[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"polycystic-ovary-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:polycystic-ovary-syndrome":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,48,0,25,[9,46,80,103,127,155,182,211,229,253,277,297,322,348,368,397,415,444,476,502,527,545,563,594,615],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100289569","phase-1-the-physiological-responses-and-adaptation-of-brown-adipose-tissue-to-chronic-treatment-with-beta3-adrenergic-receptor-agonists-100289569",false,"NCT03049462","The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists","* INCLUSION CRITERIA\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nCohort 1: (complete)\n\n1. Female\n2. Age 18-40 years\n3. BMI 18.00-40.0 kg\u002Fm\\^2\n4. Able to understand the research and willing to sign a written informed consent document\n\nCohort 2: (complete)\n\n1. Male\n2. Age 18-40 years\n3. BMI 18.00-40.0 kg\u002Fm\\^2\n4. Able to understand the research and willing to sign a written informed consent document\n\nCohort 3:\n\n1. Female\n2. Age 18-40 years\n3. BMI 25.0-50.0 kg\u002Fm\\^2 or BMI \\> 18.5 kg\u002Fm\\^2 with PCOS diagnosis\n4. Diagnosis of PCOS based on NIH Criteria; defined by the presence of both clinical and\u002For biochemical signs of hyperandrogenism and oligo- or chronic anovulation.\n5. Women of childbearing potential must agree to use a highly effective method of birth control, confirmed by the Investigator, for at least 3 months prior to the first study visit and continuing throughout the study duration.\n\n   a. Highly effective methods of birth control include:\n\n   i. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal\n\n   ii. Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable\n\n   iii. Intrauterine device\n\n   iv. Intrauterine hormone-releasing system\n\n   v. Bilateral tubal occlusion\n\n   vi. Sexual abstinence, i.e., refraining from heterosexual intercourse (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant)\n\n   vii. Vasectomized sexual partner (provided that partner is the sole sexual partner of the study participant and that the vasectomized partner has received medical assessment of the surgical success)\n\n   b. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrhoeic for \\>=12 months prior to the planned date of enrollment without an alternative medical cause.\n6. Insulin resistance defined by either\n\n   1. HOMA-IR score \\> 5.9 OR\n   2. HOMA-IR score \\> 2.8 and \\\u003C5.9, with HDL \\\u003C51 mg\u002FdL OR\n   3. Fasting Insulin \\> 10.6 microU\u002FmL\n7. Able to understand the research and willing to sign a written informed consent document\n\nEXCLUSION CRITERIA\n\n1. Hypersensitivity and associated allergic reactions to mirabegron (or similar drug substances or components)\n2. Abnormal bladder function, diagnosis of bladder outlet obstruction, urinary incontinence, urgency, and urinary frequency or use of antimuscarinic medication to treat overactive bladder (OAB)\n3. Type 1 or Type 2 Diabetes mellitus, fasting serum glucose \\>125 mg\u002FdL, and\u002For an HbA1c test \\>6.5%\n4. Hypertension, defined as blood pressure (Bullet)140\u002F90 mmHg, based on WHO guidelines (https:\u002F\u002Fwww.who.int\u002Fnews-room\u002Ffact-sheets\u002Fdetail\u002Fhypertension)\n5. Hypo- or hyper-thyroid disease (TSH \\>5.0, \\\u003C0.4 miU\u002FL) that is controlled for less than one year\n6. Anemia, defined by hemoglobin \\\u003C 11.3 g\u002FdL (females) or \\\u003C 13.8 g\u002FdL (males); sickle cell anemia or other blood disorders; and\u002For wound healing problems\n7. Cardiovascular disease, cardiac arrhythmias, orthostasis, unstable vasomotor system, or renal impairment\n8. A clinically significant abnormal ECG and\u002For QTc interval above normal\n9. Elevated liver enzymes with probable or diagnosed liver disease (other than fatty liver disease)\n10. Psychological conditions such as claustrophobia, untreated clinical depression or anxiety, untreated bipolar disorders, or forms of mental incapacity that would be incompatible with safe and successful participation in this study\n11. Recent history in last 4 weeks of any local or systemic infectious disease with fever or requiring antibiotics\n12. Self-reported intolerance of cold that would prevent the individual from spending several hours in a chilled room with a cooling vest\n13. Current use of any drugs known to:\n\n    * have major drug-drug interactions with mirabegron\n    * Prolong QT interval\n    * Alter glucose metabolism or cause insulin resistance (in last six months)\n    * Treat diabetes mellitus\n    * Treat hypertension\n    * Be drugs of abuse\n14. Self-reported weight loss or weight gain \\> 5% in the preceding 6 months.\n15. Pregnancy, childbirth within the last year, or breastfeeding in the past 12 months\n16. Individuals who spend \\>70% of daily hours outdoors since the exposure to varied environmental temperatures will potentially impact the ability to influence and measure BAT activity.\n17. Addiction to alcohol or substances of abuse within the last 5 years\n18. Self-reported current alcohol consumption of more than 2 servings of alcohol per day\n19. Self-reported current use of nicotine and\u002For tobacco products\n20. Has participated in a clinical trial with an investigational or marketed drug within 2 months\n21. Have had previous radiation exposure (X-rays, PET scans, etc.) within the last year or anticipate radiation exposure in the upcoming year - clinical and\u002For research - that would exceed research limits\n22. Donated blood within last 2 months\n23. Unwilling or unable to eat metabolic meals, as determined by dietitian consult.\n24. Any other circumstances or criteria that would preclude safe participation in the study in the clinical judgment of the investigator","ALL","18 Years","40 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Background:\n\nBrown adipose tissue (BAT) is a type of fat in the body. It may prevent weight gain, improve insulin sensitivity, and reduce fatty liver. Researchers want to see if BAT helps the body burn energy.\n\nObjective:\n\nTo learn more about how BAT works to burn energy.\n\nEligibility:\n\nPeople ages 18-40 with a body mass index between 18 and 40\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood, urine, and heart tests\n\nDietitian interview\n\nParticipants will have an overnight baseline visit. This includes:\n\nRepeats of screening tests\n\nExercise test\n\nScans. For one scan, a radioactive substance is injected into the arm.\n\nFSIVGIT: An IV is inserted into veins in the right and left arms. Glucose and insulin are injected in one arm. Blood glucose and insulin levels are measured from the other.\n\nMetabolic suite: Participants stay 18-19 hours in a room that measures their metabolic rate. Monitors on the body measure heart rate, movement, and temperature.\n\nOptional fat biopsy: A small piece of tissue is removed with a needle.\n\nParticipants will take 2-4 pills daily for 4 weeks. All women will take the drug mirabegron. Men will be randomly get either the drug or a placebo.\n\nAll participants will have a visit after 2 weeks of the pills. They will repeat the screening tests.\n\nParticipants will have an overnight visit 2 weeks later. They will repeat the baseline tests.\n\nParticipants will keep food and medication diaries.\n\nParticipants will have a follow-up visit 2 weeks after stopping the pills. This includes heart tests.",[27],"Polycystic Ovary Syndrome",[29,30,31,32],"Brown Adipose Tissue","Energy Expenditure","Energy Metabolism","Obesity","RECRUITING","2026-05-29",{"date":36,"type":37},"2026-06-01","ACTUAL",{"date":39,"type":37},"2017-03-13",{"date":41,"type":21},"2026-09-30",{"name":43,"class":44},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":53,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":4},"100639095","observational-study-on-the-causal-architecture-of-polycystic-ovary-syndrome-pcos-100639095","NCT07623551","Observational Study on the Causal Architecture of Polycystic Ovary Syndrome (PCOS)","An Observational Data Collection Study to Characterize the Hormonal, Metabolic, and Clinical Architecture of Polycystic Ovary Syndrome in Women Aged 18 to 45: A Global Recruitment Initiative","Inclusion Criteria:\n\n* Female\n* Aged 18 to 45 years\n* Diagnosed with Polycystic Ovary Syndrome (PCOS) by a licensed healthcare provider\n* Willing to voluntarily share existing lab results and clinical history\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Over 45 years of age\n* No confirmed PCOS diagnosis from a licensed healthcare provider\n* Unable or unwilling to provide informed consent","FEMALE","45 Years",{"count":20,"type":21},"OBSERVATIONAL","The goal of this observational study is to learn about the causal architecture of Polycystic Ovary Syndrome (PCOS) in women aged 18 to 45. The main questions it aims to answer are:\n\nWhat does the hormonal, metabolic, and clinical architecture of PCOS look like across a diverse global population? Can the causal architecture of PCOS be reconstructed from existing lab results and clinical data? Are there distinct architectural patterns across different groups of women with PCOS? Participants who have been diagnosed with PCOS by a healthcare provider will complete an online questionnaire about their diagnosis, symptoms, clinical history, current treatment, and existing lab results. Participants will also be asked to submit copies of their most recent blood work and lab results. No intervention or treatment is involved. All data is de-identified.",[27,59,60,61],"Polycystic Ovary Syndrome (PCOS)","PCOS","PCOS (Polycystic Ovary Syndrome)",[60,27,63,64,65,66,67,68],"Women's Health","Endocrine","Hormonal","Metabolic","Observational Study","Causal Architecture","NOT_YET_RECRUITING","2026-05-28",{"date":72,"type":37},"2026-06-03",{"date":74,"type":21},"2026-06",{"date":76,"type":21},"2026-07",{"name":78,"class":79},"AnnieGuard Corp.","INDUSTRY",{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":53,"minAge":17,"maxAge":18,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":45},"100581596","phase-2-combined-oral-contraceptive-pill-and-resistance-starch-100581596","NCT06852365","Combined Oral Contraceptive Pill and Resistance Starch","Resistant Starch Usage in Polycystic Ovary Syndrome: Impact on Cardiometabolic Dysfunction and the Gut Microbiome (CORS-PCOS)","COR-PCOS","Inclusion Criteria:\n\n1. Women between ages of 18-40 years with BMI greater than or equal to 25 kg\u002Fm² to less than or equal to 48 kg\u002Fm² diagnosed with PCOS defined by the Rotterdam criteria based on a history of chronic anovulation (8 or fewer periods), androgen excess \\[defined as total serum testosterone, free testosterone or a FAI greater than or equal to 90% of the upper limit of normal) or hirsutism (Ferriman-Gallwey score greater than 6 for Hispanics\u002F Black and greater than or equal to 2 for women of Asian descent)\\] and polycystic ovaries as defined by a pelvic ultrasound (20 or more follicles or ovarian vol greater than 10cm3) or elevated AMH.\n2. For women with more regular bleeding patterns, but who are suspected to be experiencing periodic anovulatory bleeding, a midluteal progesterone (P4) level less than 3ng\u002FdL will be evidence of ovulatory dysfunction and qualify as anovulation.\n3. Women with only hyperandrogenic PCOS phenotype (hyperandrogenism + one more criteria) will be included to decrease the heterogeneity of the cohort and as metabolic risks are increased in these women compared to normo-androgenic women with PCOS.\n4. Subjects should be willing to avoid pregnancy for the entire duration of the study.\n\nExclusion Criteria:\n\n1. Subjects with other causes for irregular menses such as pregnancy, lactation, untreated hypothyroidism, untreated hyperprolactinemia and premature menopause.\n2. Subjects with late onset adrenal hyperplasia\n3. Subjects with history of bariatric surgery\n4. Those who are unable to comply with the study procedures, for instance due to mental illness, substance abuse, or participation in other studies.\n5. Subjects taking medications that affect weight or metabolic parameters (e.g. lipid lowering medications).\n6. History of Crohn's disease and ulcerative colitis as well as current use of probiotics and laxatives are excluded.\n7. Subjects could not have taken antibiotics for at least 3 months prior to randomization visit.\n8. Subjects with greater than 20 g\u002Fday of dietary fiber intake based on pre-screening ASA-24 survey will be excluded.\n9. Subjects with medical conditions that are contraindications to use of OCP and other medical conditions such as:\n\n   1. Type 1 or 2 diabetes\n   2. liver disease or dysfunctional liver (AST\u002FALT greater than 2x normal or a total bilirubin greater than 2.5 mg\u002FdL)\n   3. renal disease (BUN greater than 30 mg\u002FdL or serum creatinine greater than 1.4 mg\u002FdL)\n   4. severe anemia (hemoglobin less than 10 mg\u002FdL)\n   5. alcohol abuse\n   6. poorly controlled hypertension\n   7. TG greater than 250 mg\u002Fdl\n   8. chronic inflammatory conditions such as psoriasis\n   9. history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; known heart disease (New York Heart Association Class II or higher)\n   10. history of cervical carcinoma, endometrial carcinoma, or breast carcinoma, adrenal or ovarian tumor secreting androgens, and Cushing's syndrome -",{"count":20,"type":21},[90],"PHASE2","This study will enroll women with PCOS to study the effects of first line therapy, oral contraceptive pills, and then either 12 weeks of resistant starch or 12 weeks of placebo to explore if resistant starch improves cardiometabolic parameters or impacts gut dysbiosis compared to placebo.",[93,27],"Metabolic Syndrome","2026-05-27",{"date":36,"type":37},{"date":97,"type":37},"2025-06-10",{"date":99,"type":21},"2028-04",{"name":101,"class":102},"University of Pennsylvania","OTHER",{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":53,"minAge":109,"maxAge":18,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":45},"100638929","efficay-of-physical-activity-program-in-pcos-females-with-fatty-pancrease-and-thyroid-hypofunction-100638929","NCT07591246","Efficay of Physical Activity Program in PCOS Females With Fatty Pancrease and Thyroid Hypofunction","Inclusion Criteria:\n\n* PCOS\n* fattty pancrease (non-alcoholic)\n* subclinical hypothyroid (signifcant with thyroid stimauted horomone more than 10 mIU\u002FL) and normal non-disordered free thyroxine horomones\n\nExclusion Criteria:\n\n* cardiac disesase\n* renal diseases\n* respiratory disease","20 Years",{"count":111,"type":21},40,[113],"NA","females of polycystic ovary syndromes may complain fatty pancreaetic disorder and thyroid hypofunctions (subclinical hypothyroidism)",[27,116,117],"Non-Alcoholic Fatty Pancreatic Disease","Subclinical hypothyroïdism","2026-05-09",{"date":120,"type":37},"2026-05-15",{"date":122,"type":37},"2026-03-07",{"date":124,"type":21},"2026-12-30",{"name":126,"class":102},"Cairo University",{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":135,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":138,"studyType":56,"phases":4,"briefSummary":139,"conditions":140,"keywords":143,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":45},"100512271","determinants-of-insulin-sensitivity-by-age-sex-raceethnicity-bmi-and-pcos-diagnosis-100512271","NCT05950282","Determinants of Insulin Sensitivity by Age, Sex, Race\u002FEthnicity, BMI, and PCOS Diagnosis","Measuring Fasting Insulin and HOMA-IR by Age, Sex, Race\u002FEthnicity, BMI, and PCOS Diagnosis","DAISY","Inclusion Criteria Age: Participants aged 18+ years Sex: Both males and females Race\u002FEthnicity: Participants from diverse racial and ethnic backgrounds BMI: Participants across a range of body mass index (BMI) values PCOS Diagnosis: Participants with and without a confirmed diagnosis of PCOS based on established diagnostic criteria\n\nParticipants must have completed metabolic testing within one month prior to enrollment, including:\n\n* Fasting insulin\n* Hemoglobin A1c (A1c)\n* Complete lipid panel\n* Triglycerides Laboratory testing must be completed through a healthcare provider, an independent laboratory, or by using an Insara Insulin Testing Kit Laboratory values must be obtained following a minimum 8-hour fast Participants must have complete laboratory data for all required measures\n\nExclusion Criteria Age: Participants below 18 years Sex: None. Both males and females are included Race\u002FEthnicity: None. Participants from all racial and ethnic backgrounds are included Endocrine Disorders: Participants with other endocrine disorders affecting insulin levels (e.g., insulin-secreting tumors) Significant recent weight change: Loss of more than 5% of body weight within the previous month Pregnancy or breastfeeding Acute illness or infection within the past 2 weeks Use of medications known to significantly affect insulin or glucose metabolism will be recorded and accounted for in analysis",true,{"count":137,"type":21},150,"1 Year","The study aims to investigate the relationship between fasting insulin and Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) across various demographic factors, including age, sex, race\u002Fethnicity, BMI, and polycystic ovary syndrome (PCOS) diagnosis. By analyzing these variables, the study seeks to identify potential variations in insulin levels, which could provide valuable insights into the impact of different factors on metabolic health and the development of insulin-related conditions.",[141,27,142,32,93],"Insulin Resistance","Hyperinsulinism",[60,144,141,93,32,145],"Hyperinsulinemia","Type 2 Diabetes","2026-04-27",{"date":148,"type":37},"2026-05-01",{"date":150,"type":37},"2024-02-01",{"date":152,"type":21},"2027-12",{"name":154,"class":102},"Ali Chappell",{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":53,"minAge":17,"maxAge":163,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":166,"briefSummary":168,"conditions":169,"keywords":171,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":180,"locationsCount":45},"100290316","phase-3-interest-of-myo-inositol-supplementation-in-women-with-polycystic-ovarian-syndrome-100290316","NCT03059173","Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome","Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome During Induction of Ovulation With Clomiphene Citrate","MYOPK","Inclusion Criteria:\n\n* Wishing pregnancy,\n* Having PCOS defined by the Rotterdam criteria: high antral follicle count (AFC) (\\> 19 per ovary) and\u002For a disorder of the cycle and\u002For hyperandrogenism (at least two of the three criteria),\n* Having never been treated with CC (or previous treatment with CC interrupted for \\> 3 months).\n* Having received complete information and having signed consent.\n* Covered by social security\n\nExclusion Criteria:\n\n* Intolerance to CC in previous treatment,\n* BMI \\> 35,\n* Other associated cause of oligoanovulation requiring specific treatment (eg., Hyperprolactinemia or functional hypothalamic anovulation),\n* Ongoing pregnancy at the time of CC initiation,\n* Other male or female cause of hypo-fertility,\n* History of ovarian drilling,\n* Negative rubella serology.","35 Years",{"count":165,"type":21},276,[167],"PHASE3","The main objective will be to check if MyoInositol (MYO) reduces the total resistance rate to Clomiphene Citrate (CC). For this, our study will be controlled, randomized and double blinded. It will include patients with PCOS (polycystic ovary syndrome, defined by the Rotterdam criteria) who wish to become pregnant and are eligible to simple ovulation induction by CC. Half of them will receive MYO + levomefolic acid (5-MTHF) in addition to the CC, while the other half will receive a placebo containing only 5-MTHF in addition to the CC. The MYO supplementation will be initiated at least one month before taking CC and will be continued throughout this treatment until pregnancy or before switching to another type of treatment for ovulation induction if no pregnancy is obtained after 6 ovulatory cycles.",[27,170],"Reproductive Medicine",[172,173],"Polycystic ovary syndrome","Reproductive medicine","2026-04-17",{"date":176,"type":37},"2026-04-22",{"date":178,"type":37},"2023-09-12",{"date":152,"type":21},{"name":181,"class":102},"University Hospital, Lille",{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":53,"minAge":17,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":196,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":45},"100630134","glucose-profiles-in-women-with-polycystic-ovary-syndrome-100630134","NCT07483723","Glucose Profiles in Women With Polycystic Ovary Syndrome","PROGLYSOPK","Inclusion Criteria:\n\n* Age \\> 18 years at inclusion criteria\n* Patient with polycystic ovary syndrome, defined by the presence of at least 2\u002F3 irregular menstrual cycles, clinical or biological hyperandrogenism, polycystic ovary morphology (pelvic ultrasound) or elevated AMH levels, after the exclusion of other disorders.\n* Agreed to carry the FSL pro\n* Signed informed consent\n\nExclusion Criteria:\n\n* Pregnancy, breast-feeding\n* Differential diagnoses: hyperprolactinemia, dysthyroidism, Cushing's syndrome, congenital adrenal hyperplasia, virilizing tumor (ovarian or adrenal), intake of exogenous androgens\n* Pre-existing diabetes\n* Patient treated within 3 months prior to inclusion\u002Fdata collection with estrogen-progestin contraception, progestin contraception, antidiabetic drugs, inositol, antiandrogen",{"count":190,"type":21},80,[113],"Polycystic ovary syndrome is a very common condition that is associated with metabolic complications. Patients with polycystic ovary syndrome exhibit insulin resistance and are at greater risk to develop type 2 diabetes. This syndrome is heterogeneous, classified according to 4 phenotypes (A-D). It seems that certain phenotypes are less exposed to insulin resistance and metabolic complications. However, only a few studies have evaluated the glucose profile according to phenotype. New technologies now make it possible to monitor glucose levels continuously. The aim of this project is to evaluate glucose profile parameters using continuous glucose monitoring, and to compare these profiles according to different PCOS phenotypes.",[27,194,141,195],"Glucose Profile","Continuous Glucose Monitoring",[197,198,199,200,201],"polycystic ovary syndrome","phenotype","glucose profile","insulin resistance","continuous glucose monitoring","2026-03-17",{"date":204,"type":37},"2026-03-19",{"date":206,"type":37},"2026-01-06",{"date":208,"type":21},"2027-07",{"name":210,"class":102},"Centre Hospitalier Universitaire, Amiens",{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":53,"minAge":17,"maxAge":18,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":225,"leadSponsor":227,"locationsCount":45},"100628740","berberine-phytosome-for-signs-and-symptoms-of-polycystic-ovary-syndrome-pcos-100628740","NCT07465575","Berberine Phytosome for Signs and Symptoms of Polycystic Ovary Syndrome (PCOS)","Effectiveness of Berberine Phytosome in Improving Signs and Symptoms of Polycystic Ovary Syndrome (PCOS): A Multicentre, Randomized, Controlled Trial","Inclusion Criteria:\n\n* Women aged 18-40 years\n* Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam criteria\n* Body mass index (BMI) ≥ 25 kg\u002Fm²\n* Evidence of insulin resistance (HOMA-IR above normal range)\n* Willingness to follow lifestyle recommendations including dietary advice and physical activity\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Use of insulin-sensitizing drugs (e.g., metformin) within the previous 3 months\n* Current hormonal therapy including oral contraceptives or anti-androgens\n* Diagnosis of diabetes mellitus\n* Known liver, renal, cardiovascular, or endocrine diseases other than PCOS\n* Use of berberine-containing supplements within the previous 3 months\n* Known hypersensitivity to berberine or related compounds",{"count":137,"type":21},[113],"This multicenter, randomized, controlled clinical trial aims to evaluate the effectiveness of berberine phytosome supplementation in improving signs and symptoms associated with polycystic ovary syndrome (PCOS). Women presenting with clinical features suggestive of PCOS, including hirsutism, acne, menstrual irregularities, and overweight, will be enrolled.\n\nParticipants will be randomly assigned to one of three groups: (1) berberine phytosome supplementation in women not previously taking inositol, (2) berberine phytosome supplementation in women already taking inositol for at least three months, or (3) a control group receiving lifestyle advice without supplementation. The intervention will consist of berberine phytosome 550 mg once daily for 12 weeks.\n\nThe study will evaluate changes in clinical manifestations associated with hyperandrogenism and metabolic dysfunction, including hirsutism, acne severity, body mass index, and metabolic parameters. The results will provide evidence on the potential role of berberine phytosome supplementation in improving clinical manifestations related to PCOS.",[27],"2026-03-16",{"date":204,"type":37},{"date":222,"type":21},{"date":226,"type":21},"2027-03-31",{"name":228,"class":102},"Liaquat University of Medical & Health Sciences",{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":135,"sex":53,"minAge":17,"maxAge":54,"enrollmentInfo":236,"targetDuration":4,"studyType":22,"phases":238,"briefSummary":239,"conditions":240,"keywords":241,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":248,"completionDateStruct":249,"leadSponsor":251,"locationsCount":45},"100558451","study-of-the-effect-of-a-nutritional-supplement-on-microbiota-metabolic-control-inflammatory-profile-and-quality-of-life-in-patients-with-polycystic-ovary-syndrome-100558451","NCT06551285","Study of the Effect of a Nutritional Supplement on Microbiota, Metabolic Control, Inflammatory Profile, and Quality of Life in Patients With Polycystic Ovary Syndrome.","Study of the Effect of a Nutritional Supplement on Microbiota, Metabolic Control, Inflammatory Profile, and Quality of Life in Patients With Polycystic Ovary Syndrome","Inclusion Criteria:\n\n* Patients aged between 18 and 45 years.\n* Patients diagnosed with PCOS using the AE-PCOS diagnostic criteria (2009).\n* Patients who agree to participate in the study and sign the informed consent form after reading it.\n\nExclusion Criteria:\n\n* Having been treated with medication or supplementation aimed at improving PCOS prior to the study (e.g., metformin, hormonal therapy, inositol, etc.).\n* Suffering from an infectious, hematological, inflammatory, or autoimmune disease.\n* Having a severe organic disease.\n* Suffering from cardiovascular disease (heart attack, ischemia, thromboembolism).\n* Diabetes Mellitus.\n* Severe arterial hypertension.\n* Alcoholism.\n* Active smoking.",{"count":237,"type":21},120,[113],"Polycystic Ovary Syndrome (PCOS) is a complex endocrine-metabolic disorder characterized by elevated androgen levels due to ovarian overproduction. Although the pathophysiology of PCOS is not fully understood, it is estimated that insulin resistance (IR) occurs in 70-80% of PCOS cases, which may contribute to hyperandrogenism in affected women.\n\nWomen with PCOS and IR are more likely to develop metabolic syndrome, increasing the risk of diabetes, cardiovascular diseases, lipid profile deterioration, elevated inflammation levels, and greater oxidative stress.\n\nThe symptoms of PCOS are varied and differ among patients. Common symptoms include androgenic alopecia, hirsutism, acne, abdominal fat accumulation, and fertility issues. These physical manifestations and related problems have been associated with reduced quality of life and self-esteem in these women. The symptoms of PCOS can be improved through lifestyle changes aimed at enhancing insulin sensitivity, such as proper nutrition and regular physical exercise.\n\nSome supplements, such as a combination of Myo-inositol and D-chiro-inositol in a 40:1 ratio, are being used to support the management of PCOS because they appear to improve insulin sensitivity, as well as reduce underlying inflammation and oxidative stress.\n\nTo determine whether nutritional intervention combined with inositol supplementation improves PCOS symptoms, various variables will be analyzed to assess improvements in oxidative stress markers, inflammation, lipid profile, hormonal profile, and microbiota. Additionally, if the metabolic profile improves, it is hypothesized that this could also enhance quality of life and self-esteem.",[27,93],[242,243,244,245],"Insulin resistance","Inflammation","Oxidative Stress","Intestinal microbiota","2026-03-15",{"date":202,"type":37},{"date":150,"type":37},{"date":250,"type":21},"2029-05-31",{"name":252,"class":102},"Celia Bañuls",{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":53,"minAge":17,"maxAge":54,"enrollmentInfo":260,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":262,"conditions":263,"keywords":264,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":45},"100519747","multidisciplinary-diagnosis-and-treatment-of-polycystic-ovary-syndrome-100519747","NCT06047574","Multidisciplinary Diagnosis and Treatment of Polycystic Ovary Syndrome","Multidisciplinary Combined Precise Diagnosis and Treatment of Polycystic Ovary Syndrome","Inclusion Criteria:\n\n* Female aged 18- 45;\n\nExclusion Criteria:\n\n* Female patients younger than 18 years old or older than 45 years old;\n* Ovulatory disorders caused by premature ovarian failure, pituitary amenorrhea, hypothalamic amenorrhea, and thyroid dysfunction;\n* Congenital adrenal hyperplasia, reservoir Hin syndrome, hyperprolactinemia, adrenal tumors and other diseases that cause hyperandrogenism;\n* Abnormal liver or renal function((≥ 3 times of the upper limit of normal range)\n* Type 1 diabetes, single gene mutation diabetes, or pancreatic damage Diabetes or other secondary diabetes caused by diabetes;\n* History of malignant tumors;\n* Severe infection, severe anemia, neutropenia and other systemic chronic diseases;\n* Undergo total hysterectomy or ovarian adnexectomy;\n* Mental illness, dementia or other cognitive behavioral problems;\n* Use hypoglycemic drugs that may affect insulin resistance and androgen levels in the last 3 months, including thiazolidinediones, metformin, SGLT-2, and acarbose and GLP-1RA and other drugs;\n* Use letrozole, clomiphene, oral contraceptives, glucocorticoids, gonadotropins, gonadotropin-releasing hormone agonists, anti-androgens (spironolactone, Cyproterone acetate, flutamide, etc.) and other drugs for the treatment of PCOS.",{"count":261,"type":21},3000,"The investigators collected clinical data and serum samples of patients with polycystic ovary syndrome (PCOS) in this study, used statistical software such as SPSS for date analysis, and used experimental techniques such as ELISA and flow cytometry to detect serum samples, aiming to explore the relationship between the body anthropometry, skin conditions, psychosomatic status, diet, sleep, exercise, glucose and lipid metabolism, gonadal hormones, and body fat distribution in patients with polycystic ovary syndrome, and to discovery new biomarkers. Multidisciplinary exploration of the mechanisms of disease occurrence and development, the establishment of a PCOS multicenter, multidisciplinary and multidimensional clinical research database, combined with the established statistical analysis strategy for big data and analysis, to promote the realization of more accurate personalized medicine.",[27],[27,265,266,267],"Clinical characteristics","New biomarkers","Multidisciplinary","2026-03-05",{"date":270,"type":37},"2026-03-09",{"date":272,"type":37},"2023-09-18",{"date":274,"type":21},"2026-07-30",{"name":276,"class":102},"Shanghai 10th People's Hospital",{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":53,"minAge":109,"maxAge":283,"enrollmentInfo":284,"targetDuration":4,"studyType":22,"phases":285,"briefSummary":286,"conditions":287,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":45},"100627311","is-there-a-benefit-from-addition-of-physical-exercise-to-diet-restrictionlimitation-in-pcos-women-with-asthma-100627311","NCT07446985","Is There a Benefit From Addition of Physical Exercise to Diet Restriction\u002FLimitation in PCOS Women With Asthma?","Inclusion Criteria:\n\n* PCOS women\n* women with asthma\n* obese women (calss I)\n\nExclusion Criteria:\n\n* cardiac problems\n* renal problems\n* liver problems","30 Years",{"count":111,"type":21},[113],"Women with polysyctic ovarian syndrome (PCOS) usually develop many complications including asthma. Nowdays, diet restriction combimed with phsyical exercises may improve both problems",[27,288],"Asthma","2026-02-26",{"date":291,"type":37},"2026-03-03",{"date":293,"type":37},"2026-02-07",{"date":295,"type":21},"2026-07-15",{"name":126,"class":102},{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":53,"minAge":17,"maxAge":54,"enrollmentInfo":304,"targetDuration":4,"studyType":22,"phases":306,"briefSummary":307,"conditions":308,"keywords":311,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":45},"100624622","identification-of-women-with-severe-insulin-resistant-syndromes-of-genetic-origin-among-patients-with-classic-polycystic-ovary-syndrome-pcos-100624622","NCT07412028","Identification of Women With Severe Insulin Resistant Syndromes of Genetic Origin Among Patients With \"Classic\" Polycystic Ovary Syndrome (PCOS)","ANDROLIPO","Inclusion Criteria:\n\n* Women aged ≥ 18 years and \\\u003C 45 years ;\n* Discontinuation of estrogen-progestin therapyfor at least 3 months ;\n* Signed informed consent ;\n* Social security affiliation.\n\nCase (n=25):\n\n\\- Patient with a lipodystrophic syndrome due to a known pathogenic variant of the LMNA gene.\n\nControl (n=50), :\n\n\\- patient consulting for polycystic ovary syndrome (PCOS according to the Rotterdam criteria) in day hospital matched on age +\u002F-5 years and BMI+\u002F-5 kg\u002Fm2.\n\nExclusion Criteria:\n\n* \\- Severe renal insufficiency (GFR \\\u003C 30 ml\u002Fmin) ;\n* Hepato-cellular insufficiency (TP \\\u003C 50%) ;\n* Taking corticosteroids or antiretrovirals ;\n* Menopausal women ;\n* Taking estrogen-progestin therapy;\n* Diabetic patients on insulin : type 1 diabetes or pancreatectomised patients\n* Other known causes of hyperandrogenism (21-hydroxylase block, Cushing's syndrome, ovarian tumor).\n* Pregnant woman\n* Breastfeeding woman",{"count":305,"type":21},81,[113],"Diagnostic case-control study (1 case for 2 controls). Inclusion of patients with severe insulin resistance syndrome of genetic origin, then inclusion of controls: patients examined for PCOS in day hospital with matching age (+\u002F- 5 years) and Body mass index (+\u002F- 5kg\u002Fm2).",[27,309,310],"Familial Partial Lipodystrophy","LMNA (LaMin Nuclear A) Related Disorders",[27,309,312],"LMNA related disorders","2026-02-13",{"date":315,"type":37},"2026-02-17",{"date":317,"type":21},"2026-02",{"date":319,"type":21},"2027-09",{"name":321,"class":102},"Assistance Publique - Hôpitaux de Paris",{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":53,"minAge":4,"maxAge":54,"enrollmentInfo":329,"targetDuration":4,"studyType":22,"phases":331,"briefSummary":333,"conditions":334,"keywords":335,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":45},"100623943","early-phase-1-the-effect-of-therapy-combination-in-pcos-with-dlbs-3233-100623943","NCT07403201","The Effect of Therapy Combination in PCOS With Dlbs 3233","The Effect of Combination Therapy Dlbs 3233 and Clomifen Citrate vs Clomifen Citrate on Homa ir, Maturation Follicle, and Menstrual Cycle in PCOS Cases at Muhammadiyah Asri Medical Center Hospital","Inclusion Criteria:\n\n* married agree to join this research\n\nExclusion Criteria:\n\n* dis agree to join research",{"count":330,"type":21},90,[332],"EARLY_PHASE1","The effect of combination therapy dlbs 3233 and clomifen citrate vs clomifen citrate on homa ir, maturation follicle, and menstrual cycle in PCOS cases at Muhammadiyah Asri Medical Center Hospital",[27],[336,337,338],"pcos","dlbbs 3233","clomifen citrat","2026-02-04",{"date":341,"type":37},"2026-02-11",{"date":343,"type":37},"2021-12-15",{"date":345,"type":21},"2026-01-31",{"name":347,"class":102},"Inlacinpenelitian",{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":4,"eligibilityCriteria":354,"healthyVolunteers":12,"sex":53,"minAge":283,"maxAge":18,"enrollmentInfo":355,"targetDuration":4,"studyType":22,"phases":356,"briefSummary":357,"conditions":358,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":45},"100621155","pcos-and-problem-of-eye-dryness-is-there-a-benefit-from-lifetyle-changes-100621155","NCT07366944","PCOS and Problem of Eye Dryness: Is There a Benefit From Lifetyle Changes","PCOS and Problem of Eye Dryness: Is There a Benefit From Lifetyle Changes in Obese Women","Inclusion Criteria:\n\n* PCOS women\n* obese class I\n* bilateral dryness of eye\n\nExclusion Criteria:\n\n* liver disoease\n* cardiac disease\n* renal disease",{"count":111,"type":21},[113],"Women with polycystic ovarian syndrome (PCOS) may complain dryness of their eyes especially obese ones. lifestye changes are main treatrment fro both problems",[27,359,32],"Dry Eye","2026-01-17",{"date":362,"type":37},"2026-01-26",{"date":364,"type":37},"2025-12-05",{"date":366,"type":21},"2026-06-05",{"name":126,"class":102},{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":53,"minAge":375,"maxAge":376,"enrollmentInfo":377,"targetDuration":4,"studyType":22,"phases":379,"briefSummary":380,"conditions":381,"keywords":382,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":4},"100617707","light-fasting-diet-and-magnesium-in-polycystic-ovary-syndrome-pcos-100617707","NCT07322120","Light Fasting Diet and Magnesium in Polycystic Ovary Syndrome (PCOS)","Investigation of the Effect of Light Fasting Diet Combined With Magnesium Supplementation on Lipid Profile, Lipid Peroxidation, and C-Reactive Protein (CRP) Levels in Women With Polycystic Ovary Syndrome (PCOS).","Inclusion Criteria:\n\n1. People between the ages of 19 and 65\n2. People with a body mass index (BMI) ≤ 25\n3. Diagnosis of polycystic ovary syndrome by a specialist based on the Rotterdam criteria\n\nExclusion Criteria:\n\n1. Failure of the participant to cooperate during the study\n2. Use of drug therapy that affects carbohydrate or fat metabolism (including oral contraceptives, insulin sensitizers, antiepileptic drugs, antipsychotics, statins, and fish oil) within the past 6 months.\n3. Planning for pregnancy, pregnant, or breastfeeding\n4. In the perimenopausal stage\n5. Low blood pressure\n6. Presence of other diseases (such as congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors, hyperprolactinemia, diabetes, thyroid disease, severe cardiovascular, gastrointestinal, renal, and hepatic diseases)\n7. Performing high-intensity exercise","19 Years","65 Years",{"count":378,"type":21},46,[113],"Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of reproductive age, which is associated with hormonal imbalances, dyslipidemia, chronic inflammation, and increased oxidative stress, and can increase the risk of cardiovascular and metabolic diseases. Evidence suggests that nutritional interventions play an important role in improving metabolic outcomes in these patients.\n\nThis study is a randomized, triple-blind, controlled clinical trial designed to investigate the effect of a light fasting diet combined with magnesium supplementation on lipid profile, lipid peroxidation (malondialdehyde), and C-reactive protein (CRP) levels in women with PCOS. In this study, 46 eligible women were randomly divided into two groups receiving a light fasting diet with magnesium supplementation or placebo, and changes in biochemical and anthropometric indices were evaluated before and after 8 weeks of intervention.",[27],[27,383,384,385,386,387],"Light Fasting","Magnesium","Lipid Profile","Lipid Peroxidation","C-Reactive Protein","2025-12-22",{"date":390,"type":37},"2026-01-07",{"date":392,"type":21},"2026-02-20",{"date":394,"type":21},"2026-06-22",{"name":396,"class":102},"Behnood Abbasi",{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":53,"minAge":163,"maxAge":54,"enrollmentInfo":403,"targetDuration":4,"studyType":22,"phases":404,"briefSummary":405,"conditions":406,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":414,"locationsCount":45},"100615191","is-there-a-benefit-from-addition-of-treadmill-walking-to-diet-restriction-in-psoriasis-women-with-pcos-100615191","NCT07289399","Is There a Benefit From Addition of Treadmill Walking to Diet Restriction in Psoriasis Women With PCOS?","Inclusion Criteria:\n\n* obese (class I) women\n* chronic plaque psoriasis\n* polyscytic ovarian syndrome\n\nExclusion Criteria:\n\n* cardiac dysfucntions\n* liver diseases\n* repsiratory disease\n* vascular diseases",{"count":111,"type":21},[113],"Women with psoriasis usually develop many complications including polysyctic ovarian syndrome (PCOS). Nowdays, diet restriction combimed with phsyical exercises may improve both problems",[407,27],"Psoriasis","2025-12-04",{"date":410,"type":37},"2025-12-17",{"date":412,"type":37},"2025-10-10",{"date":120,"type":21},{"name":126,"class":102},{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":423,"targetDuration":4,"studyType":22,"phases":425,"briefSummary":426,"conditions":427,"keywords":428,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":45},"100558023","weight-cycling-on-hyperandrogenemia-and-insulin-resistance-in-polycystic-ovary-syndrome-100558023","NCT06545721","Weight Cycling on Hyperandrogenemia and Insulin Resistance in Polycystic Ovary Syndrome","The Effect and Mechanism Of Weight Cycling on Hyperandrogenemia And Insulin Resistance in Polycystic Ovary Syndrome","WHIP","Inclusion Criteria:\n\n1. Women aged 18-45 years in the reproductive period;\n2. Women who have previously met the Rotterdam diagnostic criteria (at least 2 of the following 3 criteria have been confirmed, and have been diagnosed with PCOS): 1) Oligomenorrhea and\u002For anovulation; 2) clinical and\u002For biochemical evidence of hyperandrogenism; 3) ultrasound showing the presence of unilateral or bilateral polycystic ovaries;\n3. Inclusion of 50 women in the normal weight group: 18.5 kg\u002Fm² ≤ BMI \\\u003C 24 kg\u002Fm²; Inclusion of 400 women in the overweight\u002Fobese group: BMI ≥ 24 kg\u002Fm²;\n4. Voluntarily participate in the intervention and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Currently pregnant or lactating, or have had a recent (within 6 months) plan for pregnancy;\n2. Currently using known prescription weight loss medications (such as GLP-1RA, orlistat, topiramate, etc.);\n3. History of weight loss surgery;\n4. History of severe cardiovascular or cerebrovascular diseases; severe liver or kidney dysfunction (ALT \\> 3 times the upper limit of normal, or creatinine \\> 1.5 times the upper limit of normal); chronic or active gastrointestinal inflammatory diseases; severe systemic diseases; active malignant tumors;\n5. Secondary obesity: including hypothalamic or pituitary obesity, obesity secondary to glucocorticoid use, hypogonadism-induced obesity, etc.;\n6. Known history of serious endocrine system diseases;\n7. Poor compliance with planned dietary interventions (psychiatric disorders such as binge eating disorder, anorexia nervosa, severe anxiety\u002Fdepression);\n8. Unable to follow up on time or deemed non-cooperative by the investigator.",{"count":424,"type":21},425,[113],"This study prospectively includes PCOS patients with normal weight and overweight\u002Fobesity, closely follows up and intensively manages them, and observes the level and distribution of weight reduction achieved by patients after lifestyle intervention (high-protein diet for weight loss). Additionally, it aims to provide reference for setting weight loss targets for future PCOS patients by comparing the differences in clinical improvement among patients achieving different degrees of weight reduction (\\\u003C2% \\[equivalent to no weight loss\\], 2-5%, 5-10%, ≥10%) at different time points (3 months, 6 months) following dietary intervention. Furthermore, this study will compare the differences in reproductive and metabolic marker improvements between baseline PCOS patients experiencing weight rebound, those who successfully lost weight, and those who experienced weight rebound. This will help explore the impact of weight cycling on PCOS-related manifestations. Finally, at a genetic level, the study will analyze potential mechanisms underlying different outcome indicators by comparing differences in metagenomics, transcriptomics, and metabolomics among patient groups.\n\nAncillary\u002FNested Sub-study (12-week Precision Nutrition Trial):\n\nWithin the WHIP cohort, we will conduct a nested, prospective interventional sub-study to evaluate the efficacy of an insulin-resistance-phenotype-guided precision dietary prescription versus a standard guideline-based energy-restricted diet. Eligible participants are women with PCOS and insulin resistance enrolled in the cohort. The sub-study lasts 12 weeks with assessments at baseline and week 12. Primary endpoints include change in HOMA-IR and change in the core11 metabolic risk composite. Secondary endpoints include changes in gonadotropins (FSH, LH), sex steroid hormones (e.g., estradiol, progesterone), and patient-reported symptom scores.",[27],[429,430,141,431,432,433,434],"Weight Cycling","Hyperandrogenemia","High-protein diet","Transcriptome","Metabolome","Inflammatory status","2025-11-25",{"date":437,"type":37},"2025-12-03",{"date":439,"type":37},"2024-08-13",{"date":441,"type":21},"2026-04-01",{"name":443,"class":102},"Peking Union Medical College Hospital",{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":135,"sex":53,"minAge":17,"maxAge":18,"enrollmentInfo":451,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":453,"conditions":454,"keywords":456,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":45},"100350374","body-fat-as-determinant-of-female-gonadal-dysfunction-100350374","NCT03841981","Body Fat as Determinant of Female Gonadal Dysfunction","Amount, Distribution and Dysfunction of Body Fat as Determinants of Female Gonadal Dysfunction: From Functional Hypothalamic Amenorrhea to the Polycystic Ovary Syndrome","Inclusion Criteria\n\nGroup I\n\n* Body mass index between 18.5 and 25.0 kg\u002Fm2.\n* Group 1 ovulatory dysfunction \\[World Health Organization (WHO) classification\\].\n* Normal\u002Flow gonadotrophin levels \\[follicle-stimulating hormone (FSH) and luteinizing (LH) \\\u003C 10 IU\u002Fl\\] and low estradiol (\\\u003C 50 pg\u002Fml).\n* Moderate-vigorous intensity physical activity (\\> 5 hours per week) plus low energy availability (\\\u003C 30 kcal\u002Fper kg of lean mass).\n* Exclusion of secondary etiologies\n* Informed consent signed.\n\nGroup II:\n\n* Polycystic ovary syndrome phenotype I, II and III \\[National Institute of Health (NIH)-2012\\] with hyperandrogenemia (http:\u002F\u002Fprevention.nih.gov\u002Fworkshops\u002F2012\u002Fresources.aspx).\n* Body mass index between 18.5 and 40.0 kg\u002Fm2.\n* Informed consent signed.\n\nGroup III:\n\n* Polycystic ovary syndrome phenotype IV (NIH-2012) (http:\u002F\u002Fprevention.nih.gov\u002Fworkshops\u002F2012\u002Fresources.aspx).\n* Body mass index between 18.5 and 40.0 kg\u002Fm2.\n* Informed consent signed.\n\nGroup IV:\n\n* Body mass index between 18.5 and 25.0 kg\u002Fm2.\n* Regular menses.\n* Normal gonadotropins and estradiol levels at follicular phase.\n* Moderate-vigorous intensity physical activity (\\> 5 hours per week) with normal energy availability (\\> 30 kcal\u002Fper kg of lean mass).\n* Informed consent signed.\n\nGroup V:\n\n* No signs or symptoms of hyperandrogenism.\n* No exercise or mild intensity physical activity.\n* Regular menses.\n* Body mass index between 18.5 and 40.0 kg\u002Fm2.\n* Informed consent signed.\n\nExclusion Criteria (Groups I-V)\n\n* Oral drugs interfering with ovulation (glucocorticoids, antipsychotics, antidepressants, contraceptives, sex steroids and\u002For opioids) for the previous 6 months to study inclusion.\n* Current pregnancy or lactation, or during the previous 6 months to study inclusion.\n* Asherman's syndrome or outflow tract disorders.\n* Current smoking or alcohol intake \\> 40 g per day.\n* Previous diagnosis of glucose intolerance, hypertension, dyslipidemia, known heart or lung diseases, kidney disease, liver disease, celiac disease or any other malabsorptive condition, chronic inflammatory disease or malignancy.",{"count":452,"type":21},50,"Reproduction requires from women enough energy depots to warrant an adequate nutritional supply to the fetus. Hence, adipose tissue is able to communicate with female hypothalamic-pituitary-ovary axis. The hypothesis of the project is that abnormalities in the quantity (absolute and relative to lean body mass), distribution and\u002For function of adipose tissue are associated with functional forms of female gonadal dysfunction in predisposed women, in a spectrum of anomalies that go from hypothalamic amenorrhea to the polycystic ovary syndrome (PCOS). To challenge this hypothesis, the investigators will study 5 groups of 10 women each: women with exercise-associated hypothalamic amenorrhea, women without ovulatory dysfunction that exercise equally, non-hyperandrogenic patients with PCOS, hyperandrogenic patients with PCOS, and healthy control women comparable to those with PCOS. The aims of the study will be:\n\nPrimary objective: To identify novel signalling factors originating from adipose tissue and muscle using targeted and nontargeted evaluation of the proteome and of gene expression of superficial subcutaneous fat, deep subcutaneous fat (which mimics visceral adipose tissue) and skeletal muscle.\n\nSecondary objectives:\n\n1. To study the serum adipokine profile - including those identified by the primary objective - and circulating gut hormones during fasting and after a glucose load in the 5 groups of women, and their associations with sexual hormones and body fat distribution.\n2. To study body composition and body fat distribution in these women and their relationships with:\n\n2.1, Sex steroid profiles.\n\n2.2. Classic cardiovascular risk factors: carbohydrate metabolism, lipid profiles and blood pressure.\n\n2.3 Markers of low-grade chronic inflammation.\n\n2.4. Oxidative stress markers.\n\n2.5. Cardiovascular autonomic function.\n\n2.6. Surrogate markers of subclinical atherosclerosis.\n\n2.7. Circulating concentrations of endocrine disruptors.\n\n2.8. Oral and gut microbiome.\n\nThe results will provide a better understanding of the mechanisms linking body energy depots with the female reproductive axis and, hopefully, the identification of potential biomarkers for the diagnosis and treatment of the disorders studied here.",[27,455],"Hypothalamic Amenorrhea",[457,458,459,460,461,462,463,464,465,466],"Exercise","Sex steroids","Hyperandrogenism","Adipose tissue","Muscle","Proteome","Gene expression","Adipokine","Cardiovascular risk","Microbiome","2025-08-06",{"date":469,"type":37},"2025-08-12",{"date":471,"type":37},"2020-01-31",{"date":473,"type":21},"2025-12-31",{"name":475,"class":102},"Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal",{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":135,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":483,"targetDuration":484,"studyType":56,"phases":4,"briefSummary":485,"conditions":486,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":45},"100524929","peppi-study-identification-of-women-at-risk-for-placental-dysfunction-100524929","NCT06115122","PEPPI Study: Identification of Women at Risk for Placental Dysfunction","PEPPI Study: Identification of Women at Risk for Placental Dysfunction During the First and Third Trimesters of Pregnancy","Mothers\n\nInclusion Criteria for PEPPI-study\n\n* Pregnant (first trimester)\n* Understands Finnish\n* ≥18 years\n* Signed informed consent\n\nExclusion Criteria\n\n* Multiple pregnancy\n* Miscarriage\u002Ftermination of the index pregnancy\n* No first trimester blood sampling\n\nInclusion Criteria for FERPPI-study\n\n* Participates in PEPPI-study (criteria above)\n* Blood samples at first and third trimester of pregnancy\n* Permits blood sampling from the umbilical cord when the baby is born\n\nExclusion Criteria\n\n* No first or third trimester blood sampling\n* No umbilical cord blood sample after baby is born\n\nFathers\n\nInclusion Criteria\n\n* Biological father to the child born for the mother who participated in PEPPI study\n* ≥18 years\n* Signed informed consent\n\nExclusion Criteria\n\n• Does not understand Finnish\n\nChildren\n\nInclusion Criteria for PEPPI-study\n\n* Born to mother who participated in PEPPI study\n* Signed informed consent from parent(s)\n\nExclusion Criteria\n\n• No consent from parent(s)\n\nInclusion Criteria for PEPPI-offspring study • Mother in risk-, control-, or PCOS group during PEPPI-study with ultrasound information at gestational weeks 30-32 or a mother who developed pre-eclampsia during the pregnancy regardless of their study group during PEPPI-study\n\nExclusion Criteria\n\n• Mother\u002Ffather declines participation\n\nInclusion Criteria for FERPPI-study\n\n* Signed informed consent from parent(s)\n* Mother has blood samples taken at first and third trimester (iron status)\n* Child has blood samples taken at birth and at 3 months of age\n\nExclusion Criteria\n\n* No consent from parent(s)\n* No blood samples from mother\n* No blood samples from child",{"count":261,"type":21},"15 Years","The main purpose of this study is to evaluate Fetal Medicine Foundation's pre-eclampsia risk calculator using maternal characteristics, first trimester serum placental growth factor (PlGF) and mean arterial pressure (MAP) in a Finnish general population.\n\nCondition or disease: pre-eclampsia, intrauterine growth restriction, polycystic ovary syndrome",[487,488,27,489,490,491,492],"Pre-Eclampsia","Intrauterine Growth Restriction","Iron-deficiency","Cardiovascular Diseases","Hypertensive Disorder of Pregnancy","Proteinuria in Pregnancy","2025-07-31",{"date":495,"type":37},"2025-08-05",{"date":497,"type":37},"2022-02-15",{"date":499,"type":21},"2041-12-31",{"name":501,"class":102},"Oulu University Hospital",{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":508,"eligibilityCriteria":509,"healthyVolunteers":135,"sex":53,"minAge":510,"maxAge":511,"enrollmentInfo":512,"targetDuration":4,"studyType":22,"phases":514,"briefSummary":515,"conditions":516,"keywords":518,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":45},"100418065","early-phase-1-does-spironolactone-normalize-sleep-wake-luteinizing-hormone-pulse-frequency-in-pubertal-girls-with-hyperandrogenism-100418065","NCT04723862","Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism?","Does Spironolactone Normalize Sleep-wake Luteinizing Hormone (LH) Pulse Frequency in Pubertal Girls With Hyperandrogenism? (CBS010)","CBS010","Inclusion Criteria:\n\n* Mid- to late pubertal adolescent girls as signified by either (a) post-menarcheal status (Tanner breast stages 2-5) or (b) Tanner breast stage of 4 or 5 (whether pre-menarcheal or post-menarcheal) ages 10-17 years.\n* Hyperandrogenism, defined as a serum (calculated) free testosterone concentration greater than the Tanner stage-specific reference range and\u002For clinical hirsutism\n* General good health (excepting obesity, hyperandrogenism, PCOS, and adequately-treated hypothyroidism)\n* Willing to strictly avoid pregnancy with use of reliable non-hormonal methods during the study period.\n\nExclusion Criteria:\n\n* Inability\u002Fincapacity to provide informed consent\n* Males will be excluded (hyperandrogenism is unique to females)\n* Age \\\u003C 10 or \\> 17 years (this study is designed to elucidate mechanisms underlying emerging PCOS in mid- to late pubertal adolescent girls\n* Post-menarcheal by \\> 4 years\n* Obesity resulting from a well-defined endocrinopathy, or genetic syndrome\n* To ensure that blood withdrawal is within safe limits, weight \\\u003C 21.5 kg is an exclusion criterion.\n* Since underweight can alter pulsatile LH secretion, BMI-for-age percentile \\\u003C 5 is an exclusion criterion.\n* Positive pregnancy test or current lactation. Subjects with a positive pregnancy test will be informed of the result by the screening physician. Under Virginia law, parental notification is not required for minors. However, the screening physician will encourage the subject to tell her parent(s). We will counsel the adolescent about the importance of appropriate prenatal care\u002Fcounseling. We will offer appropriate follow-up at the Teen Health Clinic at UVA and\u002For encourage the adolescent to secure prompt care via their primary care physician's office.\n* Evidence for non-physiologic or non-PCOS causes of hyperandrogenism and\u002For anovulation\n* Evidence of virilization (e.g., rapidly progressive hirsutism, deepening of the voice, clitoromegaly)\n* Total testosterone \\> 150 ng\u002Fdl, which suggests the possibility of virilizing ovarian or adrenal tumor.\n* DHEA-S elevation \\> 1.5 times the upper reference range limit. Mild elevations may be seen in adolescent HA and in PCOS, and will be accepted in these groups.\n* Early morning 17-hydroxyprogesterone \\> 300 ng\u002Fdl measured in the follicular phase, which suggests the possibility of congenital adrenal hyperplasia (if elevated during the luteal phase, the 17-hydroxyprogesterone will be repeated during the follicular phase). NOTE: if a 17-hydorxyprogesterone \\> 300 ng\u002Fdl is confirmed on repeat testing, an ACTH stimulated 17-hydroxyprogesterone \\\u003C 1000 ng\u002Fdl performed by the subject's personal physician will be required for study participation.\n* Any abnormal TSH concentration will trigger repeat testing. In many cases when TSH is initially abnormal, a repeat TSH will be normal. These subjects will be permitted to continue study. If TSH remains abnormal on repeat testing, the subject will be referred to her primary medical provider. In some cases, a participant's primary medical provider will elect to simply observe a mildly low (\\> 0.1) or mildly elevated (\\\u003C 10) if stable. In such cases, we will accept a TSH between 0.3 and 7 (inclusive) if it has remained stable for at least 6 months-such TSH values are exceedingly unlikely to influence the central reproductive axis or to influence the risks of the study. Notably, subjects with reasonably-treated primary hypothyroidism-reflected by TSH values between 0.3 and 7-on a stable dose of thyroid hormone (i.e., same dose for at least 2 months) will not be excluded.\n* Prolactin concentration \\> 30 ng\u002FmL (confirmed on repeat). Mild prolactin elevations may be seen in adolescents and women with HA\u002FPCOS or obesity.\n* History and\u002For physical exam findings suggestive of Cushing's syndrome, adrenal insufficiency, or acromegaly.\n* History and\u002For physical exam findings suggestive of hypogonadotropic hypogonadism (e.g., symptoms of estrogen deficiency) including functional hypothalamic amenorrhea (which may be suggested by a constellation of symptoms including restrictive eating patterns, excessive exercise, psychological stress, etc.)\n* Persistent hemoglobin \\\u003C 11.5 g\u002FdL for non-African American subjects; hemoglobin \\\u003C 11.0 g\u002FdL for African American subjects (confirmed on repeat). Importantly, documentation of a hemoglobin ≥ 11.0 g\u002FdL for African American subjects or ≥ 11.5 g\u002FdL for non-African American subjects in the month prior to the CRU admission is required for frequent sampling protocol in the CRU.\n* Severe thrombocytopenia (platelets \\\u003C 50,000 cells\u002Fmicroliter) or leukopenia (total white blood count \\\u003C 4,000 cells\u002Fmicroliter)\n* Previous diagnosis of diabetes, fasting glucose ≥ 126 mg\u002Fdl, or a hemoglobin A1c ≥ 6.5%\n* Persistently abnormal sodium or potassium concentration. Bicarbonate concentrations \\\u003C 20 or \\> 30.\n* Liver test abnormalities, with two exceptions: (1) mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome or when the subject's primary care provider provides a presumptive diagnosis of Gilbert's syndrome and has no plans for further work-up; (2) mild transaminase (ALT, AST) elevations may be seen in obese\u002FHA\u002FPCOS girls, so stable elevations \\\u003C 1.5 times the upper limit of normal will be accepted in this group.\n* Absolute contraindications to spironolactone use include history of allergy to spironolactone, anuria, acute renal insufficiency, significant impairment of renal excretory function, hyperkalemia, primary adrenal insufficiency (Addison's disease), and concomitant use of eplerenone\n* Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure, asthma requiring intermittent systemic corticosteroids, etc.)\n* Decreased renal function evidenced by GFR \\\u003C 60 ml\u002Fmin\u002F1.73m2\n* History of cancer diagnosis and\u002For treatment (with the exception of basal cell or squamous cell skin carcinoma) unless they have remained clinically disease free (based on appropriate surveillance) for five years.","10 Years","17 Years",{"count":513,"type":21},32,[332],"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).",[459,27,517],"Puberty",[459,172,517],"2025-07-30",{"date":495,"type":37},{"date":522,"type":37},"2021-11-12",{"date":524,"type":21},"2025-12-01",{"name":526,"class":102},"University of Virginia",{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":531,"acronym":532,"eligibilityCriteria":533,"healthyVolunteers":135,"sex":53,"minAge":17,"maxAge":283,"enrollmentInfo":534,"targetDuration":4,"studyType":22,"phases":536,"briefSummary":537,"conditions":538,"keywords":539,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":540,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":544,"locationsCount":45},"100316551","early-phase-1-study-to-assess-potential-impairments-in-estradiol-augmentation-of-gonadotropin-secretion-in-polycystic-ovary-syndrome-100316551","NCT03401047","Study to Assess Potential Impairments in Estradiol Augmentation of Gonadotropin Secretion in Polycystic Ovary Syndrome","CRM009","Inclusion Criteria:\n\n* PCOS group: post-pubertal (\\> 4 years post-menarche) adult woman aged 18-30 years with PCOS, defined as clinical and\u002For laboratory evidence of hyperandrogenism (hirsutism and\u002For elevated serum \\[calculated\\] free testosterone concentration) plus ovulatory dysfunction (irregular menses, fewer than 9 per year), but without evidence for other potential causes of hyperandrogenism and\u002For ovulatory dysfunction\n* Control group: post-pubertal (\\> 4 years post-menarche) adult woman aged 18-30 years with regular menstrual periods (every 26-35 days) and no evidence of hyperandrogenism (i.e., no hirsutism, normal serum \\[calculated\\] free testosterone concentration)\n* General good health (excepting overweight, obesity, PCOS, and adequately-treated hypothyroidism)\n* Capable of and willing to provide informed consent\n* Willing to strictly avoid pregnancy with use of reliable non-hormonal methods during the study period\n\nExclusion Criteria:\n\n* Inability\u002Fincapacity to provide informed consent\n* Males will be excluded (hyperandrogenism is unique to females)\n* Age \\\u003C 18 years (we do not propose to study children because we have no preliminary data that would support this particular study in children)\n* Age \\> 30 years (since ovarian reserve may decrease beyond age 30)\n* Obesity resulting from a well-defined endocrinopathy or genetic syndrome\n* Positive pregnancy test or current lactation\n* Evidence for non-physiologic or non-PCOS causes of hyperandrogenism and\u002For anovulation\n* Evidence of virilization (e.g., rapidly progressive hirsutism, deepening of the voice, clitoromegaly)\n* Total testosterone \\> 150 ng\u002Fdl, which suggests the possibility of virilizing ovarian or adrenal tumor\n* DHEA-S greater than upper reference range limit for controls; and DHEA-S elevation \\> 1.5 times the upper reference range limit for PCOS. Mild elevations may be seen in PCOS, and will be accepted in this group.\n* Early morning 17-hydroxyprogesterone \\> 200 ng\u002Fdl measured in the follicular phase, which suggests the possibility of congenital adrenal hyperplasia (if elevated during the luteal phase, the 17-hydroxyprogesterone will be repeated during the follicular phase). NOTE: If a 17-hydroxyprogesterone \\> 200 ng\u002Fdl is confirmed on repeat testing, an ACTH stimulated 17-hydroxyprogesterone \\\u003C 1000 ng\u002Fdl will be required for study participation.\n* Abnormal thyroid stimulating hormone (TSH): Note that subjects with stable and adequately treated primary hypothyroidism, reflected by normal TSH values, will not be excluded.\n* Hyperprolactinemia: Any degree of hyperprolactinemia (confirmed on repeat) will be grounds for exclusion for subjects without PCOS. Hyperprolactinemia \\> 20% higher than the upper limit of normal will be grounds for exclusion for subjects without PCOS. Mild prolactin elevations may be seen in PCOS, and elevations within 20% higher than the upper limit of normal will be accepted in this group.\n* History and\u002For physical exam findings suggestive of Cushing's syndrome, adrenal insufficiency, or acromegaly\n* History and\u002For physical exam findings suggestive of hypogonadotropic hypogonadism (e.g., symptoms of estrogen deficiency) including functional hypothalamic amenorrhea (which may be suggested by a constellation of symptoms including restrictive eating patterns, excessive exercise, psychological stress, etc.)\n* Persistent hematocrit \\\u003C 36% and hemoglobin \\\u003C 12 g\u002Fdl\n* Severe thrombocytopenia (platelets \\\u003C 50,000 cells\u002Fmicroliter) or leukopenia (total white blood count \\\u003C 4,000 cells\u002Fmicroliter)\n* Previous diagnosis of diabetes, fasting glucose \\> or = 126 mg\u002Fdl, or a hemoglobin A1c \\> or = 6.5%\n* Persistent liver panel abnormalities, with two exceptions. Mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome. Also, mild transaminase elevations may be seen in obesity\u002FPCOS; therefore, elevations \\\u003C 1.5 times the upper limit of normal will be accepted in these groups.\n* Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure, asthma requiring intermittent systemic corticosteroids, etc.)\n* Decreased renal function evidenced by GFR \\\u003C 60 ml\u002Fmin\u002F1.73m2\n* A personal history of breast, ovarian, or endometrial cancer\n* History of any other cancer diagnosis and\u002For treatment (with the exception of basal cell or squamous cell skin carcinoma) unless they have remained clinically disease free (based on appropriate surveillance) for five years\n* History of allergy to transdermal estradiol patches\n* BMI \\\u003C 18 or \\> 40 kg\u002Fm2; BMI \\\u003C 18 kg\u002Fm2 is considered to be underweight, while \\> 40 kg\u002Fm2 is considered to be class 3 obesity -- both may have marked confounding effects for the outcomes of interest\n* Menstrual cycles lasting fewer than 26 days: Cycle frequency \\\u003C 26 days suggest the possibility of relatively short follicular phases (e.g., \\\u003C 12 days). If a subject with a follicular phase shorter than 12 days participates in Aim 1c, they could experience an endogenous gonadotropin surge under surveillance. Since we wish to capture only experimentally-induced surges, we will exclude such subjects.",{"count":535,"type":21},37,[332],"The purpose of this study is to determine if estradiol augmentation of luteinizing hormone (LH) secretion secretion (primary endpoint) and follicle-stimulating hormone (FSH) secretion (secondary endpoint) is reduced in adult women with polycystic ovary syndrome.",[27],[172],{"date":495,"type":37},{"date":542,"type":37},"2017-11-30",{"date":524,"type":21},{"name":526,"class":102},{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":551,"eligibilityCriteria":552,"healthyVolunteers":135,"sex":53,"minAge":510,"maxAge":511,"enrollmentInfo":553,"targetDuration":4,"studyType":22,"phases":554,"briefSummary":555,"conditions":556,"keywords":557,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":558,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":562,"locationsCount":45},"100291064","early-phase-1-hyperandrogenemia-and-altered-day-night-lh-pulse-patterns-100291064","NCT03068910","Hyperandrogenemia and Altered Day-night LH Pulse Patterns","Study to Evaluate if Androgen-receptor Blockade (Spironolactone) Improves Progesterone-suppression of Wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism","CRM008","Inclusion Criteria:\n\n* Mid- to late pubertal adolescent girl (at least Tanner breast stage 3, but no more than 2 years postmenarcheal)\n* Hyperandrogenism, defined as a serum (calculated) free testosterone concentration greater than the Tanner stage-specific reference range and\u002For unequivocal evidence for hirsutism\n* General good health (excepting overweight, obesity, hyperandrogenism, and adequately-treated hypothyroidism)\n* Capable of and willing to provide informed assent (adolescents under age 16 years) and\u002For consent (adolescents over age 16 years; custodial parents or guardians of all adolescent volunteers)\n* Willing to strictly avoid pregnancy with use of reliable non-hormonal methods during the study period\n\nExclusion Criteria:\n\n* Inability\u002Fincapacity to provide informed consent\n* Males will be excluded (hyperandrogenism is unique to females)\n* Obesity resulting from a well-defined endocrinopathy or genetic syndrome\n* Positive pregnancy test or current lactation\n* Evidence for non-physiologic or non-PCOS causes of hyperandrogenism and\u002For anovulation\n* Evidence of virilization (e.g., rapidly progressive hirsutism, deepening of the voice, clitoromegaly)\n* Total testosterone \\> 150 ng\u002Fdl, which suggests the possibility of virilizing ovarian or adrenal tumor\n* DHEA-S elevation \\> 1.5 times the upper reference range limit. Mild elevations may be seen in adolescent HA and in PCOS, and will be accepted in these groups.\n* Early morning 17-hydroxyprogesterone \\> 200 ng\u002Fdl measured in the follicular phase, which suggests the possibility of congenital adrenal hyperplasia (if elevated during the luteal phase, the 17-hydroxyprogesterone will be repeated during the follicular phase). NOTE: If a 17-hydroxyprogesterone \\> 200 ng\u002Fdl is confirmed on repeat testing, an ACTH stimulated 17-hydroxyprogesterone \\\u003C 1000 ng\u002Fdl will be required for study participation.\n* Abnormal thyroid stimulating hormone (TSH): Note that subjects with stable and adequately treated primary hypothyroidism, reflected by normal TSH values, will not be excluded.\n* Hyperprolactinemia \\> 20% higher than the upper limit of normal. Mild prolactin elevations may be seen in adolescents and women with HA\u002FPCOS, and elevations within 20% higher than the upper limit of normal will be accepted in this group.\n* History and\u002For physical exam findings suggestive of Cushing's syndrome, adrenal insufficiency, or acromegaly\n* History and\u002For physical exam findings suggestive of hypogonadotropic hypogonadism (e.g., symptoms of estrogen deficiency) including functional hypothalamic amenorrhea (which may be suggested by a constellation of symptoms including restrictive eating patterns, excessive exercise, psychological stress, etc.)\n* Persistent hematocrit \\\u003C 36% and hemoglobin \\\u003C 12 g\u002Fdl.\n* Severe thrombocytopenia (platelets \\\u003C 50,000 cells\u002Fmicroliter) or leukopenia (total white blood count \\\u003C 4,000 cells\u002Fmicroliter)\n* Previous diagnosis of diabetes, fasting glucose \\> or = 126 mg\u002Fdl, or a hemoglobin A1c \\> or = 6.5%\n* Persistent liver panel abnormalities, with two exceptions. Mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome. Also, mild transaminase elevations may be seen in obesity\u002FHA\u002FPCOS; therefore, elevations \\\u003C 1.5 times the upper limit of normal will be accepted in this group.\n* Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure, asthma requiring intermittent systemic corticosteroids, etc.)\n* Decreased renal function evidenced by GFR \\\u003C 60 ml\u002Fmin\u002F1.73m2\n* A personal history of breast, ovarian, or endometrial cancer\n* History of any other cancer diagnosis and\u002For treatment (with the exception of basal cell or squamous cell skin carcinoma) unless they have remained clinically disease free (based on appropriate surveillance) for five years\n* History of allergy to micronized progesterone or spironolactone\n* Body mass index (BMI)-for-age percentile \\\u003C 5% (underweight)\n* Due to the amount of blood being drawn, adolescent volunteers with body weight \\\u003C 25 kg will be excluded.\n* Restrictions on use of other drugs or treatments: No medications known to affect the reproductive system, glucose metabolism, lipid metabolism, or blood pressure can be taken in the 2 months prior to the screening visit and in the 3 months prior to the start of the study medications. Such medications include oral contraceptive pills, progestins, metformin, systemic glucocorticoids, some antipsychotic medications, and sympathomimetics\u002Fstimulants (e.g., methylphenidate).",{"count":513,"type":21},[332],"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).",[459,27,517],[459,172,517],{"date":495,"type":37},{"date":560,"type":37},"2016-07-21",{"date":524,"type":21},{"name":526,"class":102},{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":569,"enrollmentInfo":570,"targetDuration":4,"studyType":22,"phases":572,"briefSummary":573,"conditions":574,"keywords":581,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":45},"100519889","lifestyle-medicine-establishing-clinical-approaches-to-chronic-disease-for-rural-patients-100519889","NCT06049420","Lifestyle Medicine: Establishing Clinical Approaches to Chronic Disease for Rural Patients","Inclusion Criteria:\n\n* Program admittance will be restricted to patients with 2+ diagnosed diseases that have sufficient evidence for the efficacy of exercise therapy (obesity, hyperlipidemia, metabolic syndrome, polycystic ovarian syndrome, type II diabetes, hypertension, coronary heart disease, heart failure, depression, anxiety)\n* physician referral required\n\nExclusion Criteria:\n\n* no chronic disease diagnosis, lack of physician referral, unwillingness to participate.","64 Years",{"count":571,"type":21},95,[113],"Developed nations worldwide are currently enduring a health crisis, as chronic diseases continue to decrease quality of life and promote additional disease states or even death for much of the population. Rural populations are at a particular disadvantage, as they lack access to health clubs, wellness programs and similar resources that are more available in urban areas. Although pharmaceutical therapies have continued to show therapeutic advancements, the rates of disease onset and death from chronic disease has not seen similar improvements, and in fact continue to worsen. Excitingly, significant evidence has been published demonstrating an affordable, effective treatment to directly treat and prevent these chronic diseases, but few have demonstrated successful implementation of this therapy, which is improved lifestyle. Specifically, physical activity and healthy body composition are powerful therapeutics that have been demonstrated to effectively combat and prevent chronic diseases. Additionally, improving these lifestyle factors are often more effective than pharmaceutical interventions without the wide range of side effects. Unfortunately, barriers exist on multiple tiers in the practice of family medicine that demote the implementation of lifestyle medicine. To better serve patients at risk of, or suffering from chronic disease, the investigators are seeking to establish a lifestyle medicine prescription program for rural West Virginia. This program will provide patient education on the benefits of physical activity, body composition, and help patients identify strategies to implement healthy lifestyle choices that can be sustainable for the long-term. Patients will be advised on local opportunities to increase physical activity (yoga studio, martial arts, fitness facilities, aquatic center, etc.) and provided access to the facilities they are most likely to adhere to regularly. They will also be provided training on exercise techniques, equipment, and facilities to increase familiarity and comfort in these settings.",[32,575,27,576,577,578,579,580,93],"Hyperlipidemias","Hypertension","Coronary Heart Disease","Heart Failure","Depression, Anxiety","Type II Diabetes",[582,583,584],"lifestyle","chronic disease","physical activity","2025-07-21",{"date":587,"type":37},"2025-07-25",{"date":589,"type":37},"2025-02-01",{"date":591,"type":21},"2027-09-01",{"name":593,"class":102},"West Virginia School of Osteopathic Medicine",{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":598,"acronym":60,"eligibilityCriteria":599,"healthyVolunteers":12,"sex":53,"minAge":109,"maxAge":54,"enrollmentInfo":600,"targetDuration":4,"studyType":22,"phases":602,"briefSummary":603,"conditions":604,"keywords":605,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":609,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":614,"locationsCount":45},"100580348","phase-3-the-combined-effect-of-n-acetyl-cysteine-and-metformin-in-polycystic-ovary-syndrome-patients-100580348","NCT06836128","The Combined Effect of N-Acetyl Cysteine and Metformin in Polycystic Ovary Syndrome Patients","Inclusion Criteria:\n\n1. Female aged 20 to 45 years old.\n2. Confirmed diagnosis with PCOS according to the 2023 International Evidence-based Guideline for the Assessment and Management of PCOS.\n3. Ability to give informed consent.\n\nExclusion Criteria:\n\n1. Hypersensitivity to either metformin or NAC.\n2. Consumption of medications affecting carbohydrate metabolism, such as insulin, sulfonylureas, and taking hormonal analogues two months prior to enrollment.\n3. Hyperprolactinemia, defined as a prolactin level above laboratory reference range.\n4. Diabetes mellitus.\n5. Thyroid dysfunction, subjects with elevated or low TSH level.\n6. Renal impairment where creatinine clearance (CrCl) less than 30 ml\u002Fmin.\n7. Severe hepatic impairment, defined as significant biochemical abnormalities, including hypoalbuminemia and abnormal serum concentration (2-3 times the upper limit of normal), of at least two of the following liver function markers: total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or gamma-glutamyl transferase (GGT).\n8. Active alcohol abuse.\n9. History of lactic acidosis during metformin therapy.\n10. Active peptic ulcer.\n11. Congenital adrenal hyperplasia.\n12. Cushing's syndrome.\n13. Androgen secreting neoplasia.\n14. Patients who were using spironolactone, other anti-androgens, or any form of hormone therapy for the treatment of hirsutism at least 3 months before enrollment in the study.\n15. Decompensated heart failure.",{"count":601,"type":21},102,[167],"The study aims to evaluate the effects of combination of metformin with NAC in PCOS on biochemical and hormonal parameters.",[27],[60,606,607],"NAC","metformin","2025-07-04",{"date":610,"type":37},"2025-07-09",{"date":612,"type":37},"2025-03-01",{"date":148,"type":21},{"name":126,"class":102},{"id":616,"slug":617,"hasResults":12,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":4,"eligibilityCriteria":621,"healthyVolunteers":12,"sex":53,"minAge":17,"maxAge":4,"enrollmentInfo":622,"targetDuration":4,"studyType":22,"phases":624,"briefSummary":625,"conditions":626,"keywords":627,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":641},"100527112","phase-1-safety-of-cultured-allogeneic-adult-umbilical-cord-derived-mesenchymal-stem-cells-for-pcos-100527112","NCT06143527","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for PCOS","Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Polycystic Ovary Syndrome","Inclusion Criteria:\n\n• Ultrasound documented poly cystic ovary syndrome\n\nExclusion Criteria:\n\n* Active infection\n* Active cancer\n* Chronic multisystem organ failure\n* Pregnancy\n* Clinically significant abnormalities on pre-treatment laboratory evaluation\n* Medical condition that would (based on the opinion of the investigator) compromise patient's safety\n* Continued drug abuse\n* Previous organ transplant\n* Hypersensitivity to sulfur\n* Inability to supply proper informed consent",{"count":623,"type":21},20,[24],"This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells delivered intravenously for the treatment of Polycystic Ovary Syndrome.",[59,27,60],[59,27,60,628,629,630,631],"Stem Cell","Stem Cells","Mesenchymal Stem Cells","Umbilical Cord Derived Mesenchymal Stem Cells","2025-04-04",{"date":634,"type":37},"2025-04-08",{"date":636,"type":37},"2023-11-16",{"date":638,"type":21},"2027-11-16",{"name":640,"class":102},"The Foundation for Orthopaedics and Regenerative Medicine",2]