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Hyperandrogenism clinical trials

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NCT ID: NCT03911297 Not yet recruiting - Clinical trials for Polycystic Ovary Syndrome

DAISy-PCOS Phenome Study - Dissecting Androgen Excess and Metabolic Dysfunction in Polycystic Ovary Syndrome

Start date: June 1, 2019
Study type: Observational

Polycystic ovary syndrome (PCOS) affects 10% of all women and usually presents with irregular menstrual periods and difficulties conceiving. However, PCOS is also a lifelong metabolic disorder and affected women have an increased risk of type 2 diabetes, high blood pressure, and heart disease. Increased blood levels of male hormones, also termed androgens, are found in most PCOS patients. Androgen excess appears to impair the ability of the body to respond to the sugar-regulating hormone insulin (=insulin resistance). We found that fat tissue of PCOS patients overproduces androgens and that this can result in a build-up of toxic fat, which increases insulin resistance and could cause liver damage. In a large cohort of women registered in a GP database, we have found that androgen excess increases the risk of fatty liver disease. We aim to identify those women with PCOS who are at the highest risk of developing metabolic disease, which would allow for early detection and potentially prevention of type 2 diabetes, high blood pressure, fatty liver and cardiovascular disease. We will assess clinical presentation, androgen production and metabolic function in women with PCOS to use similarities and differences in these parameters for the identification of subsets (=clusters) of women who are at the highest risk of metabolic disease. We will do this by using a standardised set of questions to scope PCOS-related signs and symptoms and the patient's medical history and measure body composition and blood pressure. This standardised recording of a patient's clinical presentation (=clinical phenotype) is called Phenome analysis. We will collect blood and urine samples for the systematic measurement of steroid hormones including a very detailed androgen profile (=steroid metabolome analysis) and of thousands of substances produced by human metabolism (=global metabolome analysis). Phenome and metabolome data will then undergo integrated computational analysis for the detection of clusters predictive of metabolic risk.

NCT ID: NCT03905603 Not yet recruiting - Clinical trials for Polycystic Ovary Syndrome

Relative Contributions of Predictors of Hyperandrogenism in Older vs. Young Women With PCOS

Start date: April 2019
Phase: Early Phase 1
Study type: Interventional

The objective of the study is to determine the relative contributions of four established predictors of hyperandrogenism (luteinizing hormone [LH] secretion, ovarian response to recombinant human chorionic gonadotropin [r-hCG] administration, adrenal response to adrenocorticotropic hormone [ACTH] administration, and hyperinsulinemia) in older vs. young women with Polycystic Ovary Syndrome (PCOS) in a cross-sectional, physiological study. The investigators hypothesize that hyperinsulinemia is a stronger independent predictor of free testosterone (T) in older reproductive aged (vs. young) women with PCOS.

NCT ID: NCT03902301 Recruiting - Obesity Clinical Trials

Lactobacillus Rhamnosus and PCOS Treatment

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

The effect of Lactobacillus rhamnosus supplementation on body weight, hyperandrogenism and insulin resistance in overweight and obesity women with Polycystic Ovary Syndrome will be analysed.

NCT ID: NCT03864068 Not yet recruiting - Insulin Resistance Clinical Trials

Inositol Supplementation to Treat PCOS (INSUPP-PCOS)

Start date: July 1, 2019
Phase: Phase 2
Study type: Interventional

To determine if Inositol, a dietary supplement, will improve ovarian and adrenal androgen excess in women with Polycystic Ovarian Syndrome(PCOS).

NCT ID: NCT03757923 Recruiting - Hyperandrogenism Clinical Trials

Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism

Start date: June 18, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

To compare metformin with pioglitazone in improving menstrual irregularities and hyperandrogenism in women with PCOS so that an alternate and better treatment option will be available for hyperinsulinemia in pcos patients.

NCT ID: NCT03742011 Recruiting - Insulin Resistance Clinical Trials

Offspring Born to Mothers With Polycystic Ovary Syndrome in Guangzhou Cohort Study

Start date: February 1, 2012
Study type: Observational

The Offspring Born to Mothers with Polycystic Ovary Syndrome in Guangzhou Cohort study (PCOS-BIG) was established to investigate the short- and long-term effects of intrauterine exposure to maternal PCOS on the health of offspring in Guangzhou, China. Data are collected regarding maternal PCOS subtypes, nursing, diet and education as well as health outcomes in their later life. Biological samples including blood and tissue samples are also collected from participants.

NCT ID: NCT03252223 Recruiting - Healthy Clinical Trials

Ovarian Response to Recombinant Follicle Stimulating Hormone in Women With PCOS

Start date: October 2, 2017
Phase: Phase 4
Study type: Interventional

Women with PCOS suffer from anovulation and, as a result, infertility. Efforts to clinically induce ovulation in these women using follicle stimulating hormone (FSH) administered subcutaneously seemingly requires prolonged administration compared to that of ovulatory women without PCOS. The apparent differing ovarian responsiveness to FSH between PCOS and normal women has not been carefully studied. We propose to address this issue by performing a dose-response study and examine ovarian follicle (estrogen, E2) responses to FSH administered subcutaneously in women with PCOS compared to responses observed in normal women.

NCT ID: NCT03188640 Completed - Obesity Clinical Trials

Bariatric Surgery, Hormones, and Quality of Life

Start date: March 1, 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to characterize the hormonal status in fertile women undergoing laparoscopic gastric bypass, pre- and postoperatively, and evaluate if there is a correlation between health-related quality of life and proposed hormone changes post-operatively.

NCT ID: NCT03088046 Completed - Clinical trials for Polycystic Ovary Syndrome

Circulating Androgen Levels Are Not Affected by the Administration of Vaginal Micronized Progesterone for Withdrawal Bleeding in Patients With Polycystic Ovarian Syndrome

Start date: February 2014
Phase: N/A
Study type: Interventional

Hormonal evaluation of women who are suspected of having Polycystic ovary syndrome (PCOS) involves the measurement of basal levels of androgens and 17-hydroxyprogesterone (17-OHP), which are generally used to establish the presence of hyperandrogenemia. In general, these levels are obtained during the follicular phase to maintain sampling uniformity and avoid spurious increases due to corpus luteum function. However, because most hyperandrogenic patients are oligo/amenorrheic, it is frequently necessary to administer a progestogen to induce withdrawal bleeding and properly time the blood sampling. Several medications have been described to properly induce withdrawal bleeding , with medroxyprogesterone acetate (MPA) being the most widely use. However, synthetic compounds as MPA do not replicate precisely the constellation of biologic activities of the parent hormone and results in a temporary, albeit clinically relevant, suppression in ovarian function and circulating androgen levels , in addition of several adverse side effects . In this study, it is hypothesized that the administration of natural progesterone vaginally, which will avoid hepatic first pass, may result in significantly less hormonal suppression. The authors test this hypothesis by prospectively determining the effect of vaginal micronized progesterone (OMP), administered for the induction of withdrawal bleeding, on the circulating androgen and 17-OHP levels in women with PCOS.

NCT ID: NCT03068910 Recruiting - Clinical trials for Polycystic Ovary Syndrome

Hyperandrogenemia and Altered Day-night LH Pulse Patterns

Start date: July 2016
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to determine if, in mid- to late pubertal girls with hyperandrogenism, androgen-receptor blockade (spironolactone) improves the ability of progesterone to acutely reduce waking luteinizing hormone pulse frequency (primary endpoint).