[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"puberty-precocious\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:puberty-precocious":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,79,110,132],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100617998","early-phase-1-research-of-integrated-traditional-chinese-and-western-medicine-on-precocious-puberty-100617998",false,"NCT07325903","Research of Integrated Traditional Chinese and Western Medicine on Precocious Puberty","Inclusion Criteria:\n\n* pediatric patients clinically diagnosed with precocious puberty: girls who exhibit secondary sexual characteristics or gonadal development before the age of 8, accompanied by obesity (BMI ≥ P85), and classified as having a syndrome of yin deficiency with hyperactivity of fire complicated by phlegm-dampness. Inclusion age: girls aged 5 years to 9 years, all of whom are initial cases and have not received any drug treatment related to precocious puberty.\n\nExclusion Criteria:\n\n* Secondary precocious puberty, associated with diabetes, thyroid dysfunction, other endocrine disorders, and severe underlying conditions.","ALL","5 Years","9 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","Precocious puberty is characterized by the premature appearance of secondary sexual characteristics. Globally, the timing of puberty onset in children has shown a certain tendency to advance. In China, the incidence of precocious puberty has been increasing year by year. Precocious puberty exerts long-term and systemic impacts on children's health: advanced bone age leads to short stature; earlier sexual development than peers may induce emotional problems such as anxiety and inferiority; it may increase the risk of obesity and type 2 diabetes, posing long-term hazards to cardiovascular health; it may also result in irregular menstruation or dysmenorrhea, exerting indirect effects on reproductive health.\n\nModern traditional Chinese medicine (TCM) holds that: various factors lead to liver-kidney yin deficiency, hyperactivity of ministerial fire, and early arrival of tian gui (the substance responsible for promoting growth, development and reproduction), thereby triggering premature sexual development. The main syndrome types identified in clinical practice include yin deficiency with fire hyperactivity syndrome, liver stagnation transforming into fire syndrome, and phlegm-dampness internal accumulation syndrome.\n\nSince the late 1970s, the investigators' department has taken the lead in treating precocious puberty with TCM diagnostic methods, proposing that the pathogenesis of precocious puberty lies in \"kidney yin deficiency and hyperactivity of ministerial fire\", and adopting the therapy of nourishing yin and purging fire for its treatment. A number of studies have confirmed that TCM medicines with the effects of nourishing yin and purging fire can effectively alleviate the yin deficiency with fire hyperactivity syndrome in children, delay the development of secondary sexual characteristics and bone age.\n\nAt present, central precocious puberty is mostly treated with gonadotropin-releasing hormone analogs (GnRHa). However, this treatment has the drawback of inhibiting the growth axis, yielding limited benefits for children with advanced bone age, overweight or obesity, and may even affect glucose and lipid metabolism. Moreover, some children with precocious puberty complicated with obesity may be intolerant to this therapy. In contrast, TCM therapy and integrated TCM-Western medicine therapy can effectively delay the development of secondary sexual characteristics and advanced bone age, and improve final adult height, thus being widely applied in China.\n\nAlthough a large number of relevant studies have been reported in recent years and TCM diagnosis and treatment guidelines for precocious puberty have been formulated, there is still a lack of high-quality evidence-based medical research to support the advantageous aspects of integrated TCM-Western medicine diagnosis and treatment. Additionally, the underlying mechanisms of diagnosis and treatment for different syndrome types of precocious puberty remain insufficiently studied.\n\nIn this study, the investigators will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the effects of Sanghe Jianghuo Granules on the regulation of the hypothalamic-pituitary-gonadal (HPG) axis, metabolic homeostasis and inflammatory microenvironment, so as to verify its efficacy and safety. Furthermore, combined with transcriptomics, proteomics and network pharmacology, the investigators will identify the key targets and action pathways of Sanghe Jianghuo Granules, and verify its regulatory effect on the HPG axis through in vivo and in vitro experiments.",[26],"Puberty, Precocious",[28,29,30],"precocious puberty","Sanghe Jianghuo Granules","RCT","NOT_YET_RECRUITING","2026-03-17",{"date":34,"type":35},"2026-03-19","ACTUAL",{"date":37,"type":20},"2026-04-01",{"date":39,"type":20},"2028-12-31",{"name":41,"class":42},"Children's Hospital of Fudan University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100522499","early-breast-growth-in-girls-aged-6-to-8-years-in-the-current-environmental-context-100522499","NCT06083415","Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context","Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context: Clinical and Biological Parameters, Level of Impregnation With Endocrine Disruptors and Evaluation of the Impact of Environmental Health Measures","PENELOPE","For patients:\n\nInclusion Criteria:\n\n* Girls aged 6 to 8 years\n* Presenting a breast development (isolated or not)\n* Undergoing scheduled pediatric day hospital care (HDJ)\n* Who agree to participate in the study\n* Whose parents agree to their child's participation in the study\n* French speaking\n* Whose parents speak French\n* Affiliated to social security\n\nExclusion Criteria:\n\n* Organic brain causes of precocious puberty: History of neurocerebral disease (malformations, developmental abnormalities)\n* Organic causes of precocious puberty: Mac Cune Albright syndrome, ovarian cyst or tumor and adrenal hyperplasia\n* History of chemotherapy or radiation therapy\n* Presenting with a communication disorder\n* Pregnancy\n* Persons under protective measures\n* Persons deprived of liberty for judicial or administrative reasons\n\nFor controls:\n\nInclusion Criteria:\n\n* Girls aged 6 to 8\n* Tanner stage 1: Absence of breasts and hairiness\n* Coming for routine consultation in the pediatric HDJ at Saint-Vincent-de-Paul hospital, or at the BLM practice in Lambersart, or to radiology for an MRI for another medical other medical reason\n* Agree to participate in the study\n* Whose parents agree to their child's participation in the the study\n* French-speaking\n* Whose parents speak French\n* Affiliated with social security\n\nExclusion Criteria:\n\n* Signs of puberty (Tanner stages 2, 3, 4 and 5 for breast development) breast development)\n* Previous chemotherapy or radiotherapy\n* Presenting a communication disorder\n* Pregnant women\n* Persons under protective supervision\n* Persons deprived of their liberty for judicial or administrative reasons","FEMALE","6 Years","8 Years",{"count":56,"type":20},62,[58],"NA","Various studies show an increase in the number of cases of early puberty in girls with breast development with a variable clinical presentation and evolution. This increasing phenomenon concerns girls between 6 and 8 years old. In a large number of cases, from 70 to 95% depending on the series, no medical cause is found and environmental factors are suspected to be involved.\n\nDescriptive studies of these patients are scarce and not always provide an overview of all the parameters in line with the concept of the exposome.\n\nThe PENELOPE clinical trial will allow to analyze a large number of parameters, including the adipose tissue, its metabolism, the endocrine disruptors, and the epigenetic modifications, and to study the impact of environmental health measures in the evolution of these parameters.\n\nThe data from the analyses of the endocrine disruptors of the patients will be explored in parallel in experimental models (amphibians, murine, cellular) in order to test potential mechanistic hypotheses.",[26,61,62],"Breast","Environmental Exposure",[64,65,66,67,68],"Early puberty","Endocrine disruptors","Girls","Breast growth","Environmental Health Measure","RECRUITING","2026-03-16",{"date":32,"type":35},{"date":73,"type":35},"2023-05-15",{"date":75,"type":20},"2027-05-15",{"name":77,"class":42},"Lille Catholic University",2,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":15,"minAge":4,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":92,"conditions":93,"keywords":94,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100536364","first-observatory-of-precocious-puberty-100536364","NCT06263868","First Observatory of Precocious Puberty.","First Observatory of Precocious and Advanced Puberty in Private Healthcare.","PAPPEL","Inclusion Criteria:\n\nPrecocious puberty group (PP) :\n\n* Suspected precocious puberty (girl aged \\\u003C 8 years or boy aged \\\u003C 9 years when the first signs of development\\* appear)\n* Suspected precocious puberty (girl aged \\\u003C 8 years or boy aged \\\u003C 9 years when the first signs of development\\* appear)\n\nAdvanced puberty group (AP) :\n\n* Suspected advanced puberty (girl aged ≥ 8 and \\\u003C 10 years or boy aged ≥ 9 and \\\u003C 11 years when the first signs of development\\* appear)\n* First consultation with the investigator (pediatric endocrinologist).\n\nControl group :\n\n* Boy or girl without signs of pubertal development (Tanner 1);\n* Matched to the PP group on sex and age (+\u002F- 1 year);\n* Consultation with the same investigator over the same period (same quarter) as a patient in the PP group\n\nExclusion Criteria:\n\nAll groups\n\n* Consultation with the same investigator over the same period (same quarter) as a patient in the PP group\n* Family not speaking French, language barrier.",true,"11 Years",{"count":90,"type":20},3360,"OBSERVATIONAL","The age of puberty has fluctuated throughout history. Recent data shows an increase in the age of onset of puberty signs, in the United States but also in Europe. A recent Public Health France study published in 2018 reports an increase in the incidence of precocious puberty with geographical heterogeneity. The consequences of these appearances include the early onset of menarche, short adult height and the psychological impact.\n\nDue to a lack of studies and additional data, the reasons for this development are difficult to understand. Among current hypotheses, the entanglement with the evolution of our environment is at the forefront: the action of environmental endocrine disruptors and nutritional factors could play a role in the process of early appearance of pubertal signs.\n\nThe establishment of a national observatory for early and advanced puberty in collaboration with pediatric endocrinologists (on the front line) would allow a reliable and precise field approach, capable of supplementing epidemiological data, which are currently insufficient.\n\nThe investigators hypothesize that the establishment of an observatory of pubertal advances (early puberty and advanced puberty) in private medicine is possible, with inclusion of at least 75% of eligible patients, and collection of at least 80% of data.",[26],[95,96,97,98,99],"Early\u002Fprecocious puberty","advanced puberty","national observatory","private medicine","feasibility","2026-01-15",{"date":102,"type":35},"2026-01-16",{"date":104,"type":35},"2024-06-26",{"date":106,"type":20},"2028-06-26",{"name":108,"class":42},"Hospices Civils de Lyon",25,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":87,"sex":15,"minAge":16,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":43},"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","19 Years",{"count":119,"type":20},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",[122,26],"Puberty","2024-01-09",{"date":125,"type":35},"2024-01-10",{"date":127,"type":35},"2023-01-01",{"date":129,"type":20},"2056-12-31",{"name":131,"class":42},"Rigshospitalet, Denmark",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":15,"minAge":140,"maxAge":141,"enrollmentInfo":142,"targetDuration":144,"studyType":91,"phases":4,"briefSummary":145,"conditions":146,"keywords":147,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":5},"100512864","danish-precocious-puberty-study---dapp-study-a-national-cohort-study-on-incidence-and-etiologies-for-precocious-puberty-100512864","NCT05957991","Danish Precocious Puberty Study - DAPP Study A National Cohort Study on Incidence and Etiologies for Precocious Puberty","Danish Precocious Puberty Study (DAPP Study) A National Cohort Study on Incidence and Etiologies for Precocious Puberty","DAPP","Inclusion Criteria:\n\n• All children (\\> 4 years of age) referred to one of the seventeen collaborating pediatric departments with one of the following diagnosis (ICD10)\n\n* DE301\n* DE228A\n* DE308A\n* DE270B\n* DE308\n* DE309\n* DZ003\n\nExclusion Criteria:\n\n* If the investigating doctor at the local hospital observes unexpected psychological\u002Fphysical reactions, or a participant is found to be unsuitable (cf. inclusion criteria) or regrets agreeing to participate, this person can at any given time be excluded.","3 Years","10 Years",{"count":143,"type":20},1500,"2 Years","There is an urgent need to obtain more knowledge about the influence of weight and metabolism on the timing and progression of puberty. The age of pubertal onset has been constantly declining during the last decades and extremely early maturation may have yet unseen consequences for the psychosocial development of the child as well as detrimental long-term health consequences. Studies have shown that girls with early-onset puberty are more likely than their peers to enter sexual relationships at a younger age, to experience more psychological distress, and to engage in risk-taking behaviors. In addition, early maturation may have long-term health consequences since earlier menarche is associated with an increased risk of all-cause mortality and cardiovascular disease later in life in large epidemiological studies. The exact aetiology for the earlier onset of puberty in the general population remains to be elucidated, and the cause is probably to be found in a complex interplay between genetic, epigenetic, environmental and metabolic factors. However, world-wide there is a concerning increasing prevalence of overweight in childhood and early puberty is one of many consequences of this. Environmental factors such as endocrine disrupting chemicals have been suggested to play a role for both obesity and precocious puberty either directly or through epigenetic moderation. The current study of a Danish National cohort will explore the incidence and aetiology of precocious puberty for better treatment and prevention. Furthermore, a placebo-controlled randomized controlled trial may give a novel mechanistic insight of the interplay between insulin sensitivity and sex steroids. To our knowledge this study is the first of its kind and may lead to novel alternative treatment strategy for overweight girls with early puberty that may have beneficial effects on long-term morbidity and mortality.",[26],[122],"2023-07-14",{"date":150,"type":35},"2023-07-24",{"date":152,"type":20},"2023-09-01",{"date":154,"type":20},"2030-09",{"name":156,"class":42},"Copenhagen University Hospital at Herlev"]