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Progestin Androgenic Activity

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

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 breast cancer (...) . 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 treatment

2016 PDQ - NCI's Comprehensive Cancer Database

162. Endometrial Cancer Prevention (PDQ®): Health Professional Version

associated with unopposed estrogen and actually reduce the risk by 35%.[ ] Tibolone, a synthetic steroid with estrogenic, progestogenic, and androgenic properties, has been associated with an increased incidence rate ratio of endometrial cancer of 3.56 (95% CI, 3.08–4.69) for current users compared with never users. Tibolone is approved for use to manage menopausal symptoms or to prevent osteoporosis in many countries. However, it is not approved for use in Canada or the United States. Other combined (...) therapy (HT) with estrogen: Unopposed estrogen Based on solid evidence, unopposed estrogen is associated with an increased risk of endometrial cancer. This excess risk can be eliminated by adding continuous progestin to estrogen therapy, but this combination is associated with an increased risk of breast cancer.[ - ] (Refer to the PDQ summary on for more information.) Magnitude of Effect : The associated risk of endometrial cancer in women who use unopposed estrogen for 5 or more years is at least

2016 PDQ - NCI's Comprehensive Cancer Database

163. Zoely - nomegestrol / estradiol

?- estradiol (E2) and nomegestrol acetate (NOMAC), a 19-norprogesterone progestin with a potent gonadotropin-inhibiting effect in females. NOMAC binds with a strong affinity to the progesterone receptor (PR) derived from hormone-sensitive cell lines and tissues from rat, rabbit, and human origin and has no activity on other steroid receptors with the exception of a weak in vitro and in vivo anti- androgenic activity. Non- clinical studies showed that NOMAC exhibits the profile of a full progestogen, which (...) . There are two main types of hormonal contraceptive formulations: combined methods which contain both an estrogen and a progestin, and progestogen-only methods which contain only progesterone or one of its synthetic analogues (progestins). Traditionally the combined hormonal contraceptives contain two steroids: one with gestagenic and the other with estrogenic effects. The functions of progestagens are to inhibit ovulation, primarily by the central feedback mechanism resulting in decreased luteinizing

2011 European Medicines Agency - EPARs

164. Ioa - nomegestrol acetate / estradiol

. There are two main types of hormonal contraceptive formulations: combined methods which contain both an estrogen and a progestin, and progestogen-only methods which contain only progesterone or one of its synthetic analogues (progestins). Traditionally the combined hormonal contraceptives contain two steroids: one with gestagenic and the other with estrogenic effects. The functions of progestagens are to inhibit ovulation, primarily by the central feedback mechanism resulting in decreased luteinizing (...) product no longer authorisedIoa CHMP assessment report Page 14/61 activity. Non- clinical studies showed that NOMAC exhibits the profile of a full progestogen, which is intrinsically active by the oral route. NOMAC inhibits ovulation in the rat and monkey. Moreover, NOMAC displays anti-androgenic activity, anti-estrogenic activity, and pituitary inhibitory potency. The estrogen contained in Ioa is 17 ß-estradiol, a natural estrogen identical to the endogenous human 17 ß- estradiol. E2 is combined

2011 European Medicines Agency - EPARs

165. Assessment and management of polycystic ovary syndrome: summary of an evidence-based guideline (Full text)

, androgen levels should be measured; however, optimal methodology remains very controversial and is addressed in Section 1. Vaginal ultrasound is often needed for diagnosis where hyperandrogenism and anovulation are not both clearly present. Ultrasound can check for polycystic ovaries and endometrial thickness. However, vaginal ultrasound should be reserved for sexually active women. The role of ultrasound remains controversial for adolescents, among whom a polycystic appearance of the ovaries is very (...) , ovarian dysfunction and hormonal drivers to contribute to the aetiology of PCOS. , The underlying hormonal imbalance may include a combination of increased androgens and/or hyperinsulinaemia secondary to IR (Figure 1). Greater understanding of cause has been hampered by a lack of ideal methods to assess either hyperandrogenism or IR. Hyperandrogenism is detected in around 60%–80% of women with PCOS, and IR is a pathophysiological contributor in around 50%–80%. Obesity increases reproductive features

2011 MJA Clinical Guidelines PubMed abstract

166. Osteoporosis

: Anticonvulsants Phenytoin Primidone Phenobarbital Carbamazepine Hormone therapy Androgen deprivation therapy Inhibitors of gonadal hormones, including aromatase inhibitors Levothyroxine (high doses to treat thyroid cancer) Depo-medroxyprogesterone Disease-modifying antirheumatic drugs Methotrexate (when used in high doses to treat cancer) Cyclosporine Corticosteroids Note: An individual receiving (or expecting to receive) glucocorticoid (steroid) therapy equivalent to an average of 5.0 mg of prednisone (...) loss in recent years]), physical inactivity (participates in no physical activity on a regular basis [walking, climbing stairs, carrying weights, housework, or gardening]), use of oral corticosteroids, and previous fragility fracture. National Osteoporosis Foundation The National Osteoporosis Foundation recommends bone density testing in: • Women aged 65 and older • Men aged 70 and older • Postmenopausal women and men aged 50–69 when concerned with the risk factor profile • Men and women who have

2011 Kaiser Permanente Clinical Guidelines

167. Investigation and Treatment of Couples Recurrent Miscarriage

– and adverse pregnancy outcome or vascular thrombosis. 17,18 Adverse pregnancy outcomes include: three or more consecutive miscarriages before 10 weeks of gestation one or more morphologically normal fetal losses after the 10th week of gestation one or more preterm births before the 34th week of gestation owing to placental disease. The mechanisms by which antiphospholipid antibodies cause pregnancy morbidity include inhibition of trophoblastic function and differentiation, 19–23 activation (...) of complement pathways at the maternal–fetal interface resulting in a local inflammatory response 24 and, in later pregnancy, thrombosis of the uteropla- cental vasculature. 25–27 In vitro studies have shown that the effect of antiphospholipid antibodies on trophoblast function 28,29 and complement activation 30 is reversed by heparin. Antiphospholipid antibodies are present in 15% of women with recurrent miscarriage. 31 By comparison, the prevalence of antiphospholipid antibodies in women with a low-risk

2011 Royal College of Obstetricians and Gynaecologists

168. Assessment and management of polycystic ovary syndrome: summary of an evidence-based guideline

, androgen levels should be measured; however, optimal methodology remains very controversial and is addressed in Section 1. Vaginal ultrasound is often needed for diagnosis where hyperandrogenism and anovulation are not both clearly present. Ultrasound can check for polycystic ovaries and endometrial thickness. However, vaginal ultrasound should be reserved for sexually active women. The role of ultrasound remains controversial for adolescents, among whom a polycystic appearance of the ovaries is very (...) , ovarian dysfunction and hormonal drivers to contribute to the aetiology of PCOS. , The underlying hormonal imbalance may include a combination of increased androgens and/or hyperinsulinaemia secondary to IR (Figure 1). Greater understanding of cause has been hampered by a lack of ideal methods to assess either hyperandrogenism or IR. Hyperandrogenism is detected in around 60%–80% of women with PCOS, and IR is a pathophysiological contributor in around 50%–80%. Obesity increases reproductive features

2011 MJA Clinical Guidelines

169. Alopecia, androgenetic - female

testing to perform when hyperandrogenism is suspected. Free-androgen index (FAI) Androgen status can be assessed by calculating the FAI, which requires measurement of total testosterone and sex-hormone binding globulin (SHBG). Testosterone is almost entirely bound to transport proteins in the blood, mainly SHBG and albumin. Only free testosterone is biologically active, and its concentration is strongly influenced by the level of SHBG. The FAI equals the total testosterone level (in nanomol/L x 100 (...) , and scarring of hair follicles may occur. See the CKS topic on for more information. Other underlying causes of hair loss include: Hypothyroidism and other endocrine disorders such as hyperprolactinaemia. See the CKS topic on for more information. Iron deficiency and poor nutritional status. Drugs, including those: Implicated in telogen effluvium. With an androgenic effect (such as anabolic steroids or progestogens). With an antithyroid action (such as carbimazole). Other systemic disease

2016 NICE Clinical Knowledge Summaries

170. Ovarian Cancer Prevention (PDQ®): Health Professional Version

discontinued use, 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 (...) 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 and 81,211 women without

2015 PDQ - NCI's Comprehensive Cancer Database

171. Hot Flashes and Night Sweats (PDQ®): Health Professional Version

. [ ] Etiology Causes of menopausal hot flashes include the occurrence of natural menopause, surgical menopause, or chemical menopause; in the cancer patient, chemical menopause may be caused by cytotoxic chemotherapy, radiation therapy, or androgen treatment. Causes of so-called male menopause include orchiectomy, gonadotropin-releasing hormone use, or estrogen use. Drug-associated causes of hot flashes and night sweats in men and women include the use of tamoxifen, aromatase inhibitors, opioids, tricyclic (...) of such a risk.[ ] In May 2002, the Women’s Health Initiative, a large, randomized, placebo-controlled trial of the risks and benefits of estrogen plus progestin in healthy postmenopausal women, was stopped prematurely at a mean follow-up of 5.2 years (±1.3) because of the detection of a 1.26-fold increased breast cancer risk (95% confidence interval [CI], 1.00–1.59) in women receiving hormone replacement therapy. Tumors among women in the hormone replacement therapy group were slightly larger and more

2015 PDQ - NCI's Comprehensive Cancer Database

172. Locally recurrent or metastatic breast cancer

inhibitor antidepressants (e. g. paroxetine, ?uoxetine). Fulvestrant at the dose of 500mg every 4 weeks has demonstrated superiority compared with anastrozole in the ?rst-line setting [II, A]. Second and further lines of endocrine therapy may include (if not previously used) tamoxifen, steroidal or nonsteroidal AIs, fulvestrant, progestins (e.g. megestrol acetate) and androgens. No de?nitive recommendation can be given for a speci?c endocrine treatment cascade, and particularly, the best option after (...) patients, whenever available. The vast majority of MBC is incurable and hence the main treatment goal is palliation, with the aim of maintaining/ improving quality of life and possibly prolonging survival. The realistic treatment goals should be discussed with the patient and her/his caregivers from the beginning and the patient should be encouraged to actively participate in all decisions. Patient preferences should always be taken into account. Systemic treatment options for MBC are endocrine therapy

2012 European Society for Medical Oncology

173. AACE Medical Guidelines for Clinical Practice for Diagnosis and Treatment of Menopause

should not be used in women with an intact uterus (Grade D; BEL 1). • R7. Progestational agents should be used for a mini- mum of 10 to 14 days per month in women treated with estrogen who have an intact uterus (Grade A; BEL 1). • R8. Long-cycle therapy with use of a progestagen for 14 days every 3 months may be considered, in an effort to reduce breast exposure to progestagens, despite lack of definitive assessment of efficacy (Grade B; BEL 2). • R9. Amenorrhea may be achieved by using a low dose (...) of a progestagen administered continuously (daily) in conjunction with estrogen. Because recent studies suggest adverse breast outcomes with continuous pro- gesterone exposure, this form of therapy is not recom- mended (Grade D; BEL 2). Table 1 American Association of Clinical Endocrinologists Evidence Rating Based on Reference Methodology a Numerical descriptor Semantic descriptor (evidence level) (reference method) 1 Meta-analysis of randomized controlled trials (MRCT) 1 Randomized controlled trial (RCT) 2

2011 American Association of Clinical Endocrinologists

174. Diagnosis and Treatment of Hyperprolactinemia (Full text)

hyperprolactinemia must evaluate the merits of their current medication program with their physicians. Assessment should include the availability of alternative medications—such as antipsychotic agents with lower dopamine antagonist potency ( , ) or aripiprazole, an atypical antipsychotic with both dopamine agonist and dopamine antagonist activity ( ) that can lower prolactin and reverse hyperprolactinemia-related side effects ( )—and their relative merits and downsides, and the potential adverse impact (...) During pregnancy, serum prolactin levels increase 10-fold ( ), reaching levels of 150 to 300 μg/liter by term. Moreover, the pituitary gland increases in volume more than 2-fold, primarily due to estrogen-stimulated increase in the number of lactotrophs ( ). When dopamine agonists are discontinued at the start of pregnancy, serum prolactin levels increase, and subsequent increases in prolactin levels do not accurately reflect changes in tumor growth or activity. Moreover, serum prolactin levels may

2011 The Endocrine Society PubMed abstract

175. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the Diagnosis and Treatment of Acromegaly

of the hyperprolactinemia is often the tumor itself, and up to 50% of somatotroph tumors cosecrete prolactin, versus hyper- prolactinemia from the normal lactotroph cells due to stalk compression from the tumor itself (24 [EL 4], 25 [EL 4]). Menstrual irregularities, often associated with hirsutism, are common in acromegaly and are due to a combination of hyperprolactinemia, androgen excess, and, less often, compressive hypogonadotropic hypogonadism from the tumor itself (26 [EL 3]). Testosterone deficiency may (...) finding, and these changes can be disfiguring. The dental changes, including maxillary and mandibular widening with separa- tion of the teeth, mandibular overgrowth, jaw malocclu- sion, and overbite, may be disabling for patients (35 [EL 3]). Arthropathy develops early in the course of acromeg- aly and, with progression, resembles active osteoarthritis and often results in substantial disability (36 [EL 3], 37 [EL 4], 38 [EL 3]). Joint pains may be present in up to three-quarters of the patients (39

2011 American Association of Clinical Endocrinologists

176. Q&A Potpourri ? Osteoporosis, Vit D, Self-Monitoring of Blood Glucose, and Anti-Infectives

) 750ug/3mL prefilled pen syringe - anabolic: ? osteoblast activity {PTH I-84 PreOs} avail in Europe Forteo Customer Care Program: 1-877-436-7836 Possible financial assistance by Eli Lilly. Common vs pl : Nausea 9vs7% ,dizzy 8vs5% ,cramp leg 3vs1% ,syncope 3vs1% Serious vs placebo : Osteosarcoma rats , hypercalcemia symptomatic (eg. nausea, vomiting, constipation, lethargy, muscle weakness) , hyperuricemia 3 vs 0.7% , angina pectoris 3vs2% , arthralgia 10vs8% , tooth disorder 2vs1% CI: Pre-existing (...) C, et al. Effects of bazedoxifene on BMD and bone turnover in postmenopausal women: 2-yr results of a randomized, double-blind, placebo-, and active-controlled study. J Bone Miner Res 2008;23:525-535. Mosca L, Grady D, Barrett-Connor E, et al. Effect of raloxifene on stroke and venous thromboembolism according to subgroups in postmenopausal women at increased risk of coronary heart disease. Stroke 2009; 40(1):147-155. NAMS: North American Menopause Society. Management of osteoporosis

2010 RxFiles

177. Male Hormonal Contraception: Where Are We Now? (Full text)

include acne, injection site pain, mood change including depression, and changes in libido that are usually mild and rarely lead to discontinuation. Current development includes long-acting injectables and transdermal gels and novel androgens that may have both androgenic and progestational activities. Surveys showed that over 50 % of men will accept a new male method and female partners will trust their partner to take oral "male pills." Partnership between government, nongovernment agencies (...) Male Hormonal Contraception: Where Are We Now? Hormonal male contraception clinical trials began in the 1970s. The method is based on the use of exogenous testosterone alone or in combination with a progestin to suppress the endogenous production of testosterone and spermatogenesis. Studies using testosterone alone showed that the method was very effective with few adverse effects. Addition of a progestin increases the rate and extent of suppression of spermatogenesis. Common adverse effects

2016 Current obstetrics and gynecology reports PubMed abstract

178. Growth of a progesterone receptor-positive meningioma in a female patient with congenital adrenal hyperplasia (Full text)

in CAH and has affinity and biological activity at the progesterone receptor. Therefore, we hypothesise that patients who have long-standing increased adrenal androgen precursor concentrations may be at risk of meningioma growth.Patients with long-standing CAH (particularly if not optimally controlled) may present with other complications, which may be related to long-standing elevated androgen or decreased glucocorticoid levels.Chronic poor control of CAH is associated with adrenal myelolipoma (...) Growth of a progesterone receptor-positive meningioma in a female patient with congenital adrenal hyperplasia Meningioma growth has been previously described in patients receiving oestrogen/progestogen therapy. We describe the clinical, radiological, biochemical and pathologic findings in a 45-year-old woman with congenital adrenal hyperplasia secondary to a defect in the 21-hydroxylase enzyme who had chronic poor adherence to glucocorticoid therapy with consequent virilisation. The patient

2016 Endocrinology, diabetes & metabolism case reports PubMed abstract

179. An Investigation Into the Effect of Dapagliflozin on Ketogenesis in Type 1 Diabetes

, anabolic steroids, C-19 progestins) stopped for at least 8 weeks. Use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase inhibitors (finesteride, spironolactone, flutamide) stopped for at least 4 weeks Presence of hypersensitivity to dapagliflozin or other SGLT2 inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions Known hypersensitivity or contraindications to use GLP1 receptor agonists (exenatide, liraglutide) Known hypersensitivity to heparin/ IV (...) /treatment Active Comparator: Dapagliflozin Arm: dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection) Drug: Dapagliflozin Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12

2016 Clinical Trials

180. Starting a Testosterone and Exercise Program After Hip Injury

or androgen containing compound within the previous 6 months. Treatment with systemic corticosteroids (daily dose > 5 mg prednisone or equivalent) for at least 90 days within the previous 12 months. Visual or hearing impairments that interfere with following directions for research procedures. Active or unstable cardiopulmonary disease (recent MI, unstable angina, class III or IV CHF) within prior 6 months, which would limit full participation in the study. Respiratory disease requiring chronic continuous (...) following a hip fracture has been documented as late as a year after the fracture, even among women who were functioning at high levels before the event. Age-associated androgen deficiency in women contributes to deficits in muscle mass, strength and power that are common in this patient population before the fracture, and are exacerbated afterward. A pilot study of testosterone (T) supplementation in elderly female hip fracture patients has demonstrated the feasibility of T treatment in this population

2016 Clinical Trials

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