Category Archives: Hormone Replacement Therapy

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210104005200/en/

The target Prescription Drug User Fee Act (PDUFA) action date for decision by the FDA is in October 2021. Somatrogon is an investigational new biologic product that is glycosylated and comprises the amino acid sequence of human growth hormone and one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and two copies of CTP (in tandem) at the C-terminus. The glycosylation and CTP domains account for the half-life of the molecule.

The FDAs filing acceptance is an encouraging step closer to our goal of providing a long-acting, once-weekly therapy for pediatric patients living with GHD. If approved, somatrogon could help reduce the burden of daily growth hormone injections on children, their loved ones, and caregivers, said Brenda Cooperstone, MD, Chief Development Officer, Rare Disease, Pfizer Global Product Development. For 35 years, Pfizer has been committed to improving the outcomes of patients living with GHD, and somatrogon is another example of how we are working to positively impact quality of life and treatment compliance to help ensure those patients can reach their full potential.

The submission is supported by the results of a global Phase 3 trial evaluating the safety and efficacy of somatrogon administered once weekly to pediatric patients with GHD. This study met its primary endpoint of non-inferiority compared to GENOTROPIN (somatropin) for injection administered once daily, as measured by annual height velocity at 12 months. The top-line results from the study demonstrated the least square mean was higher in the somatrogon group (10.12 cm/year) than in the somatropin group (9.78 cm/year); the treatment difference (somatrogon somatropin) in height velocity (cm/year) was 0.33 with a two-sided 95% confidence interval of the difference (-0.39, 1.05). In addition, change in height standard deviation scores at 6 and 12 months, key secondary endpoints, were higher in the somatrogon dosed once-weekly cohort in comparison to the somatropin dosed once-daily cohort. Moreover, at 6 months, change in height velocity, another key secondary endpoint, was higher in the somatrogon dosed once-weekly cohort in comparison to the somatropin dosed once-daily cohort. These common measures of growth are employed in the clinical setting to measure the potential level of catch-up growth that subjects may experience relative to the heights of their age and gender matched peers.

Somatrogon was generally well tolerated in the study and comparable to that of somatropin administered once-daily with respect to the types, numbers and severity of the adverse events observed between the treatment arms.

In 2014, Pfizer and OPKO entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of GHD. Under the agreement, OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product.

About the Study

The somatrogon Phase 3 trial is a randomized, open-label, active-controlled study conducted in over 20 countries. This study enrolled and treated 224 pediatric patients, treatment-nave children with growth hormone deficiency who were randomized 1:1 into two arms: somatrogon administered at a dose of 0.66 mg/kg body weight once-weekly vs GENOTROPIN (somatropin) administered at a dose of 0.034 mg/kg body weight once daily. The primary endpoint of the trial was height velocity at 12 months. Secondary endpoints included change in height standard deviation at 6 and 12 months, safety and pharmacodynamic measures. Children completing this study had the opportunity to enroll in a global, open-label, multicenter, long-term extension study, in which they were able to either continue receiving or switch to somatrogon. Approximately 95% of the patients switched into the open-label extension study and received somatrogon treatment.

About Somatrogon

Somatrogon is an investigational biologic product that is glycosylated and comprises the amino acid sequence of human growth hormone and one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and two copies of CTP (in tandem) at the C-terminus. The glycosylation and CTP domains account for the half-life of the molecule. Somatrogon has received Orphan Drug designation in the U.S. and the EU for the treatment of children and adults with growth hormone deficiency.

About Growth Hormone Deficiency

Growth hormone deficiency is a rare disease characterized by the inadequate secretion of growth hormone from the pituitary gland and affects one in approximately 4,000 to 10,000 people. In children, this disease can be caused by genetic mutations or acquired after birth. Because the patient's pituitary gland secretes inadequate levels of somatropin, the hormone that causes growth, his or her height may be affected and puberty may be delayed. Without treatment, he or she will have persistent growth attenuation, a very short height in adulthood, and may experience other health problems.

About GENOTROPIN (somatropin)

GENOTROPIN is a man-made, prescription treatment option, approved in the United States for children who do not make enough growth hormone on their own, have the genetic condition called Prader-Willi syndrome (PWS), were born smaller than most other babies, have the genetic condition called Turner syndrome (TS) or have idiopathic short stature (ISS). GENOTROPIN is also approved to treat adults with growth hormone deficiency. GENOTROPIN is taken by injection just below the skin and is available in a wide range of devices to fit a range of individual dosing needs. GENOTROPIN is just like the natural growth hormone that our bodies make and has an established safety profile.

Important GENOTROPIN Safety Information

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

For the full Prescribing Information for GENOTROPIN, please visit http://labeling.pfizer.com/ShowLabeling.aspx?id=577.

GENOTROPIN Indications and Usage in the U.S.

GENOTROPIN is a prescription product for the treatment of growth failure in children:

GENOTROPIN is a prescription product for the replacement of growth hormone in adults with growth hormone deficiency (GHD) that started either in childhood or as an adult. Your doctor should do tests to be sure you have GHD, as appropriate.

About OPKO Health, Inc.

OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit http://www.OPKO.com.

Pfizer Rare Disease

Rare disease includes some of the most serious of all illnesses and impacts millions of patients worldwide, representing an opportunity to apply our knowledge and expertise to help make a significant impact on addressing unmet medical needs. The Pfizer focus on rare disease builds on more than two decades of experience, a dedicated research unit focusing on rare disease, and a global portfolio of multiple medicines within a number of disease areas of focus, including rare hematologic, neurologic, cardiac and inherited metabolic disorders.

Pfizer Rare Disease combines pioneering science and deep understanding of how diseases work with insights from innovative strategic collaborations with academic researchers, patients, and other companies to deliver transformative treatments and solutions. We innovate every day leveraging our global footprint to accelerate the development and delivery of groundbreaking medicines and the hope of cures.

Click here to learn more about our Rare Disease portfolio and how we empower patients, engage communities in our clinical development programs, and support programs that heighten disease awareness.

Pfizer Inc.: Breakthroughs that change patients lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at http://www.pfizer.com. In addition, to learn more, please visit us on http://www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

PFIZER DISCLOSURE NOTICE:

The information contained in this release is as of January 4, 2021. Pfizer and OPKO assume no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about an investigational growth hormone deficiency therapy, somatrogon, including a potential indication in the U.S. for once-weekly treatment of pediatric patients with growth hormone deficiency, including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any additional jurisdictions for somatrogon for the treatment of pediatric patients with growth hormone deficiency or in any jurisdictions for any other potential indications for somatrogon; whether and when the FDA may approve the BLA for somatrogon for the treatment of pediatric patients with growth hormone deficiency and whether and when regulatory authorities in any jurisdictions may approve any such other applications, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether somatrogon will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of somatrogon; uncertainties regarding the impact of COVID-19 on Pfizers or OPKOs business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer's and OPKOs respective Annual Reports on Form 10-K for the fiscal year ended December 31, 2019 and in their respective subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors", "Forward-Looking Information and Factors That May Affect Future Results" and Cautionary Statement Regarding Forward-Looking Statements, as well as in their respective subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov and, as applicable, http://www.pfizer.com and http://www.OPKO.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210104005200/en/

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US FDA Accepts Regulatory Submission from Pfizer and OPKO for Review of Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency -...

PUBLISHED: 14:07 04 January 2021

Lauren Knight

You could have a hormone imbalance if you have experienced significant changes in mood. Picture: PSMD Clinic

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The PSMD Clinic is a private medical clinic which also offers anti-ageing treatments, medical weight loss and specialist skincare, alongside hormonal health. Dr Popelyuk and her partners, Dr Kim Prescott and Dr Tania Schroeder, have a special interest in hormones and are highly trained to offer bespoke hormonal health balancing.

Q: What are the symptoms of hormonal imbalance in women?

Classically, the first symptoms to appear are changes in mood, as well as irritability, unprovoked anxiety, difficulty in focusing and concentrating. Some women also experience reduced libido and problems with sleep. One major cause of hormonal imbalance in women is becoming perimenopausal. That normally happens around the mid-40s, when hormonal changes start to happen; women are not yet menopausal but some of the hormones start going down and they become symptomatic. Very often this phase goes under the radar of both patients and doctors. The women still feel young and are still menstruating; they believe they shouldnt really be getting any help because on the surface of it everything seems to be fine. But treatments are available, and these can be helpful. Many women feel they should only seek help when their periods stop, and they start having hot flushes, vaginal dryness and a foggy mind. These are also symptoms of hormonal imbalance, which can be treated, but tend to come later on.

Q: Can hormonal imbalance cause weight gain?

Yes, weight gain can be a real problem for some women. This can start quite early on and can affect women with polycystic ovaries, as well as those who are perimenopausal or menopausal, and very often it is one of the most troubling symptoms. They can start gaining weight, especially around waistline and hips, and also start to lose muscle tissue. By seeking medical advice from us, we can advise them on how to lose weight, and this might include balancing their hormones.

Q: What else causes hormonal imbalance in women?

Premenstrual tension syndrome can also cause problems. This happens to younger women who have seemingly normal cycles but in the few days leading up to their period can suffer a lot with various symptoms. Very often they and their partners and families suffer quietly but help is available. Polycystic ovarian syndrome is another cause. Up to 30 per cent of younger women suffer with it but the extent can vary from very mild symptoms to those that are quite severe. But, again, there are various treatments and adjustments available, starting with lifestyle and diet and finishing with hormones.

Q: Can I check my hormone levels at home?

There are kits for doing it at home but we dont know how reliable they are. By having the checks performed medically we can investigate, assess the results and offer a bespoke treatment plan for you. We take a detailed history and then take venous samples, which are sent off to a laboratory to be analysed. We look for hormonal imbalances and at the adrenal gland and vitamin D levels. Each part of the suggested treatment, and the rationale behind it, is explained. It can be discussed with the patient and adjusted to suit their symptoms, requirements and wishes. We provide a seamless treatment process, which is bespoke and optimised for each particular patient.

Q: How can I balance my hormones?

There are various options. Many people respond well to diet and lifestyle changes, but for others, hormonal therapy may be an option to help with symptoms that affect your quality of life. If you are looking at bioidentical hormones (plant-based preparations of hormones that are biologically identical to the hormones produced by our body), creams can be applied to the skin or lozenges dissolved in the mouth. There are some vaginal creams too. These are all prepared by special pharmacies that create them specifically for each individual patient. If a patient would prefer a conventional therapy, like a hormone replacement therapy (HRT) treatment through patches or tablets, we can offer that as well.

Q: Can balancing my hormones help me to lose weight?

If the hormones are balanced, then it is possible the metabolism will increase, and you may well find it is easier to lose weight. With weight gain we also look at the thyroid gland, which is part of the hormone system too. Very often as women approach menopause, the function of their thyroid gland goes down. This can often be treated as well. Our hormones influence all areas of our body. So, its absolutely paramount to have them balanced out for all sorts of reasons. As well as helping with weight loss, they can enhance quality of life and improve overall wellbeing, enhancing energy, motivation and drive. If your hormones are low, balancing them out could improve your relationships; ability to function, cognition and interest in life generally.

For more information or to book a consultation visit http://www.psmd.co.uk, email info@psmd.co.uk or call 01932 422498.

Read more:
How hormones affect your health and your weight - Surrey Life

Hormone Replacement Therapy Market From XMRs Viewpoint

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XploreMR, in its latest business report elaborates the current situation of the global Hormone Replacement Therapy Market in terms of volume (x units), value (Mn/Bn USD), production, and consumption. The report scrutinizes the market into various segments, end users, regions and players on the basis of demand pattern, and future prospect. This Hormone Replacement Therapy Market study considers 2018 as the base year, 2019 as the estimated year, and 2017 to 2026 as the forecast timeframe.

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Hormone Replacement Therapy Market to Reap Excessive Revenues by 2017 to 2026 - The Monitor

A man holds a rainbow flag after taking part in the Pride Run in Shanghai on June 17, 2017. (STR/AFP/Getty)

Transgender people in China are buying hormones on the grey market because of the difficulties of obtaining them legally.

In China, being transgender is classed as a mental illness, and trans people must be diagnosed before they can get hormone replacement therapy (HRT) legally.

The official process is expensive and stigmatising, with many trans people instead buying HRT through the grey market online, or from other countries.

One 22-year-old trans man in Shanghai, Andy, told Sky News that he orders testosterone from Thailand.

In China, the channel is hidden, he said. There is also a testosterone for fitness purpose, but you are not sure whether it is a real or fake.

Many brothers [transgender men] buy these, because they just buy whatever they can buy. But I dont Im afraid of dying.

A 2019 Amnesty International report found that trans people in China are risking dangerous surgery and black-market hormone treatments because its impossible for them to access healthcare.

Widespread discrimination against trans people, a serious lack of information about accessing gender-affirming treatment and restrictive eligibility requirements on who can access healthcare are the three main barriers to getting care for trans people,Amnestysreport found.

Hospitals ask you to get a transsexualism certificate they still think you are sick, Andy said.

In fact, this is not only an issue with hospitals, but also an issue about social awareness. Our community is hidden, and no one can see it. If no one sees it, the government does not care about it.

Although the precise size of the trans population in China isnot known, Amnestys report found estimates of the number of trans people living in China that varied between 100,000 and four million.

Andy told Sky News he is hopeful about the situation for trans people in China: Just like before if the topic homosexuality was mentioned, people would be like, Eww pervert. But now people can accept it with an open mind.

I believe the future will be better.

More:
Trans people in China fear for their lives after being forced to illegally buy hormones on the 'grey market' - PinkNews

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By Application/ End-user:Menopause, Hypothyroidism, Male Hypogonadism, Growth Hormone Deficiency, Others

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North America(the United States, Canada, and Mexico)Europe(Germany, France, UK, Russia, and Italy)Asia-Pacific(China, Japan, Korea, India, and Southeast Asia)South America(Brazil, Argentina, Colombia, etc.)The Middle East and Africa(Saudi Arabia, UAE, Egypt, Nigeria, and South Africa)

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A new year is upon us, and despite the challenges we've had to face over the past several months, there appears to be light at the end of the tunnel. Now more than ever, people are looking for ways to optimize their health, and those with thyroid conditions are no exception.

Patients will often inquire about a "thyroid diet": dietary changes they can make, supplements they can take, or toxins they can avoid to treat or reverse their thyroid disease. How can I improve symptoms of hypothyroidism beyond traditional medical therapy? How can I lower serum thyroid autoantibody titers? How much of this food or supplement would be too much for my thyroid?

Truth be told, there is a lot of information out there that may sound compelling. However, the evidence is usually low quality and therefore is less than ideal as a basis for clinical recommendations. Here, we will discuss the most popular nutritional topics related to thyroid disease.

Thyroid hormone production requires adequate levels of circulating iodide taken in through the diet or in supplements. Insufficient iodine places an individual at risk of developing or worsening hypothyroidism. The Institute of Medicine of the National Academies recommends that adults take in 150 g of iodine per day, whereas pregnant and lactating women are advised higher amounts (220 g/d and 290 g/d, respectively).

Common dietary sources of iodine include iodized salt, seafood (including seaweed and fish), and some breads and grains. It is important to note that sea salt, despite the name, does not naturally contain iodine.

Iodine is not required to be labeled on food packaging in the United States, so dietary sources may be difficult to identify. And even though iodine levels can be measured in a person's urine or blood, doing so is not particularly useful because the levels reflect iodine content from only the past few days. Fortunately, most of the United States is considered iodine sufficient.

Some individuals with dietary restrictions may be at risk for low iodine. Recommending an iodine supplement of 150 g/d is particularly relevant for women who are considering pregnancy; already pregnant; or postpartum and breastfeeding, when iodine needs are greater.

Tablets labeled "iodine for thyroid health" are commonly available without a prescription and may contain several hundredfold the daily recommended amount of iodine in just a single dose. Other products labeled "for thyroid support" contain spirulina or kelp, which naturally contain iodine but in varying amounts that may potentially be excessive.

Taking in too much iodine may cause the thyroid to shut off as a result of the excess iodine (iodine-induced hypothyroidism) or to make excess thyroid hormone (iodine-induced hyperthyroidism). There is also evidence that chronic iodine excess may induce autoimmune thyroiditis, because iodinated thyroglobulin is immunogenic. For these reasons, the American Thyroid Association recommends avoiding supplements containing >500 g of iodine per daily dose.

The term "goitrogen" refers to any substance that can produce goiter or an enlarged thyroid gland. Goitrogenic substances include those that decrease the amount of available iodine to the thyroid and those that inhibit any of the other components of normal thyroid hormone production. The most common examples of goitrogens in the diet are cruciferous vegetables and soy products.

Cruciferous vegetables are defined as those in the Brassica genus and include broccoli, cabbage, Brussels sprouts, kale, turnips, cauliflower, collard greens, and bok choy. They are rich in glucosinolates and other substances that interfere with various steps in the thyroid hormone synthesis pathway. Eating cruciferous vegetables in healthy amounts certainly has its benefits, but too much and on a chronic basis may lead to or exacerbate hypothyroidism.

So how much is too much? Data on the amount of cruciferous vegetable intake needed to adversely affect thyroid function are extremely limited. In a study of euthyroid volunteers who ingested commercial kale juice twice per day for 7 days, mean 6-hour thyroid radioiodine uptake decreased by 2.52% compared with baseline values, but serum thyroid function tests were unchanged.

In an extreme example, a case report described the development of myxedema coma in an 88-year-old Chinese woman who consumed 1.0-1.5 kg of raw bok choy daily for several months in an attempt to improve her diabetes control.

More recently, however, a randomized clinical trial of euthyroid participants who ingested a broccoli sprout beverage for 12 weeks showed no changes in their serum thyroid function tests, thyroglobulin levels, or thyroid autoimmunity status compared with those in the placebo group.

So how might one address patients' questions about whether to avoid eating cruciferous vegetables? We tell both euthyroid and hypothyroid patients that although older data have suggested that frequent intake of large amounts of cruciferous vegetables may decrease thyroid hormone production, more recent clinical studies affirm that there is absolutely no need to completely stop eating these healthy foods.

Common sense is important on this topic. We advise a well-balanced diet, one that includes cruciferous vegetables in reasonable amounts. The problem is that there is little evidence of what is "reasonable" with regard to cruciferous vegetable consumption and thyroid health.

Dietary soy products, including soy milk, tofu, soy sauce, tempeh, and miso, contain isoflavones polyphenolic compounds also classified as phytoestrogens for their estrogen-like effects. Because isoflavones can inhibit the action of thyroid peroxidase, which is required for thyroid hormone synthesis, it has been proposed that dietary soy intake may increase the risk for hypothyroidism. Similarly, it is possible that a higher dose of thyroid hormone replacement may be required in patients being treated for hypothyroidism who consume high amounts of soy.

But what does the bulk of the scientific evidence show? In euthyroid individuals living in iodine-replete areas, consumption of normal amounts of soy probably has very little, if any, adverse effects on serum thyroid function. High consumption of soy among both euthyroid and subclinically hypothyroid individuals has been correlated with only minor elevations in serum thyroid-stimulating hormone (TSH)levels; there were no changes in free thyroid hormone levels.

An exception is soy-based infant formula fed to neonates with congenital hypothyroidism. An increase in the dose of levothyroxine may be required to adequately address their thyroid hormone needs.

In general, we advise our adult patients that a reasonable, normal amount of soy consumption is generally safe. There is no reason to avoid soy altogether if a patient with hypothyroidism is being treated with thyroid hormone replacement medication.

Selenium. Selenium is a micronutrient important for thyroid hormone metabolism. The US recommended daily allowance for selenium in men and nonpregnant, nonlactating women is 55 g. The richest dietary sources of selenium are seafood and organ meats. Typical sources in the US diet are breads, grains, meat, poultry, fish, and eggs.

The tolerable upper intake level for selenium is 400 g/d.Although selenium toxicity is not commonly encountered in routine clinical practice, symptoms of excessive intake include nausea; nail discoloration, brittleness, and loss; hair loss; fatigue; irritability; and foul breath (often described as "garlic breath").

The majority of data on selenium and thyroid disease are regarding chronic autoimmune thyroiditis. Some studies have suggested that selenium supplementation in autoimmune thyroid disease may be beneficial, because low levels have been associated with increased risks for goiter and thyroid nodules. However, although taking selenium can decrease serum thyroid autoantibody titers over the short term, it remains unclear whether these antibody reductions correlate with the long-term maintenance of normal thyroid function or with decreased adverse obstetric outcomes in pregnant women with serum thyroid antibody positivity.

We don't generally recommend selenium supplementation to our patients for the sole purpose of benefiting thyroid dysfunction or thyroid autoimmunity. One exception, however, is in patients with mild Graves ophthalmopathy. In this population, selenium supplementation can improve quality of life and the course of eye disease. The European Thyroid Association/European Group on Graves' Orbitopathy recommends 200 mg daily as a 6-month course for such patients.

Zinc, copper, and magnesium. The roles of zinc, copper, and magnesium in thyroid hormone synthesis and metabolism are unfortunately less well defined. Serum levels of zinc, copper, and selenium have been inconsistently associated with free or total serum thyroid hormone levels, but a meta-analysis suggested a relationship between levels of selenium, copper, and magnesium with thyroid cancer. Given the available evidence, we advise that supplementation of these trace minerals solely for the purpose of promoting thyroid function is unsupported.

Fluoride. Fluoride is found naturally in the environment or artificially in public drinking water (added for prevention of dental caries). It is also present in such products as tea, processed foods, dental products, supplements, and foods sprayed with fluoride-containing pesticides.

Animal studies dating back to the 1970s have described reductions in serum thyroid hormone levels due to fluoride exposure, although a clear mechanism has not been established. In humans, studies examining the relationship between fluoride exposure and hypothyroidism have shown conflicting results. A more recent population-based study described a mild increase in serum TSH levels among iodine-deficient adults with higher levels of urinary fluoride.

Whether these findings are clinically relevant remains unclear in the absence rigorous clinical studies. On the basis of the available observational data, it is difficult to determine what degree of fluoride exposure may adversely affect thyroid health.

Finally, popular in the functional medicine community are such interventions as gluten-free diets; sugar-free diets; and probiotics for promoting thyroid health and treating "leaky gut syndrome," the theory that increased intestinal permeability leads to various diseases. Do we have data to back up these recommendations?

Gluten-free diet. Good evidence supports the relationship between celiac disease and autoimmune thyroid disease. This is expected, given the known increased risk for another autoimmune disorder when one has already been diagnosed with a first.

A meta-analysis of nearly 95,000 patients showed a threefold increase in thyroid disease (in particular, Hashimoto thyroiditis) among those with celiac disease compared with control participants who did not have celiac disease. Thus, some have proposed screening patients with autoimmune thyroid disease for celiac disease and vice versa a reasonable consideration, particularly when there are suggestive symptoms of the other condition.

Of course, this then leads us to wonder: What is the effect of a gluten-free diet on thyroid autoimmunity, a risk factor for thyroid dysfunction? Can staying away from gluten decrease the risk of developing Hashimoto thyroiditis in those with celiac disease?

There are some limited studies on this topic. One small study showed decreased serum thyroid antibody titers but no change in serum TSH or thyroid hormone levels among participants with Hashimoto thyroiditis who followed a gluten-free diet for 6 months. In contrast, another study of patients with celiac disease showed no effect of a gluten-free diet on serum thyroid function tests, serum thyroid antibodies, or thyroid ultrasound findings after 1 year on the diet.

It is challenging to advise patients on the basis of these small observational studies with inconsistent results. At present, there are no data on whether maintaining a gluten-free diet in the absence of celiac disease plays a role in the health of patients with or without established thyroid disease.

Other eating patterns. Unfortunately, there are no rigorous data regarding whether "leaky gut syndrome," a sugar-free diet, or use of probiotics influences the thyroid. A recent study exploring differences in food consumption patterns between patients with and those without Hashimoto thyroiditis found that patients with Hashimoto thyroiditis tended to eat more animal fat and processed meat, whereas those without this condition tended to eat more red meat, whole grains, and plant oils. The clinical significance of the self-reported dietary trends among these groups remains unclear. Further studies are needed to investigate whether there is a link between these eating patterns and thyroid autoimmunity.

Coffee, tea, and alcohol appear to have no effect on thyroid cancer risk, although coffee decreases the absorption of oral levothyroxine in individuals being treated for hypothyroidism.

The potential benefit of vitamin D as a preventive or therapeutic agent for various thyroid diseases remains unclear.

So where does this leave us? We must have frank conversations with our patients, acknowledging that the relationships among thyroid disease, diet, and nutritional supplements are complex. Certainly, much remains to be better understood through continued research.

In the meantime, the following recommendations are safe and supported by sound data: 150 g of iodine daily in those with dietary restrictions or who are considering pregnancy, currently pregnant, or breastfeeding; not avoiding cruciferous vegetables or soy in adults, if consumed in reasonable amounts; and consulting a healthcare professional about thyroid eye disease, for which selenium might be of benefit. It is appropriate to advise patients that other commonly touted therapies for thyroid health are less supported, with quite limited and inconsistent data.

Angela M. Leung, MD, MSc, is an endocrinologist at UCLA Health and the VA Greater Los Angeles Healthcare System and an associate professor of medicine in the Division of Endocrinology, Diabetes, and Metabolism at the UCLA David Geffen School of Medicine. She speaks on the topics of iodine nutrition, environmental thyroid toxicants, thyroid nodules, and thyroid cancer and serves on the Medscape Endocrinology advisory board.

Gonzalo J. Acosta, MD, is an endocrinology fellow at UCLA Health and the VA Greater Los Angeles Healthcare System.

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The rest is here:
'Thyroid Diet': What's the Evidence? - Medscape

The Hormone Replacement Therapy (HRT) Market research report is the new statistical data source added by Report Ocean. Hormone Replacement Therapy (HRT) Market report focused on the comprehensive analysis of current and future prospects of the Hormone Replacement Therapy (HRT) Market industry. This report is a consolidation of primary and secondary research, which provides market size, share, dynamics, and forecast for various segments and sub-segments considering the macro and micro environmental factors. An in-depth analysis of past trends, future trends, demographics, technological advancements, and regulatory requirements for the Hormone Replacement Therapy (HRT) Market has been done in order to calculate the growth rates for each segment and sub-segments.

Major highlights from COVID-19 impact analysis:

Worldwide COVID-19 status and its implications on the economy.

Fluctuations in the supply and demand.

Impact of COVID-19 pandemic on the growth matrix in the long run.

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Key highlights of the Hormone Replacement Therapy (HRT) Market report:

Growth rate

Renumeration prediction

Consumption graph

Market concentration ratio

Secondary industry competitors

Competitive structure

Major restraints

Market drivers

Regional bifurcation

Competitive hierarchy

Current market tendencies

Market concentration analysis

Competitive Landscape:

Competitive landscape of a market explains the competition in the Hormone Replacement Therapy (HRT) Market taking into consideration price, revenue, sales, and market share by company, market concentration rate, competitive situations, trends, and market shares of top companies. Strategies incorporated by key players of the market such as investment strategies, marketing strategies, and product development plans are also further included in the report. The research integrates data regarding the producers product range, top product applications, and product specifications.

Few of the Key Vendors in the Global Hormone Replacement Therapy (HRT) Market report are:

Abbott LaboratoriesNovartisPfizerMylan LaboratoriesMerck & Co.AmgenNovo NordiskBayerEli LilyWyeth

Regional and Country-level Analysis

The market size information is provided by regions (countries) in the Hormone Replacement Therapy (HRT) Market report.

The key regions covered in the Hormone Replacement Therapy (HRT) Market report are North America, Europe, China and Japan. It also covers key regions (countries), viz, the U.S., Canada, Germany, France, U.K., Italy, Russia, China, Japan, South Korea, India, Australia, Taiwan, Indonesia, Thailand, Malaysia, Philippines, Vietnam, Mexico, Brazil, Turkey, Saudi Arabia, U.A.E, etc.

The report includes country-wise and region-wise market size for the period 2015-2026. It also includes market size and forecast by Type, and by Application segment in terms of production capacity, price and revenue for the period 2015-2026.

Why this report is useful to you?

The report on the Hormone Replacement Therapy (HRT) Market contains an in-depth analysis of vendors, which includes financial health, business units, key business priorities, SWOT, strategies, and views, and competitive landscape. Bringing out the complete key insights of the industry, the report aims to provide an insight into the latest trends, current market scenarios, and technologies related to the market. In addition, it helps the venture capitalists, Hormone Replacement Therapy (HRT) Market manufacturers, packing foundries, assembly and test service companies to understand revenue opportunities across different segments to make better decisions.

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This report can be customized to meet the clients requirements. Please connect with our sales team ([emailprotected]), who will ensure that you get a report that suits your needs. You can also get in touch with our executives on +18882123539 (US- Toll free), +91-9997112116 (Outside US) to share your research requirements.

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Table of content

1 Report Overview

1.1 Study Scope

1.2 Key Market Segments

1.3 Players Covered: Ranking by Hormone Replacement Therapy (HRT) Revenue

1.4 Market by Type

1.4.1 Global Hormone Replacement Therapy (HRT) Market Size Growth Rate by Type: 2020 VS 2026

1.4.2 Oral

1.4.3 Parenteral

1.4.4 Transdermal

1.4.5 Others

1.5 Market by Application

1.5.1 Global Hormone Replacement Therapy (HRT) Market Share by Application: 2020 VS 2026

1.5.2 Menopause

1.5.3 Hypothyroidism

1.5.4 Male Hypogonadism

1.5.5 Growth Hormone Deficiency

1.5.6 Others

1.6 Study Objectives

1.7 Years Considered

2 Global Growth Trends

2.1 Global Hormone Replacement Therapy (HRT) Market Perspective (2015-2026)

2.2 Global Hormone Replacement Therapy (HRT) Growth Trends by Regions

2.2.1 Hormone Replacement Therapy (HRT) Market Size by Regions: 2015 VS 2020 VS 2026

2.2.2 Hormone Replacement Therapy (HRT) Historic Market Share by Regions (2015-2020)

2.2.3 Hormone Replacement Therapy (HRT) Forecasted Market Size by Regions (2021-2026)

2.3 Industry Trends and Growth Strategy

2.3.1 Market Top Trends

2.3.2 Market Drivers

2.3.3 Market Challenges

2.3.4 Porters Five Forces Analysis

2.3.5 Hormone Replacement Therapy (HRT) Market Growth Strategy

2.3.6 Primary Interviews with Key Hormone Replacement Therapy (HRT) Players (Opinion Leaders)

3 Competition Landscape by Key Players

3.1 Global Top Hormone Replacement Therapy (HRT) Players by Market Size

3.1.1 Global Top Hormone Replacement Therapy (HRT) Players by Revenue (2015-2020)

3.1.2 Global Hormone Replacement Therapy (HRT) Revenue Market Share by Players (2015-2020)

3.1.3 Global Hormone Replacement Therapy (HRT) Market Share by Company Type (Tier 1, Tier 2 and Tier 3)

3.2 Global Hormone Replacement Therapy (HRT) Market Concentration Ratio

3.2.1 Global Hormone Replacement Therapy (HRT) Market Concentration Ratio (CR5 and HHI)

3.2.2 Global Top 10 and Top 5 Companies by Hormone Replacement Therapy (HRT) Revenue in 2019

3.3 Hormone Replacement Therapy (HRT) Key Players Head office and Area Served

3.4 Key Players Hormone Replacement Therapy (HRT) Product Solution and Service

3.5 Date of Enter into Hormone Replacement Therapy (HRT) Market

3.6 Mergers & Acquisitions, Expansion Plans

4 Market Size by Type (2015-2026)

4.1 Global Hormone Replacement Therapy (HRT) Historic Market Size by Type (2015-2020)

4.2 Global Hormone Replacement Therapy (HRT) Forecasted Market Size by Type (2021-2026)

5 Market Size by Application (2015-2026)

5.1 Global Hormone Replacement Therapy (HRT) Market Size by Application (2015-2020)

5.2 Global Hormone Replacement Therapy (HRT) Forecasted Market Size by Application (2021-2026)

6 North America

6.1 North America Hormone Replacement Therapy (HRT) Market Size (2015-2020)

6.2 Hormone Replacement Therapy (HRT) Key Players in North America (2019-2020)

6.3 North America Hormone Replacement Therapy (HRT) Market Size by Type (2015-2020)

6.4 North America Hormone Replacement Therapy (HRT) Market Size by Application (2015-2020)

7 Europe

7.1 Europe Hormone Replacement Therapy (HRT) Market Size (2015-2020)

7.2 Hormone Replacement Therapy (HRT) Key Players in Europe (2019-2020)

7.3 Europe Hormone Replacement Therapy (HRT) Market Size by Type (2015-2020)

7.4 Europe Hormone Replacement Therapy (HRT) Market Size by Application (2015-2020)

8 China

8.1 China Hormone Replacement Therapy (HRT) Market Size (2015-2020)

8.2 Hormone Replacement Therapy (HRT) Key Players in China (2019-2020)

8.3 China Hormone Replacement Therapy (HRT) Market Size by Type (2015-2020)

8.4 China Hormone Replacement Therapy (HRT) Market Size by Application (2015-2020)

9 Japan

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Hormone Replacement Therapy (HRT) Market will generate massive revenue by 2026 according to forecasts by Report Ocean - NeighborWebSJ

This detailed research study of the Hormone Replacement Therapy (HRT) market specializes in facts and figures with the business operation and some suggestive visions in terms of growth prospects of the market. Moreover, the research report brings an in-depth study regarding the segmentation of the global Hormone Replacement Therapy (HRT) market based on the types, product categories, applications, and more.

The study also covers the historical cost concept in the account of major concepts and understanding about how a business entity would perform in the Hormone Replacement Therapy (HRT) market and evaluations in the near future.

Get the PDF Sample Copy (Including FULL TOC, Graphs and Tables) of this report @: https://www.contrivedatuminsights.com/request-sample/14443

Top Key Players: Abbott Laboratories

Novartis

Pfizer

Mylan Laboratories

Merck & Co.

Amgen

Novo Nordisk

Bayer

Eli Lily

Wyeth

Genentech.

Also, the research report also covers broad market space, demand, and supply mechanism operating in the market that majorly determines factors behind the growth of the industry. Moreover, the research reports clarify product details and dimensions capable that deliver organizational changes in the operations, promotions, and product distribution strategies that help generate popularity of the Hormone Replacement Therapy (HRT) market across the globe.

This research report significantly covers the complex calculations involved in predicting the outcomes of a business entity in consideration of past and present performances.

Global Hormone Replacement Therapy (HRT) Market Segmentation:

On the Basis of Type:OralParenteralTransdermalOthers

On the Basis of Application:MenopauseHypothyroidismMale HypogonadismGrowth Hormone DeficiencyOthers

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Regional Outlook

As per the research study by Contrive Datum Insights, the global Hormone Replacement Therapy (HRT) market has fragmented across several regions such as North America, Latin America, Asia-Pacific, Africa, and Europe on the basis of key players. It covers the broad analysis of regional business overview including the financial overview.

Key highlights of this research report:

Overview of the key market segments propelling or hampering the market growth

The cost analysis of the Global Hormone Replacement Therapy (HRT) Market has been performed while keeping in view manufacturing expenses, labor cost, and raw materials and their market concentration rate, suppliers, and price trend. Other factors such as Supply chain, downstream buyers, and sourcing strategy have been assessed to provide a complete and in-depth view of the market. Buyers of the report will also be exposed to a study on market positioning with factors such as target client, brand strategy, and price strategy taken into consideration.

Key questions answered in the report include:

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Hormone Replacement Therapy (HRT) Market Boosting the Growth Worldwide: Abbott Laboratories, Novartis, Pfizer, Mylan Laboratories - BIZNEWS

Jefferson Health Haddonfield Primary & Specialty Care, a new LGBTQ+ Affirming Practice at 80 Tanner St. in Haddonfield, will begin seeing patients on Monday, Jan. 4.

Accessible by car and public transportation, the practice will provide a safe space for LGBTQ+ patients to seek inclusive, multidisciplinary care.

While focused on caring for LGBTQ patients, the practice will be open to all adult members of the community needing medical care, offering services in infectious diseases care, HIV, behavioral health and primary care.

We will also provide hormone replacement therapy, Medication-Assisted Treatment for opioid use disorder, and pre-exposure prophylaxis for HIV prevention upon opening, said Jefferson Medical Group ambulatory operations vice president Amanda Kimmel. In the future, gynecology services and breast surgery will be available as well.

All staff and providers at the practice will be trained and proficient in LBGTQ+ culturally competent care, Kimmel said.

Our goal is to foster a safe, positive space where the unique and specific health needs of the local LGBTQ+ community are met with compassion and expertise, says Kimmel. Despite existing federal protections, the LGBTQ+ community continues to face significant healthcare discrimination, which often leads to a delay in seeking both preventive care and care for urgent or life-threatening conditions.

Members of the LGBTQ+ community are more likely to experience issues related to mental health and substance use disorder, as well as several chronic conditions, diseases and infections.

As a member of the LGBTQ+ community myself, Ive always found it challenging to find competent healthcare, said medical director Dr. Todd Levin, an infectious diseases specialist. Our patients wont have to worry about stigma and will know that every provider is trained to provide optimal care for them specifically. Here, patients will feel accepted and we can address issues that some providers are not comfortable talking about or treating, like prescribing PrEP for HIV prevention or giving the proper health screenings to transgender patients.

Call 844-542-2273 for more information or to schedule an appointment.

Send community news to south@njadvancemedia.com.

See more here:
New Jefferson Health practice geared toward LGBTQ+ patients opens in Haddonfield - nj.com

Market Overview of Japan Bio-identical Hormone Replacement Therapy Market

The Japan Bio-identical Hormone Replacement Therapy market report provides a detailed analysis of global market size, regional and country-level market size, segmentation market growth, market share, competitive Landscape, sales analysis, impact of domestic and global market players, value chain optimization, trade regulations, recent developments, opportunities analysis, strategic market growth analysis, product launches, area marketplace expanding, and technological innovations.

The global Japan Bio-identical Hormone Replacement Therapy market size is expected to gain market growth in the forecast period of 2020 to 2025, with a CAGR of xx%% in the forecast period of 2020 to 2025 and will expected to reach USD xx million by 2025, from USD xx million in 2019.

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Market segmentation

Japan Bio-identical Hormone Replacement Therapy market is split by Type and by Application. For the period 2015-2025, the growth among segments provide accurate calculations and forecasts for sales by Type and by Application in terms of volume and value. This analysis can help you expand your business by targeting qualified niche markets.

Segment by Type, the Bio-identical Hormone Replacement Therapy market is segmented intoCreamsInjectionsImplanted pelletsPatchesGels

Segment by Application, the Bio-identical Hormone Replacement Therapy market is segmented intoMenWomen

Regional and Country-level AnalysisThe Bio-identical Hormone Replacement Therapy market is analysed and market size information is provided by regions (countries).The key regions covered in the Bio-identical Hormone Replacement Therapy market report are North America, Europe, Asia Pacific, Latin America, Middle East and Africa. It also covers key regions (countries), viz, U.S., Canada, Germany, France, U.K., Italy, Russia, China, Japan, South Korea, India, Australia, Taiwan, Indonesia, Thailand, Malaysia, Philippines, Vietnam, Mexico, Brazil, Turkey, Saudi Arabia, U.A.E, etc.The report includes country-wise and region-wise market size for the period 2015-2026. It also includes market size and forecast by Type, and by Application segment in terms of sales and revenue for the period 2015-2026.

Regional analysis is another highly comprehensive part of the research and analysis study of the global Japan Bio-identical Hormone Replacement Therapy market presented in the report. This section sheds light on the sales growth of different regional and country-level Japan Bio-identical Hormone Replacement Therapy markets. For the historical and forecast period 2015 to 2025, it provides detailed and accurate country-wise volume analysis and region-wise market size analysis of the global Japan Bio-identical Hormone Replacement Therapy market.

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The report offers in-depth assessment of the growth and other aspects of the Japan Bio-identical Hormone Replacement Therapy market in important countries (regions), including:

North America (United States, Canada and Mexico)

Europe (Germany, France, UK, Russia and Italy)

Asia-Pacific (China, Japan, Korea, India and Southeast Asia)

South America (Brazil, Argentina, etc.)

Middle East & Africa (Saudi Arabia, Egypt, Nigeria and South Africa)

Japan Bio-identical Hormone Replacement Therapy competitive landscape provides details by vendors, including company overview, company total revenue (financials), market potential, global presence, Japan Bio-identical Hormone Replacement Therapy sales and revenue generated, market share, price, production sites and facilities, SWOT analysis, product launch. For the period 2015-2020, this study provides the Japan Bio-identical Hormone Replacement Therapy sales, revenue and market share for each player covered in this report.

Competitive Landscape and Bio-identical Hormone Replacement Therapy Market Share AnalysisBio-identical Hormone Replacement Therapy market competitive landscape provides details and data information by players. The report offers comprehensive analysis and accurate statistics on revenue by the player for the period 2015-2020. It also offers detailed analysis supported by reliable statistics on revenue (global and regional level) by players for the period 2015-2020. Details included are company description, major business, company total revenue and the sales, revenue generated in Bio-identical Hormone Replacement Therapy business, the date to enter into the Bio-identical Hormone Replacement Therapy market, Bio-identical Hormone Replacement Therapy product introduction, recent developments, etc.The major vendors covered:RevitaLifeUS CompoundingAesthetics&Wellness

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The content of the study subjects, includes a total of 15 chapters:

Chapter 1, to describe Japan Bio-identical Hormone Replacement Therapy product scope, market overview, market opportunities, market driving force and market risks.

Chapter 2, to profile the top manufacturers of Japan Bio-identical Hormone Replacement Therapy , with price, sales, revenue and global market share of Japan Bio-identical Hormone Replacement Therapy in 2018 and 2019.

Chapter 3, the Japan Bio-identical Hormone Replacement Therapy competitive situation, sales, revenue and global market share of top manufacturers are analyzed emphatically by landscape contrast.

Chapter 4, the Japan Bio-identical Hormone Replacement Therapy breakdown data are shown at the regional level, to show the sales, revenue and growth by regions, from 2015 to 2020.

Chapter 5, 6, 7, 8 and 9, to break the sales data at the country level, with sales, revenue and market share for key countries in the world, from 2015 to 2020.

Chapter 10 and 11, to segment the sales by type and application, with sales market share and growth rate by type, application, from 2015 to 2020.

Chapter 12, Japan Bio-identical Hormone Replacement Therapy market forecast, by regions, type and application, with sales and revenue, from 2020 to 2025.

Chapter 13, 14 and 15, to describe Japan Bio-identical Hormone Replacement Therapy sales channel, distributors, customers, research findings and conclusion, appendix and data source.

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Japan Bio-identical Hormone Replacement Therapy Market: Expansion Strategies Set to Generate Substantial Revenue in the near Future - Eurowire