Category Archives: Testosterone Replacement Therapy

The Global Testosterone Replacement Therapy Market 2020 Industry Trends and Forecasts to 2025 is a professional and in-depth study on the current state of the Testosterone Replacement Therapy market. Annual estimates and forecasts are provided for the period 2020 through 2025. Also, a six-year historic analysis is presented for these Testosterone Replacement Therapy businesses. The global market for Testosterone Replacement Therapy is presumed to reach about xx by 2025 from xx in 2020, joining a Compound Annual Growth Rate (CAGR) of xx % during the analysis years, 2020-2025.

The report presents a primary overview of the Testosterone Replacement Therapy industry including definitions, classifications, applications, and business chain structure. And developing strategies and programs are addressed as well as manufacturing methods and cost formations.

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This report analyzing Testosterone Replacement Therapy centers on Top Companies in the global market, with capacity, production, value, income, and market share for each manufacturer, including

AbbVieAllerganBayerEli Lilly and CompanyKyowa Kirin InternationalNovartisPfizer

Global Testosterone Replacement Therapy Market 2020: Product Type Segment Analysis

General Type

Global Testosterone Replacement Therapy Market 2020: Applications Segment Analysis

Medical

Then, the Testosterone Replacement Therapy market study report concentrates on global higher leading business players with knowledge such as company profiles, product picture and specifications, sales, market share, and association information. Whats more, the Testosterone Replacement Therapy industry development trends and marketing channels are examined.

Market Segment by Regions, this report splits Global into rare key Countries, with production, expenditure, revenue, market share, and growth rate of Testosterone Replacement Therapy in these countries, from 2020 to 2025 (forecast), similar North America, Europe, Japan, Southeast Asia, India, and China.

In a word, the Testosterone Replacement Therapy market report gives important statistics on the state of the Testosterone Replacement Therapy industry and is a helpful source of guidance and direction for companies and individuals interested in the Testosterone Replacement Therapy market.

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Table of Contents

1. Testosterone Replacement Therapy Market Overview, Scope, Segment- by Types, Applications and Regions, World Market Size and of Testosterone Replacement Therapy and Country wise Status and Prospect (2015-2025).

2. Global Testosterone Replacement Therapy Market Competition by Manufacturers- Global Testosterone Replacement Therapy Production, Revenue and Share by Manufacturers (2018 and 2020), Testosterone Replacement Therapy Industry Competitive Situation and Trends.

3. Global Testosterone Replacement Therapy Production, Revenue (Value) by Regions (North America, EU, Japan, India, and China) (2015-2020).

4. Global Testosterone Replacement Therapy Supply (Production), Consumption, Export, Import by Nations (2015-2020).

5. Global Testosterone Replacement Therapy Production, Revenue (Value), Price Trend by Types (2015-2020).

6. Global Testosterone Replacement Therapy Market Analysis by Applications and Study of Market Drivers and Opportunities.

7. Global Testosterone Replacement Therapy Manufacturers Profiles/Analysis- Company Basic Information, Manufacturing Base and Sales Area, Testosterone Replacement Therapy Product Types, Application and Specification, Production, Revenue, Price and Gross Margin (2018 and 2020) and Business Overview.

8. Analysis of Testosterone Replacement Therapy Industrial Chain Analysis, Sourcing Strategy and Downstream Buyers.

10. In this report study Testosterone Replacement Therapy Marketing Channel, Positioning and Strategy Analysis and List of Testosterone Replacement Therapy Distributors/Traders.

11. Global Testosterone Replacement Therapy Market Production and Price Forecast by Countries, Type, and Application (2020-2025).

12. Research Findings and Conclusion.

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Testosterone Replacement Therapy Market Current Status, Historical Analysis and Forecast 2020 to 2025 - Fashion Trends News

The Testosterone Replacement Therapy Market report draws accurate insights by examining the latest and prospective industry trends, helping the readers recognize the products and services that are boosting revenue growth and profitability. The study performs a detailed analysis of all the significant factors impacting the market on a global and regional scale, including drivers, constraints, threats, challenges, prospects, and industry-specific trends. Additionally, the report cites worldwide certainties and endorsements, along with a downstream and upstream evaluation of leading participants.

To ask for a sample copy of the Testosterone Replacement Therapy Market Report, visit:https://www.reportsanddata.com/sample-enquiry-form/229

Scope of the Report:

The report focuses on the important geographies of sale of the Testosterone replacement therapy such as North America, Europe and Asia-Pacific, South America, Middle East and Africa. The entire testosterone replacement therapy market has been categorized into three segments in this report, namely- manufacturers, regions, type and application.

Reasons to Buy the Report:

For the purpose of this report, Reports and Data has segmented the Testosterone Replacement Therapy market on the basis of type, source, animal, application, and region:

In market segmentation by types of testosterone replacement therapies, the report covers

Get Discounts on the Testosterone Replacement Therapy Market Report at:https://www.reportsanddata.com/discount-enquiry-form/229

In market segmentation by applications of the testosterone replacement therapy, the report covers the following uses

Regional Outlook (Revenue in USD Million; 20162026)

Key highlights of the Testosterone Replacement Therapy market:

The report is distributed over 15 Chapters to display the analysis of the global Testosterone Replacement Therapy market.

Chapter 1 covers the Blow-Fill-Seal (BFS) technology product Introduction, product scope, market overview, market opportunities, market risk, market driving force;

Chapter 2 talks about the top manufacturers and analyses their sales, revenue and pricing decisions for the duration 2016 and 2017;

Chapter 3 displays the competitive nature of the market by discussing the competition among the top manufacturers. It dissects the market using sales, revenue and market share data for 2016 and 2017;

Chapter 4, shows the global market by regions and the proportionate size of each market region based on sales, revenue and market share of Blow-Fill-Seal (BS) technology product, for the period 2012- 2017;

Chapter 5, 6, 7, 8 and 9, are dedicated to the analysis of the key regions, with sales, revenue and market share by key countries in these regions;

Browse Table of Contents with Facts and Figures of Testosterone Replacement Therapy Market Report at: https://www.reportsanddata.com/report-detail/global-testosterone-replacement-therapy-market-by-manufacturers-countries-type-and-application-forecast-to-2022

We are grateful to you for reading our report. If you wish to find more details of the report or want a customization, contact us. You can get a detailed information of the entire research here. If you have any special requirements, please let us know and we will offer you the report as you want.

Continued here:
Testosterone Replacement Therapy Market Insights with Latest Statistics and Growth Prediction to 2026 | AbbVie, Endo International, Eli lilly, Pfizer,...

The Testosterone Replacement Therapy Market report draws accurate insights by examining the latest and prospective industry trends, helping the readers recognize the products and services that are boosting revenue growth and profitability. The study performs a detailed analysis of all the significant factors impacting the market on a global and regional scale, including drivers, constraints, threats, challenges, prospects, and industry-specific trends. Additionally, the report cites worldwide certainties and endorsements, along with a downstream and upstream evaluation of leading participants.

To ask for a sample copy of the Testosterone Replacement Therapy Market Report, visit:https://www.reportsanddata.com/sample-enquiry-form/229

Breadth of the Report:

The report focuses on the important geographies of sale of the Testosterone replacement therapy such as North America, Europe and Asia-Pacific, South America, Middle East and Africa. The entire testosterone replacement therapy market has been categorized into three segments in this report, namely- manufacturers, regions, type and application.

Reasons to Buy the Report:

For the purpose of this report, Reports and Data has segmented the Testosterone Replacement Therapy market on the basis of type, source, animal, application, and region:

In market segmentation by types of testosterone replacement therapies, the report covers

Get Discounts on the Testosterone Replacement Therapy Market Report at:https://www.reportsanddata.com/discount-enquiry-form/229

In market segmentation by applications of the testosterone replacement therapy, the report covers the following uses

Regional Outlook (Revenue in USD Million; 20162026)

Key highlights of the Testosterone Replacement Therapy market:

The report is distributed over 15 Chapters to display the analysis of the global Testosterone Replacement Therapy market.

Chapter 1 covers the Blow-Fill-Seal (BFS) technology product Introduction, product scope, market overview, market opportunities, market risk, market driving force;

Chapter 2 talks about the top manufacturers and analyses their sales, revenue and pricing decisions for the duration 2016 and 2017;

Chapter 3 displays the competitive nature of the market by discussing the competition among the top manufacturers. It dissects the market using sales, revenue and market share data for 2016 and 2017;

Chapter 4, shows the global market by regions and the proportionate size of each market region based on sales, revenue and market share of Blow-Fill-Seal (BS) technology product, for the period 2012- 2017;

Chapter 5, 6, 7, 8 and 9, are dedicated to the analysis of the key regions, with sales, revenue and market share by key countries in these regions;

Browse Table of Contents with Facts and Figures of Testosterone Replacement Therapy Market Report at: https://www.reportsanddata.com/report-detail/global-testosterone-replacement-therapy-market-by-manufacturers-countries-type-and-application-forecast-to-2022

We are grateful to you for reading our report. If you wish to find more details of the report or want a customization, contact us. You can get a detailed information of the entire research here. If you have any special requirements, please let us know and we will offer you the report as you want.

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Key Emerging Trends in Testosterone Replacement Therapy Market 2020 | AbbVie, Endo International, Eli lilly, Pfizer, Others - Feed Road

High levels of the sex hormone testosterone may trigger different health problems in men and women, a new study reveals.

In women, testosterone may increase the risk for type 2 diabetes, while in men it lowers that risk. But high levels of testosterone increase the risk for breast and endometrial cancer in women and prostate cancer in men, the researchers reported.

"Our findings provide unique insights into the disease impacts of testosterone. In particular, they emphasize the importance of considering men and women separately in studies, as we saw opposite effects for testosterone on diabetes," said lead researcher Katherine Ruth, of the University of Exeter in the United Kingdom.

"Caution is needed in using our results to justify use of testosterone supplements until we can do similar studies of testosterone with other diseases, especially cardiovascular disease," Ruth explained in a University of Cambridge news release.

Dr Joel Zonszein, an emeritus professor of medicine at Albert Einstein College of Medicine in New York City, said there is a "sweet spot" of normal values for men and women. "Too much is not good, and too little is also bad," he explained.

"Testosterone supplementation is widely used in both men and women with normal values with no good evidence of benefit. Testosterone replacement in truly deficient individuals is something else," said Zonszein, who had no role in the study.

For the study, British researchers collected genetic data on more than 425 000 men and women listed in the UK Biobank. The investigators found more than 2 500 genetic variations associated with levels of testosterone and the protein that binds it sex hormone-binding globulin.

The researchers checked their results with analyses of other relevant studies and used a randomisation method to see if associations between testosterone and disease are causal.

In women, a high level of testosterone was tied to a 37% increased risk for type 2 diabetes and a 51% increased risk for polycystic ovary syndrome.

In men, however, a high testosterone level was linked to a 14% lower risk of developing type 2 diabetes, the findings showed.

"The findings in men that higher testosterone has a protective effect and reduces the risk of type 2 diabetes is news to me," Zonszein said. "This needs to be shown by other studies and its mechanism needs to be elucidated."

Dr Minisha Sood, an endocrinologist at Lenox Hill Hospital in New York City, said that testosterone may not be as protective in women because it converts to estradiol, which is related to the risk for breast cancer.

"High levels of testosterone in women have also been shown to increase visceral fat, which is linked to the components of metabolic syndrome," Sood said.

That men with high testosterone are at lower risk of developing type 2 diabetes is likely related to having more lean muscle mass, which improves insulin sensitivity and reduces the likelihood of type 2 diabetes, she said.

But Sood isn't a fan of men using testosterone supplements to ward off diabetes.

"Testosterone therapy comes with potential risks, including a high red blood cell count and higher rates of high-grade prostate cancer if a man is already predisposed to develop prostate cancer," she said.

Obese men or those with type 2 diabetes would benefit more from lifestyle changes to improve testosterone levels, namely, weight loss, healthy diet and exercise.

"This approach is preferred in that population over testosterone replacement whenever possible," Sood said.

The report was published in the journal Nature Medicine.

Image credit: iStock

See the rest here:
How high testosterone levels have different health outcomes for men and women - Health24

A Long Island man is facing a host of charges for allegedly posing as a medical professional and running an illegal health clinic, where he treated patients.

Brian Michael Kaufman, 45, of Smithtown, allegedly ran Mens Health Solution of Smithtown on Middle Country Road, despite not having a medical license, Suffolk County DA Tim Sini announced.

He allegedly treated patients, including testosterone and steroid injections.

The investigation into Kaufmans practice determined that he allegedly has been operating the medical practice since at least August last year.

When he was arrested, Kaufman admitted to investigators that he was not licensed to practice any medical profession and had no training to provide medical services or provide testosterone replacement therapy, the DA said.

Mens Health Solution of Smithtown has since shuttered its doors.

"This individual put lives in danger and posed a clear threat to public health by masquerading as a medical practitioner," Sini said in a statement. "He did not have patients; he had victims. We are asking those victims to please contact the District Attorney's Office with any information they may have about Kaufman's alleged scam."

Kaufman has been charged with:

"This case is significant because it unearthed a convicted felon playing doctor who jeopardized his 'patients' lives," DEA agent Ray Donovan said. "In order to safeguard our communities, law enforcement has to act fast when they see someone threatening public health and safety.

"In this case, Brian Kaufman's alleged testosterone trafficking ring put people in harm's way while committing several crimes."

If convicted, Kaufman faces up to seven years in prison on the top count. He was arraigned this week and released with a GPS monitoring device. He will also be subjected to drug testing and is under travel restrictions.

Anyone who has received medical services from Kaufman or at Mens Health of Smithtown has been asked to contact the Suffolk County District Attorneys Office by calling (631) 853-8087.

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Read more:
Man Accused Of Running Illegal Long Island Health Clinic - Daily Voice

What do parents do when they learn their daughter suddenly wants to be a boy? When Rene entered puberty, she began to change, her hair becoming shorter and shorter, her dress more androgynous. Parents Birgid and Michael initially thought she was just trying things out, until one day Rene outed herself as transgender during a family walk. Her parents were relieved, but also very worried about what it could mean for the future. They found an experienced youth psychotherapist to accompany Rene closely for the next few years as she became Ren. After a year of psychotherapy, the therapist recommended hormone replacement therapy. The testosterone quickly changed Rens body: his voice broke, his hair became thicker and his whole posture more male. For him it was a liberation, but Birgid has to struggle with the loss of a daughter for good. How will Ren develop now? What other changes will hormone therapy bring, and what will it do to him? Its the start of a long journey for Ren and his parents.

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In the Wrong Body - Teen Girl to Teen Boy - Deutsche Welle

Jatenzo (testosterone undecanoate; Clarus Therapeutics), an oral testosterone replacement therapy, is now available for the treatment of hypogonadism.

Specifically, Jatenzo is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

Jatenzo is not intended for use in males with age-related hypogonadism and its safety and efficacy have not been established in males <18 years old.

The treatment carries a Boxed Warning related to blood pressure (BP) increases that could potentially increase the risk of major adverse cardiovascular events. In a clinical trial, Jatenzo increased systolic BP during 4 months of treatment by an average of 4.9 mmHg based on ambulatory BP monitoring and by an average of 2.8 mmHg from baseline based on BP cuff measurements. For this reason, baseline cardiovascular risk should be considered before initiating therapy and BP should be adequately controlled. Among study patients treated with Jatenzo, 7% were started on antihypertensive medications or required intensification of their antihypertensive medication regimen during the 4-month trial.

Jatenzo, a Schedule III controlled substance, is available in 158mg, 198mg, and 237mg softgels. Dosage should be individualized based on serum testosterone concentrations.

Jatenzo offers patients a convenient softgel formulation, and eliminates the worry of gel transference, skin irritation from patches, or pain from injections that other testosterone treatments carry, said Dr Ronald S. Swerdloff, lead investigator of the inTUne trial, the pivotal study that established the safety and efficacy of the treatment.

For more information visit jatenzo.com.

This article originally appeared on MPR

Read this article:
Jatenzo, an Oral Testosterone Replacement Therapy, Now Available - Renal and Urology News

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

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Read more from the original source:
Clarus Therapeutics Lauches JATENZO - Oral Testosterone Replacement Therapy - MedicalResearch.com

This intelligence report provides a comprehensive analysis of the Testosterone Replacement Therapy Market. This includes Investigation of past progress, ongoing market scenarios, and future prospects. Data True to market on the products, strategies and market share of leading companies of this particular market are mentioned. Its a 360-degree overview of the global markets competitive landscape. The report further predicts the size and valuation of the global market during the forecast period.

Testosterone is responsible for the development of male sexual characteristics and this hormone formed by the testicles. Insufficient production of testosterone causes erectile dysfunction. Testosterone Replacement Therapy (TRT) is generally termed as hormone therapy for men, designed to counteract the effects of reduced activity in the gonads or hypogonadism. Hypogonadism in men is clinical syndrome, which results in the failure of the testes to produce physiological levels of testosterone. Erectile dysfunction arises due to reduce testosterone production to overcome this testosterone replacement therapy is used to improve the problem.

Major Players in this Report Include,

AbbVie Inc. (United States), Endo International (Ireland), Eli Lilly and Company (United States), Pfizer (United States), Bayer (Germany), Actavis (Allergan) (United States), Novartis (Switzerland), Teva (Israel), Ferring Pharmaceuticals (Switzerland), Kyowa Kirin (Japan) and Mylan (United States).

Free Sample Report + All Related Graphs & Charts: https://www.advancemarketanalytics.com/sample-report/46424-global-testosterone-replacement-therapy-market

Each segment and sub-segment is analyzed in the research report. The competitive landscape of the market has been elaborated by studying a number of factors such as the best manufacturers, prices and revenues. Global Testosterone Replacement Therapy Market is accessible to readers in a logical, wise format. Driving and restraining factors are listed in this study report to help you understand the positive and negative aspects in front of your business.

This study mainly helps understand which market segments or Region or Country they should focus in coming years to channelize their efforts and investments to maximize growth and profitability. The report presents the market competitive landscape and a consistent in depth analysis of the major vendor/key players in the market.

Market Drivers

Market Trend

Restraints

Opportunities

Challenges

Furthermore, the years considered for the study are as follows:

Historical year 2013-2017

Base year 2018

Forecast period** 2019 to 2025 [** unless otherwise stated]

**Moreover, it will also include the opportunities available in micro markets for stakeholders to invest, detailed analysis of competitive landscape and product services of key players.

The titled segments and Market Data Breakdown are illuminated below:

By Type: Creams or Gels, Patches, Injections, Buccal Adhesives, Implants, Oral

Application: Hospitals, Clinics

For Early Buyers | Get Up to 20% Discount on This Premium Report: https://www.advancemarketanalytics.com/request-discount/46424-global-testosterone-replacement-therapy-market

Region Included are: North America, Europe, Asia Pacific, Oceania, South America, Middle East & Africa

Country Level Break-Up: United States, Canada, Mexico, Brazil, Argentina, Colombia, Chile, South Africa, Nigeria, Tunisia, Morocco, Germany, United Kingdom (UK), the Netherlands, Spain, Italy, Belgium, Austria, Turkey, Russia, France, Poland, Israel, United Arab Emirates, Qatar, Saudi Arabia, China, Japan, Taiwan, South Korea, Singapore, India, Australia and New Zealand etc.

Strategic Points Covered in Table of Content of Testosterone Replacement Therapy Market:

Chapter 1: Introduction, market driving force product Objective of Study and Research Scope the Testosterone Replacement Therapy Market.

Chapter 2: Exclusive Summary the basic information of the Testosterone Replacement Therapy Market.

Chapter 3: Displaying the Market Dynamics- Drivers, Trends and Challenges of the Testosterone Replacement Therapy

Chapter 4: Presenting the Testosterone Replacement Therapy Market Factor Analysis Porters Five Forces, Supply/Value Chain, PESTEL analysis, Market Entropy, Patent/Trademark Analysis.

Chapter 5: Displaying the by Type, End User and Region 2013-2018

Chapter 6: Evaluating the leading manufacturers of the Testosterone Replacement Therapy market which consists of its Competitive Landscape, Peer Group Analysis, BCG Matrix & Company Profile

Chapter 7: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries in these various regions.

Chapter 8 & 9: Displaying the Appendix, Methodology and Data Source

Finally, Testosterone Replacement Therapy Market is a valuable source of guidance for individuals and companies.

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Key questions answered

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Tags: Global Testosterone Replacement Therapy MarketTestosterone Replacement Therapy MarketTestosterone Replacement Therapy Market GrowthTestosterone Replacement Therapy Market ShareTestosterone Replacement Therapy Market SizeTestosterone Replacement Therapy Market Trends

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Testosterone Replacement Therapy analysis by stage of development - TechNews.mobi

In a multinational randomized phase 3 trial, once-weekly somapacitan demonstrated superiority over placebo for treatment of patients with adult growth hormone (GH) deficiency, according to study results published in The Journal of Clinical Endocrinology & Metabolism.

Hormone replacement is a common component of care for patients with hypopituitarism, but its daily subcutaneous injections can be burdensome for some patients. This burden may result in reduced compliance or adherence or in an unwillingness on the part of physicians to add to their patients treatment burden. Long-acting alternatives to daily injections could reduce the burden of treatment and thus lower the barrier to therapy.

Somapacitan is a novel once-weekly reversible albumin-binding GH derivative, with a similar long-lasting mechanism as insulin detemir. Studies have shown once-weekly somapacitan to be well tolerated in healthy adults, but none have examined its efficacy in adult GH deficiency treatment.

To evaluate this, researchers randomly assigned 301 patients with adult GH deficiency at 92 sites in 17 countries in a 2:1:2 ratio to receive once-weekly somapacitan, once-weekly placebo, or daily GH for 34 weeks. Patients 23 to 79 years of age with a diagnosis of adult- (69.7%) or childhood-onset (30.3%) adult GH deficiency who were naive to GH treatment or had no exposure to GH therapy for 180 days prior to treatment assignment were included. This main period of 34 weeks was followed by an extension period to examine longer-term use.

The main period was double blinded for the somapacitan and placebo cohorts but open label for daily GH use. Investigators and trial sites remained blinded throughout the entire trial. Dose titration occurred during the first 8 weeks of the main trial until a steady state insulinlike growth factor-1 (IGF-1) standard deviation score (SDS) of -0.5 to +1.75 was achieved. The remaining 26 weeks consisted of fixed-dose treatment.

The 52-week open-label extension period allowed for evaluation of efficacy and safety of somapacitan for up to 86 weeks of treatment. Patients who had been receiving somapacitan continued to do so (somapacitan/somapacitan group), those receiving placebo were switched to somapacitan (placebo/somapacitan group), and those receiving daily GH were randomly assigned 1:1 to continue with daily GH (daily GH/daily GH group) or to switch to somapacitan (daily GH/somapacitan group).

At week 34, somapacitan reduced truncal fat percentage from baseline by 1.06% compared with a 0.47% increase for placebo (estimated treatment difference, -1.53%; 95% CI, -2.68 to -0.38; P =.009), demonstrating superiority over placebo. Compared with placebo, the somapacitan group also had decreased visceral fat and increased lean body mass and appendicular skeletal muscle mass at week 34.

Similar changes in visceral fat, total lean body mass, and appendicular skeletal muscle mass were observed in the somapacitan and daily GH groups at week 34. A less pronounced reduction in truncal fat percentage was observed with somapacitan treatment compared with daily GH treatment at week 34. No significant difference in body weight from baseline to week 34 was observed for the somapacitan (+1.40 kg) or placebo (+0.39 kg) groups, but was observed between somapacitan and daily GH (+0.27 kg; estimated treatment difference, 1.13 kg; 95% CI, 0.13-2.12) groups.

At week 86, there were no notable differences between the somapacitan and daily GH groups for percentage change in visceral fat, lean body mass, or appendicular skeletal muscle mass, and improvements in visceral fat and lean body mass were maintained. However, treatment effects on other body composition measures were less pronounced with somapacitan treatment vs daily GH therapy. For patients who switched from placebo to somapacitan in the extension period, improvements were observed in all body composition measures to a similar degree as with long-term daily GH treatment.

No significant differences in mean levels of corrected total bone mineral content or density from baseline to week 86 in the somapacitan and daily GH groups were observed, nor was there a significant difference in these levels between these 2 groups.

Two individuals had severe adverse events that were possibly related to trial products during the study period. One was a patient in the daily GH/no treatment group, who was also receiving testosterone and suffered a life-threatening hemoconcentration, but recovered with treatment. The other patient was in the daily GH/somapacitan group and was diagnosed with bladder transitional cell carcinoma in week 80, but went on to complete the trial.

One of the concerns about continuous exposure to GH is that it may result in negative effects on insulin sensitivity and glucose metabolism. In this trial, fasting plasma glucose and hemoglobin A1c values did not increase over 86 weeks, and there were no new cases of diabetes in patients treated with somapacitan. The limited negative effects paired with somapacitans potentially superior effects on visceral fat reduction vs placebo by week 34 of treatment suggest that somapacitan may provide an effective alternative to daily GH in adults with GH deficiency.

Some limitations of this study included the reliance on patient reporting for adherence to treatment as well as the open-label nature of the daily GH treatment group. In addition, some patients in the active drug groups had IGF-1 SDS values below -2 at the end of the titration period and so may not have received the full benefit of GH replacement. Finally, the less pronounced effect of somapacitan on truncal fat and body weight when compared with daily GH over the long term cannot be explained by a different response in IGF-1 SDS, as mean levels and distributions were similar.

Disclosure: This study was funded by Novo Nordisk, the manufacturer of somapacitan. All but one author on the study has received either employment, contract work, or funding from Novo Nordisk.

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Reference

Johannsson G, Gordon MB, Rasmussen MH, et al. Once-weekly somapacitan is effective and well tolerated in adults with GH deficiency: a randomized phase 3 trial [published online February 5, 2020]. J Clin Endocrinol Metab. doi:10.1210/clinem/dgaa049

See the article here:
Once-Weekly Treatment for Adult GH Deficiency Effective in Phase 3 Trial - Endocrinology Advisor