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Category Archives: Hormone Replacement Therapy
Myovant Sciences and Pfizer Provide Update on Supplemental New Drug Application for MYFEMBREE for the Management of Moderate to Severe Pain Associated…
Posted: April 19, 2022 at 2:09 am
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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ROBERT WOOD JOHNSON UNIVERSITY HOSPITAL SOMERSET ADDS BEHAVIORAL HEALTH THERAPIST DEDICATED FOR MEMBERS OF LGBTQ+ COMMUNITY – InsiderNJ
Posted: April 19, 2022 at 2:09 am
ROBERT WOOD JOHNSON UNIVERSITY HOSPITAL SOMERSET ADDS BEHAVIORAL HEALTH THERAPIST DEDICATED FOR MEMBERS OF LGBTQ+ COMMUNITY
SOMERVILLE, NJ, April 13, 2022 Patients at the Babs Siperstein PROUD Center at Robert Wood Johnson University Hospital (RWJUH) Somerset, an RWJBarnabas Health facility, now have access to behavioral health services with a therapist dedicated to working with members of the LGBTQ+ community.
Kim Keyes, LCSW, an outpatient behavioral health therapist, has 18 years of experience as a social worker helping children and families. Keyes is available five days a week for in-person and telehealth appointments.
Ive always had a special interest in working with the LGBTQ+ community but recently decided to become more professionally involved as I have a close family member who identifies as transgender, she says. Im here to help support members of the LGBTQ+ community throughout their journey, from exploring gender identity or sexual orientation to coming out to their friends and family and learning to live fully as their true selves, which may include developing coping skills or ways to build their personal support network. This is a safe space where they can find understanding and acceptance and develop a plan to address the unique challenges they face.
Lesbian, gay and bisexual adults are twice as likely as heterosexual adults to experience mental health conditions and transgender individuals are four times as likely as cisgender individuals to experience a mental health condition, according to the National Alliance on Mental Illness. Depression, anxiety and suicide rates are also higher in the LGBTQ+ community. About 40 percent of transgender adults have attempted suicide in their lifetimes.
Coping with stigma, prejudice and discrimination can contribute to higher incidences of mental health issues among the LGBTQ+ community, Keyes says.
The transitioning process can be very stressful for transgender individuals. They are worried about how to tell others and what their reaction will be as well as anxious about starting hormone replacement therapy and considering surgical options, she says. Talking it through with someone who is supportive helps them develop healthy coping skills.
Too many members of the LGBTQ+ community suffer in silence. We are excited to be able to offer our patients convenient access to behavioral health services right here on our campus, said Perry Farhat, Esq., director of diversity and inclusion at RWJUH Somerset and director of the Babs Siperstein PROUD Center. Mental health is a key part of patients overall health and wellness.
RWJUH Somerset has been nationally recognized for providing culturally competent care and reducing health care disparities. The Human Rights Campaign has honored the hospital as a Leader in LGBTQ+ Healthcare Equality seven years in a row.
RWJUH Somerset was the first hospital in New Jersey to offer specialized primary care services for the LGBTQ+ community. The Babs Siperstein PROUD Center, which celebrates its fifth anniversary this year, offers hormone therapy and monitoring, HIV care, health education, counseling, support groups and referrals for specialty services.
Most major insurance plans are accepted. Costs for behavioral health services for uninsured LGBTQ+ patients will be covered through funding from a grant from TD Bank.
About RWJ University Hospital Somerset
Robert Wood Johnson University Hospital Somerset is a nationally accredited, 341-bed hospital in Somerville, New Jersey, providing comprehensive emergency, medical/surgical and rehabilitative services.
The hospital is nationally recognized as a Magnet hospital for nursing excellence and has earned an A Hospital Safety Score from Leapfrog its highest patient safety rating.
The Steeplechase Cancer Center at Robert Wood Johnson University Hospital Somerset has been honored with the prestigious Outstanding Achievement Award from the Commission on Cancer of the American College of Surgeons. The hospital is also distinguished for its Joint Surgery Institute, receiving the Joint Commissions Gold Seal of Approval for total knee and total hip replacement surgery, and is designated as a Primary Stroke Center by the Joint Commission and the New Jersey Department of Health and Senior Services. Robert Wood Johnson University Hospital Somerset has been named a Center of Excellence in Metabolic and Bariatric Surgery by the Surgical Review Corporation. In addition, it has received the Joint Commissions Gold Seal of Approval for its acute myocardial infarction program.
Honored as a Leader in LGBT Healthcare Equality by the Human Rights Campaign, the hospital was the first in New Jersey to offer primary care services for the LGBTQIA community.
Robert Wood Johnson University Hospital Somerset also offers outpatient services at convenient locations in Central New Jersey, including physical therapy services in Bedminster, Bridgewater, Hillsborough, Princeton and Flemington and an urgent care center and a sleep disorders center in Hillsborough. In addition, the hospitals affiliated physician practices provide care for families throughout its community.
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‘I’m 43 and just married my much younger husband. It’s made me worried about ageing.’ – Mamamia
Posted: April 19, 2022 at 2:09 am
Id heard that your experience of menopause is often similar to your mothers, but my mum had already had a hysterectomy by my age. Shed been placed on the old form of Hormone Replacement Therapy (HRT) and then slipped quietly into post-menopause.
I didnt even notice, she said. Would that be my experience too?
I opened the book and couldnt put it down. I read it in three days, and the more I read, the more excited I got. I looked up every site the book recommended. I joined three perimenopause and menopause Facebook groups. I watched TED Talks. I was hooked.
Listen to The Quicky's episode on menopause. Post continues after podcast.
I talked with dozens of women and devoured their stories, the good ones and the awful ones. I wanted to hear about every symptom, every stage, every treatment. I learned about the new Menopausal Hormone Therapy (MHT) and looked up specialists to readtheir recommendations. I found podcasts and blogs and more books.
It felt like being let in on a secret - one I no longer found scary, but empowering. I brought up menopause with every single person I met: the hairdresser, friends at a barbecue, my sisters, my chiropractor, my doctor. Did other people know what I knew?I had to find out.
My husband listened attentively to way more than he probably cared to hear.
I wanted to make sure everyone had heard about perimenopause because to me, and many of the women I interviewed, it had been such a mystery.
The chiropractor and the doctor had only briefly heard about it in their training.
Ive always felt like I was missing something with my women patients. Like I was treating disconnected symptoms I knew were somehow connected, the chiropractor said.
The doctor, a young man who was trained within the last decade, said theyre taught almost nothing about menopause at medical school, unless theyre specifically interested in the topic. Nothing at all about perimenopause.
Its strange how little were told, considering its not rare, he said. Half the population will go through it.
I told my husband what hed said.
Well, its not a very sexy topic, he replied.
I stared at him. Seriously? Dont judge him too harshly here. I didnt. My husband is usually a smart manand this topic is new for him too. I decided to hold my tongue.
Bowel cancer isnt sexy and they learn about that.
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'I'm 43 and just married my much younger husband. It's made me worried about ageing.' - Mamamia
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Does hormone replacement therapy (HRT) increase cancer …
Posted: April 6, 2022 at 2:41 am
What is HRT?
HRT is a treatment that can reduce symptoms of the menopauseby changing hormone levels in the body. Hormones are chemical messengers. They can affect things like growth, fertility and our mood.
During the menopause, the ovaries start to produce less of the hormone oestrogen. This means some people may experience menopausal symptoms, such as hot flushes and mood changes. For some, these symptoms are very uncomfortable, and HRT can help to reduce them.
Trans men and women may also use hormone therapy. But there isnt yet enough research about cancer risk associated with this. This webpage only covers menopausal HRT and cancer risk.
The main types of HRT are:
Some other forms of HRT are less commonly prescribed, such as tibolone (external link). Your GP can give you more information about the different types if you think HRT might help you.
Risk from HRT depends on many different things. This includes the type of HRT, when people start taking it, how long they take it for, age, and general health. And the benefits of taking HRT will vary from person to person too.
Everyones different, so talk to your GP about your options.
Its also important to remember that there are other things that affect cancer risk more than HRT. For example, you can reduce your cancer risk by stopping smoking, keeping a healthy weight, and drinking less alcohol.
Most types of HRT increase the risk of breast cancer. But the risk is higher for those using combined HRT, which uses bothoestrogen and progestogen.
Vaginal oestrogens are not linked to an increased risk of breast cancer, whereas tibolone is.
Taking HRT for 1 year or less only slightly increases breast cancer risk. However, the longer you take HRT the greater the risks are, and the longer they last.
The risk of breast cancer due to HRT can also vary from person to person. Things such as what age you are when you first start taking HRT, other medicines you may be taking, and your general health can impact the risk.
People who begin HRT before or soon after the menopause may have a bigger risk than those who start HRT later.
Yes, both oestrogen-only and combined HRT slightly increase the risk of ovarian cancer. But when HRT is stopped, the risk starts to go back to what it would have been if HRT wasnt taken.
Its not yet clear if theres any link between ovarian cancer and tibolone.
The risk of womb cancer depends on the type of HRT.
Oestrogen-only HRT increases the risk of womb cancer. The longer this type of HRT is used, the bigger the risk. Thats why oestrogen-only HRT is usually only offered to those who have had their womb removed (a hysterectomy) as they have no risk of womb cancer to begin with.
Combined HRT can reduce womb cancer risk. But combined treatment causes the biggest increase in breast cancer risk. So, its important to talk to your doctor about the balance of possible benefits and risks for you.
Similar to oestrogen-only HRT, tibolone also increases the risk of womb cancer.
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Hormone Replacement Therapy Market Size estimated to exhibit at a 5.2% CAGR, Future Business Opportunities through 2028 | Abbott, Mylan N.V., Merck…
Posted: April 6, 2022 at 2:41 am
Coherent Market Insights has released a new research study on the Hormone Replacement Therapy Market which aims to provide a thorough examination of the factors influencing global business introduction and outlook. The Global Hormone Replacement Therapy Market Report detailed information and overview highlight the most recent trends in various regions. Leading market participants will benefit from the trading insights provided in this report. The Hormone Replacement Therapy Market research report is an intelligence report that includes precise and valuable data on market size, development countries, market share, and revenue forecasts through 2028. It also provides information on the markets development and capabilities.
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Moreover, it will also include the opportunities available in micro markets for stakeholders to invest, a detailed analysis of the competitive landscape, and product services of key players. Analysis of Hormone Replacement Therapy companies, key tactics followed by Leading Key Players: Abbott Laboratories, Mylan N.V., Merck KgaA, Bayer AG, Pfizer Inc., Novo Nordisk A/S, QuatRx Pharmaceuticals, Novartis AG, Teva Pharmaceutical Industries Ltd., Amgen, Inc., and Eli Lilly and Company.
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The Global Hormone Replacement Therapy Market Analysis Report provides a detailed analysis of the market size of various segments and countries in previous years, as well as forecasts for the coming years. The Hormone Replacement Therapy Market report presents a detailed competitive landscape of the global market. The market dynamics, drivers, and segmentation by application, type, region, and manufacturer are all discussed in this report. With respect to the regions and countries covered in the report, this Hormone Replacement Therapy Market report provides both qualitative and quantitative aspects of the industry.
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Following are the various regions covered by the Hormone Replacement Therapy Market research report:
North America (the U.S., Canada, and Mexico), Europe (Germany, UK, France, Italy, Russia, Spain, and Rest of Europe), Asia Pacific (China, India, Japan, South Korea, Australia, South East Asia, and Rest of APAC), South America (Brazil, Argentina, Columbia and Rest of Latin America), Middle East & Africa (Saudi Arabia, South Africa, Turkey, Nigeria, UAE and Rest of MEA)
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Health center to provide gender-affirming care on campus by fall 2022 – The Collegian – The Collegian
Posted: April 6, 2022 at 2:41 am
Students and staff have advocated for over a year for the Student Health and Counseling Center (SHCC) to offer gender-affirming care (GAC) for transgender and nonbinary students. In response to their efforts, the SHCC now plans to incorporate GAC by fall 2022.
Jordan Fitzpatrick, a first-year graduate student in the sasters in social work program, planned an informational meeting for students via Zoom on April 1 in response to students and staff being met with reluctance or refusal by the health center to incorporate GAC.
GAC includes counseling support as well as medical support, such as providing hormone replacement therapy (HRT) on campus, for transgender and nonbinary students.
Fitzpatrick was expecting to involve students in advocating for the inclusion of GAC. Instead, he was able to present attendees with the SHCCs plan for GAC, with both counseling and medical support, including having an experienced physician [to] provide HRT services on-site, according to the plan.
The plan states its primary goal is to provide a sustainable programmatic operational plan supporting our students with gender-affirming care.
The plan includes counseling and psychological services, medical services, an improved website with updated resources, a GAC care group, additional SHCC positions to hire for and a Cross-Cultural and Gender Center (CCGC) student liaison, all by the start of the fall 2022 term.
Fitzpatrick, who also uses the pronoun they, explained that offering HRT on campus rather than being referred out is particularly important due to the limited options for GAC within the Central Valley.
Most people have to travel outside the Central Valley in order to receive basic care. Often, when transgender and gender nonconforming people do seek medical care in the Central Valley, they face doctors who are not informed on how to care for [them], or refuse care, or are outright hostile to [them], they said.
Fitzpatrick noted that these students, who paid for services at the health center as part of their tuition just like other students, should be able to receive this care and not be denied hormones due to gender.
During the meeting, Fobear explained that the refusal to offer GAC, and in particular HRT, is an equity issue.
Fobear noted that currently two women can go to the SHCC, one cisgender and one transgender, and one can be given hormonal treatment in the form of birth control, and one can be denied hormonal treatment in the form of HRT, and called this an instance of discrimination.
Its really important that we make sure that this actually happens and we hold them accountable, and that we have a way to make sure that it stays in place, Fitzpatrick said.
Fobear and Fitzpatrick assured attendees that despite the promise to incorporate GAC, there was more to be done, and that the process to get there hadnt been simple, either.
The need to begin offering GAC care arose about a year and a half ago before the meeting, according to Fobear, when John Beynon from the English department spoke to the Fresno State LGBT+ Allies Network on the need for and the possibility of providing GAC at the SHCC, which he had seen being done at other CSU campuses, such as Chico State and Cal Poly.
Concerned campus members formed a GAC subcommittee focused on bringing GAC to campus, and have been in talks for the last year on how to begin offering this care to students as well as protecting transgender and nonbinary students seeking GAC from discrimination, Fobear said.
[The talks] intensified within the past four months, where the biggest sticking issue was about providing HRT on campus. There seem to have been a lot of maybe reticence, maybe roadblocks, but basically no sort of commitment into providing this, Fobear said.
Recent talks, which Fobear described as intense, showed no sign of improvement. Despite initially hesitating to involve students out of reluctance to stress out transgender and nonbinary students, Fobear said this is when she and Fitzpatrick decided to reach out.
Fitzpatrick sent out the invite to the first informational meeting for the student collective, but on March 31, the SHCC sent in its care model before the meeting even took place.
Still, due to the struggles to get to that point, attendees stressed the need to ensure accountability by the health center.
Fobear encouraged attendees to continue advocating for the need for GAC on campus and to stay involved in the process, attributing the current successes to student and facultys efforts and attention.
The logistics of ensuring accountability and making the GAC sustainable were discussed at the end of the meeting, and will continue to be specified in any upcoming meetings.
Other topics pertaining to LGBTQ+ students were discussed during the meeting, such as the possibility of turning the University Student Union into an LGBTQ+ center once the Resnick Student Union (RSU) opens. Concerns raised about gender neutral bathrooms in the RSU were settled by ASI President DAungullique Jackson, who also attendes and assured other attendess the gender neutral bathrooms would be available.
Students who are interested in attending future meetings and participating in these discussions can email Fitzpatrick at gac4fresnostate@gmail.com to be added to the mailing list and be alerted when future announcements are made.
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How to ease joint pain during the menopause – Patient.info
Posted: April 6, 2022 at 2:41 am
What causes menopause joint pain?
It may be a natural part of the female ageing process, but menopause can bring discomfort and pain in a number of ways. Learning how to manage your symptoms can make a big difference in your quality of life during this period.
From hot flushes and vaginal dryness to disturbed sleep and anxiety, there are lots of possible symptoms that may make daily activities more challenging. These noticeable changes reflect the significant change that's taking place in your body, as your sex hormone levels fluctuate and cause your ovaries to lose their reproductive function.
Ann Clare, a physiotherapist for MBST UK, explains how these changes can lead to menopause joint pain: "Oestrogen, the hormone that plays a key role in regulating your menstrual cycle, helps to decrease inflammation and keep the joints lubricated. During the menopause and perimenopause, oestrogen levels decrease and as a result, some women experience joint pain."
"Recent studies have suggested that a decrease in oestrogen not only reduces natural bone density but also affects muscle strength and tendon health. In turn, this may result in longer injury recovery times," says Kirsty Lee, senior physiotherapist and pelvic health lead at Ascenti.
Menopause joint pain can affect joints all over your body and can also result in longstanding injuries becoming more painful.
According to Lee, menopause joint pain most commonly affects the following areas:
"As oestrogen continues to decrease, joints can become more inflamed and painful, resulting in an increased risk of osteoporosis (thinning of the bone) and osteoarthritis (inflammation of the joints) developing," she adds.
When it could be osteoarthritis
Osteoarthritis is more likely to occur in people over 50 years, around the same time that many women start menopause. While joint pain and stiffness around the time of menopause doesn't always indicate osteoarthritis, it can be a symptom. Osteoarthritis joint pain is more likely to occur in the knees, hips, lower spine, fingers, and thumbs.
When it could be osteoporosis
Being over 40 and going through menopause increases your chances of rapid bone loss, which may lead to osteoporosis. Unlike menopause joint pain and osteoarthritis, you usually won't feel pain unless you break a bone. Your doctor may wish to test you for osteoporosis if you are menopausal and have had a bone breakage from a minor injury.
Back pain, and particularly lower back pain, can become a problem for many women as they go through menopause. In fact, one survey of 5,325 women found that postmenopausal women were twice as likely to report lower back pain as premenopausal women.
Your spine is made up of multiple joints, including facet joints that allow movement in your back. Decreased oestrogen results in greater inflammation of these joints and also causes your spinal (intervertebral) discs to wear down.
Menopause joint pain of the knees is also very common. This may not be surprising, given that your knee is one of your largest joints, connecting and supporting your thighbone (femur), kneecap (patella), shinbone (tibia), and calf bone (fibula). Your knees are subject to a great deal of pressure and wear throughout your life as they support a large portion of your weight.
The good news is, there are both medical and non-medical forms of pain management that are proven to significantly reduce menopause joint pain. This can start with simple routines in the home.
Home treatments include:
Your diet is hugely important in both preventing and managing health issues, and menopause joint pain is no different. "Try to eat a healthy, balanced diet that is high in fibre with lots of fruit, vegetables and wholegrain foods," advises Clare.
Eating the right foods can improve a range of menopause symptoms. The key is to consume lots of nutrients from various food groups.
The foods that most directly impact joint and bone health include:
"You should also try to avoid large quantities of saturated fats. If you are suffering from hot flushes, try to make a note of what seems to bring them on - for some people it is alcohol and for others caffeine," adds Clare.
If you experience menopause joint pain, you may be tempted to limit your movements. It may feel counter-intuitive at first, but the experts recommend staying as physically active as possible.
Lee says: "Move! Motion is lotion, and if this is managed and progressed slowly it can be an effective tool for pain management."
Why: "Unfortunately, weight gain is also a common side effect of menopause, and increased weight can have a detrimental effect on joint and muscle pain due to increased load. Therefore, weight management is a key part of managing joint pain."
What: "There are lots of forms of exercise that can help with pain as well as other menopause symptoms. An effective 'menopause friendly' programme should consist of endurance, strength/resistance, and balance exercises."
Clare says: "It is best to be as active as possible and most of all enjoy your sports."
Why: "Weight-bearing exercises will strengthen your musculoskeletal system which will help to alleviate joint aches and pains, protect brittle bones, and may prevent osteoporosis."
What:
Ivana Daniell, movement and posture expert, says: "The right choice of exercise programme can be of great support during the time of menopause, both physically and mentally. Be aware of not pushing your body too hard, especially during this delicate hormonal transition."
Why: "When the female body is pushed too hard, it goes into adrenal stress and this creates havoc in the incredibly engineered yet delicate hormonal balance."
What: "Quality of movement versus quantity is paramount. Regular and consistent exercise is better than sporadic visits to the gym that make you exhausted. Choose activities that uplift your mood and practise 2-3 times per week in addition to your daily 30-40 minute walk."
You may also use over-the-counter medicines to help reduce inflammation and painful joints. These include common painkillers and anti-inflammatory gels and medication. Your pharmacist will be able to advise.
It should also be noted that hormone replacement therapy (HRT) is widely accepted as the most effective method for managing the symptoms of menopause. By restoring the oestrogen levels you lose during menopause, there is strong evidence that HRT can ease menopause joint pain alongside a whole host of other symptoms.
There are also several menopause herbal remedies and supplements on the market. Biomedical gerontologist Dr Marios Kyriazis says that supplementation should be used alongside - and not as a substitute for - healthy lifestyle changes:
"The most effective lifestyle changes include switching to an anti-inflammatory diet, incorporating light to moderate physical activity, practising breathing and relaxation exercises on a daily basis, and improving sleep patterns. Under these conditions, herbal blends and anti-inflammatory supplements work best."
Kyriazis recommends supplementing curcumin, the active ingredient in turmeric.
Curcumin may:
"By fermenting turmeric, its curcumin content becomes more bio-available at a smaller dose and is gentler on the stomach than the usual raw turmeric with black pepper that is generally recommended," he adds.
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What’s behind the trend of women posting make-up free photos on social media? – Fox News
Posted: April 6, 2022 at 2:41 am
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What do Michelle Pfeiffer, Tyra Banks, Jennifer Aniston, Jennifer Lopez and Helen Mirren have in common?
Social media platforms dont just harm teenagers, but can be harmful to women as they age, so these women are fighting back with make-up selfies to embrace their age, according to a recent Wall Street Journalreport.
"Were also bombarded by images on our phones all the timethis five years ago, this 10 years ago," New York psychiatrist Dr. Samantha Boardman, noting, " its a reminder of the passage of time and how we do look different."
She said we should be paying more attention how social media affects women as they get older, because it makes older women feel as bad as teenagers, especially when the way a woman looks doesnt match how she is feeling.
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"I have a craving to see real faces of my age, so I dont feel so alone in aging," said model Paulina Porizkova, who is56.
MIAMI, FL - MAY 11: Paulina Porizkova attends the Sports Illustrated Swimsuit Celebrates 2019 Issue Launch at Myn-Tu on May 11, 2019, in Miami, Florida. ((Photo by John Parra/Getty Images for Sports Illustrated))
Middle age is often a time of high stress for women, because many are trying to balance careers, raise children and also care for aging parents, according to theJournal.
As more older women begin to embrace their natural look, posting make-up selfies can be empowering.
"Its satisfying to feel connected and not so alone in how you look, so I think there is a generosity in that when its authentic," saidBoardman.
She cautioned the natural look might be staged at times with products, treatments and injectables that contribute to that look, so when sometimes celebrities post the "natural" hashtag, it might be supported by ring lights, secret makeup and even a filter, per the paper.
"Often were barraged with images that we dont even know are touched up," New Yorkbased psychiatrist and dermatologist Dr. Amy Wechsler told thepaper.
Some beauty brands, like Milk, Dove and Olay, are supporting this trend, using real photos that are not retouched across a wide spectrum of ages to showcase womens beauty at their stage inlife.
But make-up free selfies arent the only remedy middle-age women are using to take care of their mental health many are resorting to antidepressants, according to the Wall StreetJournal.
Tyra Banks recalled once holding her dress together while filming 'Dancing with the Stars.' (Getty Images)
But some doctors are concerned antidepressants are being overprescribed for symptoms that may actually be attributed to menopause, which the median age in the U.S. is 51, per the newsreport.
Approximately one in five women ages 40-59 and an estimated one in four women ages 60 and older used antidepressants in the last 30 days during 2015 to 2018, compared to one in 10 for women ages 18-39, according to the most recent data from the National Center for Health Statistics.
In general women are at higher risk for depression than men, but the risk of depression is highest leading up to menopause and immediately after it. Its sometimes difficult, however, to tease out the root cause of peri-menopausal symptoms, because the imbalance of hormones during this period that are responsible for typical symptoms, such as hot flashes and night sweats, can also affect a womans mood, per theJournal.
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The most effective treatment for hot flashes and night sweats is hormone therapy with either estrogen or combined with progestogen, according to the North American Menopause Society and the American College of Obstetricians and Gynecologists.
But women are looking for alternative treatments since many are " so deathly afraid of prescribing hormones," said Dr. Stephanie Faubion, medical director of the North American Menopause Society and the director of Mayo Clinic WomensHealth.
Jennifer Aniston attends 26th Annual Screen Actors Guild Awards at The Shrine Auditorium on January 19, 2020, in Los Angeles, California. (Photo by Leon Bennett/Getty Images)
So now scientists are trying to develop anti-depressants that will target depression symptoms related to estrogen withdrawal without the side effects of hormone replacement therapy, according to Dr. Peter Schmidt, chief of the Behavioral Endocrinology branch in National Institute of Mental Health Intramural Research program.
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"While I look with wonder and awe at the women who age backwards, Id like a little more choice in representation of age. So I hope to provide a little of that for women who feel like I do, that age is coming into ones true beauty and character, and it should be celebrated, not erased," Porizkova said.
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Why so many women in middle age are on antidepressants – Mint
Posted: April 6, 2022 at 2:41 am
About one in five women ages 40 to 59 and nearly one in four women ages 60 and over used antidepressants in the last 30 days during 2015 to 2018, according to the latest data from the National Center for Health Statistics. Among women ages 18 to 39, the figure was about one in 10. Among men, 8.4% of those ages 40 to 59 and 12.8% of those 60 and older used antidepressants in the last 30 days, according to the NCHS data.
The figures are drawing increasing attention from scientists and doctors. Many are alarmed at how high depression rates were among midlife women even before the pandemic, now that the past two years have exacerbated mental-health issues for many Americans. And some doctors are also concerned that antidepressants are being overprescribed for menopausal symptoms.
In general, women have higher rates of depression than men throughout much of their lives according to scientific research. In midlife, the risk is greatest during the years leading up to menopause and right after it. The dramatic fluctuations in hormones that cause the most-commonly known symptoms of hot flashes and night sweats can wreak havoc on mood, too.
Estrogen and progesterone are fluctuating a great deal," says Lucy Hutner, a reproductive psychiatrist in New York City. Those shifts can be hard for our brain to take."
Scientists are working to understand just how hormones may drive depression, but receptors for estrogen and progesterone are found throughout the brain including in regions involving movement, cognition and mood regulation, says Hadine Joffe, a professor of psychiatry at Brigham and Womens Hospital and Harvard Medical School in Boston.
New treatments for depression in midlife women may be on the horizon. Scientists at the National Institute of Mental Health, for example, are studying a medication that acts on an estrogen receptor in the brain. The hope is that, unlike typical antidepressants, it will directly target depression symptoms related to estrogen withdrawal but without the side effects of traditional hormone therapy commonly used for menopausal symptoms, notes Peter Schmidt, chief of the Behavioral Endocrinology branch in NIMHs Intramural Research program.
Studies have found that womens risk of having an episode of major depression is two to four times higher around menopause than at other times during their lives; it is even greater for women who have a had a previous episode of depression. Menopause is defined to have occurred one year after a womans last menstrual period. The median age of menopause in the U.S. is 51.
Doctors also note that midlife is often a time of marked stress for womenand stress can increase the risk of depression. Many women are juggling careers, raising children and caring for elderly parents. You have a lot on your shoulders, and theres not a lot of room for taking time for yourself," says Dr. Hutner. Women also may be more likely to seek care for a mental-health problem than men, which may lead to higher rates of diagnosis and treatment.
Valerie DeMartin, 59 years old, says she fell into a depression in 2020. She was dealing with sleep problems, the stress of the pandemic and a move with two teenagers from the familys longtime home in California to Texas. An avid exerciser, she says she was also feeling sad to see her body changing in ways she felt she couldnt control.
I went through a life-altering move, my kids were angry with me, dealing with middle age and Covid and my body changing," says Ms. DeMartin, who works in home remodeling in Frisco, Texas.
Ms. DeMartin says she didnt seek therapy or take antidepressant medication. She says she has coped by reaching out to friends and staying busy with work. Shes also planning to try hormone-replacement therapy. Hopefully Ill have a little more energy and sleep better," she says.
Researchers at NIMH who have been following 90 women since 1988 have found that the incidence of womens midlife depression is concentrated in the two years before and after the last menstrual period, says Dr. Schmidt. The quality of womens midlife depression is distinct, too, Dr. Schmidt says, in that it often involves intense anxiety, irritability and sleep problems along with the more typical sadness and loss of pleasure in once-enjoyed activities.
Doctors speculate that antidepressant use among middle-aged women is being driven in part by the reluctance of womenand many of their physiciansin recent decades to use hormone-replacement therapy for menopausal symptoms. In 2002, a large study, the Womens Health Initiative, was stopped after women taking hormone therapy had an increased risk of breast cancer, heart attacks and strokes. Later analyses found that the risks were largely concentrated among women who were older when they started hormone therapy. For women in their 50s, hormone therapy actually reduced the risk of heart disease and death from any cause.
Hormone therapy, either estrogen alone or combined with a progestogen, is the most effective treatment for hot flashes and night sweats, according to the North American Menopause Society and the American College of Obstetricians and Gynecologists. Some research has found that it can also improve mood.
Still, many women and doctors are looking for alternatives. People are so deathly afraid of prescribing hormones," says Stephanie Faubion, medical director of the North American Menopause Society and the director of Mayo Clinic Womens Health. A lot of women, unfortunately, who are going to their doctors because of hot flashes and night sweats are getting slapped on antidepressants."
Research has shown that some antidepressants can ease hot flashes and night sweats. But Dr. Faubion says they are much less effective than hormones. The even higher rates of antidepressant use among women 60 and over may partly result from women being put on them when theyre younger, during this earlier period of mental-health vulnerability, and then being left on them by default, says Dr. Hutner.
This story has been published from a wire agency feed without modifications to the text
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Legislature needs to stop its attacks on the LGBTQ community – messenger-inquirer
Posted: April 6, 2022 at 2:41 am
Im writing in response to Senate Bill 83, which was recently passed in the Kentucky legislature. Its referred to as the transgender sports ban. This bill is not necessary and a waste of time.
The bill, since it passed and is now waiting for Gov. Andy Beshears signature, effectively bans trans women from playing on the sports teams they want to play on. What Republicans fail to recognize is the fact that scientific studies have been done that show that transgender women hold zero physical advantage over cisgender women.
In fact, a year after being on hormone replacement therapy, trans women have the same strength as their cisgender female counterparts.
What the state legislature should focus on instead of passing LGBTQ discrimination laws is the child abuse rate. Currently, Kentucky ranks fifth in the country in reported child abuse.
The legislature needs to stop the hate of the LGBTQ community and start representing all Kentuckians equally.
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Legislature needs to stop its attacks on the LGBTQ community - messenger-inquirer
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