market size and upcoming 5 years growth of this industry.

New research report to its expanding repository. The research report, titled Male Hypogonadism Therapy Market, mainly includes a detailed segmentation of this sector, which is expected to generate massive returns by the end of the forecast period, thus showing an appreciable rate of growth over the coming years on an annual basis. The research study also looks specifically at the need for Male Hypogonadism Therapy Market.

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The study includes the profiles of key players in the Male Hypogonadism Therapy market with a significant global and/or regional presence. The Male Hypogonadism Therapy market competition by Top Manufacturers Covers:

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The report contains the profiles of various prominent players in the Global Male Hypogonadism Therapy Market. Different strategies implemented by these vendors have been analyzed and studied to gain a competitive edge, create unique product portfolios and increase their market share. The study also sheds light on major global industry vendors. Such essential vendors consist of both new and well-known players. Besides, the business report contains important data relating to the launch of new products on the market, specific licenses, domestic scenarios and the strategies of the organization implemented on the market.

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Male Hypogonadism Therapy Market Size Current and Future Industry Trends, 2020- - News by aeresearch

A leading research firm, Zion Market Research added a latest industry report on "Global Male Hypogonadism Market" consisting of 110+ pages during the forecast period and Male Hypogonadism Market report offers a comprehensive research updates and information related to market growth, demand, opportunities in the global Male Hypogonadism Market.

According to the report the Global Male Hypogonadism Market 2019 Comprehensive Study with On-Going Trends, Majors Players and Forecast 2025

The Male Hypogonadism Market report provides in-depth analysis and insights into developments impacting businesses and enterprises on global and regional level. The report covers the global Male Hypogonadism Market performance in terms of revenue contribution from various segments and includes a detailed analysis of key trends, drivers, restraints, and opportunities influencing revenue growth of the global consumer electronics market.This report studies the global Male Hypogonadism Market size, industry status and forecast, competition landscape and growth opportunity. This research report categorizes the global Male Hypogonadism Market by companies, region, type and end-use industry.

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The Male Hypogonadism Market report mainly includes the major company profiles with their annual sales & revenue, business strategies, company major products, profits, industry growth parameters, industry contribution on global and regional level.This report covers the global Male Hypogonadism Market performance in terms of value and volume contribution. This section also includes major company analysis of key trends, drivers, restraints, challenges, and opportunities, which are influencing the global Male Hypogonadism Market. Impact analysis of key growth drivers and restraints, based on the weighted average model, is included in this report to better equip clients with crystal clear decision-making insights.

The Male Hypogonadism Market research report mainly segmented into types, applications and regions.The market overview section highlights the Male Hypogonadism Market definition, taxonomy, and an overview of the parent market across the globe and region wise.To provide better understanding of the global Male Hypogonadism Market, the report includes in-depth analysis of drivers, restraints, and trends in all major regions namely, Asia Pacific, North America, Europe, Latin America and the Middle East & Africa, which influence the current market scenario and future status of the global Male Hypogonadism Market over the forecast period.

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The Male Hypogonadism Market report provides company market size, share analysis in order to give a broader overview of the key players in the market. Additionally, the report also includes key strategic developments of the market including acquisitions & mergers, new product launch, agreements, partnerships, collaborations & joint ventures, research & development, product and regional expansion of major participants involved in the market on the global and regional basis.

Major Company Profiles Covered in This Report:

Astrazeneca Plc., Merck & Co. Inc., Laboratories Genevrier, Allergan Plc., Endo International Plc., Ferring, AbbVie Inc., Eli Lilly and Company Ltd., Finox Biotech, Teva Pharmaceutical Industries Ltd., Bayer AG, and IBSA Institut Biochimque.

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Global Male Hypogonadism Market 2019 Comprehensive Study with On-Going Trends, Majors Players and Forecast 2025 - Global Newspaper

Hypothyroidism, hyperglycemia, and low adrenocorticotrophic hormone (ACTH) levels are associated with lower bone mass in patients with thalassemia major, according to study results published in The Journal of Clinical Endocrinology & Metabolism.

The major mechanisms of endocrine dysfunction that lead to decreased bone mineral density (BMD) and increased risk for fracture in patients with thalassemia major remain poorly understood. Researchers aimed to identify the mineral and hormonal factors associated with low BMD in adults with -thalassemia major in a retrospective study of patients who received treatment at the National Taiwan University Hospital (ClinicalTrials.gov Identifier: NCT03951818).

Medical history was obtained for 29 patients (51.7% women), including bone-associated biochemical markers such as serum calcium, phosphorus, intact parathyroid hormone, vitamin D, and fibroblast growth factor 23 levels. Pituitary function and thyroid hormone levels were used as a proxy for endocrine function. BMD was measured using dual-energy x-ray absorptiometry. Expected height was calculated for each individual based on parental height from patient records.

The mean observed height across all patients was lower than expected (women, -3.7 cm; men, -7.3 cm). Abnormal BMD, defined as a z score 2 standard deviations away from normal BMD, was observed in 42.9% of women and 23.1% of men. In addition, 26.7% of women and 35.7% of men had a history of fracture. Vitamin D deficiency (women, 100%; men, 81.8%), hypogonadism (women, 60%; men, 57.1%), and growth hormone deficiency (women, 75%; men, 57.1%) were highly prevalent in the study group.

Several factors were associated with either femoral neck or lumbar spine BMD, but only thyroid status and lower ACTH levels correlated with BMD at both sites (P <.05). Along with thyroid status (P =.016) and ACTH levels (P =.005), glycated hemoglobin levels (P =.039) were significantly different in patients with normal vs abnormal BMD. When included in a multivariate regression model adjusted for ferritin level, age, and sex, however, hypothyroidism was the only factor significantly associated with lower femoral neck BMD (P =.034). Patients with hypothyroidism had lower BMD at both the lumbar spine (P =.024) and femoral neck (P =.004). No association was found with fracture risk.

Our study is the first study to review the complete endocrine and mineral profiles to identify factors related to the severity of decreased BMD in patients with [thalassemia major], the researchers noted. We found that hypothyroidism and hyperglycemia were the most relevant factors of lower bone mass, while ACTH had a protective role.

The researchers also noted that the interplay between these factors supports the idea that iron overload may be a driver of decreased bone mass in patients with thalassemia major.

Based on these findings, it is promising to conduct interventional trials in the future that evaluate the effect of treating hypothyroidism or glycemic control on BMD and the risk of fracture in patients with [thalassemia major], the researchers concluded.

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Reference

Yang WP, Chang HH, Li HY, et al. Iron overload associated endocrine dysfunction leading to lower bone mineral density in thalassemia major [published online January 7, 2020]. J Clin Endocrinol Metab. doi:10.1210/clinem/dgz309

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Mineral and Hormonal Dysfunction Associated With Lower BMD in Thalassemia Major - Endocrinology Advisor

By Marie White

Nithyananda Swami is accused of raping a woman named Aarthi Rao some 40 times over a period of five years. There are three arguments that suggest the criminal accusation is false.

Aarthi Rao, alleged victim of rape.

Nithyananda had a sexual potency test taken at Victoria Hospital in Chennai, done supposedly under strict medical supervision. The results have been released and reportedly entered into evidence in his rape case.

The test shows Nithyananda has a testosterone level that precludes his having sex. and that this has been the case since before the alleged five-year span of rapes began.

The test reveals he has a lower testosterone level than a child and, additionally, lack of blood flow, anorchidism, and hypogonadism make it impossible for him to have penile penetration.

Blood flow, hypogonadism, and anorchidism are measured independently of testosterone levels. The test was reportedly studied by a government appointed panel and a private panel of experts and it was unanimously concluded that the Swami is not physically capable of having sex.

It has been argued that there are other kinds of rape, that he could have forcibly held her and assaulted her with his tongue or a flaccid penis. But this is not what the alleged victim claims.She said she was raped by a virile man with full penetration more than 40 times.

The alleged victim, Aarthi Raos purportedly authentic medical records from the University of Michigan were released as part of discovery in a civil lawsuit in Michigan State Court. They show that Aarthi Rao has STDs including a longstanding case of contagious genital herpes.

Nithyananda also reportedly took a test, which shows he is 100 percent STD free.

If this is true, could Nithyananda have had 40 rape sessions with Aarthi Rao, all unprotected, as she claims, and not contract herpes from Aarthi Rao? According to medical reports, she has had herpes for more than a decade.

The alleged victim, Aarthi Rao claims the tests that show she has genital herpes are fake. However, the Indian courts have accepted these records as authentic.

Aarthi Rao claims she was raped repeatedly over a period of five years. She lived in Michigan during the rape period and had to leave the US and come to India where she alleges she was raped.

Even if she was raped the first time, it is undisputed that she continued to visit the ashram of Nithyananda.

If she chose not to tell anyone of being raped, as many fearful victims do, why did she choose to go back?

She did not live with Nithyananda. She lived with her husband in the US. She came periodically to visit the ashram in India where Nithyananda lived.

Her emails show she had to argue with her husband to get permission to come to India to stay at the ashram. Sometimes her husband did not permit her to go and she was despondent.Why would she be despondent about being forbidden to go and get raped?

Most victims would avoid their rapist if they could, even if they do not tell authorities.

Instead she fought to get back.She lied to her husband. She never told him she was raped during the five year period of her alleged rapes.

It defies reasonable credulity and speaks to this being, as some people say, a purely political prosecution.

No rape victim keeps coming back for five years.Its not as if the rapist and his victim lived in the same house and she had no option but to tolerate being raped again and again out of fear or lack of means to escape.

She did not have to escape him. She had to escape her husband to get raped. She had to make extraordinary efforts and undertake international travel to get to her alleged rapist.

We have seen emails that show her husband did not want her to leave and go to Nithyananda. All she had to do was to not come to India and to his ashram to avoid being raped. But she did not.

She fought with her husband to get to India and get raped.

This is what Aarthi Rao wants us to believe.

Obviously, if there was sex, she wanted it. That is so clear that it boggles the mind that anyone could think this is a reasonable prosecution and not a political prosecution.

Something must have changed for Aarthi Rao that made her want to file a charge of rape against her former guru.Perhaps she saw an opportunity to profit.

Nithyananda claims he is a life long celibate and the tests suggest he cannot have sex. Perhaps the tests are fake. Perhaps Aarthi Raos herpes tests are also fake.

But one thing is not fake. It is based on her own admissions: A woman flew halfway across the world to keep getting raped and spending her and her husbands money to go back and get raped!

I think it interesting that her husband left her after finding out she had sex, [or was raped].

He is not a disciple of Nithyananda. I suspect he did not believe her when she said she kept going back and getting raped?

He may have thought she was lying and that she wanted to have sex with Nithyananda.Think about this. She flies to India from America. She has sex with her guru/lover 40 times over 5 years on numerous, separate trips.

Her husband finds out she has herpes. He is angry. She tells him she was raped by Nithyananda and that is how she got herpes.

He does not buy it and decides to leave her. He remembers the fights they had, with her pleading and demanding to got to India. And when she came back she did not act as if she were raped. She could not wait to go back again.

Nithyananda is wealthy. It might be a financial incentive, or perhaps, as likely, she had to defend herself from claims of adultery by charging rape.

In India, adultery is look down upon far more than it is in the USA. Her family is from India and live there still. After her husband left her, she has returned to India.She had motive to lie and offers an implausible story.

The rape case against Nithyananda should be dropped.

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The Rape Case Against Nithyananda Should Be Dropped If They Had Sex, She Obviously Wanted It! - Frank Report