[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100361428":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":62,"collaborators":10,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":10,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":10,"studyType":78,"phases":10,"briefSummary":79,"conditions":80,"keywords":85,"overallStatus":47,"whyStopped":10,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8,12,15,18,21,24,27],{"label":9,"type":10,"description":11,"interventionNames":10},"At-risk girls",null,"Girls with first degree relative diagnosed with Polycystic Ovary Syndrome (PCOS) age 8-\\\u003C15",{"label":13,"type":10,"description":14,"interventionNames":10},"early post-menarche girls","Healthy, early post-menarchal girls age 8-\\\u003C15",{"label":16,"type":10,"description":17,"interventionNames":10},"Healthy control women","Women age \\>18-34 without PCOS at least 3-years post-menarchal with regular menstrual cycles every 21-35 days",{"label":19,"type":10,"description":20,"interventionNames":10},"late post-menarche girls","Late post-menarchal girls age 11-\\\u003C17.5 (gynecological age 2-5)",{"label":22,"type":10,"description":23,"interventionNames":10},"Mothers of pediatric study participants","Mothers age 18-65 whose daughter has provided at least one vaginal swab sample for the First Period study.",{"label":25,"type":10,"description":26,"interventionNames":10},"pre-menarche girls","Healthy, pre-menarchal girls age 8-\\\u003C14.5",{"label":28,"type":10,"description":29,"interventionNames":10},"Women with PCOS","Women diagnosed with PCOS \\>18-34 at least 3-years post-menarchal with irregular menstrual cycles",[31],{"name":32,"affiliation":33,"role":34},"Natalie D Shaw, M.D.","National Institute of Environmental Health Sciences (NIEHS)","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":10,"email":40},"NIEHS Join A Study Recruitment Group","CONTACT","(855) 696-4347","myniehs@nih.gov",{"name":32,"role":38,"phone":42,"phoneExt":10,"email":43},"(984) 287-3716","natalie.shaw@nih.gov",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"NIEHS Clinical Research Unit (CRU)","RECRUITING","Research Triangle Park","North Carolina","27709","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-78.86029,35.89709,{"lat":57,"lon":56},[60],{"name":37,"role":38,"phone":61,"phoneExt":10,"email":40},"855-696-4347",{"type":63,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100361428","reproductive-axis-maturation-in-the-early-post-menarchal-years-100361428",false,"NCT03986021","Reproductive Axis Maturation in the Early Post-Menarchal Years","Reproductive Axis Maturation in the Early Post-Menarchal Years: A Pilot Study","* Part 1 - Pre-menarche monitoring (\"holding pattern\"):\n\nInclusion Criteria:\n\n* Age 8-14.5 years old\n* Healthy weight, defined as having a body weight \\>85% of expected (EBW) and a body mass index (BMI) \\\u003C99th percentile\n* Some breast development\n* Pre-menarche\n\nExclusion Criteria:\n\n* Taking or planning to take medications that affect reproductive hormones in the next 2 to 3 years (e.g. birth control pills, biotin supplements).\n* Planning to move more than 60 miles from the CRU within the next 2 to 3 years\n* Chronic medical condition, including but not limited to diabetes mellitus, congenital adrenal hyperplasia, cystic fibrosis, sickle cell disease, inflammatory bowel disease, juvenile rheumatoid arthritis, and lupus.\n* First-degree relative with polycystic ovarian syndrome, premature ovarian insufficiency, hypogonadotropic hypogonadism, or other pubertal development disorder\n* Excessive exercise (defined as running \\>20 miles per week or its equivalent)\n* Pregnancy\n\nPart 2 - Post-menarche cycle tracking:\n\nInclusion Criteria:\n\n* Age at menarche 10-14.5 years old\n* Healthy weight, defined as having a body weight \\>85% of expected (EBW) and a body mass index (BMI) \\\u003C99th percentile\n* Approximately \\\u003C 6 months post-menarchal (will typically have completed 4 or fewer menstrual cycles)\n* Biochemical criteria: normal thyroid hormone, prolactin, and testosterone levels\n\nExclusion Criteria:\n\n* Taking or planning to take medications that affect reproductive hormones in the next 2 to 3 years (e.g. birth control pills, biotin supplements).\n* Planning to move more than 60 miles from the CRU within the next 2 to 3 years\n* Chronic medical condition, including but not limited to diabetes mellitus, congenital adrenal hyperplasia, cystic fibrosis, sickle cell disease, inflammatory bowel disease, juvenile rheumatoid arthritis, and lupus.\n* First-degree relative with polycystic ovarian syndrome, premature ovarian insufficiency, hypogonadotropic hypogonadism, or other pubertal development disorder\n* Excessive exercise (defined as running \\>20 miles per week or its equivalent)\n* Anemia (defined as hemoglobin \\\u003C12.0 g\u002Fdl)\n\n  --Participants with hemoglobin between 11.5 g\u002Fdl and 12.0 g\u002Fdl may still participate by providing dried blood spots, or no more than 18 ml of blood during any given interval.\n* Pregnancy\n\nPart 3 - Intensive monitoring of ovarian follicle growth\n\nInclusion Criteria:\n\n* Age at menarche 10-14.5 years old\n* Healthy weight, defined as having a body weight \\>85% of expected (EBW) and a body mass index (BMI) \\\u003C99th percentile\n* Within 1 year of menarche\n* Biochemical criteria: normal thyroid hormone, prolactin, and testosterone levels\n\nExclusion Criteria:\n\n* Taking or planning to take medications that affect reproductive hormones in the next 1-2 years (e.g. birth control pills, biotin supplements).\n* Planning to move more than 60 miles from the CRU within the next year\n* Chronic medical condition, including but not limited to diabetes mellitus, congenital adrenal hyperplasia, cystic fibrosis, sickle cell disease, inflammatory bowel disease, juvenile rheumatoid arthritis, and lupus.\n* First-degree relative with polycystic ovarian syndrome, premature ovarian insufficiency, hypogonadotropic hypogonadism, or other pubertal development disorder\n* Excessive exercise (defined as running \\>20 miles per week or its equivalent)\n* Anemia (defined as hemoglobin \\\u003C12.0 g\u002Fdl)\n\n  --Participants with hemoglobin between 11.5 g\u002Fdl and 12.0 g\u002Fdl may still participate by providing dried blood spots, or no more than 18 ml of blood during any given interval.\n* Pregnancy\n\nPart 4 - Late Post-menarche cycle tracking:\n\nInclusion Criteria:\n\n* Age 11-17.5 years old\n* Approximately 2-5 years post-menarchal\n* Biochemical criteria: normal thyroid hormone and prolactin\n\nExclusion Criteria:\n\n* Taking or planning to take medications that affect reproductive hormones in the next 2 to 3 years (e.g. birth control pills, biotin supplements).\n* Planning to move more than 60 miles from the CRU within the next 6 months\n* Chronic medical condition, including but not limited to diabetes mellitus, congenital adrenal hyperplasia, cystic fibrosis, sickle cell disease, inflammatory bowel disease, juvenile rheumatoid arthritis, and lupus.\n* Anemia (defined as hemoglobin \\\u003C12.0 g\u002Fdl)\n\n  --Participants with hemoglobin between 11.5 g\u002Fdl and 12.0 g\u002Fdl may still participate by providing dried blood spots, or no more than 18 ml of blood during any given interval.\n* Pregnancy\n\nAdolescent girls, at-risk daughters, or sisters of women with PCOS\n\nThe girls with mothers or sisters with PCOS group will complete the Screening Visit and Parts 1-3. The same inclusion and exclusion criteria apply for Parts 1, 2, and 3 as stated above except that these individuals must have a first-degree relative with PCOS and they can have high androgen levels, excess body hair, and severe acne at screening.\n\nWomen with known PCOS (activities for 8 weeks only)\n\nInclusion Criteria:\n\n* Age \\>=18-34 years old\n* PCOS diagnosis\n* at least 3-years post-menarchal with irregular menstrual cycles\n* Biochemical (blood) or clinical signs of high androgen levels\n\nExclusion Criteria:\n\n* Cannot be taking any medications that affect reproductive or metabolic hormones (e.g. birth control pill, biotin supplements, spironolactone, metformin).\n* Chronic medical condition, including but not limited to diabetes mellitus, congenital adrenal hyperplasia, cystic fibrosis, sickle cell disease, inflammatory bowel disease, juvenile rheumatoid arthritis, and lupus.\n* Pregnancy\n\nHealthy control women (Activities x 2 menstrual cycles)\n\nInclusion Criteria:\n\n* Age \\>=18-34 years old\n* at least 3-years post-menarchal with regular menstrual cycles every 21-35 days\n\nExclusion Criteria:\n\n* Cannot be taking any medications that affect reproductive or metabolic hormones (e.g. birth control pill, biotin supplements, spironolactone, metformin).\n* Chronic medical condition, including but not limited to diabetes mellitus, congenital adrenal hyperplasia, cystic fibrosis, sickle cell disease, inflammatory bowel disease, juvenile rheumatoid arthritis, and lupus.\n* PCOS diagnosis or first-degree relative with disorder\n* Pregnancy\n\nMothers of pediatric participants (Activities for 8 weeks \u002F 2 menstrual cycles)\n\nInclusion Criteria:\n\n* Age \\>=18-65 years old\n* Biological mother of A Girl's First Period participant\n\nExclusion Criteria:\n\n* Chronic medical condition, including but not limited to diabetes mellitus, congenital adrenal hyperplasia, cystic fibrosis, sickle cell disease, inflammatory bowel disease, juvenile rheumatoid arthritis, and lupus.\n* Pregnancy",true,"FEMALE","8 Years","65 Years",{"count":76,"type":77},400,"ESTIMATED","OBSERVATIONAL","Background:\n\nMost adult women with irregular periods of unknown cause report symptoms dating back to early adolescence. This study aims to learn how girls' periods change in the 2 years after their first period. We are also looking at girls who may have a condition called PCOS. This will help researchers learn what healthy puberty looks like and how they can spot signs of hormone problems early on.\n\nObjective:\n\nTo learn how long it takes girls to develop regular menstrual cycles after their first period.\n\nEligibility:\n\nHealthy girls ages 8-14 who either (1) haven't had their first period but show signs of puberty, such as breast development and hair in the genital area; or (2) had their first period in the past 6 months\n\nGirls at risk for PCOS age 8-14 who have a mom or sister with PCOS\n\nGirls with irregular menstrual cycles age 11-17.5\n\nTo compare with the girls, we are looking at women \\>=18-34 years old with PCOS,\n\nHealthy women \\>= 18-34 years old without PCOS,\n\nand Mothers of pediatric participants age 18-65\n\nDesign:\n\nBoth parents or guardians must allow their daughter to participate. They must attend all study visits with her.\n\nParticipants will first be screened by phone. Those who qualify will be screened in person. They will have a physical exam. They will give blood and urine samples. They will have an ultrasound of their abdomen. They will fill out questionnaires. They will sit in a BOD POD for 6 minutes: This is an egg- shaped machine that takes body measurements. They have the option to provide DNA samples.\n\nParticipants will have sets of visits at home or at the clinic about every 6 months. The number of visits in each set will depend on their menstrual cycle. Then they will have a final visit. Visits will include repeats of the screening tests. There are additional parts that participants may choose to be involved in depending on how involved they want to be.\n\nAt home, participants will collect their urine daily to measure hormones. They will keep a diary of their periods.\n\nAdults: Women with known PCOS will complete the same Screening Visit as the girls and will collect dried urine specimens at home for 8 weeks;\n\nThe Healthy control women group will complete the same Screening Visit as the girls and collect dried urine specimens at home for 2 menstrual cycles;\n\nThe Mothers of pediatric participants group will complete a Screening Visit (informed consent, urine pregnancy test) and collect vaginal swab specimens at home for 2 menstrual cycles (approx. 8 weeks)....",[81,82,83,84],"Reproductive Physiological Processes","Pediatrics","Adolescent Health","Adolescent Development",[86,87,88,89,90],"Menarche","Adolescent","Physiology","Hormones","Natural History","2026-07-01",{"date":93,"type":94},"2026-07-02","ACTUAL",{"date":96,"type":94},"2019-12-19",{"date":98,"type":77},"2029-07-01",{"name":33,"class":6},1]