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Progestin Androgenic Activity

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101. The Effect of Fasting on ICSI Outcomes in Patients With Polycystic Ovary Syndrome

adequate water and non calorie beverages intake daily (2-3 liters) Subjects are instructed to wait for spontaneous menses, or to be prescribed progestins orally (as Norethisterone 5mg) twice daily for 21 days starting from the fifth day of menses. Patients should continue taking oral metformin 500-1000 mg daily, until confirmation of pregnancy. The next visit is scheduled on day 2 of next cycle when transvaginal ultrasound is done to confirm that endometrial thickness <5mm, no ovarian cyst (...) by ultrasound. Body mass index (BMI) and waist/hip ratio (WHR) are calculated. Blood samples are taken for Fasting insulin , fasting plasma glucose, Homeostatic model assessment (HOMA) index, lipid profile ( Triglycerides (TGs), total cholesterol, High density Lipoprotein (HDL), Low density Lipoprotein (LDL), free and total testosterone , Sex Hormone Binding Globulin (SHBG), Free Androgen index (FAI), AntiMullerian Hormone (AMH), Basal Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol

2018 Clinical Trials

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

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 (postmenopausal (...) al.: Postmenopausal serum androgens, oestrogens and breast cancer risk: the European prospective investigation into cancer and nutrition. Endocr Relat Cancer 12 (4): 1071-82, 2005. [ ] Kaaks R, Berrino F, Key T, et al.: Serum sex steroids in premenopausal women and breast cancer risk within the European Prospective Investigation into Cancer and Nutrition (EPIC). J Natl Cancer Inst 97 (10): 755-65, 2005. [ ] Collaborative Group on Hormonal Factors in Breast Cancer: Menarche, menopause, and breast

2016 PDQ - NCI's Comprehensive Cancer Database

103. Genetics of Breast and Ovarian Cancer (PDQ®): Health Professional Version

replacement therapy 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 ( ), 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

2016 PDQ - NCI's Comprehensive Cancer Database

104. 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

2016 PDQ - NCI's Comprehensive Cancer Database

105. 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

106. 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

107. 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

108. Functional Study of the Hypothalamus in Magnetic Resonance Imaging (MRI) in Polycystic Ovary Syndrome (PCOS)

Identifier: NCT03043924 Recruitment Status : Recruiting First Posted : February 6, 2017 Last Update Posted : May 18, 2018 See Sponsor: University Hospital, Lille Collaborator: National Research Agency, France Information provided by (Responsible Party): University Hospital, Lille Study Details Study Description Go to Brief Summary: The aim to evaluate whether activation of the hypothalamic-pituitary-gonadal axis in PCOS is associated with transient microstructural and metabolic changes in the female (...) ) will be recruited. Drug: Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet Healthy volunteers receive combined oral contraceptive (COC) consisting 0.02 mg ethinylestradiol and 0.1mg of progestins (Leeloo Gé®) Other Name: Leeloo Gé® Outcome Measures Go to Primary Outcome Measures : Change in the Apparent Diffusion Coefficient (ADC) [ Time Frame: Baseline and 3 months after treatment start ] The change in the ADC will be analyzed in healthy volunteers and PCOS women before starting the oral contraceptives

2017 Clinical Trials

109. Study to Evaluate a Nutraceutical Supplement for Treatment of Hair Loss and Thinning in Females

Completion Date : November 10, 2017 Resource links provided by the National Library of Medicine related topics: related topics: Arms and Interventions Go to Arm Intervention/treatment Active Comparator: Active Dietary Supplement: Nutrafol Eligible subjects will receive Nutrafol® to take daily for 180 days Placebo Comparator: Placebo Dietary Supplement: placebo Eligible subjects will receive Placebo to take daily for 180 days Outcome Measures Go to Primary Outcome Measures : change in hair density [ Time (...) for the duration of the study, an effective contraception method (ie, abstinence, barrier control, intrauterine device [IUD], or hormonal [estrogen/progestin] contraceptives) for at least one menstrual cycle prior to study; if using IUD or hormonal contraceptives - then at least 2 years prior to screening, the initiation of which should not have been associated with initiation of hair loss/thinning. Be willing and able to cooperate with the requirements of the study. Voluntarily sign and date an informed

2017 Clinical Trials

110. How DHEA Supplements Affect Coagulation in Women Using Birth Control Pills

), controversy exists over whether the various synthetic progestogens (progestins) used in combination with ethinyl estradiol in COC formulations may modify the risk of venous thromboembolism (VTE). Several studies have demonstrated that different types of progestins used in COCs influence the magnitude of the estrogen-induced changes in coagulation pathway proteins. However, since hepatocytes do not express progesterone receptor, any activity of a progestin must be indirect. While all progestins (...) on the market are strong agonists for the progesterone receptor (PR), most have variable affinity for the androgen receptor (AR), glucocorticoid receptor (GR), and mineralocorticoid receptor (MR). Generations of progestins have been developed, each successive generation exhibiting decreasing levels of androgenicity. Recent epidemiologic studies have suggested an increased risk of VTE in women using low-androgen progestins relative to those using levonorgestrel-containing products. Although no pattern

2017 Clinical Trials

111. A Pre-operative Window Study of Letrozole Plus PR Agonist (Megestrol Acetate) Versus Letrozole Alone in Post-menopausal Patients With ER-positive Breast Cancer

Measures : Change in tumour apoptosis, measured by Caspase 3 (IHC) [ Time Frame: Over 15 days of treatment with letrozole (alone or in combination with high or low dose megestrol acetate) ] Caspase-3 is activated by cleavage in cells undergoing apoptosis. Capase-3 IHC has been validated as a marker of apoptosis in breast cancer. Change in expression of Androgen receptor and Progesterone receptor by IHC [ Time Frame: Over 15 days of treatment with letrozole (alone or in combination with high or low dose (...) megestrol acetate) ] IHC of PR will be performed as a surrogate of ER activity. IHC of AR will be performed as AR influences ER-alpha activity in breast cancer, and has been shown to be a predictor of response to other synthetic progestins in breast cancer. Both PR and AR levels will be correlated with Ki67 changes Change in expression of Epithelial-Mesenchymal Transition (EMT) markers by IHC [ Time Frame: Over 15 days of treatment with letrozole (alone or in combination with high or low dose megestrol

2017 Clinical Trials

112. Treating Inflammation in Polycystic Ovary Syndrome to Ameliorate Ovarian Dysfunction

androgens. In addition, in vitro exposure to proinflammatory stimuli is capable of directly stimulating ovarian theca cell androgen production. Nonacetylated salicylates suppress NFĸB activation and are well tolerated in humans. The proposed research is a randomized double-blind placebo-controlled study of 90 women with PCOS. Forty-five subjects with PCOS (15 lean without IR), 15 lean with IR and 15 obese) receiving salsalate, a nonacetylated salicylate, at an oral dose of 3-4 gm daily for 12 weeks (...) and protein content of inflammation markers, NFĸB activation and cytokine release in culture. The investigators expect that women with PCOS receiving salsalate will exhibit decreased ovarian androgen secretion and reduced inflammation regardless of adiposity or IR status. These results will be significant if they show a causal contribution of inflammation to ovarian dysfunction in PCOS, thus improving our understanding of the pathogenesis of PCOS, opening previously unexplored therapeutic avenues

2017 Clinical Trials

113. Comparing the Effects of Oral Contraceptive Pills Versus Metformin

randomized clinical trials (RCTs) have shown that 20mcg ethinyl estradiol/norethindrone 1.0 mg was well tolerated. The study will utilize a 20mcg OCP but a less androgenic third generation progestin (desogestrel 0.15mg) with potentially lesser impact on lipids and insulin sensitivity. The OCP will be started on the first Sunday after spontaneous or induced menses. All subjects with no menses the 4 weeks before randomization will be given medroxyprogesterone acetate after a negative pregnancy test (...) and metformin (OCP, through lowering androgens, and metformin, through improvement in insulin sensitivity) will affect the prevalence of MetS, thereby altering the risk profile for the development of diabetes and possible cardiovascular disease (CVD) in young women with PCOS. Condition or disease Intervention/treatment Phase PCOS Drug: OCP + Metformin Drug: OCP + Placebo Drug: Metformin + Placebo Phase 3 Detailed Description: The intervention will consist of randomizing subjects to one of three arms

2017 Clinical Trials

114. Dienogest Versus GnRH-a Pre-treatment in Women With Endometriosis Undergoing IVF

pain. It is well tolerated with no androgenic, glucocorticoid or mineralocorticoid activity. Dienogest creates a hyperprogestogenic and hypoestrogenic environment that initially induces a secretory state and then a decidualization of the ectopic endometrium and finally its atrophy. It also inhibits aromatase and COX-2 expression as well as prostaglandin E2 production in endometriotic stromal cells. It also normalizes the activity of natural killer cells and decreases the release of interleukin-1b (...) % of infertile women have the diagnosis of endometriosis . Infertility secondary to endometriosis is thought to be multifactorial. Women with endometriosis often require in vitro fertilization (IVF). One medical intervention that has been shown to improve IVF outcomes in women with endometriosis is hormonal suppression with gonadotropic releasing hormone agonist (GnRH-a) for a period of 3 to 6 months . In recent years, the effectiveness of dienogest, a fourth-generation progestin, for endometriosis treatment

2017 Clinical Trials

115. Combination Study of AZD5069 and Enzalutamide.

Intervention/treatment Phase Metastatic Castration Resistant Prostate Cancer Drug: AZD5069 Drug: Enzalutamide 40 MG Phase 1 Phase 2 Detailed Description: The purpose of this study is to find out the side effects and safety of a combination of the CXCR2 antagonist, AZD5069 in combination with the androgen receptor antagonist, enzalutamide in patients with metastatic castration resistant prostate cancer and to determine the most appropriate dose of this combination. In the Phase I part of this study groups (...) in combination with enzalutamide at 160mg OD. [ Time Frame: 12 months ] The maximum dose at which no more than 1 of 6 patients at same dose level experience a drug related toxicity (DLT), as defined in the protocol. Antitumour activity of AZD5069 in combination with enzalutamide as measured by response rate in Phase II [ Time Frame: 12 months ] Prostate specific antigen (PSA) decline ≥ 50% criteria confirmed 4 weeks or later and/or, Confirmed soft tissue objective response by RECIST (v1.1) in patients

2017 Clinical Trials

116. 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

117. 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

118. Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society

neuronsinthevagina.Thisfunctionmayservetodecreasethe discomfort associated with VVA. 11 The term vulvovaginal atrophy refers specifically to the changes in the vaginal and vulvar surfaces that on examina- tion arethin,pale,anddry.Thevaginacannarrowandshorten, and the introitus may constrict, especially in the absence of penetrative sexual activity. The vaginal lining may exhibit petechiae and become thinner (often only a few cell layers thick),lesselastic,andprogressivelysmootherasrugalfolds decrease. Vaginal blood flow diminishes. Although (...) ability to have pain-free sexual activity. 33<36 Dyspareunia has been shown to be strongly associated with female sexual dysfunction in postmeno- pausal women. 31 Decreased genital arousal and vulvar pain disorders may occur as a consequence of VVA. Atrophy and phimosis of the prepuce of the clitoris may result in dyspareuniathatleads todecreasedinterestinandavoidance of sexual activity. 37 In these scenarios, dyspareunia or avoid- ance of sexual activity may be a presentation of VVA. Vulvar

2013 The North American Menopause Society

119. Osteoporosis: Prevention and Treatment

glucocorticoids would benefit from treatment. Table 5 provides guidelines for patient management based on both BMD and clinical risk factors. Non-Pharmacologic Strategies Exercise. Observational data and clinical trials indicate that weight-bearing activities, such as aerobics, walking, and resistance training are effective at increasing spine BMD. Most of these studies are of limited quality, primarily due to the difficulty of blinding patients. Exercise has not been shown to reduce the risk of osteoporotic (...) exposed to ultraviolet light and is the form of vitamin D present in fish. Both D3 and ergocalciferol (D2) can be synthesized and are used in vitamin supplements and to fortify foods, such as milk. D2 and D3 are converted to the active form of vitamin D, calcitriol (1,25-dihydroxyvitamin D), by hydroxylation first in the liver and then in the kidney. In spite of multiple studies and meta-analyses, the effects of calcium and vitamin D on fracture risk remain unclear. Most studies that have shown

2013 University of Michigan Health System

120. Diagnosis and Treatment of Polycystic Ovary Syndrome

and the European Society of Endocrinology reviewed and commented on preliminary drafts of these guidelines. Two systematic reviews were conducted to summarize supporting evidence. Conclusions: We suggest using the Rotterdam criteria for diagnosing PCOS (presence of two of the following criteria: androgen excess, ovulatory dysfunction, or polycystic ovaries). Establishing a diagnosis of PCOS is problematic in adolescents and menopausal women. Hyperandrogenism is central to the presentation in adolescents (...) , whereas there is no consistent phenotype in postmenopausal women. Evaluation of women with PCOS should exclude alternate androgen-excess disorders and risk factors for endometrial cancer, mood disorders, obstructive sleep apnea, diabetes, and cardiovascular disease. Hormonal contraceptives are the first-line management for menstrual abnormalities and hirsutism/acne in PCOS. Clomiphene is currently the first-line therapy for infertility; metformin is beneficial for metabolic/glycemic abnormalities

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2013 The Endocrine Society

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