[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypothalamic-amenorrhea\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypothalamic-amenorrhea":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,57,87,119],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100053509","phase-2-kisspeptin-administration-subcutaneously-to-patients-with-hypothalamic-amenorrhea-100053509",false,"NCT07224438","Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea","Inclusion Criteria:\n\n* Female\n* Ages 18-45 years\n* Acquired HH (hypothalamic amenorrhea, aka functional hypogonadotropic hypogonadism)\n* Normal blood pressure (systolic BP \\\u003C 140 mm Hg, diastolic \\\u003C 90 mm Hg)\n* Hemoglobin no less than 0.5 g\u002FdL below the lower limit of the reference range for normal women\n* Negative serum hCG pregnancy test\n* No current or recent use of a medication (including hormonal replacement) that, in the opinion of a study investigator, can modulate the reproductive axis OR willing to complete an appropriate washout for that particular medication and its method of administration\n* If applicable, willing to use birth control methods (as approved by a study medical professional) during the entire study and for one month after the last dose of study drug\n\nExclusion Criteria:\n\n* Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in\u002Fcompletion of the protocol\n* Excessive alcohol consumption (\\>10 drinks\u002Fweek)\n* Active use of illicit drugs\n* Pregnant\n* Trying to become pregnant during protocol participation\n* Breast feeding\n* History of any of the following: bilateral oophorectomy (ovaries were removed), breast cancer, thromboembolic disease, coronary artery disease, stroke, thrombophilic disorders, or undiagnosed abnormal genital bleeding","FEMALE","18 Years","45 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in women with hypothalamic amenorrhea (HA). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered subcutaneously (SC) for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth and frequent blood sampling (every 10 minutes for up to two hours) will be performed to assess the physiologic response to kisspeptin over time.",[26,27],"Hypothalamic Amenorrhea","Hypogonadotropic Hypogonadism",[29,30,31],"hypothalamic amenorrhea","hypogonadotropic hypogonadism","kisspeptin","RECRUITING","2026-07-09",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":36},"2025-12-09",{"date":40,"type":20},"2030-05",{"name":42,"class":43},"Stephanie B. Seminara, MD","OTHER",1,{"id":46,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":24,"conditions":49,"keywords":50,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":54,"completionDateStruct":55,"leadSponsor":56,"locationsCount":44},"100610196",{"count":19,"type":20},[23],[26,27],[29,30,31],"2025-12-29",{"date":53,"type":36},"2025-12-31",{"date":38,"type":36},{"date":40,"type":20},{"name":42,"class":43},{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":64,"enrollmentInfo":65,"targetDuration":67,"studyType":68,"phases":4,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100560919","the-registry-of-very-early-estrogen-and-anovulation-100560919","NCT06583408","The REgistry of Very Early Estrogen and AnovuLation","REVEAL","Inclusion Criteria:\n\n* 3 or more months of consecutive amenorrhea with a diagnosis of functional hypothalamic amenorrhea or screening hormones consistent with functional hypothalamic amenorrhea including but not limited to:\n\n  * Estradiol: \\\u003C 50pg\u002FmL\n  * LH: \\\u003C 10 IU\u002FmL\n  * FSH: \\\u003C 10 IU\n  * Testosterone: 2 - 45 ng\u002FdL\n  * Free Testosterone: 0.1 - 6.4 pg\u002FmL\n  * FT4: 0.93 - 1.70 ng\u002FdL\n  * Prolactin: \\\u003C 20 ng\u002FmL\n  * AMH: \\> 1 ng\u002FmL\n  * Urine or serum human chorionic gonadotropin: Negative\n* LH:FSH Ratio \\\u003C1\n* No signs of male-like hair growth on the upper lip, chin, chest, abdomen, buttocks, or back\n* Does not have a diagnosis for secondary amenorrhea, including prolactinoma, PCOS, premature ovarian insufficiency, pituitary surgery, infection, or infarction\n* Premenopausal status determined by WISE criteria\n* Able to give informed consent\n* Able to read English\n\nExclusion Criteria:\n\n* Parturition\u002Flactating in the last 6-12 months\n* Lack of consent","40 Years",{"count":66,"type":20},100000,"5 Years","OBSERVATIONAL","The purpose of this study is to to build a registry of women with early estrogen loss due to Functional Hypothalamic Amenorrhea (FHA) to understand the prevalence, racial and ethnic diversity of this condition.",[71,26,72],"Hypothalamic Amenorrhea, Functional","Functional Hypogonadotropic Hypogonadism",[74,75,76],"Anovulation","Estrogen Loss","Hypoestrogenemia","2025-11-18",{"date":79,"type":36},"2025-11-21",{"date":81,"type":36},"2024-07-01",{"date":83,"type":20},"2029-08-01",{"name":85,"class":43},"Mayo Clinic",2,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":94,"sex":15,"minAge":16,"maxAge":64,"enrollmentInfo":95,"targetDuration":4,"studyType":68,"phases":4,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":117,"locationsCount":44},"100350374","body-fat-as-determinant-of-female-gonadal-dysfunction-100350374","NCT03841981","Body Fat as Determinant of Female Gonadal Dysfunction","Amount, Distribution and Dysfunction of Body Fat as Determinants of Female Gonadal Dysfunction: From Functional Hypothalamic Amenorrhea to the Polycystic Ovary Syndrome","Inclusion Criteria\n\nGroup I\n\n* Body mass index between 18.5 and 25.0 kg\u002Fm2.\n* Group 1 ovulatory dysfunction \\[World Health Organization (WHO) classification\\].\n* Normal\u002Flow gonadotrophin levels \\[follicle-stimulating hormone (FSH) and luteinizing (LH) \\\u003C 10 IU\u002Fl\\] and low estradiol (\\\u003C 50 pg\u002Fml).\n* Moderate-vigorous intensity physical activity (\\> 5 hours per week) plus low energy availability (\\\u003C 30 kcal\u002Fper kg of lean mass).\n* Exclusion of secondary etiologies\n* Informed consent signed.\n\nGroup II:\n\n* Polycystic ovary syndrome phenotype I, II and III \\[National Institute of Health (NIH)-2012\\] with hyperandrogenemia (http:\u002F\u002Fprevention.nih.gov\u002Fworkshops\u002F2012\u002Fresources.aspx).\n* Body mass index between 18.5 and 40.0 kg\u002Fm2.\n* Informed consent signed.\n\nGroup III:\n\n* Polycystic ovary syndrome phenotype IV (NIH-2012) (http:\u002F\u002Fprevention.nih.gov\u002Fworkshops\u002F2012\u002Fresources.aspx).\n* Body mass index between 18.5 and 40.0 kg\u002Fm2.\n* Informed consent signed.\n\nGroup IV:\n\n* Body mass index between 18.5 and 25.0 kg\u002Fm2.\n* Regular menses.\n* Normal gonadotropins and estradiol levels at follicular phase.\n* Moderate-vigorous intensity physical activity (\\> 5 hours per week) with normal energy availability (\\> 30 kcal\u002Fper kg of lean mass).\n* Informed consent signed.\n\nGroup V:\n\n* No signs or symptoms of hyperandrogenism.\n* No exercise or mild intensity physical activity.\n* Regular menses.\n* Body mass index between 18.5 and 40.0 kg\u002Fm2.\n* Informed consent signed.\n\nExclusion Criteria (Groups I-V)\n\n* Oral drugs interfering with ovulation (glucocorticoids, antipsychotics, antidepressants, contraceptives, sex steroids and\u002For opioids) for the previous 6 months to study inclusion.\n* Current pregnancy or lactation, or during the previous 6 months to study inclusion.\n* Asherman's syndrome or outflow tract disorders.\n* Current smoking or alcohol intake \\> 40 g per day.\n* Previous diagnosis of glucose intolerance, hypertension, dyslipidemia, known heart or lung diseases, kidney disease, liver disease, celiac disease or any other malabsorptive condition, chronic inflammatory disease or malignancy.",true,{"count":96,"type":20},50,"Reproduction requires from women enough energy depots to warrant an adequate nutritional supply to the fetus. Hence, adipose tissue is able to communicate with female hypothalamic-pituitary-ovary axis. The hypothesis of the project is that abnormalities in the quantity (absolute and relative to lean body mass), distribution and\u002For function of adipose tissue are associated with functional forms of female gonadal dysfunction in predisposed women, in a spectrum of anomalies that go from hypothalamic amenorrhea to the polycystic ovary syndrome (PCOS). To challenge this hypothesis, the investigators will study 5 groups of 10 women each: women with exercise-associated hypothalamic amenorrhea, women without ovulatory dysfunction that exercise equally, non-hyperandrogenic patients with PCOS, hyperandrogenic patients with PCOS, and healthy control women comparable to those with PCOS. The aims of the study will be:\n\nPrimary objective: To identify novel signalling factors originating from adipose tissue and muscle using targeted and nontargeted evaluation of the proteome and of gene expression of superficial subcutaneous fat, deep subcutaneous fat (which mimics visceral adipose tissue) and skeletal muscle.\n\nSecondary objectives:\n\n1. To study the serum adipokine profile - including those identified by the primary objective - and circulating gut hormones during fasting and after a glucose load in the 5 groups of women, and their associations with sexual hormones and body fat distribution.\n2. To study body composition and body fat distribution in these women and their relationships with:\n\n2.1, Sex steroid profiles.\n\n2.2. Classic cardiovascular risk factors: carbohydrate metabolism, lipid profiles and blood pressure.\n\n2.3 Markers of low-grade chronic inflammation.\n\n2.4. Oxidative stress markers.\n\n2.5. Cardiovascular autonomic function.\n\n2.6. Surrogate markers of subclinical atherosclerosis.\n\n2.7. Circulating concentrations of endocrine disruptors.\n\n2.8. Oral and gut microbiome.\n\nThe results will provide a better understanding of the mechanisms linking body energy depots with the female reproductive axis and, hopefully, the identification of potential biomarkers for the diagnosis and treatment of the disorders studied here.",[99,26],"Polycystic Ovary Syndrome",[101,102,103,104,105,106,107,108,109,110],"Exercise","Sex steroids","Hyperandrogenism","Adipose tissue","Muscle","Proteome","Gene expression","Adipokine","Cardiovascular risk","Microbiome","2025-08-06",{"date":113,"type":36},"2025-08-12",{"date":115,"type":36},"2020-01-31",{"date":53,"type":20},{"name":118,"class":43},"Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":94,"sex":126,"minAge":4,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":68,"phases":4,"briefSummary":129,"conditions":130,"keywords":137,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":44},"100178744","genetics-of-reproductive-disorders-including-kallmann-syndrome-and-cleft-lip-andor-palate-100178744","NCT01601171","Genetics of Reproductive Disorders (Including Kallmann Syndrome) and Cleft Lip and\u002For Palate","The Genetics of Neuroendocrine Reproductive Disorders and of the Cleft Lip and\u002For Palate","Inclusion Criteria:(any of the following conditions)\n\n* hypogonadotropic hypogonadism\n* Kallmann syndrome\n* adult-onset hypogonadotropic hypogonadism\n* hypothalamic amenorrhea\n* polycystic ovarian syndrome\n* primary gonadal failure\n* precocious puberty\n* cleft lip\u002Fpalate\n* family members of the above groups\n\nExclusion Criteria:\n\n* acute illness\u002Fhospitalization\n* pituitary tumors\n* iron overload (hemochromatosis)\n* infiltrative diseases (sarcoidosis)\n* chronic alcohol abuse\n* illicit drug use\n* anabolic steroid abuse","ALL",{"count":128,"type":20},2000,"The purpose of this study is to explore the genetic basis of reproductive disorders and cleft lip and\u002For palate.",[131,27,26,132,133,134,135,136],"Kallmann Syndrome","Polycystic Ovarian Syndrome","Precocious Puberty","Cleft Lip and Palate","Cleft Palate","Cleft Lip",[138,139,140,141,142,143,144,145],"GnRH deficiency","hypogonadism","anosmia","infertility","cleft lip","cleft palate","cryptorchidism","microphallus","2022-06-17",{"date":148,"type":36},"2022-06-21",{"date":150,"type":4},"2012-03",{"date":152,"type":20},"2030-03",{"name":154,"class":43},"Centre Hospitalier Universitaire Vaudois"]