A Guide to Feminizing Hormones – Estrogen
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Progestin-Only Systemic Hormone Therapy for Menopausal Hot Flashes
EDITORIAL Progestin-only systemic hormone therapy for menopausal hot flashes Clinicians treating postmenopausal hot flashes often recommend “systemic estrogen treatment.” However, progestin-only therapy also can effectively treat hot flashes and is an option for women with a contraindication to estrogen therapy. Robert L. Barbieri, MD Editor in Chief, OBG MANAGEMENT Chair, Obstetrics and Gynecology Brigham and Women’s Hospital Boston, Massachusetts Kate Macy Ladd Professor of Obstetrics, Gynecology and Reproductive Biology Harvard Medical School he field of menopause medi- women. In one study, 133 postmeno- in postmenopausal women with cine is dominated by studies pausal women with an average age an American Heart Association risk T documenting the effective- of 55 years and approximately 3 years score greater than 10% over 10 years.3 ness of systemic estrogen or estro- from their last menstrual period were Additional contraindications to sys- gen-progestin hormone therapy for randomly assigned to 12 weeks of temic estrogen include women with the treatment of hot flashes caused treatment with placebo or micronized cardiac disease who have a throm- by hypoestrogenism. The effective- progesterone 300 mg daily taken at bophilia, such as the Factor V Leiden ness of progestin-only systemic bedtime.1 Mean serum progesterone mutation.4 hormone therapy for the treatment levels were 0.28 ng/mL (0.89 nM) and For women who are at high risk of hot flashes is much less studied 27 ng/mL (86 nM) in the women taking for estrogen-induced cardiovascu- and seldom is utilized in clinical placebo and micronized progesterone, lar events, micronized progesterone practice. -
Affect Breast Cancer Risk
HOW HORMONES AFFECT BREAST CANCER RISK Hormones are chemicals made by the body that control how cells and organs work. Estrogen is a female hormone made mainly in the ovaries. It’s important for sexual development and other body functions. From your first monthly period until menopause, estrogen stimulates normal breast cells. A higher lifetime exposure to estrogen may increase breast cancer risk. For example, your risk increases if you start your period at a young age or go through menopause at a later age. Other hormone-related risks are described below. Menopausal hormone therapy Pills Menopausal hormone therapy (MHT) is The U.S. Food and Drug Administration also known as postmenopausal hormone (FDA) recommends women use the lowest therapy and hormone replacement dose that eases symptoms for the shortest therapy. Many women use MHT pills to time needed. relieve hot flashes and other menopausal Any woman currently taking or thinking symptoms. MHT should be used at the Birth control about taking MHT pills should talk with her lowest dose and for the shortest time pills (oral doctor about the risks and benefits. contraceptives) needed to ease menopausal symptoms. Long-term use can increase breast cancer Vaginal creams, suppositories Current or recent use risk and other serious health conditions. and rings of birth control pills There are 2 main types of MHT pills: slightly increases breast Vaginal forms of MHT do not appear to cancer risk. However, estrogen plus progestin and estrogen increase the risk of breast cancer. However, this risk is quite small alone. if you’ve been diagnosed with breast cancer, vaginal estrogen rings and suppositories are because the risk of Estrogen plus progestin MHT breast cancer for most better than vaginal estrogen creams. -
Detectx® Serum 17Β-Estradiol Enzyme Immunoassay Kit
DetectX® Serum 17β-Estradiol Enzyme Immunoassay Kit 1 Plate Kit Catalog Number KB30-H1 5 Plate Kit Catalog Number KB30-H5 Species Independent Sample Types Validated: Multi-Species Serum and Plasma Please read this insert completely prior to using the product. For research use only. Not for use in diagnostic procedures. www.ArborAssays.com KB30-H WEB 210308 TABLE OF CONTENTS Background 3 Assay Principle 4 Related Products 4 Supplied Components 5 Storage Instructions 5 Other Materials Required 6 Precautions 6 Sample Types 7 Sample Preparation 7 Reagent Preparation 8 Assay Protocol 9 Calculation of Results 10 Typical Data 10-11 Validation Data Sensitivity, Linearity, etc. 11-13 Samples Values and Cross Reactivity 14 Warranty & Contact Information 15 Plate Layout Sheet 16 ® 2 EXPECT ASSAY ARTISTRY KB30-H WEB 210308 BACKGROUND 17β-Estradiol, C18H24O2, also known as E2 or oestradiol (1, 3, 5(10)-Estratrien-3, 17β-diol) is a key regulator of growth, differentiation, and function in a wide array of tissues, including the male and female reproductive tracts, mammary gland, brain, skeletal and cardiovascular systems. The predominant biological effects of E2 are mediated through two distinct intracellular receptors, ERα and ERβ, each encoded by unique genes possessing the functional domain characteristics of the steroid/thyroid hormone superfamily of nuclear receptors1. ERα is the predominant form expressed in the breast, uterus, cervix, and vagina. ERβ exhibits a more limited pattern and is primarily expressed in the ovary, prostate, testis, spleen, lung, hypothalamus, and thymus2. Estradiol also influences bone growth, brain development and maturation, and food intake3, and it is also critical in maintaining organ functions during severe trauma4,5. -
Informed Consent for Feminizing Hormone Therapy
Informed Consent for Feminizing Hormone Therapy For _________________________ Date of Birth: _____________ Name Used: ____________________ Patient Name as listed in chart Name if different from chart This form will assist you (and your guardian) to think through the expected effects of hormone therapy including possible unwanted side effects. You are encouraged to talk about this treatment with your medical provider and decide if hormone therapy is right for you (your child). By signing this form, you are stating that you have discussed the effects and risks of this medication with your medical provider or a member of the medical team and that you understand and accept these effects and possible risks. You (and your guardian) may ask questions and talk about any concerns you have related to this treatment at any time in this process. Estrogen (usually estradiol) is used to feminize the body (make it look more traditionally female). This medical treatment will reduce some male features and increase some female features of the body. Androgen (testosterone) blockers further decrease the amount of and/or block the effect of testosterone and masculinization of the body. Your medical provider will help decide which form and the amount of estrogen (shots, pills, gels, patches) and androgen blockers (pills, gels, shots, implanted) that are best for you based on your personal needs and any medical or mental health conditions you might have. Each person’s body responds to estrogen differently and it is hard to promise or predict with certainty how each person may respond to treatment. Your medical provider will talk with you throughout the treatment and will help you achieve the best results safely. -
Hormonal Treatment Strategies Tailored to Non-Binary Transgender Individuals
Journal of Clinical Medicine Review Hormonal Treatment Strategies Tailored to Non-Binary Transgender Individuals Carlotta Cocchetti 1, Jiska Ristori 1, Alessia Romani 1, Mario Maggi 2 and Alessandra Daphne Fisher 1,* 1 Andrology, Women’s Endocrinology and Gender Incongruence Unit, Florence University Hospital, 50139 Florence, Italy; [email protected] (C.C); jiska.ristori@unifi.it (J.R.); [email protected] (A.R.) 2 Department of Experimental, Clinical and Biomedical Sciences, Careggi University Hospital, 50139 Florence, Italy; [email protected]fi.it * Correspondence: fi[email protected] Received: 16 April 2020; Accepted: 18 May 2020; Published: 26 May 2020 Abstract: Introduction: To date no standardized hormonal treatment protocols for non-binary transgender individuals have been described in the literature and there is a lack of data regarding their efficacy and safety. Objectives: To suggest possible treatment strategies for non-binary transgender individuals with non-standardized requests and to emphasize the importance of a personalized clinical approach. Methods: A narrative review of pertinent literature on gender-affirming hormonal treatment in transgender persons was performed using PubMed. Results: New hormonal treatment regimens outside those reported in current guidelines should be considered for non-binary transgender individuals, in order to improve psychological well-being and quality of life. In the present review we suggested the use of hormonal and non-hormonal compounds, which—based on their mechanism of action—could be used in these cases depending on clients’ requests. Conclusion: Requests for an individualized hormonal treatment in non-binary transgender individuals represent a future challenge for professionals managing transgender health care. For each case, clinicians should balance the benefits and risks of a personalized non-standardized treatment, actively involving the person in decisions regarding hormonal treatment. -
Feminizing Hormone Therapy
FEMINIZING HORMONE THERAPY Julie Thompson, PA-C Medical Director of Trans Health, Fenway Health April 2020 fenwayhealth.org GOALS AND OBJECTIVES 1. Review process of initiating hormone therapy through the informed consent model 2. Provide an overview of feminizing hormone therapy 3. Review realistic expectations and benefits of hormone therapy vs their associated risks 4. Discuss recommendations for monitoring fenwayhealth.org PROTOCOLS AND STANDARDS OF CARE fenwayhealth.org WPATH STANDARDS OF CARE, 2011 The criteria for hormone therapy are as follows: 1. Well-documented, persistent (at least 6mo) gender dysphoria 2. Capacity to make a fully informed decision and to consent for treatment 3. Age of majority in a given country 4. If significant medical or mental health concerns are present, they must be reasonably well controlled fenwayhealth.org INFORMED CONSENT MODEL ▪ Requires healthcare provider to ▪ Effectively communicate benefits, risks and alternatives of treatment to patient ▪ Assess that the patient is able to understand and consent to the treatment ▪ Informed consent model does not preclude mental health care! ▪ Recognizes that prescribing decision ultimately rests with clinical judgment of provider working together with the patient ▪ Recognizes patient autonomy and empowers self-agency ▪ Decreases barriers to medically necessary care fenwayhealth.org INITIAL VISITS ▪ Review history of gender experience and patient’s goals ▪ Document prior hormone use ▪ Assess appropriateness for gender affirming medical treatment ▪ WPATH criteria -
Structure and Origin of Uterine and Extragenital L=Ibroids Induced
Structure and Origin of Uterine and Extragenital l=ibroids Induced Experimentally in the Guinea Pig by Prolonged Administration of Estrogens* Alexander Lipschotz, M.D., and Louis Vargas, Jr., M.D. (From Department o/ Experimental Medicine, National Health Service o/the Republic o/Chile, Santiago, Chile) (Received for publication December 13, x94o) The purpose of this communication is to present the These experimentally induced abdominal tumors findings of a detailed microscopical study of the sites present a smooth surface formed of a capsule com- of origin and stages of development of the subserous posed of flattened superficial cells (Plate 2, Figs. 2-A fibroid tumors induced in guinea pigs by prolonged and 2-B). The cells beneath the capsule resemble administration of estrogens. Details of treatment of fibroblasts. These cells have definite boundaries or the animals are given in the explanations of Plates I- 5. they are separated from each other by collagenous Subserous uterine tumors which can be induced in fibers (Plate 4, Fig. ix-C). guinea pigs by prolonged administration of estrogens, The masses of fibroid tumors arising from the apex as described by Nelson (26, 27), were found to be of the uterine horn may enclose the tubes or large fibroids. Lipschiitz, Iglesias, and Vargas (i3, 18, 22) tubal cysts. The demarcation between the muscular have shown that extragenital tumors in the abdominal coat of the tube and the tumor is not always sharp. cavity, induced by estrogens, also were fibroids. The In some instances, especially when the apical fibroid localization of these tumo~:s at various sites on the is small, the tumor is in close contact with an abun- uterus, pancreas, kidney, spleen, etc., have been de- dance of smooth muscle and adipose tissue (Plate 2, scribed by Iglesias (5), Vargas and Lipschiitz (32), Fig. -
Exposure to Female Hormone Drugs During Pregnancy
British Journal of Cancer (1999) 80(7), 1092–1097 © 1999 Cancer Research Campaign Article no. bjoc.1998.0469 Exposure to female hormone drugs during pregnancy: effect on malformations and cancer E Hemminki, M Gissler and H Toukomaa National Research and Development Centre for Welfare and Health, Health Services Research Unit, PO Box 220, 00531 Helsinki, Finland Summary This study aimed to investigate whether the use of female sex hormone drugs during pregnancy is a risk factor for subsequent breast and other oestrogen-dependent cancers among mothers and their children and for genital malformations in the children. A retrospective cohort of 2052 hormone-drug exposed mothers, 2038 control mothers and their 4130 infants was collected from maternity centres in Helsinki from 1954 to 1963. Cancer cases were searched for in national registers through record linkage. Exposures were examined by the type of the drug (oestrogen, progestin only) and by timing (early in pregnancy, only late in pregnancy). There were no statistically significant differences between the groups with regard to mothers’ cancer, either in total or in specified hormone-dependent cancers. The total number of malformations recorded, as well as malformations of the genitals in male infants, were higher among exposed children. The number of cancers among the offspring was small and none of the differences between groups were statistically significant. The study supports the hypothesis that oestrogen or progestin drug therapy during pregnancy causes malformations among children who were exposed in utero but does not support the hypothesis that it causes cancer later in life in the mother; the power to study cancers in offspring, however, was very low. -
Menopausal Hormone Therapy
GYNAECOLOGY ENDOCRINOLOGY Menopausal hormone therapy: where are we now? Menopausal hormone therapy (MHT) is an effective treatment for symptoms associated with menopause, such as hot flushes, night sweats, mood changes, sleep disturbances and changes in sexual function. While the evidence around MHT has changed over the years, there is now international consensus that the benefits of MHT are likely to outweigh the risks for most women aged < 60 years or within ten years of menopause, for whom menopausal symptoms are affecting their quality of life. KEY PRACTICE POINTS: Every woman’s experience of menopause is different, and Among the oestrogen and progestogen formulations perceptions of menopause vary across cultures. Most available, transdermal oestrogen (funded) and micronised women will experience some menopause symptoms, progesterone (not funded) are associated with the lowest however, only some will seek treatment. risk of adverse effects Menopausal hormone therapy (MHT) is likely to offer overall There is no specific recommended duration for MHT. The benefit to women with menopausal symptoms affecting decision to continue treatment should be reviewed on their quality of life if they are aged < 60 years or within ten an annual basis, taking into account any changes in the years of menopause patient’s risk factors, adverse effects and extent of benefit. Adverse outcomes associated with MHT include breast If women primarily seek assistance for urogenital symptoms cancer, stroke and venous thromboembolism (VTE). of menopause, vaginal products are recommended instead However, the risk of these outcomes depends on factors of MHT. This includes moisturisers, lubricants or a vaginal such as the age or time since menopause when MHT oestrogen cream or pessary. -
Gender-Affirming Hormone Therapy
GENDER-AFFIRMING HORMONE THERAPY Julie Thompson, PA-C Medical Director of Trans Health, Fenway Health March 2020 fenwayhealth.org GOALS AND OBJECTIVES 1. Review process of initiating hormone therapy through the informed consent model 2. Provide an overview of masculinizing and feminizing hormone therapy 3. Review realistic expectations and benefits of hormone therapy vs their associated risks 4. Discuss recommendations for monitoring fenwayhealth.org PROTOCOLS AND STANDARDS OF CARE fenwayhealth.org WPATH STANDARDS OF CARE, 2011 The criteria for hormone therapy are as follows: 1. Well-documented, persistent (at least 6mo) gender dysphoria 2. Capacity to make a fully informed decision and to consent for treatment 3. Age of majority in a given country 4. If significant medical or mental health concerns are present, they must be reasonably well controlled fenwayhealth.org INFORMED CONSENT MODEL ▪ Requires healthcare provider to ▪ Effectively communicate benefits, risks and alternatives of treatment to patient ▪ Assess that the patient is able to understand and consent to the treatment ▪ Informed consent model does not preclude mental health care! ▪ Recognizes that prescribing decision ultimately rests with clinical judgment of provider working together with the patient ▪ Recognizes patient autonomy and empowers self-agency ▪ Decreases barriers to medically necessary care fenwayhealth.org INITIAL VISITS ▪ Review history of gender experience and patient’s goals ▪ Document prior hormone use ▪ Assess appropriateness for gender affirming medical -
ESTROSTEP Fe (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets*) *Ferrous Fumarate Tablets Are Not USP for Dissolution and Assay
ESTROSTEP Fe (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets*) *Ferrous fumarate tablets are not USP for dissolution and assay. ESTROSTEP® Fe (Each white triangular tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol; each white square tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol; each white round tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol; each brown tablet contains 75 mg ferrous fumarate.) Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. DESCRIPTION ESTROSTEP® Fe is a graduated estrophasic oral contraceptive providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. ESTROSTEP Fe provides for a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each white triangle-shaped tablet contains 1 mg norethindrone acetate [(17 alpha)-17- (acetyloxy)-19-norpregna-4-en-20-yn-3-one] and 20 mcg ethinyl estradiol [(17 alpha)-19- norpregna-1,3,5(10)-trien-20-yne-3,17-diol]; each white square-shaped tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol; and each white round tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol. Each tablet also contains calcium stearate; lactose; microcrystalline cellulose; and starch. The structural formulas are as follows: Each brown tablet contains ferrous fumarate, mannitol, povidone, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, sucralose and spearmint flavor. -
Quantitative High-Throughput Profiling of Environmental Chemicals and Drugs That Modulate Farnesoid X Receptor
OPEN Quantitative High-Throughput Profiling of SUBJECT AREAS: Environmental Chemicals and Drugs that SCREENING SMALL MOLECULES Modulate Farnesoid X Receptor Chia-Wen Hsu1, Jinghua Zhao1, Ruili Huang1, Jui-Hua Hsieh2, Jon Hamm3, Xiaoqing Chang3, Keith Houck4 Received & Menghang Xia1 27 June 2014 Accepted 1National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD, 2Division of the National 29 August 2014 Toxicology Program, National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, NC, 3Integrated Laboratory Systems, Inc., Morrisville, NC, 4U.S. Environmental Protection Agency, Research Triangle Park, NC. Published 26 September 2014 The farnesoid X receptor (FXR) regulates the homeostasis of bile acids, lipids, and glucose. Because endogenous chemicals bind and activate FXR, it is important to examine which xenobiotic compounds Correspondence and would disrupt normal receptor function. We used a cell-based human FXR b-lactamase (Bla) reporter gene assay to profile the Tox21 10K compound collection of environmental chemicals and drugs. requests for materials Structure-activity relationships of FXR-active compounds revealed by this screening were then compared should be addressed to against the androgen receptor, estrogen receptor a, peroxisome proliferator-activated receptors d and c, and M.X. ([email protected]. the vitamin D receptor. We identified several FXR-active structural classes including anthracyclines, gov) benzimidazoles, dihydropyridines, pyrethroids, retinoic acids, and vinca alkaloids. Microtubule inhibitors potently decreased FXR reporter gene activity. Pyrethroids specifically antagonized FXR transactivation. Anthracyclines affected reporter activity in all tested assays, suggesting non-specific activity. These results provide important information to prioritize chemicals for further investigation, and suggest possible modes of action of compounds in FXR signaling.