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Jun 10

Innovent Announces Phase 2 study of MazdutideIBI362 in Chinese Participants with Overweight or Obesity Met Primary and All Key Secondary Endpoints -…

SAN FRANCISCO and SUZHOU, China, June 7, 2022 /PRNewswire/ --Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, announces that the primary and all key secondary endpoints were met in a randomized, double-blind, placebo-controlled phase 2 study of mazdutide (R&D code: IBI362), a glucagon-like peptide-1 receptor (GLP-1R)/glucagon receptor (GCGR) dual agonist, in Chinese participants with overweight or obesity.

This study (ClinicalTrials.gov, NCT04904913) was designed to evaluate the efficacy and safety of mazdutide in Chinese participants with overweight or obesity. A total of 248 subjects were randomized to receive 1.5-3.0 mg, 1.5-3.0-4.5 mg, or 2.0-4.0-6.0 mg of mazdutide or placebo subcutaneously and once-weekly for 24 weeks. The primary endpoint was the percentage change from baseline in body weight at week 24. A total of 230 participants (92.7%) completed week 24.

Mazdutide demonstrated superior weight loss efficacy in Chinese participants with overweight or obesity compared with placebo in a dose-dependent manner. After 24 weeks of treatment:

Meanwhile, mazdutide markedly reduced body-mass index, waist circumference, liver fat content and blood pressure; lowered lipid, transaminase and serum uric acid levels, and improved insulin sensitivity, delivering comprehensive metabolic benefits for participants with overweight or obesity.

In terms of safety, mazdutide was well tolerated. Only one participant discontinued the treatment due to an adverse event, which was not related to mazdutide as judged by the investigator. The overall safety profile was similar to those observed in early phase development and with other GLP-1-based agonists and co-agonists. The most frequently-reported treatment-emergent adverse events were diarrhea, nausea and upper respiratory tract infection, mostly mild or moderate in severity and transient.

Professor Linong Ji, the principal investigator of the study, Peking University People's Hospital, stated," In recent years, the prevalence of obesity in China has increased rapidly and resulted in the increase of the prevalence of diabetes, fatty liver, sleep disorders and cardiovascular diseases. Therefore, effective and safe weight-loss drugs are urgently needed. We are pleased to see the exciting results of the phase 2 study of mazdutide in Chinese participants with overweight or obesity, suggesting that mazdutide could potentially be the best-in-class agent. The half-year treatment of mazdutide achieved on average 12.6% weight reduction from baseline compared with placebo, which was comparable to the most cutting-edge weight-loss drugs under development in the world. The excellent efficacy of mazdutide in weight loss and multiple metabolic parameters truly reflects the advantages of weekly formulation based on dual incretin receptor agonists. I am confident and looking forward to the success of mazdutide in the upcoming phase 3 study."

Dr. Lei Qian, Vice President of Clinical Development of Innovent,stated, "The Phase 2 study of mazdutide in Chinese participants with overweight or obesity achieved the primary and all key secondary endpoints,while showing improvement on multiple metabolic parameters including blood pressure, lipids, transaminase and serum uric acid. These results demonstrate the great utility value of GLP-1R/GCGR dual agonist, further demonstrating the potential to be the best-in-class agent and paving solid foundation for further clinical development. Of note, the auto-injector has been used in the phase 2 studies, greatly improving the quality of life and compliance of participants, while demonstrating the quality and capability of domestic enterprises in device development and manufacturing; we will actively promote the development of phase 3 clinical study of mazdutide and anticipate more clinical data later this year, striving to provide more convenient, user-friendly, effective and safe drug for overweight and obese population as soon as possible."

* Due to the outbreak of Covid-19, the data are being collected and under further analysis. The data disclosed in this press release may have some deviation from the final results.

About Obesity

China has the largest obese population in the world, with obesity rate likely to increase. Obesity can lead to a range of complications or related diseases that impact life expectancy and lead to a decrease in quality of life. In more severely obese patients, the incidence and mortality of cardiovascular disease, diabetes, and certain tumors increase significantly. Obesity is a chronic disease that requires long-term management, and there is a lack of long-term effective and safe treatments. Lifestyle intervention is the first choice and basic treatment for patients with overweight or obesity. However, a considerable percentage of patients fail to achieve the desired weight loss goal upon lifestyle intervention due to various reasons and may require pharmacological intervention. Traditional anti-obesity drugs have limited weight-loss effects and are associated with safety issues.

About Mazdutide (IBI362)

Innovent entered into a licensing agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of OXM3 (also known as mazdutide), a GLP-1R and GCGR dual agonist, in China. In parallel, Lilly is developing OXM3 outside China. Mazdutide is a long-acting synthetic peptide related to mammalian oxyntomodulin (OXM), which uses a fatty acid side chain to prolong the duration of action and allow once-weekly administration. Mazdutide is thought to exert its biological effects by activating GLP-1 receptor and glucagon receptor in human beings, which improves glucose tolerance and induces weight loss, mimicking the effects of endogenous oxyntomodulin.

In addition to the effects of GLP-1 receptor agonists on promoting insulin secretion, lowering blood glucose and reducing body weight, mazdutide may also increase energy expenditure and improve hepatic fat metabolism through the activation of glucagon receptor. The treatment of metabolic diseases by activating multiple metabolism-related targets simultaneously is currently the worldwide trend in drug development.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic, ophthalmology and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 32 valuable assets in the fields of cancer, autoimmune, metabolic, ophthalmology and other major therapeutic areas, with 7 products approved for marketing in China TYVYT (sintilimab injection), BYVASDA (bevacizumab biosimilar injection), SULINNO (adalimumab biosimilar injection), HALPRYZA (rituximab biosimilar injection) , Pemazyre (pemigatinib oral inhibitor) and olverembatinib (BCR-ABL TKI)and Cyramza (ramucirumab), 2 asset under NMPA NDA review, 4 assets in Phase 3 or pivotal clinical trials, and an additional 19 molecules in clinical studies.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: http://www.innoventbio.com. and http://www.linkedin.com/company/innovent-biologics/.

Note:

TYVYT (sintilimab injection) is not an approved product in the United States.

BYVASDA (bevacizumab biosimilar injection), SULINNO, and HALPRYZA (rituximab biosimilar injection) are not approved products in the United States.

TYVYT (sintilimab injection, Innovent) BYVASDA (bevacizumab biosimilar injection, Innovent)HALPRYZA (rituximab biosimilar injection, Innovent)SULINNO (adalimumab biosimilar injection, Innovent)Pemazyre (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.CYRAMZA (ramucirumab, Eli Lilly). Cyramza was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Disclaimer:

1. This indication is still under clinical study, which hasn't been approved in China.2.Innovent does not recommend any off-label usage.

Forward-looking statement

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions.

The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect.

SOURCE Innovent Biologics

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Jun 10

Explained: Testosterone deficiency & the safety of replacement therapy – The Indian Express

Hypogonadism is a condition caused by the deficiency of the male sex hormone, testosterone, and a new study in Lancet Health Longevity looks at the short- to medium-term safety of testosterone treatment. Analysis of data from more than 3,400 patients with hypogonadism from 17 clinical trials found little evidence that testosterone treatment increases the risk of cardiovascular events such as arrhythmia, heart attack, and stroke, in the short to medium terms.

Testosterone replacement therapy is the standard treatment for hypogonadism, which can cause sexual dysfunction, weakening of bones and muscles, and reduced quality of life. Risk factors include ageing (as testosterone levels decline with age), obesity and diabetes. Contacted via email, Dr Channa Jayasena, Reader in Reproductive Endocrinology, Imperial College London and study author, said that worldwide, 2% of men aged over 40 are affected, and this is growing as the population gets older.

Despite being widely used, the cardiovascular safety of testosterone treatment had so far remained unclear due to inconsistent findings. Most previous clinical studies relied on aggregate data, rather than individual participant data and have not published details of individual adverse events.

Prescribing of testosterone for hypogonadism is increasing globally, but conflicting messages about its safety may have led to many patients not receiving the treatment. Ongoing studies should help to determine the longer-term safety of testosterone but, in the meantime, our results provide much-needed reassurance about its short-to-medium term safety. Our findings could have important implications for the treatment of men with hypogonadism worldwide, lead author Jemma Hudson from the University of Aberdeen said in the report.

Funded by the UK National Institute for Health Research Health Technology Assessment Programme, the study identified 35 eligible clinical trials published since 1992, of which 17 provided individual participant data. None of the studies were from India, Dr Jayasena said.

In the 17 trials, 1,750 participants received testosterone and 1,681 were given a placebo. The average length of testosterone treatment was 9.5 months. The rate of cardiovascular events was not significantly higher for participants receiving testosterone treatment (7.5%) compared to placebo (7.2%). Fewer deaths were reported during testosterone treatment (0.4%) than in the placebo group (0.8%]), but these numbers were too small to establish whether testosterone reduced mortality risk, according to the study authors.

The researchers found that testosterone significantly reduced serum total cholesterol, HDL, and triglycerides compared with placebo.

However, there were no significant differences in LDL, blood pressure, glycaemic parameters, diabetes incidence, and prostate adverse outcomes between the testosterone and placebo groups, according to the report.

The authors have acknowledged some limitations to their study. There was little available data evaluating the cardiovascular safety of testosterone treatment beyond 12 months, and the very small number of deaths recorded during testosterone trials hampered the authors ability to analyse why they occurred. However, the longer-term safety of testosterone treatment is currently being investigated in another clinical trial, Dr Jayasena said.

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Jun 10

Testosterone Replacement Therapy Market Research Outlook: 2022, Recent Developments, Growth Opportunities and New Innovations – Digital Journal

The Testosterone Replacement Therapy Market research report provides an in-depth examination of the key factors stimulating market expansion. This report provides statistics on the markets current situation, size, regional analysis, and growth factors. The research report helps gain a truly global perspective of the Testosterone Replacement Therapy industry as it covers 60 geographies worldwide. It also includes important information on financial conditions, growth status, product portfolios, revenue, and gross profit margins, as well as technological and research advances. The Testosterone Replacement Therapy market research focuses on the industrys most significant acquisitions, collaborations, and product launches.

To understand how our report can bring a difference to your business strategy request a sample PDF report: https://www.stratagemmarketinsights.com/sample/58549

The primary objective of the report is to educate business owners and assist them in making an astute investment in the market. The study highlights regional and sub-regional insights with corresponding factual and statistical analysis. The Testosterone Replacement Therapy market report will facilitate business owners to comprehend the current trend of the market and make profitable decisions.

Top Listed Company Profiles are:

AbbVie, Endo International, Eli lilly, Pfizer, Actavis (Allergan), Bayer, Novartis, Teva, Mylan, Upsher-Smith

Report Analysis & Segments:

The Testosterone Replacement Therapy market is segmented as per the type of product, application, and geography. All of the segments of the Testosterone Replacement Therapy market are carefully analyzed based on their market share, CAGR, value and volume growth, and other important factors.The research also looks at the top participants in the market, as well as distributors and the complete industrial chain structure. It also assesses the factors and criteria that may have an impact on market sales growth. The report also constitutes recent development undertaken by key players in the market which includes new product launches, partnerships, mergers, acquisitions, and other latest developments.

Based on Product Type Testosterone Replacement Therapy Market is segmented into

Gels, Injections, Patches, Other

Based on the Application Testosterone Replacement Therapy Market is segmented into

Hospitals, Clinics, Others

The report provides insights on the following pointers:

1 Market Penetration: Comprehensive information on the product portfolios of the top players in the Testosterone Replacement Therapy market.

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5 Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the Testosterone Replacement Therapy market.

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Geographical Analysis Covered:

Regional assessment of the Testosterone Replacement Therapy market has been carried out over six key regions which include North America, Asia-pacific, Europe, Latin America, Middle East, and Africa. Moreover, the report also delivers deep insights on the ongoing research & development activities, revenue, innovative services, the actual status of demand and supply, and pricing strategy. In addition to this, this report also delivers details on consumption figures, export/import supply, and gross margin by region. In short, this report provides a valuable source of guidance and clear direction for the marketer and the part interested in the market.

North America (United States, Canada) Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, Others) Europe (Germany, France, United Kingdom, Italy, Spain, Russia, Others) Latin America (Brazil, Mexico, Others) The Middle East and Africa

Frequently Asked Questions:

Q1. Which are the leading market players active in the Testosterone Replacement Therapy market?Q2. What are the current trends that will influence the market in the next few years?Q3. What are the driving factors, restraints, and opportunities in the market?Q4. What are the projections for the future that would help in taking further strategic steps?

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Stratagem Market Insights is a management consulting organization providing market intelligence and consulting services worldwide. We bring the expertise of consultants with a cumulative industry experience of more than 70 years. The firm has been providing quantified B2B research and currently offers services to over 350+ customers worldwide. Our team includes analysts that leverage their years of experience and expertise to create accurate and error-free reports.

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Jun 10

Do You Need Hormone Testing? – Health Essentials from Cleveland Clinic

Its probably not an exaggeration to say that every woman on the planet has, at one point or another, heard someone say, Oh, its probably just your hormones. People seem to be inclined to blame just about everything from headaches to hot flashes and all kinds of conditions in between on good old hormones.

Cleveland Clinic is a non-profit academic medical center. Advertising on our site helps support our mission. We do not endorse non-Cleveland Clinic products or services.Policy

Sometimes itisyour hormones, though. Andhormonal imbalancescan mean more for your health than just a grumpy day or a few zits before your period. So, how can you tell when its hormones and when its something else?

Womens health specialistPelin Batur, MD, talks about a few types of hormonal imbalances commonly seen in women, including symptoms you shouldnt ignore and when to see a medical professional.

To decide whether you need hormone testing (and if so, what kind), your doctor will likely start by asking you lots of questions about your symptoms. This will help them put together the puzzle pieces of what might be going on.

The workflow in my head focuses on three questions, Dr. Batur says. First, do these symptoms sound hormonal? If so, do they sound like theyre related to estrogen, progesterone, testosterone or some other type of hormone? And finally, is it because theyre too low or too high?

Once your doctor has a sense of what might be happening, theyll figure out which tests to (or not to) run.

One symptom that indicates that you may need testing is irregular periods.

If youre having regular menstrual cycles and not having symptoms throughout the month, I dont usually start with lots of estrogen, progesterone or testosterone tests, Dr. Batur says. But if youre experiencing a lot of irregularities in your cycle, Im likely to do more testing.

We have at least 50 different hormones in our body, and very complex symptoms can arise from them, Dr. Batur says. Having too much or too little of certain hormones causes symptoms and issues with your health.

Here are some of the most common hormonal imbalances seen in people assigned female at birth (AFAB).

There are less-common hormonal imbalances, too, likeCushings syndromeandAddisons disease. Only a doctor can help identify which hormonal imbalance youre experiencing and what course of treatment is best.

Heres the thing: Hormonal imbalances can have a lot of symptoms and they can have a lot ofdifferentsymptoms, depending on which ones are at the root of your issues. Those symptoms may seem muddled or initially unrelated, and theyre not always related to hormones at all.

Hormones can cause so many symptoms, but that doesnt mean theyre always the cause of your symptoms, Dr. Batur says, so its really important to be seen by a doctor for an individualized assessment.

Here are some common symptoms of hormonal imbalances in women and what theymight signify.

Weird periods are a key sign of a hormonal imbalance.Irregular menstruationcan be a sign of perimenopause but can have a number of other causes, too, especially if youre not yet nearing menopausal age.

If your menstrual cycles are disrupted or if youre going through menopause, you should definitely come in to be seen and to talk things out, Dr. Batur advises.

If a woman comes in complaining of acne, Im concerned about potentially high levels of hormones such as testosterone, Dr. Batur says. We see this in women withpolycystic ovary syndrome. PCOS causes higher levels of male hormones called androgens (including testosterone), which can lead to acne.

If you start to notice differences in your hair whether on your head, face or someplace else, like your arms and legs it could be a sign of a hormone imbalance.

Starting to see chin hairs or a bit of a mustache? Increased testosterone can cause excess hair growth (hirsutism). This can be a symptom of PCOS or menopause, but it has other causes, too.

On the flip side, hormonal imbalances can also cause thinning hair on your head, legs and pubic region.During menopause, a drop in estrogen can lead to slower hair growth, or cause it to fall out more easily.Hypothyroidism and hyperthyroidism can cause hair loss, too. Or your hair loss may be related to something else entirely something nonhormonal.

It can be really complex to figure out, Dr. Batur says. You might assume hair loss is hormonal, but it can be related to high or low thyroid level, low estrogen, high testosterone or something else, like vitamin deficiency or lifestyle stressors.

These symptoms usually indicate that a womans hormones are lower, like the kind of dropping estrogen levels we see in perimenopause or postmenopause, Dr. Batur says. They can alsobe a side effect of some medications and treatments.

Your doctor can help you find ways tomanage your hot flashesso they dont negatively affect your quality of life.

Weight gain can be a symptom of a variety of hormonal imbalances, as well as lifestyle-related factors, so doctors use other clues about your health to get a sense of whats going on.

Difficulty losing weight is a very common problem in the United States, and its often blamed on hormones, Dr. Batur says. Sometimes, its related to high testosterone levels, like with PCOS, and menopause is associated with weight gain, too. But if you have weight gain with regular menstrual cycles, its more likely to be related to something likecortisol, thyroid, insulin or lifestyle habits.

Havent changed your lifestyle habits but have suddenly dropped 15 lbs.? This symptom is often a sign of an overactive thyroid, orhyperthyroidism. When your body produces too much thyroid hormone, your metabolism speeds up, which can cause weight loss along with rapid heartbeat, an intolerance to heat and other symptoms.

Althoughvaginal drynesscan be a sign of a few issues, its one of the most common symptoms of menopause. Your estrogen levels drop during menopause, which can to lead vaginal dryness that causesdiscomfort during sex.

The vagina is quite sensitive to lack of estrogen, Dr. Batur says. About 50% of women have vaginal dryness that may get in the way of intercourse, and it tends to get worse over time.

While its important to advocate for your health, try not to be swayed by broad, overarching claims (looking at you, social media) that insist thateveryoneneeds hormone testing or that every symptom youre experiencing is related to your hormones.

Just because youre experiencing symptoms of a hormonal imbalance doesntmean you haveahormonal imbalance. Nearly every symptom of a hormonal imbalance can have other causes, as well.

Its important to not lump everything together under hormones, and to instead break down each symptom individually, Dr. Batur advises. We have to take a deep dive to make sure were not missing anything, whether its lifestyle factors or another medical condition.

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Do You Need Hormone Testing? - Health Essentials from Cleveland Clinic

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Jun 10

Kaplan USMLE Step 1: Woman treated with linear doses of a hormone – American Medical Association

If youre preparing for the United States Medical Licensing Examination (USMLE) Step 1 exam, you might want to know which questions are most often missed by test-prep takers. Check out this example from Kaplan Medical, and read an expert explanation of the answer. Also check outall posts in this series.

This months stumper

A double-blind study of fertility-enhancing drugs is conducted. A 28-year-old woman is being treated with sequential doses of a hormone which produces a progressive rise in the hormone's plasma level over several days. Initially, the patients plasma levels of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) decline, but later FSH and LH suddenly and dramatically increase.

Which of the following hormones is she most likely being treated with?

A. Estrogen.

B. Gonadotropin-releasing hormone.

C. Inhibin.

D. Progesterone.

E. Testosterone.

The correct answer is A.

Kaplan Medical explains why

The drug is promoting changes in estrogen levels and estrogen induced FSH and LH levels that would be expected to be occurring during a normal menstrual cycle. Estrogen levels are relatively low at the beginning of the menstrual cycle but rise slowly during the follicular phase.

Estrogen suppresses FSH and LH secretion during the follicular phase through negative feedback inhibition of the hypothalamicpituitaryovarian axis. Once plasma estrogen levels reach a critical threshold (as occurs with the repeated dosing described in this question), and that level is maintained for at least two days, the negative feedback loop changes to a positive feedback loop and a surge in FSH and LH secretion occurs. This sequence occurs at the end of the follicular phase, and the LH surge induces ovulation.

Why the other answers are wrong

Choice B: Gonadotropin-releasing hormone (GnRH) is produced by the hypothalamus and targets gonadotropes in the anterior pituitary. GnRH administration would initially stimulate FSH and LH secretion, but levels of both hormones would then fall due to downregulation of the GnRH receptors. A pulsatile infusion that mimics the normal pattern of GnRH release from the hypothalamus would promote a sustained increase in LH through GnRH receptor upregulation and gonadotroph sensitization.

Choice C: Inhibins are peptide hormones produced by follicular granulosa cells that create a negative feedback control pathway regulating FSH secretion by the anterior pituitary. Inhibins are produced in response to FSH and once released, inhibit FSH secretion. Administration of inhibin would not result in an FSH surge such as that described in the scenario above.

Choice D: Prolonged administration of progesterone inhibits GnRH-induced FSH secretion from the anterior pituitary.

Choice E: Testosterone normally provides the negative feedback for LH and does not directly affect FSH, although very high nonphysiologic levels of testosterone will reduce plasma FSH due to suppression of GnRH release.

Tips to remember

For more prep questions on USMLE Steps 1, 2 and 3, viewother posts in this series.

The AMA selected Kaplan as a preferred provider to support you in reaching your goal of passing the USMLE or COMLEX-USA.AMA members can save 30% on access to additional study resources, such as Kaplans Qbank and High-yield courses. Learn more.

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Kaplan USMLE Step 1: Woman treated with linear doses of a hormone - American Medical Association

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Jun 10

What Is Hormone-Replacement Therapy? – POPSUGAR

If you've experienced gender dysphoria the distressing feeling that occurs when your gender identity differs from the one you were assigned at birth you might have considered hormone-replacement therapy. Originally, HRT referred to the process of prescribing sex hormones like estrogen to people going through menopause as a way of treating symptoms such as hot flashes (a practice that has since been the subject of some controversy). But today, the term "HRT" is commonly used to describe "gender affirming hormone therapy" for "individuals who are seeking to alter their secondary sex characteristics for a more 'masculine' or more 'feminine' gender presentation," as defined by Folx, an online health and wellness provider for the LGBTQ+ community. At Folx and other gender-affirming-therapy providers, HRT involves using hormones like estrogen or testosterone to give the body a more traditionally feminine or masculine appearance to match one's gender identity.

While many trans and nonbinary people describe the medicine as life-saving, the process isn't for everyone, nor is it a requirement for trans and nonbinary people. "HRT does not make a trans person trans," stresses TikToker and professional actor Dylan Mulvaney, a trans woman who has been chronicling her self-described girlhood on the app. "If there is a trans person out there, and for whatever reason, they don't think HRT is right for them right now, or ever, we need to see them as such and respect their pronouns as such," Mulvaney adds.

The decision to start HRT is individual and can be complex. Sade Bolger, a Vermont-based activist and public-affairs organizer for Planned Parenthood, started HRT specifically testosterone therapy (or T) in May of 2017. But when he began, the decision was one of uncertainty. "When I did start T, I didn't really actually fully feel like I did know that for certain this is going to be the right thing," Bolger says. "I stepped into T in an explorative way, having seen other people who had gone through that process, and utilized it as a tool for self-discovery and self-exploration."

California-based Mulvaney echoes a similar sentiment: "The initial reason for going on HRT was just to sort of explore what that side to me was." Before beginning HRT, the actor had considered themself nonbinary for about 18 months. "But I always knew that I wanted to be more feminine," she says. "And even while I was nonbinary I knew that I loved the features on a woman, that I would love to have." Even so, she tells POPSUGAR, "I was so nervous to start [HRT] because it really is a huge decision to be potentially altering your body."

Josie Moon, another trans TikToker, also described her decision to start HRT as a tough one. Moon says she didn't know what the word "trans" meant until she was late into high school. The Nashville-based content creator got married at 24 years old, came out to her now-ex-wife as trans about two years into their marriage, and decided to get divorced just before the 2020 COVID lockdown. Through her own research, she discovered that some trans people don't take hormones. When making the choice for herself, she considered how it would affect her. "I was very concerned that even if I went on hormones at 29, it wasn't going to be enough for me to feel comfortable in my body," Moon tells POPSUGAR.

So she gathered more information, reading relevant threads on Reddit and Twitter and speaking to others in the trans community to make sure HRT was the right decision for her. "There's a subreddit called Trans timelines which shows pictures of mostly trans women but also trans men, really trans people in general before and after hormones," Moon says. "And I was like, wow, these people are the same age as me . . . and they look amazing. The results are amazing. So maybe this could work for me too." It had gotten to the point, Moon says, where she was constantly looking at these pictures and "imagining just feeling comfortable in my body and what that would look like." Now, two years on HRT, Moon is happy with her decision to start the therapy. So are Mulvaney and Bolger. "I look at myself in the mirror now and every day I get a little bit closer to finding myself to be a beautiful woman," Mulvaney says. "I think it was through the process of experiencing the changes that came alongside taking T that really kind of confirmed for me that this was what I wanted to do and who I wanted to be on the planet," says Bolger.

If you're still trying to figure out whether HRT is right for you, this explainer will help answer some of your questions, including what to ask your doctor, when to expect changes, and what side effects to be aware of.

Masculinizing or feminizing hormone therapy, also commonly referred to as hormone-replacement therapy or HRT, is a process used to "induce the physical changes in your body" caused by male or female hormones "to promote the matching of your gender identity and body (gender congruence)," per the Mayo Clinic.

Someone transitioning from male to female (MTF) would typically use feminizing hormone therapy and "be given medication to block the action of the hormone testosterone. You'll also be given the hormone estrogen to decrease testosterone production and induce feminine secondary sex characteristics," the Mayo Clinic states. In a female to male (FTM) transition with hormone therapy, "you'll be given the male hormone testosterone, which suppresses your menstrual cycles and decreases the production of estrogen from your ovaries."

The method in which those hormones are administered can vary, says Dave Usman, nurse practitioner at Radiant Health Centers, a California-based LGBTQIA+ Health and HIV care center. "It depends on the comfortability of the individual that's seeking hormone therapy," he says. For those receiving masculinizing HRT through testosterone, there are two options, Usman says. The most common route is injection. "It can be self-administered or office-administered," he says. There's also a topical gel option. For estrogen therapy, there's a pill, injectable, or patch.

Not every hospital or clinic provides gender-affirming healthcare. There are some instances in which medical providers can get exceptions, specifically hospitals and clinics with religious affiliations. It's important to do your research beforehand to ensure that you can get the care you need.

Bolger was referred to an endocrinologist after expressing to his therapist that he was considering HRT. Mulvaney recommends going to a queer health center in your area. "The great part is that they focus primarily on queer trans clients, so they are very in the know as far as treatment plans," she explains. Another good option? An informed-consent clinic, which means that a referral or therapy note is not required to receive care. (Planned Parenthood is an informed-consent clinic.) You can also receive hormone therapy online through services like Folx and Plume.

As far as cost goes, many insurance plans cover hormone therapy. For those who are uninsured or have trouble accessing hormone therapy, health centers like Radiant Health rely on contracted pharmacies that provide the medication at a low out-of-pocket cost for patients. Brands like Folx also offer an HRT care fund which distributes financial resources to an annual grant covering 12 months of hormone-replacement therapy, including prescription medication, unlimited clinical visits and messaging, and labs. Eighty percent of the Folx HRT grants are reserved for BIPOC. Eligibility starts at 18 years old, and you must live in a state where Folx is currently available.

"The first visit is mainly educating the patient, asking questions, and telling them what is expected," Usman says. "And then, once they have all the questions answered, they feel like they're ready, they're mentally and physically ready, that's when we start initiating therapy." That initiation point can be that day or weeks later. It's really about the patient's comfortability level.

Mulvaney first went to get information and ask questions about the process and then was prescribed spironolactone and estradiol. Spironolactone is a testosterone blocker and estradiol is a form of estrogen. "I went for the information, I got it, I got my mind put at ease. And then I started [the hormones] a few weeks later," Mulvaney says. She adds that she started out with a low dosage "because I was still new to it. I was nervous. I just didn't want to throw myself into it too fully quite yet."

One major conversation you should have with your provider, Mulvaney stresses, is about reproductive options, which will change during hormone therapy. Testosterone and estrogen therapy can lower your sperm count or egg production and may permanently change or stop your body's production of eggs and/or sperm altogether. So if someone is planning to undergo hormone therapy and they may want to conceive a child in the future, Usman says it's encouraged to do egg or sperm retrieval or freezing. "I actually didn't start the spironolactone until recently because I wanted to freeze my sperm first," Mulvaney says. "Being in my 20s, I just wanted to keep all my options open for the future and family planning because I don't know what that's going to look like when I'm older." But Bolger adds that not knowing what you want your reproductive options to be is OK, too. They started T when they were 19 years old. "I didn't know what I wanted to do reproduction wise I still don't. I'm 23 now, and I'm still figuring it out." But it's important that you know all of your options and make the decision that's best for you.

Everyone's timeline of changes is different, but Usman says you can start to see small physical changes as early as a month in.

"My first sort of notice was stretch marks on my booty," says Mulvaney. It was an unexpected surprise to her less than three months on HRT, in addition to a smoothing of her face and the loss of muscle mass in the chest. "I never had hard nipples before," Mulvaney says. "And now they are starting to bud."

For Bolger, the most notable initial changes were voice deepening, peach-fuzz hairs on the lip, and clitoral enlargement, which is commonly referred to as bottom growth. In terms of mood, Bolger says, "My libido pretty greatly increased and stayed kind of intense for the first couple of months into that first year." They also dealt with recurring mood swings. But this was predominantly "just during the period of time where my hormone balance was off because I was transitioning between estrogen and testosterone. And once I kind of plateaued with the T in my body, and that became the main hormone in my body, then all that stuff kind of settled out."

What's important to note is that the mental and emotional changes are just as important to address as the physical ones, and they may hit you sooner. "The first two weeks, I'm not gonna lie, were tough. I didn't feel like myself in some ways. My mind was foggy, I felt very emotional, I had some anxiety," says Mulvaney. These changes ultimately went away, or Mulvaney became accustomed to them. "I think my body learned to accept that this was the new normal and I started to feel like myself again," she says.

Therapy also helped, she adds. "I'm in therapy once a week and I have been with the same therapist for two years, it's changed my whole life and outlook on things." With HRT, you're seeing a doctor every three months or so for check-ins. "But you also need to have a support system in place that can help you with the day-to-day, because it can get pretty overwhelming," says Mulvaney.

Moon agrees that at times, the emotional aspects of HRT can become overwhelming. "When I was younger, I used to say I had three emotions angry, happy, neutral and that was just how it was," says Moon. But in starting HRT, she unlocked a new range of emotions with various depths and layers. "Angry is actually, 'I'm a little bit hungry, but I feel hurt and misunderstood and just sad in general.' And then when I was happy, I'm not just happy or euphoric, it's like, 'I'm excited about this and there's a little bit of joy about this.'" The whole process is "also a little bit bittersweet, because in transitioning, I get to be myself, but I also lost so, so much and had to rebuild," Moon says. "I think emotionally, it took me off guard."

One change that Bolger says he was the most unprepared for is the way others perceive him. "I absolutely took on male privilege," he says. "I noticed that I was being treated differently. The men in the room would shake my hand before they left. I was listened to more. There was more of a platform in a space, people kind of waited for me to have something to say." Emotionally, Bolger says it was "so weird." Because they don't identify as a man, "it was like switching from feeling misgendered on one side to feeling misgendered on the other side." He also says the transition between living the first 18 years experiencing sexism against women only then to be welcomed and respected by sexist men was "not ever in my intentions." There's this layer of complexity for nonbinary individuals, Bolger says, because T or no T, "we live in a society where people assume that you're either a man or a woman."

Another unexpected change? Anecdotally, many people on T have said that it changes their sexual attraction, especially as it pertains to men. Bolger says that being on T hasn't necessarily changed his attraction level to men but rather his comfortability level being with a man. "I felt really uncomfortable being with men, for example, when I was younger, because I knew that that would make people see me as a girl," Bolger says. Being on T changed the way people perceived them and how Bolger perceived himself. Ultimately, "T didn't make me stop loving women. T didn't make me start loving men. T didn't change anything about who I loved or who I f*cked. It changed my comfort, being in those relationships and having those experiences because of how I was feeling and perceiving myself."

Yes. "That's why we screen people initially for their past medical history and family history, because both [hormones] have side effects and adverse effects that can affect their overall health," says Usman. Hormone therapy can aggravate pre-existing depression and anxiety. Other complications include developing diabetes, high cholesterol, high blood pressure, and blood clots. If you're a chronic smoker in particular and you're on estrogen, "there's higher risk of developing blood clots," Usman says. So be sure to be honest about all of your lifestyle habits within that first meeting so that your provider can assess your needs and design a hormone-therapy plan that works best for you.

Bolger, for example, is neurodivergent. "I have ADHD. I sometimes struggle with routine, like hygiene care, because of that," Bolger says, and talking to his provider about that openly was "really important" in figuring out which form of T was right for them. For example, the topical gel has to be applied once a day. "It has to be a part of your routine and for me with my ADHD, that wasn't something that I really thought was going to be plausible," Bolger says. So he went with the weekly injections instead. Even so, Bolger experienced health complications, including ovarian cysts, which were caused by going off schedule on T, a diversion caused by his ADHD. That's why Bolger emphasizes the importance of seeking out a provider who can assess and treat your whole self someone who will be looking our for your mental, physical, and emotional health not just you as a trans person, but you as a whole human, too.

Image Source: Getty Images

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What Is Hormone-Replacement Therapy? - POPSUGAR

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Jun 10

Atkins diet: Lose up to 14lb in the first month with low-carb eating – ‘it can work’ – Express

The Atkins diet is one of the more well-known diets around today, with its low carb approach to weight loss leading to countless success stories around the world. And for those who haven't tried it yet, you could lose up to 14lb in the first month, according to researchers.

In his book 'Dr. Atkins New Diet Revolution', the founder of the popular weight loss plan reveals slimmer are "more likely" to lose about 10 to 14lbs during the first month on the diet.

And over the years, numerous studies have shown that low carb diets are effective for weight loss.

The Atkins diet itself emphasises protein and fats, such as:

Meat

Poultry

Seafood

Eggs

Butter

Oils

Cheese

READ MORE:Diet: Expert warns against common mistake

The Atkins diet is split into four different phases:

Slimmers are to stick to under 20 grams of carbs per day for two weeks.

They are permitted to consume high-fat and high-protein foods, with low carb vegetables such as leafy greens.

This phase is said to "kick-start" the weight loss.

Here, dieters are allowed to slowly add more nuts, low-carb vegetables and small amounts of fruit back into their diets.

Healthline reveals that some people choose to skip the induction phase altogether and include plenty of vegetables and fruit from the start.

They point out that this method can be "very effective" as it ensures the body is still getting enough nutrients and fibre while losing weight.

People on this specific diet also don't need to partake in any strenuous exercise, but should be sticking to the recommended guidelines of 150 minutes of aerobic activity per week.While there have been questions around whether the diet really works, Doctor Arefa Cassoobhoy explained that "the research shows it can work".

"If you fill your day with processed carbs like white bread, pasta, and white potatoes, and you dont eat many fruits and veggies, then this diet may be the jump-start you need to lose weight," she said.

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Atkins diet: Lose up to 14lb in the first month with low-carb eating - 'it can work' - Express

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Jun 10

What Is The 5:2 Diet And Does It Really Work? – Glam

While it may seem like cutting calories for two days each week is an obvious way to lose some weight and that's true there are a few other potential benefits to the 5:2 diet, according to Healthline. This intermittent fasting option also reduces issues with inflammation and improves the body's response to insulin. Beyond that, it can help to target any fat that you might have around your midsection while keeping your muscles in great shape. With those kinds of results, it's no wonder Kelly Plowe, M.S., R.D., told Verywell Fit,"The 5:2 diet is one of the most popular intermittent diets." However, Plowe also noted, "It's a highly regimented diet and can be hard to follow, especially on fasting days."

Indeed, during a 2021 study by the U.K.'s Queen Mary University of London, the number of participants who stuck with the 5:2 diet dropped to 74% after just six weeks, and that number was down to 31% by six months. After a year, only 22% of the participants were still using the 5:2 diet.With that in mind, it's important to remember that this option isn't ideal or easy for everyone, which is why you may want to talk to a dietitian or your doctor before giving it a try.

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What Is The 5:2 Diet And Does It Really Work? - Glam

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Jun 10

Paleo diet for weight loss: How it works and what to eat – Livescience.com

The paleo diet is inspired by the eating habits of our hunter-gatherer ancestors, becoming a popular diet in recent years for weight loss and a more natural way of eating. Using the paleo diet for weight loss is effective mostly because of the unprocessed nature of the foods it encourages you to consume, which are often naturally low in sugar, salt and saturated fat.

The diet cuts out most grains, legumes, potatoes and dairy products, relying heavily on fresh fruit and vegetables, nuts and seeds and lean meat and fish. As a result, the paleo diet is fairly low-carb and has a slightly higher risk of calcium deficiency, due to the lack of dairy products.

While it may seem a good idea to return to our roots and eat in the way early humans did, how practical is the paleo diet for weight loss in a modern sense? With a wider range of foods available to us than our ancestors had, what benefits might we gain by restricting ourselves to a diet based on ancient practices? We asked the experts.

The paleo diet shifts focus from starchy foods such as grains, legumes, potatoes and foods made from these ingredients (pasta, bread, potato chips) and encourages you to base your meals around a lean protein source instead.

Dr Nurisa Kumaran, medical director and founder of Elemental Health Clinic (opens in new tab), tells us that the paleo diet puts a heavy focus on eating natural foods. The paleo diet, also known as the caveman diet, focuses on eating lean grass-fed meat, fish, fruit and vegetables, she says. This means that you should eliminate processed foods and most dairy products, and instead eat a diet rich in nuts, seeds, fruit, lean meat such as lamb and chicken and omega 3 containing fish, such as salmon and mackerel.

The paleo diet can be helpful for those with obesity or diabetes, due to the reduction of heavily processed foods and reliance on lean meats and vegetables. A study from the International Association for the Study of Obesity (opens in new tab) indicates that the hunter-gatherer lifestyle and diet contributes to excellent cardiovascular and metabolic health.

Due to the protein-rich nature of the paleo diet, those who eat paleo for weight loss may find they have a higher success rate due to the feelings of satiety associated with eating protein, according to one study by the British Journal of Nutrition (opens in new tab).

As well as protein, the paleo diet is full of high-fiber foods, such as nuts, seeds and vegetables, which are also great for an increased sense of satiety according to a study in Nutrition Reviews (opens in new tab). Fiber is a bulking agent that slows stomach emptying, which helps you to feel fuller for longer, as well as taking longer to break down in the digestive system than low-fiber foods. Feeling full is important when keeping people motivated to stick to eating habits, so the paleo diet might be good for weight loss due to its ability to keep you feeling full and satisfied.

However, one review in the American Journal of Clinical Nutrition (opens in new tab) indicates that while there was a downward trend in weight and other positive metabolic markers, without the intensive dietary support of a clinical trial, many participants lapsed and stopped following it. This might indicate that the carbohydrate-restricted nature of the paleo diet isnt as sustainable without proper nutritional support.

Dr Kumaran agrees with the benefits of using the paleo diet for weight loss. There has been research so far to show that the paleo diet can produce greater benefits compared to other diets for weight loss and other associated metabolic health conditions, she says. Additionally, a study in the European Journal of Clinical Nutrition (opens in new tab) indicated that the paleo diet can be useful in supporting those with type 2 diabetes, increasing their insulin sensitivity over time. As diabetes is often a secondary condition to obesity, the research in this area is promising.

The paleo diet requires you to eat lots of fresh foods and lean meats, so there is often a little more prep involved in eating paleo than a traditional western diet that relies on ready meals and processed foods. Many of us are used to building our meals around starchy foods, as advised by the USDA government dietary guidelines (opens in new tab), so there may be a learning curve in making your meals paleo-friendly.

Paleo appropriate foods include:

Kumaran also advises caution when undertaking restrictive diets, such as paleo or keto, despite evidence of positive weight loss trends. As with all diets that can be restrictive such as the paleo diet, it is important to work with a qualified health professional to ensure you do not risk nutritional deficiencies, she says.

This article is for informational purposes only and is not meant to offer medical advice.

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Paleo diet for weight loss: How it works and what to eat - Livescience.com

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Jun 10

The #1 Eating Habit the World’s Oldest Male Athlete Follows To Run at 111 Eat This Not That – Eat This, Not That

Being an athlete does not come with an age constraint. That's the mentality that Fauja Singh, the world's oldest marathon runner, has to this day. Born in April 1911 in Punjab, India, Singh has since then moved to England where he took part in many races throughout his lifetime. But running was not originally in the cards for him.

Singh's legs were so weak that he could not walk until the age of 5. Eventually, he grew stronger, and at the age of 89, he ran his first marathon in London. For a man who could barely walk in his adolescent years, how did he grow to become a strong, inspiring marathon runner? According to Religion News, Fauja Singh says the key to a long, balanced life is nutritious eating.

To coincide with his advice, Singh has become an advocate for health and wellness. He has encouraged people of all ages to exercise and eat healthy, all while treating the world and all creation with respect. The article also states that Singh has supported People for the Ethical Treatment of Animals (PETA) in campaigns to support vegetarian diets.6254a4d1642c605c54bf1cab17d50f1e

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Study authors from the University of Glasgow helped to show that the vegetarian diet has some great benefits that could lead to a healthy, longer lifestyle. The authors examined the self-reported diet habits of healthy adults in the United Kingdom, ranging from 37 to 73 years old. The group of 166,516 people was split into vegetarians and meat-eaters.

The research showed that despite common risk factors of age, sex, education, ethnicity, obesity, smoking, and alcohol intake, vegetarians showed "significantly lower" levels of 13 biomarkers. These included total cholesterol, LDL (bad) cholesterol, and proteins linked to cardiovascular disease. Some of the biomarkers are also connected to a lower risk of liver function, kidney function, and cancer cells.

RELATED:The Eating Habit the World's Oldest Couple Followed Every Day

It is also important to stress that although supporting vegetarianism, the world's oldest runner followed a healthy, nutritious diet. That entails not eating ultra-processed foods, which can increase the risk of mortality.

Although no longer actively competing and participating in marathons, Singh ran until he reached his 100s. He has held many age-related world records, including the 100-meter run and the marathon for men over 100. Today, Singh continues to remain active by walking about five miles a day around the London neighborhoods. He still prefers to walk around as his mode of transportation, but he does have a passion for racing motorcycles.

Throughout his growing fame, Singh was a spokesperson and influence. He highlighted issues like classism, racism, literacy bias, ableism, and ageism. He also has refused to make personal gain from the money obtained through his sponsorships. Instead, he insisted that all sponsorship money be donated to charity.

RELATED: The Foods the World's Oldest Athlete Ate To Live Until 106

Kayla Garritano

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The #1 Eating Habit the World's Oldest Male Athlete Follows To Run at 111 Eat This Not That - Eat This, Not That

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