[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"delayed-puberty\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:delayed-puberty":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100659090","insl3-as-a-biomarker-of-pubertal-activation-role-in-evaluating-precocious-and-delayed-puberty-100659090",false,"NCT07859787","INSL3 as a Biomarker of Pubertal Activation: Role in Evaluating Precocious and Delayed Puberty","INSL3 as an Early Marker of Pubertal Activation: Evaluation of Its Potential Role as a New Biomarker in the Diagnosis of Central Precocious Puberty and Delayed Puberty.","INSL3GNRH","Inclusion Criteria:\n\n* Age between 0 and 16 years at the time of enrollment.\n* Males with suspected Central Precocious Puberty (CPP), defined by a testicular volume ≥4 mL before 9 years of age.\n* Females with suspected CPP, defined by the onset of thelarche before 8 years of age.\n* Males with suspected Delayed Puberty (DP), defined by testicular volume \\\u003C4 mL by 14 years of age.\n* Females with suspected DP, defined by the absence of thelarche by 13 years of age.\n* Written informed consent for study participation and personal data processing provided by the parents\u002Flegal guardians, with the assent of the participating minor.\n\nExclusion Criteria:\n\n* Presence of congenital or acquired conditions known to primarily alter pubertal development or gonadal function, regardless of HPG axis physiology (e.g., disorders of sex development, anorchia, previous ovariectomy, uncorrected bilateral cryptorchidism, previous iatrogenic gonadotoxicity).\n* Primary endocrine diseases interfering with hypothalamic-pituitary-gonadal axis regulation (e.g., congenital hypogonadotropic hypogonadism, panhypopituitarism).\n* Use of hormonal therapies or drugs capable of modifying gonadal function or the response to the GnRH test (e.g., exogenous sex steroids, androgens\u002Fanabolic steroids).","ALL","0 Years","18 Years",{"count":21,"type":22},100,"ESTIMATED","OBSERVATIONAL","This is an observational study in children up to 16 years old who are suspected of having central precocious puberty or delayed puberty. The main questions it aims to answer are:\n\n* Can the level of insulin-like peptide 3 (INSL3) predict if a child's puberty has truly started?\n* Can this marker help reduce the need for more complex and invasive tests?\n\nParticipants will:\n\n* Give one extra blood sample just before starting the standard gonadotropin-releasing hormone (GnRH) stimulation test (during the baseline blood draw).\n* Have this extra sample used to measure the INSL3 hormone.\n* Complete the rest of the GnRH test as prescribed by their doctor.\n\nResearchers will compare the INSL3 hormone levels in children who have a positive GnRH test to those who have a negative test. This will help researchers learn if INSL3 can be used as a new, simple tool to diagnose early or delayed puberty.",[26,27],"Precocious Puberty, Central","Delayed Puberty","RECRUITING","2026-09-30",{"date":31,"type":32},"2026-10-06","ACTUAL",{"date":34,"type":22},"2026-10-02",{"date":36,"type":22},"2029-01-01",{"name":38,"class":39},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","OTHER"]