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Hyperandrogenism clinical trials

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NCT ID: NCT04006171 Completed - Clinical trials for Polycystic Ovary Syndrome

Comparison of Serum C Type Natriuretic Peptide Levels Between Polycystic Ovary Syndrome Patients and Healthy Women

CNP
Start date: July 15, 2019
Phase: N/A
Study type: Interventional

Recent studies have shown that C natriuretic peptide is produced from granulosa cells, increasing cumulative guanosine monophosphate (cGMP) production by affecting cumulus cells through natriuretic peptide receptors. It is suggested that produced cGMP maintains the transport of oocytes via the gap junctions and leads to a continuous increase in cyclic adenosine monophosphate (cAMP) levels in the oocyte. An important role of increased internal cAMP levels in the oocyte is shown to suppress meiotic progression. Deoxyribonucleic acid studies in animals have shown that expression of the natriuretic peptide precursor increases during the periovulatory period and shows that this increase decreases rapidly after luteinizing hormone / human chorionic gonadotropin (hCG) stimulation.Human studies have shown that after ovulation induction, the CNP level in follicular fluid decreases following ovulatory dose of hCG.Polycystic ovary syndrome (PCOS) is the most common endocrine disease in the reproductive period, characterized by hyperandrogenism, oligo-anovulation, and polycystic ovarian morphology on ultrasonography, and in an animal study investigating the relationship between CNP and PCOS, serum CNP levels were increased in polycystic ovary syndrome.CNP serum level is thought to show differences between healthy women and women with polycystic ovary syndrome.

NCT ID: NCT03902301 Completed - Obesity Clinical Trials

Lactobacillus Rhamnosus and PCOS Treatment

ProjectPCOS
Start date: April 1, 2018
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: NCT03252223 Completed - 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

OBLIV
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: NCT02651636 Completed - Clinical trials for Polycystic Ovary Syndrome

Combined Therapy With Myo-inositol and Alpha-Lipoic Acid in PCOS Women

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

The aim of our study is to investigate the effects of a combined treatment of alpha-lipoic acid and myoinositol on clinical, endocrine and metabolic features of women affected by PCOS. The study Group included 40 patients treated with a combined therapy of alpha-lipoic acid (800 mg), myoinositol (2000 mg) and folic acid (400 mcg) daily for six months. The investigation includes menstrual pattern, hirsutism score, hormonal assays, oral glucose tolerance test, lipidic profile at baseline and after six months of treatment.

NCT ID: NCT02460445 Completed - Hyperandrogenism Clinical Trials

Phlebotomy and Polycystic Ovary Syndrome

Start date: January 2015
Phase: N/A
Study type: Interventional

AIMS To study the effects of the decrease in iron tissue depots after scheduled bloodletting on insulin sensitivity, carbohydrate metabolism, classic and non-classic cardiovascular risk factors in patients with functional hyperandrogenism (polycystic ovary syndrome & idiopathic hyperandrogenism) on standard treatment with combined oral contraceptives (COC) according to usual clinical practice. METHODOLOGY Open label, controlled, parallel, prospective study of 12 months of duration, with 2 randomized arms of follow-up: i) Intervention Group: Patients with functional hyperandrogenism on standard COC treatment randomly allocated to perform scheduled phlebotomies from the third month of treatment to the end of the study (3 times with a 3-month interval between them). ii) Control Group: Patients with functional hyperandrogenism on standard COC treatment randomly allocated to follow-up without bloodletting. The whole group of patients will undergo a comprehensive anthropometric and hormonal assessment, evaluation of classic cardiovascular risk factors (insulin sensitivity and carbohydrate metabolism after a standard oral glucose test- 75 g), lipid profile, ambulatory and office blood pressure monitoring, proinflammatory profile, oxidative stress status, autonomic function assessment, and iron-related metabolism parameters at baseline, after 3-month COC treatment and after reduction of iron tissue depots plus OC in the Intervention Group of patients, and throughout follow-up under treatment with COC in the Control Group of patients. If a significant relationship between circulating hepcidin levels and elevated ferritin concentrations is observed, a study of the potential influence of mutations/polymorphic variants of hepcidin gene on ferritin values will be performed as well.

NCT ID: NCT01940666 Completed - Clinical trials for Cardiovascular Disease.

Presentations of Hyperandrogenic Phenotypes in Taiwanese Women

Start date: September 2012
Phase: N/A
Study type: Observational

STUDY QUESTION: Which of the four abnormally elevated androgen groups (total testosterone [TT], androstenedione [A4], free androgen index [FAI], or dehydroepiandrosterone-sulfate [DHEA-S]) present with an unfavorable metabolic and hormonal profile, appear to be more insulin-resistant and pose additional cardiovascular risk? SUMMARY ANSWER: Subjects with excess free androgen index tend to be obese and face the highest metabolic syndrome risk, adipocytokine alterations, insulin resistance (IR) and cardiovascular risk. The excess TT group presents with a marginal IR risk, while the excess A4 group has the highest antimüllerian hormone (AMH), and may counterbalance obesity; this group and the excess DHEA-S group have a favorable association with IR.

NCT ID: NCT01889199 Completed - Clinical trials for Polycystic Ovary Syndrome (PCOS)

Androgen Excess as a Cause for Adipogenic Dysfunction in PCOS Women

Start date: April 2013
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to collect specimen samples and study medical information from women with Polycystic Ovary Syndrome (PCOS) and women without PCOS. The goal is to learn more about the changes that take place in the body that result in PCOS. We anticipate that 32 women will take part in this study (16 without PCOS and 16 with PCOS). All patients will undergo a physical exam, blood tests, and ultrasound of their ovaries. If they meet the criteria for this study, they will then undergo additional blood tests, removal of a small amount of subcutaneous abdominal fat, measurement of regional body fat (i.e., DXA scan) and a modified frequently-sampled intravenous glucose tolerance test (FSIGTT). The women without PCOS will complete the study at this point. The women with PCOS will be randomized to receive the drug flutamide 125 mg/day or placebo. They will take the drug every day for six 28-day cycles. They will be asked to collect and store a urine sample once a week. They will also be asked to complete a pill diary and menstrual diary. Once a month while they are taking the flutamide/placebo, they will return to the clinic and bring their frozen urine samples. At that time they will undergo a physical exam, toxicity assessment, and blood draw. Quality of Life assessments will be done at the beginning of the study for all participants. Women with PCOS who are taking the flutamide or placebo will be asked to repeat the Quality of Life assessments during the study and at the end of the study. After the six 28-day cycles are completed they will then undergo additional blood tests, removal of a small amount of subcutaneous abdominal fat, measurement of regional body fat (i.e., DXA scan) and a modified frequently-sampled intravenous glucose tolerance test (FSIGTT). Six months following the completion of all study protocol procedures, participants who received flutamide/placebo will be contacted by phone to check on the status of their health. They will be asked if they have experienced any health problems or have become pregnant since they completed the study procedures.

NCT ID: NCT01859312 Completed - Clinical trials for Adrenal Insufficiency

Comparison of Cortisol Pump With Standard Treatment for Congenital Adrenal Hyperplasia

Start date: May 6, 2013
Phase: Phase 2
Study type: Interventional

Background: - Congenital adrenal hyperplasia (CAH) is a genetic disorder of the adrenal gland. The adrenal gland is located in the abdomen and produces small amounts of hormones such as cortisol, aldosterone, and androgen. These hormones help control blood pressure, protect the body, and maintain good health, especially during development. People with CAH do not make enough cortisol and aldosterone, and make too much androgen. This can lead to serious medical problems. The standard treatment is to take pills that mimic the effects of cortisol and aldosterone. However, treatment with pills can have long-term side effects because of the higher doses needed, and may not work well for some people. - A possible new treatment for CAH is to use a pump to deliver cortisol under the skin. Similar pumps are often used to give insulin to people with diabetes. Researchers think that a cortisol pump might be able to help the body use the cortisol more effectively than taking pills. They want to compare the results of a cortisol pump and standard pill treatments for CAH. Objectives: - To compare the effectiveness of a cortisol pump with standard cortisol pill therapy for CAH. Eligibility: - Men and women at least 18 years of age who have CAH (see more details in Eligibility section below). Design: - This study will involve four inpatient hospital stays at the National Institutes of Health in Bethesda, MD over 6 months (spaced 2 months apart). The first and last stays will last about 5 days. The second and third stays will last about 3 days. - Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. - At the first study visit, participants will provide regular blood and urine samples. They will also have imaging studies. These studies will look at the bones, fat, and muscles in the abdomen and pelvis. - Participants will receive a cortisol pump during the first visit. They will be shown how to use the pump. They will also learn what to do, if they need to take extra "stress dose" cortisol pills. - At the second and third visits, the cortisol dose given with the pump will be adjusted as needed. Blood and urine samples will also be collected. No imaging studies are scheduled for these visits. - The last study visit will have the same tests as the first visit. Participants will be offered the chance to continue with the pump treatment for 1 more year, or go back to their standard pill treatment. Study type: Interventional non-randomized trial Official title: A Pilot Study Assessing the use of Continuous Subcutaneous Hydrocortisone Infusion In the Treatment of Congenital Adrenal Hyperplasia Estimated enrollment: 8 Study Start Date: May 2013 Estimated Study Completion Date: December 2016 Sponsoring Institute: National Institute of Child Health and Human Development <TAB>ELIGIBILITY Inclusion criteria 1. Men and women 18 years of age or older with classic congenital adrenal hyperplasia (21-Hydroxylase deficiency) 2. High adrenal androgens in the blood, and 3. One or more of the following conditions: obesity, fatty liver, risk for diabetes, low bone mass, inability to tolerate cortisol pills Exclusion criteria 1. Pregnancy 2. Breast feeding 3. Use of inhaled or oral steroids for diseases other than CAH 4. Use of estrogen-containing birth control pills 5. Use of medicines that cross-react with hydrocortisone 6. Use of stress dose steroids for illness during the last 30 days prior to joining the study