[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"puberty\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:puberty":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,45,76,102,138,166,184,206,233,258,289],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100253877","investigating-the-impact-of-obesity-on-pubertal-development-in-girls-100253877",false,"NCT02583646","Investigating the Impact of Obesity on Pubertal Development in Girls","* INCLUSION CRITERIA:\n* Girls without a chronic medical condition\n* Normal weight (BMI 5th-85th%) or overweight\u002Fobese (BMI \\> 85th%)\n* 8-14 years old\n* Some breast development\n* Pre-menarchal\n\nEXCLUSION CRITERIA:\n\n* Treated with medications that may affect reproductive hormones (e.g. birth control pills).\n* Pregnancy\n\nDuring the study, the PI s discretion may be used to determine final eligibility. The PI s discretion may be used at any point in the study (pre-screening, clinical\u002Flab assessments, etc.) to ensure participants are not subjected to unnecessary procedures or visits.",true,"FEMALE","8 Years","14 Years",{"count":20,"type":21},150,"ESTIMATED","OBSERVATIONAL","Background:\n\nStudies suggest that overweight girls may be developing breast tissue, and therefore starting puberty, earlier than normal weight girls. However, it is hard to distinguish breast tissue from fatty tissue. Researchers think that by using breast ultrasound, among other tests, they can do a better job of telling whether an overweight girl has breast tissue. This will help them understand if overweight girls are truly entering puberty before normal weight girls.\n\nObjective:\n\nTo find out if overweight girls go through puberty earlier than normal weight girls.\n\nEligibility:\n\nHealthy girls 8-14 years old who:\n\n* Are normal weight or overweight\n* Have some breast development\n* Have not started their first period\n\nDesign:\n\nParents of participants will be screened over the phone.\n\nMost participants will have 1 visit. However, they can choose to have multiple visits within 4 weeks. The visit will include:\n\n* Physical exam that includes examination of the breasts and genital area\n* Breast ultrasound: A small hand-held device will be passed back and forth over the chest. It uses sound waves to create a picture of the breast tissue.\n* Pelvic ultrasound: A small, handheld device will be passed back and forth over the lower belly. It uses sound waves to create a picture of the ovaries.\n* Urine and blood test\n* A special x-ray called a DXA to measure the amount of fat in the body: The participant will lie still on a table while the x-ray takes pictures of the body.\n\nX-ray of the hand: The picture will tell researchers how mature the participant s bones are.\n\nParticipants may be asked to come back 6 months later to repeat these tests.",[25,26,27],"Obesity","Puberty","Normal Physiology",[25,26,29,30,31],"Ultrasound","Pediatric","Natural History","RECRUITING","2026-06-05",{"date":35,"type":36},"2026-06-08","ACTUAL",{"date":38,"type":36},"2015-12-15",{"date":40,"type":21},"2026-09-30",{"name":42,"class":43},"National Institute of Environmental Health Sciences (NIEHS)","NIH",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":15,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":44},"100575864","rejection-sensitivity-and-puberty-in-mental-health-vulnerability-to-social-media-experiences-in-early-adolescent-girls-100575864","NCT06777823","Rejection Sensitivity and Puberty in Mental Health Vulnerability to Social Media Experiences in Early Adolescent Girls","Inclusion Criteria:\n\n* female aged 10-11 years\n* engagement in social media use\n* proficient in the English language\n* family\u002Fpersonal device that can complete daily diaries\n\nExclusion Criteria:\n\n* previously diagnosed chronic medical illness\n* autism spectrum disorder\n* significant developmental or speech delay\n* endocrine disorder\n* not assigned female at birth (AFAB)","10 Years",{"count":53,"type":21},250,"INTERVENTIONAL",[56],"NA","This longitudinal study is designed to test bidirectional relationships between preteen girls' mental health and social media experiences. We will explore how pubertal development and experiences of rejection influence these relationships.",[59,26,60],"Rejection Sensitivity","Psychopathology",[62,63,64,65],"puberty","rejection sensitivity","psychopathology","social media","2026-04-30",{"date":68,"type":36},"2026-05-06",{"date":70,"type":36},"2025-02-05",{"date":72,"type":21},"2029-06-30",{"name":74,"class":75},"Washington University School of Medicine","OTHER",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":54,"phases":84,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":44},"100600846","activegirls-physical-activity-hormone-health-and-diabetes-risk-in-early-adolescence-100600846","NCT07102797","ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence","Inclusion Criteria:\n\n* Caregiver: Caregiver of child (ie mother, father, or other legal guardian), English-speaking, Access to a device where they are able to receive study e-mails or texts\n* Child: English-speaking, Female, ages 8-12 years old at time of enrollment, Pre-menarchal at time of baseline visit, at risk for Polycystic Ovary Syndrome (PCOS)\u002Finsulin resistance, as defined by (1) History of maternal PCOS\u002Fmaternal GDM, (2) BMI \\>\u002F= 85th percentile, (3) History of premature adrenarche, or (4) Small (\\\u003C10th %ile) for gestational age\n\nExclusion Criteria (Child):\n\n* Medications at time of enrollment: Metformin, GLP-1R Agonist, Insulin, GnRH agonist\n* Endocrine conditions that would impact either insulin sensitivity, androgen concentrations, or growth\n* Insulin dynamics: Type 1 diabetes, Type 2 diabetes, Congenital Hyperinsulinism\n* Androgen Conditions: Adrenal tumor, Congenital Adrenal Hyperplasia\n* Hyperthyroidism or uncontrolled hypothyroidism (TSH \\>7.0 mIU\u002FmL)\n* Growth Hormone Deficiency\n* Medical conditions that would impact PA participation: Type 1 diabetes; Cardiovascular, neurologic, and\u002For musculoskeletal conditions limiting ability to participate in physical activity.\n* Other medical comorbidities that would limit generalizability of findings, including: Severe congenital heart disease, Congenital anomalies, Cystic fibrosis, Cerebral palsy, Condition requiring use of nasogastric, gastric tube, or other alternative method of feeding, Undiagnosed conditions with significant impact on child's growth and development; Significant cardiac, hepatic, oncologic, inflammatory, or psychiatric disease.",{"count":83,"type":21},40,[56],"This study explores how a physical activity program can affect hormone health and diabetes risk in girls ages 8-12 who may be at higher risk. The study aims to address:\n\n* Does the 'ActiveGirls' program meet the needs of girls and families in engaging them to increase physical activity?\n* What is the trend of markers of diabetes risk and puberty hormones over a 1-year period and how are these levels related to physical activity levels?\n\nParticipants in this study will either:\n\n* Participate in a 'full' intensity intervention that includes educational messages (text\u002Femail) as well as health coaching visits to support physical activity over a 6 month period\n* Participate in a delayed 'lower intensity' intervention that includes only educational messages (text\u002Femail)\n* Participants in both groups will complete at-home activity monitoring, two study visits for check-ups and tests, and surveys",[87,26,88,89],"PCOS (Polycystic Ovary Syndrome)","Insulin Resistance","Physical Activity",[91,92,89],"PCOS","Prevention","2026-03-17",{"date":95,"type":36},"2026-03-19",{"date":97,"type":36},"2025-11-24",{"date":99,"type":21},"2027-12",{"name":101,"class":75},"Massachusetts General Hospital",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":17,"enrollmentInfo":109,"targetDuration":4,"studyType":54,"phases":111,"briefSummary":112,"conditions":113,"keywords":117,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":44},"100628354","improving-health-among-disadvantaged-girls-to-slow-pubertal-onset-and-reduce-long-term-health-risks-100628354","NCT07460544","Improving Health Among Disadvantaged Girls to Slow Pubertal Onset and Reduce Long-term Health Risks","Inclusion Criteria:\n\n1. Child female biological sex\n2. Child BMI percentile in the overweight\u002Fobese range (BMI percentile ≥85th for age and sex)\n3. Low child household income based on local income requirements for subsidized housing\n4. At least 50% enrollment of child Black or Latina or 'multiple' race or ethnicity identification (self- or mother-identified)\n5. Child between ages 6.5 and 8.0 years at screening\n6. Participation of child with mother who identifies as a primary caregiver\n7. Confirmed child prepubertal status by mother-report on the indicated pubertal staging scale\n8. Child and mother speak English\n9. Successful completion of the 'run-in' protocol, which includes screening and the baseline assessment\n\nExclusion Criteria:\n\n1. Child has medical contraindications to participate in a weight loss program (e.g., chromosomal abnormality, phenylketonuria, syndromal cause of obesity, type 1 diabetes) as determined by child's pediatrician or study pediatrician\n2. Mother has major medical or psychiatric conditions likely to interfere with participation (e.g., dementia, schizophrenia, terminal illness with life expectancy \\\u003C12 months)\n3. Family lives in temporary or group housing or has plans to relocate outside the Seattle metropolitan area in the next 12 months","6 Years",{"count":110,"type":21},240,[56],"This study is testing whether improving health in girls during the prepubertal period may slow the onset of puberty. This study will focus on prepubertal girls who have a high weight status (at or above the 85th percentile for body mass index). Half of the girls who join the study will participate in a treatment program to reduce weight and improve lifestyle behaviors, and half of the girls will participate in a control condition. The frequency of pubertal onset will be compared across the groups. This research is important because girls who experience puberty at an earlier age are at risk for poor psychological and physical health.\n\nGirls in the treatment condition will participate in the Family Based Treatment (FBT) program, an established treatment for children who are overweight or obese. Families attend 20 weekly sessions (30 minutes each) over a 5-month period. Sessions are led by a trained interventionist and focus on healthy eating and physical activity behaviors.\n\nGirls in the control condition will receive their usual medical care through their pediatric care doctor or other care provider. Families will also receive educational handouts about 1 time per month, addressing topics related to healthy eating and physical activity behaviors.\n\nFamilies in both the treatment and control conditions will participate in assessments conducted at baseline and approximately 6-, 12-, 18-, 24-, 30-, and 36 months follow-up. These assessments are led by a data collector and include the measurement of height and weight, pubertal status, and health behaviors.",[114,26,115,116],"Overweight\u002FObesity","Health Behavior","Cardiometabolic Health",[118,119,62,120,121,122,123,124,125,126,127],"obesity","overweight","pubertal onset","pubertal development","behavioral intervention","family-based treatment","cardiometabolic health","health behaviors","health behavior change","weight loss","NOT_YET_RECRUITING","2026-03-03",{"date":131,"type":36},"2026-03-10",{"date":133,"type":21},"2026-05",{"date":135,"type":21},"2030-06",{"name":137,"class":75},"University of Washington",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":15,"sex":16,"minAge":51,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":54,"phases":149,"briefSummary":151,"conditions":152,"keywords":155,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":44},"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.","17 Years",{"count":148,"type":21},32,[150],"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).",[153,154,26],"Hyperandrogenism","Polycystic Ovary Syndrome",[153,156,26],"Polycystic ovary syndrome","2025-07-30",{"date":159,"type":36},"2025-08-05",{"date":161,"type":36},"2021-11-12",{"date":163,"type":21},"2025-12-01",{"name":165,"class":75},"University of Virginia",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":15,"sex":16,"minAge":51,"maxAge":146,"enrollmentInfo":174,"targetDuration":4,"studyType":54,"phases":175,"briefSummary":176,"conditions":177,"keywords":178,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":183,"locationsCount":44},"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":148,"type":21},[150],"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).",[153,154,26],[153,156,26],{"date":159,"type":36},{"date":181,"type":36},"2016-07-21",{"date":163,"type":21},{"name":165,"class":75},{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":15,"sex":16,"minAge":51,"maxAge":146,"enrollmentInfo":192,"targetDuration":4,"studyType":54,"phases":194,"briefSummary":195,"conditions":196,"keywords":197,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":201,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":205,"locationsCount":44},"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":193,"type":21},36,[150],"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.",[26,153],[198,199,200],"hyperandrogenemia","pubertal","polycystic ovary syndrome",{"date":159,"type":36},{"date":203,"type":36},"2008-06",{"date":163,"type":21},{"name":165,"class":75},{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":15,"sex":213,"minAge":17,"maxAge":18,"enrollmentInfo":214,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":232},"100439898","puberty-diabetes-and-the-kidneys-when-eustress-becomes-distress-panther-study-100439898","NCT05008276","Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)","PANTHER Study: Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress","Inclusion Criteria:\n\n* HbA1c ≥6.0% for untreated high-risk group\n* BMI ≥ 85th %ile for high-risk group\n* Normal HbA1c ≤5.6% for control group\n* Type 1 diabetes (T1D) Antibody negative\n\nExclusion Criteria:\n\n* History of Chronic kidney disease (CKD) or acute kidney injury (AKI)\n* Metabolic disorder prohibiting safe fasting\n* Iodine or penicillin allergy\n* Pregnancy\n* Thrombophilia\n* MRI contraindications\n* Hormone therapy","ALL",{"count":215,"type":21},100,"Early diabetic kidney disease (DKD) occurs in 50-70% of youth with type 2 diabetes (T2D) and confers high lifetime risk of dialysis and premature death. Youth-onset T2D typically manifests during or shortly after puberty in adolescents with obesity. Epidemiological data implicate puberty as an accelerator of kidney disease in youth with obesity and diabetes and the investigators posit that the link between puberty and T2D-onset may explain the high burden of DKD in youth-onset T2D. A better understanding of the impact of puberty on kidney health is needed to promote preservation of native kidney function, especially in youth with T2D.",[218,219,220,221,222,26],"Type 2 Diabetes Mellitus","Diabetic Kidney Disease","Adolescent Obesity","Pre Diabetes","Kidney Hypoxia","2025-03-20",{"date":225,"type":36},"2025-03-24",{"date":227,"type":36},"2021-09-27",{"date":229,"type":21},"2027-12-01",{"name":231,"class":75},"Petter Bjornstad",2,{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":146,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":241,"conditions":242,"keywords":245,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":44},"100569178","negative-emotionality-and-epigenetics-during-puberty-100569178","NCT06690866","Negative Emotionality and Epigenetics During Puberty","Negative Emotionality in Relation to Epigenetics of Estrogen Signaling During Puberty","Inclusion Criteria:\n\n* healthy girls\n* aged between 8-10 and having pubertal stage 1 or between 15-17 and having pubertal stage 5\n* normal body mass index according to age (between 5th and 85th percentile)\n* non-smoking\n* German language fluency\n* Attending age-appropriate schools\n\nExclusion Criteria:\n\n* neurological or psychiatric disease\n* medical problems such as hormonal, metabolic, developmental or chronic diseases (e.g., congenital disorders, precocious puberty, polycystic ovarian syndrome, diabetes or congestive heart failure)\n* any kind of hormonal, pharmacological or psychotropic treatment in the last three months\n* engaging in competitive\u002Fextreme sports\n\nAdditional exclusion criteria for MRI:\n\n* People with non-removable metal objects on or in the body\n* Tattoos (if not MRI-incompatible according to expert guidelines)\n* Pathological hearing or increased sensitivity to loud noises\n* Claustrophobia\n* Surgery less than three months ago\n* Moderate or severe head injury",{"count":215,"type":21},"Pubertal transition leads to enduring neuroendocrine changes along with changes in the epigenome. The prevalence of psychiatric disorders significantly increases in females compared to males after puberty. There is likely to be an interaction between epigenetics, hormones and neurophysiological processes during puberty, leading to the increased prevalence of mental disorders in females. This study aims to shed light on these interactions underlying the emerging sex differences after puberty. Specifically, it seeks to investigate the epigenetic modifications and subsequent changes in gene expression during the pubertal transition and their association with negative emotionality (e.g., acute stress response and depressive symptoms) at molecular, neuronal, subjective and physiological levels.",[26,243,244],"Healthy","Stress",[246,247,248],"Stress reactivity","DNA methylation","fMRI","2024-11-14",{"date":251,"type":36},"2024-11-15",{"date":253,"type":36},"2024-03-26",{"date":255,"type":21},"2026-04",{"name":257,"class":75},"International Research Training Group 2804",{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":15,"sex":16,"minAge":266,"maxAge":146,"enrollmentInfo":267,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":269,"conditions":270,"keywords":273,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":288},"100395092","ovarian-morphology-in-girls-100395092","NCT04424576","Ovarian Morphology in Girls","Trajectory of Ovarian Morphology During the Adolescent Reproductive Transition","OMG","Inclusion Criteria:\n\n* Female adolescents aged 9 to 17 years\n* Menarche within 11 months of the enrollment visit\n* University of Rochester site only: Family history of PCOS (i.e., mother or aunt)\n\nExclusion Criteria:\n\n* Current or recent use of medications or supplements known or suspected to interfere with reproductive or metabolic function in the past 2 months (e.g., contraceptives, metformin, steroids, anti-seizure medications)\n* Untreated and\u002For unstable medical or mental health condition known or suspected to interfere with reproductive or metabolic function\n* Currently pregnant or breast feeding\n* History of ovarian surgery\n* Presence of significant acute or chronic illness which may interfere with study participation","9 Years",{"count":268,"type":21},60,"Establishment of regular menstrual cycles is a key component of reproductive maturation and a recognized vital sign for health and well-being. Irregular menstrual cycles are especially common for the first 2-3 years after an adolescent's first menstrual period (i.e., menarche), which delays the identification and diagnosis of early reproductive disturbances such as polycystic ovary syndrome (PCOS). The purpose of this research study is to determine whether the ovary can serve as a reliable predictor of normal or abnormal development by following the trajectory of ovarian morphology in conjunction with menstrual cyclicity using 3D transabdominal ultrasound imaging in a prospective cohort study of adolescents. A secondary objective is to identify potential environmental factors such as diet and the gut microbiome which influence the trajectory towards normal or abnormal reproductive development.",[271,272,26],"Amenorrhea","Oligomenorrhea",[274,275,276,277,278],"Ovary","Transabdominal Ultrasound","Menarche","Periods","Microbiome","2024-08-08",{"date":281,"type":36},"2024-08-12",{"date":283,"type":36},"2020-01-31",{"date":285,"type":21},"2025-03-31",{"name":287,"class":75},"Cornell University",3,{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":15,"sex":213,"minAge":296,"maxAge":297,"enrollmentInfo":298,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":44},"100430403","the-3rd-copenhagen-puberty-study-100430403","NCT04884620","The 3rd COPENHAGEN Puberty Study","The COPENHAGEN School Study. Normal Pubertal Development in Youth 2021 and Long-term Disease and Death Risk After Extremely Early Puberty","Inclusion Criteria:\n\n* Healthy children and adolescents\n\nExclusion Criteria:\n\n* In case of acute disease, cancer, cancer therapy, or chronic disease (History of malignant disease, chemotherapy or radiation, cystic fibrosis, juvenile rheumatoid arthritis, systemic lupus erythematosus, sickle cell disease, thalassemia, chronic renal disease or known numerical chromosome aberration)\n* Non-Caucasian","5 Years","19 Years",{"count":299,"type":21},3000,"The COPENHAGEN School Study is a combined cross-sectional and longitudinal study of healthy Danish school children. This study will by clinical examinations and withdrawal of blood samples investigate whether age of pubertal onset is continuing to decline in Denmark over the past 15 years. Furthermore, we will investigate the mechanism driving earlier onset of puberty and the long term health risks of extremely early puberty using Danish registry data",[26,302],"Puberty, Precocious","2024-01-09",{"date":305,"type":36},"2024-01-10",{"date":307,"type":36},"2023-01-01",{"date":309,"type":21},"2056-12-31",{"name":311,"class":75},"Rigshospitalet, Denmark"]