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Hyperandrogenism clinical trials

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NCT ID: NCT05926115 Recruiting - Clinical trials for Polycystic Ovary Syndrome

Phenotype and Epidemiology of the Polycystic Ovary Syndrome (PCOS) in Colombia (PEP - Colombia) Study.

PEP-Colombia
Start date: March 4, 2023
Phase:
Study type: Observational

The goal of this observational study is to know the prevalence of PCOS among economically productive and reproductive age women from Medellín and the Valle de Aburrá, Colombia. The main questions it aims to answer are: 1. What is the phenotypic distribution of PCOS detected in women seeking medical attention as a requirement for employment in Medellín and the Valle de Aburrá, Colombia? 2. What is the effect of environmental factors, such as geographical location and diet, and biological factors (such as obesity and ethnicity/race) on the prevalence and phenotype of PCOS in this populatión? Participants will undergo anthropometric measurements and physical examination for hirsutism, acne, alopecia, acanthosis nigricans, and thyroid enlargement. During the initial visit, a transvaginal or transabdominal pelvic ultrasonography will be performed. A sample of venous blood will be collected in plain tubes for serum cryopreservation and for immediate glucose estimation. Some participants will be rescheduled for a second evaluation visit for additional assessment when they have a possible PCOs.

NCT ID: NCT05734287 Recruiting - Clinical trials for PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

The Frequency of Polycystic Ovary Syndrome Among Young Reproductive Females Presenting With Hyperandrogenism: a Mixed Cohort Study

Start date: December 28, 2023
Phase:
Study type: Observational [Patient Registry]

This mixed cohort study will test the frequency of PCOS among young females presenting with one of the clinical hyperandrogenism criteria: acne, hirsutism and/or hair loss. Diagnosis will be based on the recent PCOS clinical, biochemical and biophysical criteria recently published " International evidence-based guideline for the assessment and management of polycystic ovary syndrome (PCOS) 2018".

NCT ID: NCT05647356 Not yet recruiting - Clinical trials for Polycystic Ovary Syndrome

The RolE oF Androgen Excess in MUscle Energy MetaboLism in Women With PolyCystic Ovary Syndrome (REFUEL PCOS) Study 2

REFUEL PCOS
Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Polycystic ovary syndrome (PCOS) affects 10% of all women, and it usually co-exists with high levels of sex hormones called androgens, such as testosterone. Women with PCOS are at increased risk of metabolic complications such as diabetes, non-alcoholic fatty liver disease, high blood pressure and heart disease. However, very little is understood about how androgen excess may drive the metabolic complications observed in women with PCOS. Skeletal muscle is an important site of energy metabolism; increasingly, it is suspected that skeletal muscle energy balance is adversely impacted by androgens, thereby driving metabolic complications. To take this theory forward, we want to investigate the effects of androgens on muscle energy metabolism. We will perform detailed metabolic testing (including blood tests and muscle biopsies) in women with PCOS before and after taking tablets that block the action of testosterone for 28 days. In addition, we will be using a gold standard technique to see how women with PCOS metabolise fat and other nutrients by measuring markers in blood and breath samples after a breakfast test meal. This clinical research will increase our understanding of the complex relationships between hormonal abnormalities and metabolic disease in women with PCOS.

NCT ID: NCT05555680 Recruiting - Clinical trials for PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Effect of Hyperandrogenism on IVF Outcomes in PCOS Patients

HIP
Start date: January 21, 2022
Phase:
Study type: Observational

Ovulatory dysfunction affects 18 to 25% of infertile women, the most common identifiable condition is polycystic ovarian syndrome (PCOS). The most frequent symptoms of PCOS are oligo-anovulation, hyperandrogenism and polycystic ovary appearance. Hyperandrogenism is the main contributor that affects oocyte and embryo quality and decreases the success rates in PCOS patients undergoing IVF treatments. The aim of this study is to determine the effect of hyperandrogenism as an independent factor on IVF success rates and oocyte/embryo quality in PCOS patients undergoing IVF.

NCT ID: NCT05112029 Recruiting - Obesity Clinical Trials

Metabolic Profile and Adipokine Levels in Young Hyperandrogenemic Females

Start date: September 22, 2021
Phase:
Study type: Observational

Assessement of basic metabolic profile and adipokine levels in young hyperandrogenemic females.

NCT ID: NCT04979377 Recruiting - Type 1 Diabetes Clinical Trials

Prevalence of Hyperandrogenism in Type 1 Diabetes

Start date: March 9, 2020
Phase:
Study type: Observational

The investigators aim to estimate the prevalence of functional ovarian hyperandrogenism [idiopathic hyperandrogenism, idiopatic hirsutism, and polycystic ovary syndrome (PCOS)] in adult patients with type 1 diabetes (T1DM) in an observational cross-sectional study. Study population is comprised of premenopausal adult women with a diagnosis of T1DM, consecutively recruited from a Diabetes outpatient clinic at a tertiary hospital in Spain, Europe.

NCT ID: NCT04912648 Recruiting - Metabolic Disease Clinical Trials

FEmale Metabolic Risk and Androgens: an Irish Longitudinal (FEMAIL) Study

FEMAIL
Start date: April 1, 2021
Phase:
Study type: Observational

Androgen excess is the cardinal biochemical feature of polycystic ovary syndrome (PCOS), a lifelong metabolic disorder affecting 10% of women. Serum testosterone correlates with insulin resistance in women, however, there is an urgent need to improve our understanding of the association between androgens and the risk of type 2 diabetes. Recently, a new subclass of androgenic steroids known as 11-oxygenated androgens has been identified. Utilising highly sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) techniques, our group has recently demonstrated that 11-oxygenated steroids are the predominant androgens in both health controls and women with PCOS, and that these correlate closely with markers of insulin resistance. The bioactive 11-oxygenated androgen 11-ketotestosterone (11KT) binds and activates the androgen receptor with equal affinity to testosterone, yet nothing is known about its impact on metabolism or glucose homeostasis. Intriguingly, unlike testosterone, 11-oxygenated androgens do not decline with age in women, and, therefore, may mediate an increased risk of T2DM in women across their life course. Therefore, this previously ignored androgen class is likely of major importance in female metabolic health, and may represent a novel metabolic risk factor and biomarker. However, 11-oxygenated androgens are not currently measured in routine clinical practice. To date, no population-based or human in vivo physiology studies have examined the association between 11-oxygenated androgens, glucose metabolism and diabetes risk in women, despite the high prevalence of PCOS in the female population. There is emerging evidence, even in women without a confirmed history of PCOS, that the levels of androgens over time correlate with their likelihood of developing metabolic and cardiovascular disease. This has not been studied to date in a prospective manner in healthy women in the background population using long term follow up data.

NCT ID: NCT04738409 Active, not recruiting - Clinical trials for Polycystic Ovary Syndrome

Ovarian Hyperandrogenism in Normal and Excessive Body Weight Adolescent Girls and Their Relation to Diet (HAstudy)

Start date: April 1, 2018
Phase: N/A
Study type: Interventional

The objective was 1. to check whether serum androgen levels and concomitant metabolic changes, oxidative stress and inflammation in adolescent girls with hyperandrogenism may be related to diet. 2. to identify the factors that increase the risk of being overweight and of obesity among adolescents with clinical features of PCOS, related to diet and DEA (Disordered Eating Attitudes) 3. to investigate the relationships between markers of oxidation and markers of Systemic Inflammation and macronutrients intake 4. to assess the relation between oral health of girls with PCOS (including condition of periodontium and dental caries) and their dietary habits, hormonal, metabolic and oxidative and inflammatory status.

NCT ID: NCT04723862 Recruiting - Clinical trials for Polycystic Ovary Syndrome

Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism?

CBS010
Start date: November 12, 2021
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to determine if, in mid- to late pubertal girls with hyperandrogenism (HA), androgen-receptor blockade (spironolactone) alone normalizes sleep-wake luteinizing hormone (LH) pulse frequency (primary endpoint) and overall LH and follicle-stimulating hormone secretion (secondary endpoints).

NCT ID: NCT04524325 Withdrawn - Blood Pressure Clinical Trials

Mechanisms of Blood Pressure Dysfunction in Transmen Receiving Testosterone

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this research is to explore the effects of chronic androgen exposure on sympathetic nervous system activity (SNSA) and baroreflex control of blood pressure responses in transgender men (trans men) taking gender affirming hormone therapy (HT). Blood pressure, baroreflex gain, and frequency of sympathetic responses to changes in blood pressure will be assessed in trans men and a control group of cisgender women. To fully understand HT effects on blood pressure regulation in trans men, it is crucial to understand how both SNSA, and the pattern of SNSA, can be influenced by high levels of androgen exposure in the female cardiovascular system, as well as how the two regulatory components may interact.