[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hyperandrogenism\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hyperandrogenism":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,40,66,97,115,137,168,190],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100612428","combined-use-of-machine-learning-and-metabolomics-to-improve-the-diagnosis-and-management-of-hyperandrogenism-100612428",false,"NCT07253454","Combined Use of Machine Learning and Metabolomics to Improve the Diagnosis and Management of Hyperandrogenism","HYPERMETABO","Inclusion Criteria:\n\n* Patients of childbearing age (16 to 45 years old)\n* Suffering from hyperandrogenism\n* Established etiological diagnosis with elimination of differential diagnoses\n* Informed and not opposed to the collection of their data for the purposes of the study\n\nExclusion Criteria:\n\n* Pregnancy\n* Patients under legal protection measures","FEMALE","16 Years","45 Years",{"count":20,"type":21},800,"ESTIMATED","OBSERVATIONAL","Hyperandrogenism is a common reason for consultation, the causes of which can range from common conditions (PCOS) to rarer conditions with major genetic implications (NC21OHD). It is characterized by elevated levels of circulating androgens, mainly testosterone. This excess of androgens usually manifests clinically as increased male-pattern hair growth and, less specifically, acne and alopecia. Its prevalence is estimated at between 6 and 12% in women of reproductive age, and its incidence is increasing.\n\nIt is also responsible for infertility. As a reminder, infertility is a major public health issue and affects more and more couples around the world.\n\nThe investigators therefore wish to develop innovative tools to improve the diagnosis and management of hyperandrogenism",[25],"Hyperandrogenism",[27],"fertility","NOT_YET_RECRUITING","2025-11-27",{"date":31,"type":32},"2025-12-04","ACTUAL",{"date":34,"type":21},"2026-01",{"date":36,"type":21},"2040-12",{"name":38,"class":39},"Assistance Publique - Hôpitaux de Paris","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100584447","cardiovascular-and-endothelial-markers-during-ogtt-before-and-at-six-and-twelve-months-post-treatment-in-women-with-pcos-100584447","NCT06889454","Cardiovascular and Endothelial Markers During OGTT Before and at Six and Twelve Months Post-treatment in Women With PCOS","The Effect of Different Treatment Options on Markers of Vascular, Myocardial and Endothelial Function in Women With Polycystic Ovary Syndrome and the Association With Metabolic and Hormonal Abnormalities of the Syndrome","Inclusion Criteria:\n\n1. Age \\> 16 years old\n2. Diagonis of PCOS according to Rotterdam criteria: presence of two of the three of the following:\n\n   * Clinical or biochemical hyperandrogenism\n   * Anovulation or oligo-ovulation\n   * Polycystic ovarian morphology (PCOM)\n3. Absence of treatment for PCOS the last six months\n4. Patients who have the ability to understand and sign the consent form.\n\nExclusion Criteria:\n\n1. Disorders with clinical presentation similar to PCOS: thyroid disease, hyperprolactinemia, and non-classic congenital adrenal hyperplasia (primarily 21-hydroxylase deficiency by serum 17-hydroxyprogesterone \\[17-OHP\\]), Cushing syndrome, acromegaly\n2. Treatment with contraceptive or metformin\n3. Type 2 diabetes mellitus\n4. Treatment for diabetes\n5. Pregnancy\n6. Lactation\n7. Malignancy","18 Years",{"count":49,"type":21},120,"The aim of the present study is to investigate a) the presence of subclinical markers of vascular, myocardial and endothelial function in women with PCOS b) the acute alterations in these markers during the oral glucose tolerance test (OGTT) c) the impact of potential treatment interventions in these markers.",[52,53,25,54],"PCOS","Hyperinsulinism","Metabolic Syndrome","RECRUITING","2025-11-15",{"date":58,"type":32},"2025-11-19",{"date":60,"type":32},"2024-02-01",{"date":62,"type":21},"2026-02-01",{"name":64,"class":39},"Attikon Hospital",1,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":16,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":65},"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.",true,"10 Years","17 Years",{"count":78,"type":21},32,"INTERVENTIONAL",[81],"EARLY_PHASE1","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).",[25,84,85],"Polycystic Ovary Syndrome","Puberty",[25,87,85],"Polycystic ovary syndrome","2025-07-30",{"date":90,"type":32},"2025-08-05",{"date":92,"type":32},"2021-11-12",{"date":94,"type":21},"2025-12-01",{"name":96,"class":39},"University of Virginia",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":74,"sex":16,"minAge":75,"maxAge":76,"enrollmentInfo":105,"targetDuration":4,"studyType":79,"phases":106,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":110,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":114,"locationsCount":65},"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":78,"type":21},[81],"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).",[25,84,85],[25,87,85],{"date":90,"type":32},{"date":112,"type":32},"2016-07-21",{"date":94,"type":21},{"name":96,"class":39},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":74,"sex":16,"minAge":75,"maxAge":76,"enrollmentInfo":123,"targetDuration":4,"studyType":79,"phases":125,"briefSummary":126,"conditions":127,"keywords":128,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":136,"locationsCount":65},"100127574","early-phase-1-acute-progesterone-suppression-of-wake-vs-sleep-luteinizing-hormone-pulse-frequency-in-pubertal-girls-with-and-without-hyperandrogenism-100127574","NCT00929006","Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism","Study to Assess Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism","CRM003","Inclusion Criteria:\n\n* Mid- to late pubertal adolescent girl (at least Tanner breast stage 3, but no more than 2 years postmenarcheal)\n* For girls without hyperandrogenism: serum (calculated) free testosterone concentration within the Tanner stage-specific reference range and the absence of hirsutism\n* For girls with hyperandrogenism: 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: Mild prolactin elevations may be seen in 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* 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 such girls.\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.\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":124,"type":21},36,[81],"The purpose of this study is two-fold. (1) We will determine if in mid- to late pubertal girls without hyperandrogenism (HA), progesterone (P4) acutely reduces waking luteinizing hormone (LH) frequency to a greater extent than sleep-associated LH frequency. (2) We will determine if in mid- to late pubertal girls with HA, P4 will acutely suppress waking LH frequency to a lesser degree than it does in girls without HA.",[85,25],[129,130,131],"hyperandrogenemia","pubertal","polycystic ovary syndrome",{"date":90,"type":32},{"date":134,"type":32},"2008-06",{"date":94,"type":21},{"name":96,"class":39},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":74,"sex":16,"minAge":47,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":79,"phases":148,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":167},"100258785","phase-2-acupuncture-or-metformin-for-insulin-resistance-in-women-with-pcos-100258785","NCT02647827","Acupuncture or Metformin for Insulin Resistance in Women With PCOS","Acupuncture or Metformin for Insulin Resistance in Women With Polycystic Ovary Syndrome: A Randomized Controlled Trial","PIAII","Inclusion criteria - women with PCOS:\n\n1. Age 18 to 40 years\n2. Body mass index (BMI) ≥25 to ≤40 given that 95% of all women with PCOS with a BMI ≥25 are insulin resistant (71,72).\n3. PCOS diagnosis according to Rotterdam criteria 2003 (73), with at least two of the following three symptoms: Clinical signs of hyperandrogenism (hirsutism or acne); oligo\u002Famenorrhea; and\u002For polycystic ovaries (PCOS). Hirsutism is defined as a self-reported Ferriman-Gallwey (FG) score ≥8 (≥5 Asian) (74,75). Acne is defined by a positive response to the question Do you have acne? Oligomenorrhea is defined as an intermenstrual interval \\>35 days and \\\u003C8 menstrual bleedings in the past year. Amenorrhea as \\\u003C3 cycles per year. PCO is defined by transvaginal ultrasound with ≥12 follicles 2-9 mm and\u002For ovarian volume ≥10 ml in one or both ovaries.\n4. Willing to sign the consent form.\n\nInclusion criteria - controls:\n\nControls should have BMI \\>25 to \\\u003C40, regular cycles with 28 days ± 2 days, and no signs of hyperandrogenism. They are excluded if they have menstrual irregularities, signs of hyperandrogenism (FG \\>4), or evidence of PCO morphology on ultrasound.\n\nExclusion criteria for all women\n\n1. Age \\>40\n2. Exclusion of other endocrine disorders such as non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone \\\u003C 3nmol\u002FL), androgen secreting tumors or suspected Cushing's syndrome.\n3. Having known renal disease (creatinine clearance \\\u003C 60 mL\u002Fmin), hepatic insufficiency, autoimmune disorders or cancer.\n4. Any acute condition with potential to alter renal function or cause tissue hypoxia.\n5. Type I diabetes.\n6. Pharmacological treatment (cortizon, antidepressant, other antidiabetic treatment such as insulin and acarbose, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 weeks. Depo Provera or similar within 6 months.\n7. Hypersensitivity to metformin hydrochloride or to any of the excipients.\n8. Blood pressure \\>160 \u002F 100 mmHg\n9. Pregnancy or breastfeeding the last 6 months\n10. Acupuncture the last 2 months\n11. Daily smoking and alcoholic intake\n12. Language barrier or disabled person with reduced ability to understand the information given.\n\nIn total 50 controls will be matched at baseline (age, weight and BMI) to women with PCOS. Controls will undergo screening and baseline visit, but will not be randomized to any treatment.","40 Years",{"count":147,"type":21},303,[149],"PHASE2","The hypothesis is that acupuncture is equally effective as metformin (both treatments combined with lifestyle management) in improving whole body glucose homeostasis in insulin resistant women with polycystic ovary syndrome (PCOS), and that both are superior to lifestyle management alone. The investigators hypothesize that acupuncture and metformin induce ovulation and improve hyperandrogenism, as well as health related quality of life (HRQoL) and symptoms of anxiety and depression. Although equally effective (acupuncture and metformin), the investigators hypothesize that acupuncture is associated with less negative side-effects. The investigators also hypothesize that these treatments have the potential to restore epigenetic and molecular alterations in target tissues (endometrial-, adipose-, and skeletal muscle tissue) and thus have the potential to prevent the development of type 2 diabetes (T2D).",[84,152,25],"Insulin Resistance",[154,155,156,157],"Acupuncture","Metformin","Glucose metabolism","Hba1c","2024-10-07",{"date":160,"type":32},"2024-10-09",{"date":162,"type":4},"2015-12",{"date":164,"type":21},"2026-06",{"name":166,"class":39},"Karolinska Institutet",2,{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":74,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":65},"100432556","female-metabolic-risk-and-androgens-an-irish-longitudinal-femail-study-100432556","NCT04912648","FEmale Metabolic Risk and Androgens: an Irish Longitudinal (FEMAIL) Study","FEMAIL","Inclusion Criteria:\n\n* Age 18 years or above\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding at the time of planned recruitment\n* History of significant renal (eGFR\\\u003C30) or hepatic impairment (AST or ALT \\>two-fold above ULN; pre-existing bilirubinaemia \\>1.2 ULN)\n* The investigators will retain the right not to recruit potential participants with severe health disorders which may impact on their ability to participate in the study; these may include, but are not limited to, metastatic cancer, severe cardio-respiratory disease or other life-limiting health disorders\n* Participants who have participated in another research study involving an investigational medicinal product in the 12 weeks preceding the planned recruitment\n* Glucocorticoid use via any route within the last six months\n* Current intake of drugs known to impact upon steroid or metabolic function or intake of such drugs during the six months preceding the planned recruitment\n* Use of combined oral hormonal contraception in the three months preceding the planned recruitment",{"count":176,"type":21},500,"Androgen excess is the cardinal biochemical feature of polycystic ovary syndrome (PCOS), a lifelong metabolic disorder affecting 10% of women. Serum testosterone correlates with insulin resistance in women, however, there is an urgent need to improve our understanding of the association between androgens and the risk of type 2 diabetes. Recently, a new subclass of androgenic steroids known as 11-oxygenated androgens has been identified. Utilising highly sensitive liquid chromatography-tandem mass spectrometry (LC-MS\u002FMS) techniques, our group has recently demonstrated that 11-oxygenated steroids are the predominant androgens in both health controls and women with PCOS, and that these correlate closely with markers of insulin resistance. The bioactive 11-oxygenated androgen 11-ketotestosterone (11KT) binds and activates the androgen receptor with equal affinity to testosterone, yet nothing is known about its impact on metabolism or glucose homeostasis. Intriguingly, unlike testosterone, 11-oxygenated androgens do not decline with age in women, and, therefore, may mediate an increased risk of T2DM in women across their life course. Therefore, this previously ignored androgen class is likely of major importance in female metabolic health, and may represent a novel metabolic risk factor and biomarker. However, 11-oxygenated androgens are not currently measured in routine clinical practice. To date, no population-based or human in vivo physiology studies have examined the association between 11-oxygenated androgens, glucose metabolism and diabetes risk in women, despite the high prevalence of PCOS in the female population. There is emerging evidence, even in women without a confirmed history of PCOS, that the levels of androgens over time correlate with their likelihood of developing metabolic and cardiovascular disease. This has not been studied to date in a prospective manner in healthy women in the background population using long term follow up data.",[25,179,180],"Metabolic Disease","Sex Hormones Adverse Reaction","2024-05-01",{"date":183,"type":32},"2024-05-02",{"date":185,"type":32},"2021-04-01",{"date":187,"type":21},"2031-08-31",{"name":189,"class":39},"Royal College of Surgeons, Ireland",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":74,"sex":198,"minAge":4,"maxAge":47,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":201,"conditions":202,"keywords":207,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":65},"100342698","offspring-born-to-mothers-with-polycystic-ovary-syndrome-in-guangzhou-cohort-study-100342698","NCT03742011","Offspring Born to Mothers With Polycystic Ovary Syndrome in Guangzhou Cohort Study","Health of Offspring Born to Mothers With Polycystic Ovary Syndrome in Guangzhou Cohort Study","PCOS-BIG","Inclusion Criteria:\n\n* Offspring born to women diagnosed with PCOS\n* Offspring born to women with \\\u003C20 weeks of gestation, intended to eventually deliver in Guangzhou Women and Children's Medical Center\n* Permanent residents or families intended to remain in Guangzhou for ≥3 years\n\nExclusion Criteria:\n\n* None","ALL",{"count":200,"type":21},2000,"The Offspring Born to Mothers with Polycystic Ovary Syndrome in Guangzhou Cohort study (PCOS-BIG) was established to investigate the short- and long-term effects of intrauterine exposure to maternal PCOS on the health of offspring in Guangzhou, China. Data are collected regarding maternal PCOS subtypes, nursing, diet and education as well as health outcomes in their later life. Biological samples including blood and tissue samples are also collected from participants.",[52,203,25,204,152,205,206],"Offspring, Adult","Epigenetics","Endocrine Disorder","Metabolic Disturbance",[52,25,204,208],"Glucolipid metabolism disorder","2024-02-22",{"date":211,"type":32},"2024-02-26",{"date":213,"type":32},"2012-02-01",{"date":215,"type":21},"2038-12-31",{"name":217,"class":39},"Guangzhou Women and Children's Medical Center"]