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Progestin Androgenic Activity

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81. Clinical practice guidelines for the care of girls and women with Turner syndrome: proceedings from the 2016 Cincinnati International Turner Syndrome Meeting (Full text)

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 PubMed abstract

82. Endometrial Hyperplasia, Management of

, especially when identifiable risk factors can be reversed. However, women should be informed that treatment with progestogens has a higher disease regression rate compared with observation alone. Progestogen treatment is indicated in women who fail to regress following observation alone and in symptomatic women with abnormal uterine bleeding. RCOG/BSGE Green-top Guideline No. 67 2 of 30 © Royal College of Obstetricians and Gynaecologists P D B B B C P P P P PWhat should the first-line medical treatment (...) of hyperplasia without atypia be? Both continuous oral and local intrauterine (levonorgestrel-releasing intrauterine system [LNG-IUS]) progestogens are effective in achieving regression of endometrial hyperplasia without atypia. The LNG-IUS should be the first-line medical treatment because compared with oral progestogens it has a higher disease regression rate with a more favourable bleeding profile and it is associated with fewer adverse effects. Continuous progestogens should be used (medroxyprogesterone

2016 Royal College of Obstetricians and Gynaecologists

83. Senshio - ospemifene

to the pharmacological action of metabolite M-1, compared to humans. The potency of M-1 regarding effects on rat vaginal and uterine tissue, however, was largely similar to that of the parent compound. In vitro receptor selectivity Based on limited competitive binding data it was considered possible that both the progesterone receptor and the androgen receptor contribute to effects of Ospemifene, and that the progesterone receptor contributes to effects of metabolites M-1 and M-2. In vitro receptor activation In two (...) Procedure No. EMEA/H/C/002780/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/78875/2015 Page 2/116 Table of contents 1. Background information on the procedure 7 1.1. Submission of the dossier 7 1.2. Manufacturers 8 1.3. Steps taken for the assessment of the product 8 2. Scientific discussion 9 2.1. Introduction 9 2.2. Quality aspects 11 2.2.1. Introduction 11 2.2.2. Active Substance 11 2.2.3. Finished

2015 European Medicines Agency - EPARs

84. Addyi - Flibanserin

, characterized by a deficiency or absence of sexual fantasies and desire for sexual activity (criterion A)” that causes “marked distress or interpersonal difficulty (criterion B).” 1 Additionally, this disorder cannot be better accounted for by a general medical, other psychiatric, or a substance or drug-related condition (criterion C). HSDD is classified as either acquired (symptoms beginning after a period of relatively normal sexual function) or lifelong (present since the individual became sexually (...) active); in addition, HSDD can be either generalized (not limited to certain types of stimulation, situations, or partners) or situational (only occurs with certain types of stimulation, situations or partners). HSDD, along with disorders of arousal, orgasm, and sexual pain in women, are 1 Diagnostic and statistical manual of mental disorder (DSM), Washington, DC: American Psychiatric Association: DSM-III-R, published in 1987; DSM-IV, published in 1994; DSM-IV, primary care version, published in 1995

2015 FDA - Drug Approval Package

85. Combined oral contraception: nomegestrol/estradiol (Zoely)

with other contraceptive formulations. See the Faculty of Sexual & Reproductive Healthcare's guidance for more information. Combined oral contraception: nomegestrol/estradiol (Zoely) (ESNM28) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 6 of 23Product o Product ov verview erview Drug action The active tablets in nomegestrol/estradiol (Zoely) contain 2.5 mg nomegestrol acetate, a highly selective progestogen (...) that is similar to human progesterone and has no oestrogenic, androgenic, glucocorticoid or mineralocorticoid activity, and 1.5 mg 17ß-estradiol (as hemihydrate), a synthetically produced oestrogen that is chemically identical to human 17ß-estradiol. Licensed therapeutic indication Nomegestrol/estradiol (Zoely) is a combined oral contraceptive that received a marketing authorisation for oral contraception in July 2011. It was not marketed in the UK until May 2013. Course and cost One tablet is taken daily

2013 National Institute for Health and Clinical Excellence - Advice

86. Guideline on the management of premature ovarian insufficiency

.a Breast cancer 110 12.2.b Endometrial cancer and endometrial hyperplasia 111 12.2.c Stroke 112 12.2.d Thromboembolic disease 112 12.3. HRT – treatment options 112 12.3.a Type of preparations: Estrogens and progestogens 113 12.3.b Regimens 114 12.3.c Route of administration 115 12.3.d Dose 117 12.3.e Duration 118 12.4. Monitoring HRT 119 12.5. POI women with special issues 120 12.5.a Women with Turner Syndrome 120 12.5.b Women with POI and a BRCA gene mutation or after breast cancer 121 12.5.c Women (...) with POI and endometriosis 123 12.5.d Women with POI and other medical issues 123 12.6. Treatment with androgens 127 12.6.a Indications 128 12.6.b Risks of androgen therapy 129 12.6.c Routes of administration, dose, duration, monitoring 129 13. Puberty induction 138 14. Complementary treatments in POI 144 Appendix 1: Abbreviations 148 Appendix 2: Glossary 150 Appendix 3: Guideline group 152 Appendix 4: Research recommendations 154 Appendix 5: Methodology 156 Appendix 6: Reviewers of the guideline draft

2015 European Society of Human Reproduction and Embryology

87. Drugs to avoid in 2015

). There is no justification for exposing patients with simple constipation to such risks. If dietary measures are ineffective, then bulk-forming laxatives, osmotic laxatives or, very occasionally, other laxatives (lubricants, stimulants, or rectal prepa- rations), used carefully and patiently, are safer than prucalopride. Gynaecology - Endocrinology – Tibolone, a synthetic steroid hormone used for postmenopausal replacement therapy, has androgenic, oestrogenic and progestogenic properties and carries a risk (...) is collected once marketing authorisation has been granted (2). 71 drugs more dangerous than beneficial Between 2010 and 2014, we identified 71 drugs marketed in France that are more dangerous than beneficial. They are listed below, based first on their thera- peutic class and then in alphabetical order of their international nonpropri- etary names (INN). These 71 drugs comprise: – Active substances with adverse effects that are disproportionate to the benefits they provide; – Older drugs that have been

2015 Prescrire

88. Breast Cancer Treatment (PDQ®): Health Professional Version

factors for breast cancer include the following: Family health history.[ ] Major inheritance susceptibility.[ , ] - Germline mutation of the BRCA1 and BRCA2 genes and other breast cancer susceptibility genes.[ , ] Alcohol intake. Breast tissue density (mammographic).[ ] Estrogen (endogenous).[ - ] - Menstrual history (early menarche/late menopause).[ , ] - Nulliparity. - Older age at first birth. Hormone therapy history. - Combination estrogen plus progestin hormone replacement therapy. Obesity (...) , Gierach GL, et al.: Mammographic density and breast cancer risk in White and African American Women. Breast Cancer Res Treat 135 (2): 571-80, 2012. [ ] [ ] Key TJ, Appleby PN, Reeves GK, et al.: Circulating sex hormones and breast cancer risk factors in postmenopausal women: reanalysis of 13 studies. Br J Cancer 105 (5): 709-22, 2011. [ ] [ ] Kaaks R, Rinaldi S, Key TJ, et al.: Postmenopausal serum androgens, oestrogens and breast cancer risk: the European prospective investigation into cancer

2018 PDQ - NCI's Comprehensive Cancer Database

89. Breast Cancer Prevention (PDQ®): Health Professional Version

, compared with women who have the lowest breast density.[ ] Study Design : Cohort, case-control studies. Internal Validity : Good. Consistency : Good. External Validity : Good. Modifiable Factors With Adequate Evidence of Increased Risk of Breast Cancer Combination hormone therapy Based on solid evidence, combination hormone therapy (HT) (estrogen-progestin) is associated with an increased risk of developing breast cancer. Magnitude of Effect : Approximately a 26% increase in incidence of invasive (...) studies. Internal Validity : Good. Consistency : Good. External Validity : Poor. Interventions With Adequate Evidence of Decreased Risk of Breast Cancer Selective estrogen receptor modulators (SERMs): benefits Based on solid evidence, tamoxifen and raloxifene reduce the incidence of breast cancer in postmenopausal women, and tamoxifen reduces the risk of breast cancer in high-risk premenopausal women. The effects observed for tamoxifen and raloxifene show persistence several years after active

2018 PDQ - NCI's Comprehensive Cancer Database

90. Genetics of Breast and Gynecologic Cancers (PDQ®): Health Professional Version

Data exist from both observational and randomized clinical trials regarding the association between postmenopausal HRT and breast cancer. A meta-analysis of data from 51 observational studies indicated a RR of breast cancer of 1.35 (95% CI, 1.21–1.49) for women who had used HRT for 5 or more years after menopause.[ ] The (NCT00000611), a randomized controlled trial of about 160,000 postmenopausal women, investigated the risks and benefits of HRT. The estrogen-plus-progestin arm of the study (...) , in which more than 16,000 women were randomly assigned to receive combined HRT or placebo, was halted early because health risks exceeded benefits.[ , ] Adverse outcomes prompting closure included significant increase in both total (245 vs. 185 cases) and invasive (199 vs. 150 cases) breast cancers (RR, 1.24; 95% CI, 1.02–1.5, P < . 001) and increased risks of coronary heart disease, stroke, and pulmonary embolism. Similar findings were seen in the estrogen-progestin arm of the prospective

2018 PDQ - NCI's Comprehensive Cancer Database

91. Breast Cancer Prevention (PDQ®): Health Professional Version

, compared with women who have the lowest breast density.[ ] Study Design : Cohort, case-control studies. Internal Validity : Good. Consistency : Good. External Validity : Good. Modifiable Factors With Adequate Evidence of Increased Risk of Breast Cancer Combination hormone therapy Based on solid evidence, combination hormone therapy (HT) (estrogen-progestin) is associated with an increased risk of developing breast cancer. Magnitude of Effect : Approximately a 26% increase in incidence of invasive (...) studies. Internal Validity : Good. Consistency : Good. External Validity : Poor. Interventions With Adequate Evidence of Decreased Risk of Breast Cancer Selective estrogen receptor modulators (SERMs): benefits Based on solid evidence, tamoxifen and raloxifene reduce the incidence of breast cancer in postmenopausal women, and tamoxifen reduces the risk of breast cancer in high-risk premenopausal women. The effects observed for tamoxifen and raloxifene show persistence several years after active

2018 PDQ - NCI's Comprehensive Cancer Database

92. Ovarian, Fallopian Tube, and Primary Peritoneal Cancer Prevention (PDQ®): Health Professional Version

, with greater effects for longer periods of cessation. Risks did not differ by preparation types (estrogen only vs. combined estrogen/progestin). Risks also did not differ by age at use.[ , ] Tibolone, a synthetic steroid with estrogenic, progestogenic, and androgenic properties, has been associated with an increased incidence rate ratio of 3.56 (95% CI, 3.08–4.69) for endometrial cancer for current users compared with never-users. Tibolone is approved for use to manage menopausal symptoms or to prevent (...) only vs. combined estrogen/progestin).[ , ] Magnitude of Effect : Modest with observed RRs of 1.20 to 1.8. Study Design : One randomized clinical trial, cohort and case-control studies. Internal Validity : Good. Consistency : Fair. External Validity : Good. Obesity and height Based on fair evidence, increases in height and body mass index (BMI) are associated with a modest increased risk of ovarian cancer. Magnitude of Effect : Based on an overview analysis of 25,157 women with ovarian cancer

2018 PDQ - NCI's Comprehensive Cancer Database

93. Acne vulgaris

(if not contraindicated) in combination with topical agents can be considered as an alternative to systemic antibiotics in women. Oral progesterone only contraceptives or progestin implants with androgenic activity may exacerbate acne, second and third generation combined oral contraceptives are generally preferred. Co-cyprindiol (Dianette®) or other ethinylestradiol/cyproterone acetate containing products may be considered in moderate to severe acne where other treatments have failed but require careful discussion (...) on the trunk and upper limbs. Acne fulminans is a sudden severe inflammatory reaction that precipitates deep ulcerations and erosions, sometimes with systemic effects (such as fever and arthralgia). [ ; ; ; ; ; ; ] Causes What causes it? The pathogenesis of acne is not completely understood but is thought to involve several processes including: Altered follicular keratinocyte proliferation leading to formation of follicular plugs (comedones). Androgen induced seborrhoea (increased sebum production) within

2018 NICE Clinical Knowledge Summaries

94. Polycystic ovary syndrome

[ ]. The theca cells in women with PCOS seem to be more efficient at converting androgen precursors to testosterone than normal theca cells [ ]. Women with PCOS may have increased serum oestrogen levels. Follicular development is arrested at some stage short of full maturation of an ovulatory follicle. Therefore, although there is no ovulation, oestrogen production continues and there is no oestrogen deficiency. However, as a result of continued exposure to oestrogen unopposed by progestogen, the endometrium (...) with PCOS and provides a surrogate measurement of the degree of hyperinsulinaemia. Calculate free androgen index (100 multiplied by the total testosterone value divided by the SHBG value) to assess the amount of physiologically active testosterone present — this is normal or elevated in women with PCOS (the normal range is usually less than 5, but this depends on local laboratories). Measure the following to rule out other causes of oligomenorrhoea and amenorrhoea (such as premature ovarian failure

2018 NICE Clinical Knowledge Summaries

95. Infertility

inhibitors — can have a negative local effect on ovulation [ ]. Spironolactone — can cause infertility and menstrual irregularities. Normal menstruation resumes within 2 months of treatment withdrawal [ ]. Chemotherapy with cytotoxic drugs — can induce ovarian failure, which may be permanent [ ]. Neuroleptic drugs — may cause amenorrhoea and infertility [ ]. Contraceptives — normal fertility returns immediately after stopping the combined oral contraceptive (COC), the progestogen-only pill (POP (...) ), the levonorgestrel intrauterine system (LNG-IUS), and the copper intrauterine device (Cu-IUD). After stopping the combined contraceptive patch and the combined vaginal ring, there may be a delay of up to a few months in return to normal fertility. After stopping the progestogen-only injectables, there could be a delay of up to 1 year in the return of normal fertility (menstruation can take several months to return to normal) [ ; ; ; ; ]. Recreational drugs (such as marijuana and cocaine) — have been associated

2018 NICE Clinical Knowledge Summaries

96. Guideline for the Treatment of Acne

in response to changes in androgens and other hormones with start at puberty. Dihydrotestosterone is the most potent hormone to stimulate sebocytes in the acne prone areas. The critical enzyme in the metabolic pathway is 5- alpha Reductase isoenzyme 1. Adrenal DHEA-S is hormonal active but can also be a stimulator of IL-2 driven T-cells and, therefore, driving the inflammatory process. [81] Oxidized squalene can stimulate hyperproliferative behaviour of keratinocytes, and lipoperoxides produce leukotriene (...) two perspectives: objective disease activity (based on measurement of visible signs) and quality of life impact. There are other aspects of measurement, such as sebum excretion rate, colonisation by Propionibacterium acnes (P. acnes), scarring development or economic impact. Accurately assessing outcomes from therapy is notoriously difficult in acne [8]. Many different approaches have been adopted but very few are validated. The inconsistent application of a standard method for assessing acne

2016 European Dermatology Forum

97. Acne clinical guideline (Full text)

, A. Hormonal profiles and prevalence of polycystic ovary syndrome in women with acne. J Dermatol . 1997 ; 24 : 223–229 | | , x 53 Lucky, A.W. Endocrine aspects of acne. Pediatr Clin North Am . 1983 ; 30 : 495–499 | , x 54 Lucky, A.W., McGuire, J., Rosenfield, R.L., Lucky, P.A., and Rich, B.H. Plasma androgens in women with acne vulgaris. J Invest Dermatol . 1983 ; 81 : 70–74 | | | , x 55 Abulnaja, K.O. Changes in the hormone and lipid profile of obese adolescent Saudi females with acne vulgaris. Braz J Med (...) : 25–33 | | | | | Spironolactone B II, III x 102 Shaw, J.C. Low-dose adjunctive spironolactone in the treatment of acne in women: a retrospective analysis of 85 consecutively treated patients. J Am Acad Dermatol . 2000 ; 43 : 498–502 | | | | , x 103 Sato, K., Matsumoto, D., Iizuka, F. et al. Anti-androgenic therapy using oral spironolactone for acne vulgaris in Asians. Aesthetic Plast Surg . 2006 ; 30 : 689–694 | | | Flutamide C III x 104 Wang, H.S., Wang, T.H., and Soong, Y.K. Low dose flutamide

2016 American Academy of Dermatology PubMed abstract

98. Hormonal contraception in women with polycystic ovary syndrome: choices, challenges, and noncontraceptive benefits (Full text)

estrogen that exerts antiandrogenic properties by triggering the hepatic synthesis of sex hormone-binding globulin that reduces the free testosterone levels. Moreover, the progestogen present in CHCs and in progestogen-only contraceptives suppresses luteinizing hormone secretion. In addition, some types of progestogens directly antagonize the effects of androgens on their receptor and also reduce the activity of the 5α reductase enzyme. However, PCOS is related to clinical and metabolic comorbidities

2017 Open access journal of contraception PubMed abstract

99. Lymphangioleiomyomatosis Diagnosis and Management Part I: An Official ATS/JRS Clinical Practice Guideline

invasive management (conditional recommendation based on very low-quality evidence). d We suggest NOT using doxycycline as treatment for LAM (conditional recommendation based on low-quality evidence). d WesuggestNOTusinghormonal therapy as treatment for LAM (conditional recommendation based on very low- quality evidence). Hormonal therapies include progestins, gonadotrophin- releasing hormone agonists, selective estrogen receptor modulators like tamoxifen, and oophorectomy. ORCID ID: 0000-0001-7168 (...) for LAM. (“Hormonal therapy” includes the progestins, GnRH agonists, selective estrogen receptor modulators like tamoxifen, and oophorectomy.) Conditional Very low VEGF-D as a diagnostic test For patients whose CT scan shows cystic abnormalities characteristic of LAM but have no con?rmatory clinical or extrapulmonary radiologic features of LAM, we recommend VEGF-D testing before consideration of proceeding to diagnostic lung biopsy. (“Con?rmatory features of LAM” include tuberous sclerosis complex

2016 American Thoracic Society

100. Preventing and Experiencing Ischemic Heart Disease as a Woman: State of the Science (Full text)

fraction is higher in women Physiology Women have reduced sympathetic and enhanced parasympathetic activity Women have lower plasma concentrations of norepinephrine Cardiovascular adaptations In response to stress, women experience an increased pulse rate, resulting in increased cardiac output; men have increased vascular resistance, resulting in increased BP Women are more sensitive to altitude or body positioning changes and experience more orthostatic hypotension and syncope Hematologic indexes (...) , older women, who are more at risk for IHD, tend to be more physically inactive than men. Many older women lack experience in team activities and group exercise, contributing to their PI. However, this is changing as more baby boomers age and participate in group activities such as water aerobics, yoga, and Pilates. The National Institute on Aging has excellent step-by-step instructional material to encourage safe activity in the older population, Your Everyday Guide from the National Institute

2016 American Heart Association PubMed abstract

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