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Progestin Androgenic Activity

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61. Evaluation and Management of Testosterone Deficiency

Education and Research, Inc.® 9 testosterone differ. Given these inconsistences, prevalence of low testosterone has varied dramatically among studies, with statistics reporting 2 – 50%. 5-8 A summary of findings from four large-scale contemporary prevalence studies can be found in Table 3. Testosterone Measurement Testosterone is the predominant androgen in males and is involved in a multitude of physiological and biochemical processes throughout the body. It is bound to albumin (50%, loosely-bound (...) on age, varicocele grade, baseline testosterone level) has not been defined. 75 Gynecomastia is a benign enlargement of the male breast tissue that can occur at times of male androgen/ estrogen change (alteration in testosterone/estradiol [E2] ratio), infancy, adolescence, or old age, and may be a sign of low serum testosterone. Male breast growth can be classified as pharmacological (associated with risperidone, cimetidine, anti-androgens, digoxin, clomiphene, methadone, marijuana, chlorpromazine

2018 American Urological Association

62. Aromatase Inhibitors in Gynecologic Practice

of thrombosis, endometrial cancer, andvaginalbleeding.Forwomenwithpolycysticovarysyndrome,andabodymassindexgreaterthan30,letrozole should be considered first-line therapy for ovulation induction because of the increased live birth rate compared with clomiphene citrate. Lifestyle changes that result in weight loss should be strongly encouraged. Aromatase inhibitorsareapromisingtherapeuticoptionthatmaybehelpfulforthemanagementofendometriosis-associated pain in combination therapy with progestins (...) that ovulationinductionwithletrozoleresulted inlowerlive birth rates and multiple gestation rates compared with gonadotropins; however, live birth and multiple gestation rates did not differ significantly between ovulation induction with letrozole compared with clo- miphene citrate. c Aromatase inhibitors are a promising therapeutic option that may help manage endometriosis-associated pain in combination therapy with progestins. This Committee Opinion revision provides updated information on the use of aromatase inhibitors in breast

2018 American College of Obstetricians and Gynecologists

63. Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome

and if anovulation needs to be con?rmed serum progesterone levels can be measured. _ Biochemicalhyperandrogenism EBR Calculated free testosterone, free androgen index, or calculated bioavailable testosterone should be used to assess biochemical hyperandrogenism in the diagnosis of PCOS. **** 44BB EBR High quality assays such as liquid chromatography–mass spectrometry (LCMS) and extraction/ chromatographyimmunoassays,shouldbeusedforthemostaccurateassessmentoftotalorfree testosterone in PCOS. *** 44BB EBR (...) on hormonal contraception, due to effects on sex hormone-binding globulin and altered gonadotrophin- dependent androgen production. _ CPP Where assessment of biochemical hyperandrogenism is important in women on hormonal contraception,drugwithdrawalisrecommendedforthreemonthsorlongerbeforemeasurement, and contraception management with a non-hormonal alternative is needed during this time. _ CPP Assessment of biochemical hyperandrogenism is most useful in establishing the diagnosis of PCOS

2018 Society for Assisted Reproductive Technology

64. Progestagen Type in Postmenopausal Hormone Therapy and Blood Gene Expression Profile

adding more. Progestagen Type in Postmenopausal Hormone Therapy and Blood Gene Expression Profile (ProGEP) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT01123538 Recruitment Status : Unknown Verified November 2011 by University Hospital of North Norway. Recruitment status was: Active, not recruiting (...) for MeSH terms Hormones Progesterone Progestins Chlormadinone Acetate Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Androgen Antagonists Hormone Antagonists Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents

2010 Clinical Trials

65. Menopause: diagnosis and management

this is important An increase in the risk of VTE (deep vein thrombosis [DVT] or pulmonary embolism [PE]) is a significant side effect of HRT, particularly because PEs can be fatal. This risk appears to be greater with oral than transdermal HRT. DVT risk increases with age and BMI, among other risk factors. The progestogen component of HRT may also influence the risk of a DVT, which may be greater with androgenic synthetic progestogens than natural progesterone (but findings from observational studies need (...) reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 5 of 30antral follicle count ovarian volume. 1.2.4 Do not use a serum follicle-stimulating hormone (FSH) test to diagnose menopause in women using combined oestrogen and progestogen contraception or high-dose progestogen. 1.2.5 Consider using a FSH test to diagnose menopause only: in women aged 40 to 45 years with menopausal symptoms, including a change in their menstrual cycle in women aged

2015 National Institute for Health and Clinical Excellence - Clinical Guidelines

66. Management of Uterine Fibroids

of Evidence 15 Strength of Evidence Assessments 15 Overall Strength of Evidence 15 Peer Review and Public Commentary 16 Results 17 Content of the Literature About Effectiveness 19 Key Question 1. Effectiveness of Treatment for Uterine Fibroids 20 Key Points 20 Expectant Management: Overview 21 Expectant Management: Results 22 Medical Management: Overview 24 Medical Management: Results 25 GnRH Agonists 25 Progesterone Receptor Agents: Anti-Progestins, Selective Receptor Modulators, and Levonorgestrel IUD (...) , more than 70 percent of white women and 84 percent of African American women have fibroids documented by imaging or surgical records. 1 The personal and societal costs of diminished quality of life, disruption of usual activities and roles, lost work time, and healthcare expenditures are substantial. Including all types of interventions, direct annual healthcare costs in the United States are projected to exceed $9.4 billion. 8 Lost wages, productivity, and short-term disability are estimated

2017 Effective Health Care Program (AHRQ)

67. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults

: measures, modification; office visits; patient outcome; performance measures; physical activity; potassium intake; protein intake; renin inhibitor; risk reduction: behavior, counseling; screening; sphygmomanometers; spironolactone; therapy; treatment: adherence, compliance, efficacy, outcome, protocol, regimen; weight. Additional relevant studies published through June 2016, during the guideline writing process, were also considered by the writing committee and added to the evidence tables when (...) disease and hypertension ACC/AHA/AMA-PCPI 2011 Interventions to promote physical activity and dietary lifestyle changes for cardiovascular risk factor reduction in adults AHA 2010 Resistant hypertension: diagnosis, evaluation, and treatment AHA 2008 * The full-text SIHD guideline is from 2012. A focused update was published in 2014. AATS indicates American Association for Thoracic Surgery; ACC, American College of Cardiology; ACOG, American College of Obstetricians and Gynecologists; ACR, American

2017 American Heart Association

68. Non-Epithelial Ovarian Cancer: ESMO Clinical Practice Guidelines

origin. SCSTs and steroid cell tumours constitute a heterogeneous group of tumours (Table 3) and vary in their capacity to produce clinically signi?cant amounts of steroid hormones. Granulosa cell tumours are typically oestrogenic and may be associated with various clinical syndromes, depending upon the age of the patient. SLCTs typically produce androgens, and clinical virilisa- tion is observed in 70%–85% of patients. Those with sex cord ele- ments may be malignant, with granulosa cell tumours (...) that the most used combination is the 5-day bleomycin/etoposide/cisplatin (BEP) regimen [III, A] [31]. Clinical Practice Guidelines Annals of Oncology iv4 | Ray-Coquard et al. Volume 29 | Supplement 4 | October 2018 Downloaded from https://academic.oup.com/annonc/article-abstract/29/Supplement_4/iv1/4983953 by guest on 16 April 2019When ChT is not offered, a close and active surveillance pro- gramme should be proposed [III, C]. Vazquez and Rustin postulate a surveillance schedule involving regular clinical

2018 European Society for Medical Oncology

69. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary Full Text available with Trip Pro

coat, masked, ambulatory, isolated ambulatory, isolated clinic, diagnosis, reverse white coat, prevention, therapy, treatment, control; intervention; lifestyle: measures, modification; office visits; patient outcome; performance measures; physical activity; potassium intake; protein intake; renin inhibitor; risk reduction: behavior, counseling; screening; sphygmomanometers; spironolactone; therapy; treatment: adherence, compliance, efficacy, outcome, protocol, regimen; weight. Additional relevant (...) 2014 An effective approach to high blood pressure control AHA/ACC/CDC 2014 Ambulatory blood pressure monitoring ESH 2013 Performance measures for adults with coronary artery disease and hypertension ACC/AHA/AMA-PCPI 2011 Interventions to promote physical activity and dietary lifestyle changes for cardiovascular risk factor reduction in adults AHA 2010 Resistant hypertension: diagnosis, evaluation, and treatment AHA 2008 * The full-text SIHD guideline is from 2012. A focused update was published

2017 American Heart Association

70. Obesity in Adolescents

in preventing short-term and long-term morbidity. The obstetrician–gynecologist who is knowledgeable about the behavioral and environmental factors that influence obesity may be better able to educate parents, guardians, and adolescents and advocate for programs that increase physical activity and improve nutrition. The obstetrician–gynecologist should be able to identify obese adolescents, particularly those at risk of comorbid conditions. They may have the opportunity to initiate behavioral counseling (...) should be knowledgeable about the behavioral and environmental factors that influence obesity and should educate adolescents and their parents about an active lifestyle and healthy caloric intake. The obstetrician–gynecologist should be able to identify obese adolescents, particularly those at risk of comorbid conditions. Obstetrician–gynecologists may have the opportunity to initiate behavioral counseling, participate in multidisciplinary teams that care for overweight and obese adolescents

2017 American College of Obstetricians and Gynecologists

71. The 2017 hormone therapy position statement of The North American Menopause Society

in cognitive outcomes between types of estrogen and the brain serotonergic system, with estradiol providing more robust anxiolytic and antidepressant effects. 6,7 Progestogen indication: need for endometrial protection Chronic unopposed endometrial exposure to estrogen increases the risk for endometrial hyperplasia or cancer. 8,9 The primary menopause-related indication for progestogen use is to prevent endometrial overgrowth and the increased risk of endometrial cancer during ET use. Progestins com- monly (...) vaginal bleeding, severe active liver disease, prior estrogen-sensitive breast or endometrial cancer, coronary heart disease (CHD), stroke, dementia, personal history or inherited high risk of thromboembolic disease, porphyria cutanea tarda, or hyper- triglyceridemia, with concern that endometriosis might reac- tivate, migraine headaches may worsen, or leiomyomas may grow. More common AEs include nausea, bloating, weight gain, fluid retention, mood swings (progestogen-related), break- through bleeding

2017 The North American Menopause Society

72. Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons: An Endocrine Society Clinical Practice Guideline Full Text available with Trip Pro

hormone levels; (3) the requirement for and the effects of progestins and other agents used to suppress endogenous sex steroids during treatment; and (4) the risks and benefits of gender-affirming hormone treatment in older transgender people. To successfully establish and enact these protocols, a commitment of mental health and endocrine investigators is required to collaborate in long-term, large-scale studies across countries that use the same diagnostic and inclusion criteria, medications, assay (...) identity, the prevalence of GD/gender incongruence was much greater in this group than in the general population without a DSD. This supports the concept that there is a role for prenatal/postnatal androgens in gender development ( – ), although some studies indicate that prenatal androgens are more likely to affect gender behavior and sexual orientation rather than gender identity per se ( , ). Researchers have made similar observations regarding the potential role of androgens in the development

2017 Pediatric Endocrine Society

73. European Society of Endocrinology Clinical practice guidelines for the care of girls and women with Turner syndrome

and then annually with (free) T4 and TSH measurements beginning in early childhood and throughout the lifespan (⨁⨁◯◯). R 6.4. We suggest counseling on healthy nutrition and physical activity starting in early childhood (⨁⨁◯◯). R 6.5. We recommend lifelong annual measurement of HbA1c with or without fasting plasma glucose starting at age of 10 years (⨁⨁◯◯). R 6.6. We recommend that a lipid profile be performed in individuals who have at least one risk factor for cardiovascular disease starting at age 18 years (...) a separate systematic literature search was performed, and for which available evidence was synthesized. For each question, the eligibility criteria, endpoint definition, search strategy and main findings are described below. What is the effect of growth-promoting treatment in TS? (GRADE question 1) Short stature, present in most individuals with TS, is treated with GH, with/without oxandrolone (a non-aromatizable androgen), with the goals of increasing adult height. We systematically searched

2017 European Society of Endocrinology

74. Interventions to Prevent Age-Related Cognitive Decline, Mild Cognitive Impairment, and Clinical Alzheimer's-Type Dementia

to facilitate analysis; strength of evidence was assessed by MCI or CATD incidence and cognitive outcome domain. Results. We identified 263 eligible studies addressing 13 classes of interventions: cognitive training, physical activity, nutraceuticals, diet, multimodal interventions, hormone therapy, vitamins, antihypertensive treatment, lipid lowering treatment, nonsteroidal anti-inflammatory drugs (NSAIDs), antidementia drugs, diabetes treatment, and “other interventions.” We found no high-strength (...) activity interventions show no consistent benefit in preventing cognitive decline, but the percent of results showing benefit was unlikely to be explained solely by chance, providing a signal of a possible relationship. A few other interventions (vitamin B 12 plus folic acid; nutraceuticals; one multimodal intervention using diet, physical activity, and cognitive training; antihypertensives; and NSAIDs) showed at least one positive finding for a specific outcome, some reaching low strength of evidence

2017 Effective Health Care Program (AHRQ)

75. Interventions to Prevent Age-Related Cognitive Decline, Mild Cognitive Impairment, and Clinical Alzheimer's-Type Dementia

to facilitate analysis; strength of evidence was assessed by MCI or CATD incidence and cognitive outcome domain. Results. We identified 263 eligible studies addressing 13 classes of interventions: cognitive training, physical activity, nutraceuticals, diet, multimodal interventions, hormone therapy, vitamins, antihypertensive treatment, lipid lowering treatment, nonsteroidal anti-inflammatory drugs (NSAIDs), antidementia drugs, diabetes treatment, and “other interventions.” We found no high-strength (...) activity interventions show no consistent benefit in preventing cognitive decline, but the percent of results showing benefit was unlikely to be explained solely by chance, providing a signal of a possible relationship. A few other interventions (vitamin B 12 plus folic acid; nutraceuticals; one multimodal intervention using diet, physical activity, and cognitive training; antihypertensives; and NSAIDs) showed at least one positive finding for a specific outcome, some reaching low strength of evidence

2017 Effective Health Care Program (AHRQ)

76. Fertility problems: assessment and treatment

management should be the result of discussions between the couple, a fertility specialist and an HIV specialist. [new 2013] [new 2013] 1.3.10.2 Advise couples where the man is HIV positive that the risk of HIV transmission to the female partner is negligible through unprotected sexual intercourse when all of the following criteria are met: the man is compliant with highly active antiretroviral therapy (HAART) the man has had a plasma viral load of less than 50 copies/ml for more than 6 months (...) Men with idiopathic semen abnormalities should not be offered anti- oestrogens, gonadotrophins, androgens, bromocriptine or kinin-enhancing drugs because they have not been shown to be effective. [2004] [2004] 1.4.1.3 Men should be informed that the significance of antisperm antibodies is unclear and the effectiveness of systemic corticosteroids is uncertain. [2004] [2004] 1.4.1.4 Men with leucocytes in their semen should not be offered antibiotic treatment unless there is an identified infection

2013 National Institute for Health and Clinical Excellence - Clinical Guidelines

77. Management of osteoporosis and the prevention of fragility fractures

for fracture is unclear at present. 3.5.8 HORMONAL CONTRACEPTION A systematic review investigated the association between the use of progestogen-only contraception and fracture risk or BMD change. Only one RCT was identified which included fracture as an outcome, and this did not show a significant association between depot medroxyprogesterone acetate (DMPA) and fracture risk in female military recruits after adjusting for baseline BMD. 91 In observational studies current DMPA users had lower mean BMD than (...) have never used DMPA. 91 A Cochrane review identified 16 RCTs reporting bone outcomes in women using hormonal contraception. No trials reported fracture outcomes. Four studies included the injectable progestogen-only contraceptive DMP A of which two were placebo controlled. Since the oestrogen preparations and routes of administration differed for the trials, no meta-analysis was conducted. The two trials showed BMD increases for the women who received DMPA plus oestrogen supplement and decreases

2015 SIGN

78. Palbociclib (Ibrance) - locally advanced or metastatic breast cancer

or nonsteroidal AIs, progestins, and androgens 6 . In the pivotal studies for the present application, letrozole and fulvestrant were used as endocrine backbone therapy and comparators. Letrozole (Femara) is an oral nonsteroidal aromatase inhibitor (AI) approved worldwide for the first-line treatment of postmenopausal women with hormone receptor-positive advanced breast cancer. Fulvestrant (Faslodex) is a potent anti-oestrogen drug that is currently indicated for the treatment of postmenopausal women (...) . Biologic features and clinical presentation 10 2.1.4. Management 11 2.2. Quality aspects 13 2.2.1. Introduction 13 2.2.2. Active Substance 14 2.2.3. Finished Medicinal Product 17 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 21 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 21 2.3. Non-clinical aspects 21 2.3.1. Introduction 21 2.3.2. Pharmacology 22 2.3.3. Pharmacokinetics 24 2.3.4. Toxicology 25 2.3.5. Ecotoxicity/environmental risk assessment 28

2016 European Medicines Agency - EPARs

79. Neofordex - dexamethasone. To treat adults with multiple myeloma

Up to 40 µg/ml 4, 8, 12 days • 80 µg/ml impaired follicle differentiation and oocyte maturation. • Androgen, estrogen and progestin secretion patterns were impaired at all doses levels Assessment report EMA/CHMP/6613/2016 Page 23/61 Female fertility (Baldwin, 1974) Rat; 4 to 12F Subcutaneous 100, 200, or 500 µg (0.25, 0.5 and 1.25 mg/kg) Up to 4 days • Ovulation reduced or inhibited • Delayed ovulation by. • Extended oestrous cycle to 5 days Female fertility (Rockwell, 2009) Rat; 86F (...) International non-proprietary name: dexamethasone Procedure No. EMEA/H/C/004071/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/CHMP/6613/2016 Page 2/61 Table of contents 1. Background information on the procedure 6 1.1. Submission of the dossier 6 1.2. Steps taken for the assessment of the product 7 2. Scientific discussion 8 2.1. Introduction 8 2.2. Quality aspects 9 2.2.1. Introduction 9 2.2.1. Active substance 9

2016 European Medicines Agency - EPARs

80. Clinical practice guidelines for the care of girls and women with Turner syndrome: proceedings from the 2016 Cincinnati International Turner Syndrome Meeting Full Text available with Trip Pro

and then annually with (free) T4 and TSH measurements beginning in early childhood and throughout the lifespan (⨁⨁◯◯). R 6.4. We suggest counseling on healthy nutrition and physical activity starting in early childhood (⨁⨁◯◯). R 6.5. We recommend lifelong annual measurement of HbA1c with or without fasting plasma glucose starting at age of 10 years (⨁⨁◯◯). R 6.6. We recommend that a lipid profile be performed in individuals who have at least one risk factor for cardiovascular disease starting at age 18 years (...) a separate systematic literature search was performed, and for which available evidence was synthesized. For each question, the eligibility criteria, endpoint definition, search strategy and main findings are described below. What is the effect of growth-promoting treatment in TS? (GRADE question 1) Short stature, present in most individuals with TS, is treated with GH, with/without oxandrolone (a non-aromatizable androgen), with the goals of increasing adult height. We systematically searched

2016 European Society of Human Reproduction and Embryology

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