On this pageWhat is MHT/HRT?

Menopausal hormonal therapy (MHT), formerly called hormone replacement therapy (HRT), is when hormones are used to treat the symptoms of menopause, especially hot flushes and night sweats. There are benefits and risks with MHT, so it is important to talk to your doctor if you are considering it.

The main types of MHT are based on hormones, such as oestrogen, progesterone and testosterone, that occur naturally in the body.

During menopause, hormone levels go up and down, resulting in symptoms such as hot flushes and night sweats.

MHT helps restore hormone levels, which may improve some menopause symptoms.

The main hormone used in MHT is oestrogen. In women who have not had a hysterectomy, progesterone needs to be taken at the same time to reduce the risk of endometrial cancer.

Some women benefit from a low-dose testosterone replacement to improve low libido, lack of energy and fatigue.

Other forms of MHT are Tibolone or Duavive tablets.

MHT can be taken as:

MHT/HRT is usually helpful if you experience problems with hot flushes and night sweats. Mood, sleep and sex drive problems may also improve. Some women also say they find improvements in joint aches, vaginal dryness and incontinence.

The main risk is that some types of MHT lead to a slightly increased risk of developing breast cancer or thrombosis (blood clots in the legs or lungs). However, it can prevent other conditions such as osteoporosis, heart disease, fractures, diabetes and some types of cancers.

Current international recommendations say that the benefits outweigh the risks in women who are having significant symptoms from menopause, and that MHT is effective and safe for most healthy women.

Some women have side effects such as nausea, fluid retention, bloating, breast tenderness and swelling, and irregular bleeding. These often go away with time.

MHT may not be suitable for you if you have or have had:

The risks of MHT depend on your age, the type and dose of hormone therapy you take, duration of treatment, and your medical history.

Talk to your doctor to find out which risks apply to you. If you are unable to take MHT, your doctor may suggest other medications that may be helpful.

You can minimise the risks associated with MHT by:

If you are interested in taking MHT, please talk to your doctor to see if it is right for you.

Continue reading here:
Hormone replacement therapy (HRT) | healthdirect

How does menopause affect the bones?What is the menopause?

Menopause is the time in a womans life when the ovaries stop producing enough hormones for pregnancy. Around the menopause, the level of oestrogen can vary for a time and then eventually decreases. This often causes symptoms such as hot flushes and sweats.

You've completed your menopause (or are post-menopausal) when you havent had a period for at least one year. The average age for this to happen is 51 years.

Some women have an early menopause, before the age of 45. This can happen naturally, or after surgery to remove your ovaries. Early menopause can also be triggered by chemotherapy or radiotherapy, as these treatments can cause a sudden drop in hormones.

The inside of our bones is constantly being broken down and rebuilt by specialist bone cells. This process, called bone remodelling, helps to keep bones healthy and strong.

During the menopause, the drop in oestrogen causes this process to become out of balance. More bone is broken down than formed, leading to bone loss.

Bone loss happens more quickly for a few years around the menopause. You then continue to lose bone at a slower rate as you get older. Over time, you may develop osteoporosis and a higher risk of breaking bones in later life. This is particularly likely if you have an early menopause.

HRT is medication that mimics oestrogen and progesterone.

HRT usually combines both hormones. This is because oestrogen taken on its own could make your womb lining too thick and increase your risk of womb cancer. But if youve had surgery to remove your womb (a hysterectomy), youll only need to take oestrogen.

There are more than 50 different HRT products available for prescription in the UK, including tablets, patches that you stick on your skin, small implants that are placed under the skin, and gels you rub on your skin. Progestogen is also available via a contraceptive device called a coil.

There are also rings, creams and pessaries (small removable devices) that can be placed inside the vagina to treat symptoms such as vaginal dryness. But these aren't used to treat osteoporosis, as they only contain very low levels of oestrogen.

HRT comes in the following three forms. Your healthcare professional should explain which form is most suitable for you and why.

Sequential combined therapyYou take oestrogen every day and progestogen for around 12 days per month. The progestogen causes you to have a bleed like a menstrual period.

Continuous combined therapyYou have both oestrogen and progestogen every day, so you wont have periods. The progestogen stops your womb lining from getting too thick. You need to be at least a year past your last period before having continuous combined therapy, or it may cause irregular bleeding.

Oestrogen-only HRTThis doesnt contain any progestogen. You can have oestrogen-only HRT if youve had an operation to remove your womb (a hysterectomy). You wont have any periods.

Tibolone (Livial)This is taken as a tablet once a day. Its similar to taking combined HRT, but contains the ingredient tibolone, rather than oestrogen and progestogen. Tibolone mimics oestrogen, progesterone, and the hormone testosterone inside the body. It can be used if you completed your menopause over a year ago. It may be helpful for libido (desire for sex) and bone strength.

Regulated bio-identical hormonesThese medications are designed to be more similar to the hormones we produce naturally. They include:

Some clinicians prescribe these with oestrogen, instead of standard progestogen, as they are less likely to cause side effects or increase risks of blood clots and stroke. They may also be less likely to increase the risk of breast cancer. There isnt as much research about these newer products, which is why most doctors still prescribe standard progestogen.

Natural bio-identical hormonesThese unregulated products are different to the regulated bio-identical hormones mentioned above. They havent been tested in the same way to prove they work and are safe. Its important to remember that just because a product says it is natural, this doesnt automatically mean it is safe or effective.

Visit the Womens Health Concern website for more information about all of these treatments.

HRT causes your oestrogen levels to increase. This can help to prevent bone loss and reduce your risk of developing osteoporosis and of breaking bones.

If you already have osteoporosis or a high risk of breaking bones, HRT can help to strengthen your bones and make fractures less likely.

Is it as effective as other osteoporosis drugs?

There havent been many studies comparing HRT with other osteoporosis drug treatments. But its thought that HRT probably reduces the risk of breaking a bone by a similar amount to other osteoporosis medications, including bisphosphonates.

As with all medications, HRT has both benefits and risks.

The levels of risk vary from one person to another and depend on things such as your age, weight, medical and family history. As you reach your 60s, the overall risks of HRT may outweigh the benefits. This is because your risk of the health problems mentioned above increases naturally with age, and taking HRT could add to this risk.

Its important to discuss your own benefits and risks with your doctor, so you can decide whats right for you. A regular review of treatment choices is also useful.

Worried by stories you've seen in the news?

You may have seen news stories about HRT, and be feeling worried and confused about its safety. But it's important to remember that news stories arent always accurate or balanced.

Experts regularly review the safety and use of treatments. If official guidance on HRT changes, well update our information on this website. You can also find reliable, up-to-date information on the NHS website, or on other websites such as Womens Health Concern and Menopause Matters.

As with any drug, HRT can cause side effects. But most people dont get any side effects and they dont usually last for long. Possible side effects include:

The patient information leaflet that comes with your treatment will have more information on possible side effects of HRT.

If you do get side effects that don't go away, speak to your doctor or pharmacist.

Its very important to consider taking HRT if you reach menopause early. This is because you will start losing bone at an earlier age than the average woman, increasing your risk of osteoporosis and broken bones. If youve had an early menopause, talk to your healthcare professional about taking HRT, at least until you are about 50.

Many women take HRT to treat symptoms caused by the menopause. Even if this is your main reason for taking HRT, you can be reassured that youll also be helping your bones.

HRT is also an option after the menopause as an osteoporosis drug treatment. Its particularly helpful for women needing a bone-strengthening medication who also have menopausal symptoms.

The decision about which osteoporosis treatment to use will depend on lots of things, including your own level of fracture risk, whether youve already broken a number of bones, your age, and your own needs and preferences. Youll need to speak with your healthcare professional about the most suitable treatment for you.

Like any osteoporosis medication, HRT wont reduce the pain caused by broken bones. But dont worry there are other medications and treatments for pain that can help.

Make sure it's the right treatment for youGet all the information you need and discuss any questions or concerns with your doctor. For many women, HRT will be a useful option. But it may not be right for you if youve previously had a blood clot, breast, ovarian or womb cancer, heart disease, untreated high blood pressure, or liver disease.

Its important to read the information in the patient information leaflet that comes with your treatment. You can also read more detailed information in our fact sheet, 'Hormone replacement therapy (HRT) and bone health'.

Ourspecialist nurse Helplineis here for you, if you have any questions or concerns. Call free on 0808 800 0035.

Make sure you understand your dose, monitoring regime, and what happens nextHRT as a tablet, patch or gel will usually help with bone strength, even if youre having a low dose such as 1mg oestradiol. But you may need a higher dose, such as 2mg, if your menopausal symptoms are severe or arent improving.

You wont need regular blood tests to check your oestrogen levels while youre taking HRT. You probably wont need regular bone density scans either, even if youre taking HRT to help strengthen your bones. However, your healthcare professional may recommend regular scans if you have a high risk of breaking bones.

You should have a medication review about once a year, to make sure HRT is still the right choice for you. Make sure you mention any side effects youre getting. Its important to understand the possible side effects and ways to reduce them.

You can keep taking HRT as long as the benefits outweigh any risks. Some women stay on HRT for several years. How long you take it for will depend on your own situation talk to your doctor about this.

When you stop taking HRT, the beneficial effect on your bones will begin to decrease straight away. If you still have an increased risk of breaking a bone, your doctor will probably recommend you start a different type of osteoporosis drug treatment. Or they may suggest you have a bone density scan or other tests.

Lead a healthy lifestyleIt's important to follow the usual guidance on healthy living while you're on HRT, and aim for a calcium intake of around 1,000mg a day. Your doctor may prescribe calcium and vitamin D supplementsif you cant get enough from your diet.

Content reviewed: February 2022

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Hormone replacement therapy - Royal Osteoporosis Society

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Global Hormone Replacement Therapy Market 2022 Key Trends, Competitor Analysis and Research Report by 2028 Bloomingprairieonline -...

Menopause and rheumatoid arthritis may share a connection related to hormones. However, experts dont fully understand or agree on the link.

Menopause occurs when a person doesnt have their period for 12 consecutive months for no other reason. It naturally occurs around the age of 50, though it can occur earlier or later based on the person.

Some studies and anecdotal evidence suggest that when a person goes through menopause, their RA symptoms get worse.

However, a 2020 study has shown that female reproductive hormones play no role in the development or severity of RA. They also noted that previous studies showed hormones had a protective effect, negative effect, or no effect at all.

Previous studies have shown a connection may exist between menopause and RA. The problem is that the studies havent agreed on exactly how or even if menopause has any effect on RA.

In a 2017 review of studies, researchers also noted that the effects of menopause on RA couldnt be determined. The review noted some of the discrepancies across studies including the following:

Still, a report published in 2018 indicated that menopause can cause additional or worsening symptoms in people living with RA. The study authors said that hormones may play a protective role in RA but also noted that additional research is needed to fully show or understand the connection.

Another study published in 2017 also noted that several hormone factors in women, including early onset and postmenopause onset, play a role in RA development and worsening. However, like other studies, they noted that additional research is needed to fully show and prove the connection between female hormones and RA.

You can take steps to manage the symptoms of both menopause and RA. For some people, treatments that help with menopause may also help with RA symptoms, but this isnt necessarily always the case.

Treatments for menopause often include one or more of the following:

You may find that certain supplements, such as soy, may help with menopause symptoms. You may also benefit from body and mind practices such as yoga, acupuncture, and meditation.

Some other steps you can take to manage menopause symptoms and risks can include:

Some suggestions for managing RA are similar to managing menopause. Some home-based care you can try include:

Some evidence suggests that hormone therapy may have an effect on both menopause and RA, while other evidence suggests not.

According to a 2017 review, studies have shown both positive and negative effects of hormone replacement therapy on RA symptoms. They indicate that more evidence is needed to make any conclusions regarding this treatment option and how it relates to RA.

You should talk with your doctor before making any major changes to your RA treatment routine, such as stopping or increasing the use of medication.

Also, you should talk with your doctor before adding a supplement to your diet to make sure it does not interfere with your current treatments.

You may also want to consider talking with your doctor if your RA or menopause symptoms become worse. They may be able to recommend additional therapies, make changes to current treatments, or make other recommendations.

RA and menopause may share a common connection due to the possible interaction between RA and hormones.

At this time, data isnt sufficient enough to show whether hormones and menopause have a negative effect, a protective effect, or no effect at all.

If you find your symptoms of RA getting worse during menopause, you should talk with your doctor to let them know what is going on. They may be able to suggest changes to your treatment.

You can also take steps at home, including getting regular exercise, eating a balanced diet, practicing good sleep hygiene, and using supplements to help improve your symptoms.

Originally posted here:
Menopause and Rheumatoid Arthritis: What to Know - Healthline

Hot flashes are common, long-term symptoms associated with menopause.

While hot flashes can be uncomfortable and disruptive for many people, they may also come with an unexpected link: a reduced risk of breast cancer.

In this article, we discuss what the latest research says about the possible link between hot flashes and a lower risk of breast cancer. We also take a look at options for treating hot flashes.

Hot flashes develop when estrogen and progesterone levels begin to change before and during menopause. Its thought that these hormonal fluctuations may disrupt the thermoregulatory center in your brain, leading to changes in heat production.

While hot flashes increase in frequency during the 2 years after you start menopause, they can last for 7 to 11 years or longer.

One 2016 review revealed an increase in breast cancer risk in those who had higher estrogen levels. Additionally, researchers found up to a 50 percent reduction in breast cancer risk in people who experienced menopausal vasomotor symptoms (VMS) like hot flashes and night sweats.

Also, a 2018 study of postmenopausal women with persistent VMS found a higher risk of breast cancer diagnosis but a reduced risk of related death. This may suggest a longer presence of hormones influencing the subsequent development of breast cancer.

While more clinical research is needed to determine whether hot flashes could provide a concrete indicator of a reduced breast cancer risk, such menopausal symptoms do indicate a decrease in lifetime exposure to the hormones (estrogen and progesterone) that may be associated with this cancer.

Its also important to note that researchers have found VMS in individuals post-breast cancer diagnosis. In such cases, the onset of VMS may also be attributed to tamoxifen, a type of estrogen modulator used in breast cancer treatment.

While hot flashes may be associated with a lower risk of breast cancer, there are still treatment options if you want to reduce their occurrence.

If youre interested in treatment for hot flashes, your doctor will likely recommend nonhormonal methods first. These may include:

In some cases, hormone replacement therapy (HRT) may be recommended if your hot flashes and other symptoms of menopause significantly impact your overall quality of life.

However, HRT isnt appropriate for everyone. It may increase your risk of developing breast cancer as well as the following:

If your doctor does recommend HRT, theyll likely start with the lowest, most effective dose. Its important to discuss all of the potential risks versus the benefits with your doctor.

In addition to medical treatments, you can ask your doctor about certain complementary therapies for hot flashes. These include:

While some herbal remedies and phytoestrogens are marketed to people experiencing hot flashes, its important to discuss these with your doctor before using them.

Herbs and supplements may potentially interact with medications you take, and theres a lack of clinical evidence supporting their efficacy. Additionally, some herbal remedies may cause liver damage.

To help manage hot flashes, you can also:

While the development of breast cancer depends on a variety of factors, the risk of receiving a breast cancer diagnosis may be higher if you:

Some lifestyle factors that may also increase your risk of developing breast cancer include the following:

Other possible, but not yet proven, risk factors for breast cancer may include:

Hot flashes occur before, during, and after menopause as estrogen and progesterone hormones start declining.

While the exact relationship still requires further clinical research, some studies have revealed a link between hot flashes and a reduced risk of developing breast cancer.

Hot flashes alone dont decrease the risk of breast cancer developing, but they may indicate a lowered lifetime exposure to hormones that do contribute to cancer risk.

In the meantime, if youre currently experiencing hot flashes, you may consider talking with a doctor about treatment options that could help you find relief without contributing to your overall breast cancer risk.

Its also important to understand your own personal breast cancer risks to help reduce the chances of its development.

See original here:
Hot Flashes and Breast Cancer Risk: What the Research Shows - Healthline

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As the creator of Black Girl's Guide to Surviving Menopause podcast and social media project, Omisade Burney-Scott, 55, has two missions. The first is to normalize menopause, a natural event that will happen to more than half of the population yet still remains shrouded in silence. The second: to center the voices of Black women and gender-expansive individuals, who experience many of the same symptoms that white women dohot flashes, insomnia, joint painbut often do so in a very different (and usually more intense) way.

Hers is an enormous undertaking, with 50 million+ U.S. women, women-identifying people, and nonbinary people currently in menopausedefined as the end of ones menstrual cyclesand millions more in perimenopause, the four to 10 years leading up to it. More than a third of these are women of color, yet this universal hormonal phenomenon is rarely discussed within their communities, and the experiences and stories of Black and Latinx women are rarely centered in the media or by physicians, according to Denise Pines, Immediate Past President of the Medical Board of California and founder of WisePause Wellness, a pro-aging platform.

When we read about menopause, we think of white womens menopause [experiences] because those are the stories that get told, Pines says. But while our biology may be the same, our experiences are not. Black and Latinx women enter menopause earlier and have longer-lasting, more intense symptoms. Hispanic women are more likely to report feeling bothered by vaginal dryness, urine leakage, and increased heart rate, whereas Black women frequently cite hot flashes and night sweats, according to the Study of Womens Health Across the Nation (SWAN), a decades-long study examining the health of midlife women across ethnicities.

Burney-Scott notes that news reports will often briefly mention the fact that Black and Latinx women have longer and more intense symptoms of menopause but then there is a hard stop. What about the why?

The average age of menopause in the U.S. is 51. SWAN findings reveal that Black women tend to begin menopause about nine months earlier than white women. Other SWAN findings show that Black and Hispanic women endure hot flashes for several years longer than other racial and ethnic groups (10 years and nine years, respectively, versus 6.5 for non-Hispanic white women) and Black women experience irregular bleeding for longer periods of time than white women.

Michelle A. Albert, MD, MPH, professor of medicine at the University of California at San Francisco, president-elect of the American Heart Association, and president of the Association of Black Cardiologists, says this phenomenon, called early-onset menopause, triggers a cascade of events leading to worsened health outcomes for BIPOC women. Cardioprotective estrogen plummets during menopause, meaning all women, regardless of race or ethnicity, experience an increase in heart disease and stroke risk during and after the menopausal transition, but the earlier the age of menopause, the greater the risk. Female hormones also help to protect you from obesity and insomnia, as well as keep cholesterol levels down, and those are all factors associated with elevated heart disease risk, too, Albert says. Additionally, early-onset menopause ups the risk of osteoporosis (estrogen helps keep bones strong) and depression.

Black women are also three times more likely to experience premature menopausemenopause before age 40, sometimes caused by smoking or autoimmune conditions such as lupus or rheumatoid arthritiscompared with white women, leading to a 40 percent higher risk of developing coronary heart disease over their lifetime, per research presented at a 2021 American Heart Association (AHA) meeting.

A 2022 SWAN study published in Womens Midlife Health proposes that some of the disparities that exist between white women and women of color in perimenopause and menopause are likely attributable to structural racism in the U.S. This link has yet to be definitively proven, notes study coauthor and SWAN investigator Ten T. Lewis, PhD, associate professor of epidemiology at Emory Universitys Rollins School of Public Health in Atlanta, but we know that stress matters.

Explains Albert, Its called allostatic load, which refers to the wear-and-tear from lifetime and ongoing stressors that Black women disproportionately face compared with white women. Systemic racism, including poor access to healthcare, toxic work environments, unsafe neighborhoods, socioeconomic challenges, and more, can weather the body, over-taxing various hormonal and biological processes and fueling chronic inflammation. This can lead to long-lasting health ramifications, including an earlier, more challenging menopause.

Despite the fact that Black women enter menopause earlier, and the symptoms last longer, they are the least likely to leave the office with a prescription for hormone treatment, says Sharon Malone, MD, Washington, D.C.based ob-gyn and chief medical officer of Alloy Womens Health. This may have to do with the common but erroneous belief that Black people have a higher pain tolerance, suggest some experts. Women of color often go to the doctor and the doctor says, Oh, no, youre too young [for menopause], Pines says, or they want you to grind it out, and women walk away with nothing. Or they assume patients cant afford hormone replacement therapy or other solutions. This goes beyond a comfort issue: Symptoms like hot flashes and weight gain can be linked to future heart disease, diabetes, and other serious conditions that are already more prevalent among Black and Latinx women.

Several of the experts interviewed for this story said there are concrete steps BIPOC women can take to help flip the script and improve the odds of an easier, healthier menopausal transition.

Malone notes there are plenty of positives accompanying this time of life in general. For a lot of women, its the first time they get to focus on themselves. Youve been concerned about your children, your job, the lens through which people view you, and trying to live up to those expectations. You get to 55, and its freeing.

This content is imported from OpenWeb. You may be able to find the same content in another format, or you may be able to find more information, at their web site.

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If You're a Woman of Color, Here's What to Know About Menopause - Oprah Mag

In 2017, the British Government Equalities Office reported that significant numbers of working women experience problems at work as a result of individual symptoms ... The evidence also paints a consistent picture of women in transition feeling those around them at work are unsympathetic or treat them badly, because of gendered ageism.

The U.K. has approximately 4 million employed women between 45 and 55, accounting for more than 25% of all women in the workforcethe largest cohort. So, you might think that this sort of affliction in the workplace might be protected by law. It is, after all, both an occupational health and equality issue.

But menopause is sadly not covered by the 2010 Equalities Act, which deals with protected characteristics in the workplace (among other things). What is covered: pregnancy and maternity, race, religion, sexual orientation, gender reassignment, marriage/civil partnership, sex, age and disability. You could argue that menopause is covered by age, sex and disability, but its discomforting for it to be so vagueand its why there is a huge push to get menopause formally categorized.

A couple of years ago, I started experiencing menopausal symptoms. It was insidious and gradual but became increasingly problematic to keep hidden. I felt that I needed to understand moreabout the symptoms, the biology and why there is such a stigma. More importantly, I felt I needed to talk about it, for my own sanity and also because the stigma will fade only if talking about menopause becomes as normal as talking about pregnancy.

However, thats easier said than done.

Male supervisors are often uncomfortable talking about womens issues, and women are reluctant to reveal any inadequacy for fear of judgement or retribution. As Brits, we are disciplined, self-controlled and unemotional, stoical and stiff upper-lipped. Theres a crisis, just pop the kettle on. We keep smiling and waving, or, at the very least, only slightly awkwardly staring into the middle distance.

But this pointless taboo can be addressed only by acknowledging such behavior is not a badge of honor; its repressed, regressive and damaging to business. If leaders truly want to lead, they need to create open and inclusive working environments that offer care and support to their staff. And if they want to retain talented, experienced and dynamic women, they not only need to have menopause on the radarthey need to have it in the spotlight.

Developing strong menopause policies and robust support strategies isnt just good emotional quotient, its good business sense. It will create better workplaces for everyonemale, female or non-binaryaffected by the change. It will help the gender pay gap, it will help diversity and it will help business.

Here are some ways to begin the shift in mindset:

Start by publicly recognizing the challenges that menopausal women face and develop strategies about how they can be supported. Its important for women to feel that they dont need to hide their symptoms, and that any discussions will be met with empathy and support.

There doesnt need to be loads of research and soul-searching. Both Channel 4 and Dark Horses made menopause policies public for anyone to use, adapt and improve. Make sure the policy is for everyone, not just for women, as employees of all ages and genders need to understand more about it, as they will inevitably come across menopausal womenas colleagues, clients, suppliers, friends and family. But a policy on its own is not enough.

Ensure that line managers understand their role in delivering good working practices. They need to be prepared to make accommodations and aware of the easy adjustments and small tweaks that can make a significant difference. These include a safe environment to bring up any challenges their staff are facinghow long they can concentrate, what impact physical symptoms might have on them. Its good to be able to agree some basics, so there is no guilt or feelings of underdelivery, including working from home/flexible working, condensed or shorter hours, desk fans, cameras off and so on.

Hold a menopause workshop; there are plenty of great organizations that dont cost a fortune and make it an engaging and interactive experience. Appoint a menopause champion. Commit to paying for hormone replacement therapy treatment for staff.

Menopause symptoms are wide and varied and sometimes challenging to cope with. But structured support and good management can make a huge difference. Lets really try to stop losing women each year to this. Lets change the change.

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How to remove the stigma of menopause in the workplace - AdAge.com

BASEL, Switzerland, NEW YORK -- April 12, 2022 (GLOBE NEWSWIRE) Myovant Sciences (NYSE: MYOV) and Pfizer (NYSE: PFE) announced today an update on the Supplemental New Drug Application (sNDA) for MYFEMBREE (relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg) for the management of moderate to severe pain associated with endometriosis.

In accordance with the ongoing review of the application, on April 6, 2022, the U.S. Food and Drug Administration (FDA) provided notice to the companies that the agency identified deficiencies that preclude discussion of labeling and/or post-marketing requirements and commitments at this time. The FDA did not provide additional detail. The FDA noted that the letter does not reflect a final decision on the pending sNDA and that the application is still under review.

Myovant and Pfizer will continue to work with the FDA to determine next steps with the application.

About MYFEMBREEMYFEMBREE (relugolix, estradiol, and norethindrone acetate) is the first once-daily oral treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women approved by the U.S. Food and Drug Administration, with a treatment duration of up to 24 months. MYFEMBREE contains relugolix, which reduces the amount of estrogen (and other hormones) produced by ovaries, estradiol (an estrogen) which may reduce the risk of bone loss, and norethindrone acetate (a progestin) which is necessary when women with a uterus (womb) take estrogen.

For full prescribing information including Boxed Warning and patient information, please click here.

Indications and UsageMYFEMBREE is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Limitations of Use: Use of MYFEMBREE should be limited to 24 months due to the risk of continued bone loss which may not be reversible.

Important Safety InformationBOXED WARNING: THROMBOEMBOLIC DISORDERS AND VASCULAR EVENTSEstrogen and progestin combination products, including MYFEMBREE, increase the risk of thrombotic or thromboembolic disorders including pulmonary embolism, deep vein thrombosis, stroke and myocardial infarction, especially in women at increased risk for these events.

MYFEMBREE is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events, including women over 35 years of age who smoke or women with uncontrolled hypertension.

CONTRAINDICATIONSMYFEMBREE is contraindicated in women with any of the following: high risk of arterial, venous thrombotic, or thromboembolic disorder; pregnancy; known osteoporosis; current or history of breast cancer or other hormone-sensitive malignancies; known hepatic impairment or disease; undiagnosed abnormal uterine bleeding; known hypersensitivity to components of MYFEMBREE.

WARNINGS AND PRECAUTIONSThromboembolic Disorders: Discontinue immediately if an arterial or venous thrombotic, cardiovascular, or cerebrovascular event occurs or is suspected. Discontinue at least 4 to 6 weeks before surgery associated with an increased risk of thromboembolism, or during periods of prolonged immobilization, if feasible. Discontinue immediately if there is sudden unexplained partial or complete loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate for retinal vein thrombosis as these have been reported with estrogens and progestins.

Bone Loss: MYFEMBREE may cause a decrease in bone mineral density (BMD) in some patients, which may be greater with increasing duration of use and may not be completely reversible after stopping treatment. Consider the benefits and risks in patients with a history of low trauma fracture or risk factors for osteoporosis or bone loss, including medications that may decrease BMD. Assessment of BMD by dual-energy X-ray absorptiometry (DXA) is recommended at baseline and periodically thereafter. Consider discontinuing MYFEMBREE if the risk of bone loss exceeds the potential benefit.

Hormone-Sensitive Malignancies: Discontinue MYFEMBREE if a hormone-sensitive malignancy is diagnosed. Surveillance measures in accordance with standard of care, such as breast examinations and mammography are recommended. Use of estrogen alone or estrogen plus progestin has resulted in abnormal mammograms requiring further evaluation.

Depression, Mood Disorders, and Suicidal Ideation: Promptly evaluate patients with mood changes and depressive symptoms including shortly after initiating treatment, to determine whether the risks of continued therapy outweigh the benefits. Patients with new or worsening depression, anxiety, or other mood changes should be referred to a mental health professional, as appropriate. Advise patients to seek immediate medical attention for suicidal ideation and behavior and reevaluate the benefits and risks of continuing MYFEMBREE.

Hepatic Impairment and Transaminase Elevations: Steroid hormones may be poorly metabolized in these patients. Instruct women to promptly seek medical attention for symptoms or signs that may reflect liver injury, such as jaundice or right upper abdominal pain. Acute liver test abnormalities may necessitate the discontinuation of MYFEMBREE use until the liver tests return to normal and MYFEMBREE causation has been excluded.

Gallbladder Disease or History of Cholestatic Jaundice: Discontinue MYFEMBREE if signs or symptoms of gallbladder disease or jaundice occur. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, assess the risk-benefit of continuing therapy. Studies among estrogen users suggest a small increased relative risk of developing gallbladder disease.

Elevated Blood Pressure: For women with well-controlled hypertension, monitor blood pressure and stop MYFEMBREE if blood pressure rises significantly.

Change in Menstrual Bleeding Pattern and Reduced Ability to Recognize Pregnancy: Advise women to use non-hormonal contraception during treatment and for one week after discontinuing MYFEMBREE. Avoid concomitant use of hormonal contraceptives. MYFEMBREE may delay the ability to recognize pregnancy because it alters menstrual bleeding. Perform testing if pregnancy is suspected and discontinue MYFEMBREE if pregnancy is confirmed.

Risk of Early Pregnancy Loss: MYFEMBREE can cause early pregnancy loss. Exclude pregnancy before initiating and advise women to use effective non-hormonal contraception.

Uterine Fibroid Prolapse or Expulsion: Advise women with known or suspected submucosal uterine fibroids about the possibility of uterine fibroid prolapse or expulsion and instruct them to contact their physician if severe bleeding and/or cramping occurs.

Alopecia: Alopecia, hair loss, and hair thinning were reported in phase 3 trials with MYFEMBREE. Consider discontinuing MYFEMBREE if hair loss becomes a concern. Whether the hair loss is reversible is unknown.

Effects on Carbohydrate and Lipid Metabolism: More frequent monitoring in MYFEMBREE-treated women with prediabetes and diabetes may be necessary. MYFEMBREE may decrease glucose tolerance and result in increased blood glucose concentrations. Monitor lipid levels and consider discontinuing if hypercholesterolemia or hypertriglyceridemia worsens. In women with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations in triglycerides levels leading to pancreatitis. Use of MYFEMBREE is associated with increases in total cholesterol and LDL-C.

Effect on Other Laboratory Results: Patients with hypothyroidism and hypoadrenalism may require higher doses of thyroid hormone or cortisol replacement therapy. Use of estrogen and progestin combinations may raise serum concentrations of binding proteins (e.g., thyroid-binding globulin, corticosteroid-binding globulin), which may reduce free thyroid or corticosteroid hormone levels. Use of estrogen and progestin may also affect the levels of sex hormone-binding globulin, and coagulation factors.

Hypersensitivity Reactions: Immediately discontinue MYFEMBREE if a hypersensitivity reaction occurs.

ADVERSE REACTIONSMost common adverse reactions for MYFEMBREE (incidence 3% and greater than placebo) were hot flush/hyperhidrosis/night sweats, abnormal uterine bleeding, alopecia, and decreased libido. These are not all the possible side effects of MYFEMBREE.

DRUG INTERACTIONSP-gp Inhibitors: Avoid use of MYFEMBREE with oral P-gp inhibitors. If use is unavoidable, take MYFEMBREE first, separate dosing by at least 6 hours, and monitor patients for adverse reactions.

Combined P-gp and Strong CYP3A Inducers: Avoid use of MYFEMBREE with combined P-gp and strong CYP3A inducers.

LACTATIONAdvise women not to breastfeed while taking MYFEMBREE.

About Myovant SciencesMyovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Founded in 2016, Myovant has executed five successful Phase 3 clinical trials across oncology and womens health leading to two regulatory approvals by the U.S. Food and Drug Administration for men with advanced prostate cancer, women with heavy menstrual bleeding associated with uterine fibroids, respectively. The company also has received regulatory approvals by the European Commission (EC) and the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency for women with symptomatic uterine fibroids. Additionally, Myovant has two regulatory submissions under review, a Marketing Authorization Application in advanced prostate cancer and a supplemental New Drug Application in endometriosis-associated pain. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending the approval of ORGOVYX (relugolix, 120 mg) for the treatment of adult patients with advanced hormone-sensitive prostate cancer. The CHMP recommendation is under review by the European Commission. Myovant is conducting a Phase 3 study to evaluate the prevention of pregnancy in women with uterine fibroids or endometriosis. Myovant is also developing MVT-602, an investigational oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Pharma Co., Ltd., is Myovants majority shareholder. For more information, please visit http://www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

About Pfizer: Breakthroughs That Change Patients LivesAt 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 170 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.

MYOVANT FORWARD-LOOKING STATEMENTSThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Myovant Sciences forward-looking statements are based on managements current expectations and beliefs and are subject to a number of risks, uncertainties, assumptions, and other factors known and unknown that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements. In this press release, forward-looking statements include, but are not limited to, all statements reflecting Myovant Sciences plans and expectations with respect to its sNDA for MYFEMBREE for the management of moderate to severe pain associated with endometriosis. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of MYFEMBREE; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for 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 the clinical studies; whether and when applications may be filed in any additional jurisdictions for MYFEMBREE for the management of moderate to severe pain associated with endometriosis or in any jurisdictions for any other potential indications for MYFEMBREE; whether and when the FDA may approve the sNDA for MYFEMBREE for the management of moderate to severe pain associated with endometriosis and whether and when regulatory authorities in any jurisdictions may approve any such other applications for MYFEMBREE that may be pending or filed, which will depend on myriad factors, including making a determination as to whether the products benefits outweigh its known risks and determination of the products efficacy and, if approved, whether MYFEMBREE 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 MYFEMBREE; whether our collaboration with Pfizer will be successful; uncertainties regarding the impact of COVID-19 and the Ukraine conflict on Myovants business, operations and financial results; and competitive developments.

For a further discussion of factors that could materially affect Myovant Sciences operations and future prospects or which could cause actual results to differ materially from expectations, see the risks and uncertainties listed in Myovant Sciences filings with the United States Securities and Exchange Commission (SEC), including under the heading Risk Factors in Myovant Sciences Quarterly Report on Form 10-Q filed on January 26, 2022, as such risk factors may be amended, supplemented, or superseded from time to time. These risks are not exhaustive. New risk factors emerge from time to time and it is not possible for Myovant Sciences management to predict all risk factors, nor can Myovant Sciences assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof, and, except as required by law, Myovant Sciences undertakes no obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements.

Pfizer Disclosure NoticeThe information contained in this release is as of April 12, 2022. Pfizer assumes 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 MYFEMBREE (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg), including a potential indication in the U.S. for the management of moderate to severe pain associated with endometriosis, 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, uncertainties regarding the commercial success of MYFEMBREE; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for 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 the clinical studies; whether and when applications may be filed in any additional jurisdictions for MYFEMBREE for the management of moderate to severe pain associated with endometriosis or in any jurisdictions for any other potential indications for MYFEMBREE; whether and when the FDA may approve the supplemental new drug application for the management of moderate to severe pain associated with endometriosis and whether and when regulatory authorities in any jurisdictions may approve any such other applications for MYFEMBREE that may be pending or filed, which will depend on myriad factors, including making a determination as to whether the products benefits outweigh its known risks and determination of the products efficacy and, if approved, whether MYFEMBREE 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 MYFEMBREE; whether our collaboration with Myovant Sciences will be successful; uncertainties regarding the impact of COVID-19 on Pfizers business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results, as well as in its 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 http://www.pfizer.com.

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Myovant Sciences and Pfizer Provide Update on Supplemental New Drug Application for MYFEMBREE for the Management of Moderate to Severe Pain Associated...

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Indian J Med Res. 2021 Apr;154(4):559-570. doi: 10.4103/ijmr.IJMR_313_19.

ABSTRACT

Immune checkpoint inhibitors (ICIs) are a relatively newer class of drugs approved for the treatment of malignancies such as melanoma, renal, bladder and lung cancer. Immune-related adverse events (IrAEs) involving the endocrine system are a common side effect of these drugs. The spectrum of endocrine adverse events varies by the drug class. Cytotoxic T-lymphocyte-associated antigen-4 inhibitors commonly cause hypophysitis/hypopituitarism, whereas the incidence of thyroid disease is higher with programmed cell death (PD)-1/ ligand (PD-L) protein 1 inhibitors. The focus of this review is to describe the individual endocrinopathies with their possible mechanisms, signs and symptoms, clinical assessment and disease management. Multiple mechanisms of IrAEs have been described in literature including type II/IV hypersensitivity reactions and development of autoantibodies. Patients with pre-existing autoimmune endocrine diseases can have disease exacerbation following ICI therapy rather than de novo IrAEs. Most of the endocrinopathies are relatively mild, and timely hormone replacement therapy allows continuation of ICIs. However, involvement of the pituitary-adrenal axis could be life-threatening if not recognized. Corticosteroids are helpful when the pituitary-adrenal axis is involved. In cases of severe endocrine toxicity (grade 3/4), ICIs should be temporarily discontinued and can be restarted after adequate hormonal therapy. Endocrinologists and general internists need to be vigilant and maintain a high degree of awareness for these adverse events.

PMID:35435341 | DOI:10.4103/ijmr.IJMR_313_19

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The side effects of immune checkpoint inhibitor therapy on the endocrine system - DocWire News