[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prolactinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prolactinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,79,109],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":4,"leadSponsor":43,"locationsCount":46},"100054596","an-investigation-of-pituitary-tumors-and-related-hypothalmic-disorders-100054596",false,"NCT00001595","An Investigation of Pituitary Tumors and Related Hypothalmic Disorders","A Clinical and Genetic Investigation of Pituitary and Hypothalamic Tumors and Related Disorders","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study.\n2. Male or female with:\n\n   1. Evidence for the existence of a tumor of the hypothalamic-pituitary unit or related disorder, as indicated by previously obtained imaging studies or biochemical investigation of the hypothalamo-hypophyseal function (aged 2 years to 70 years)\n\n      or\n   2. Family members (any age) of patients with a family history of tumors of the hypothalamic-pituitary unit or related disorders as part of the linkage part of the study, or\n   3. Members (any age) of a kindred suspected of having an inherited form of neoplasia of the hypothalamic-pituitary unit or related disorder, as evidenced by results of a patient enrolled in this protocol, as part of the linkage part of the study\n3. Ability of the subject or LAR to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Pregnancy: Pregnancy will be evaluated only in participants of reproductive age (from 10 years old until 60 years of age unless menopause has already occurred per clinical report of the participant).\n\n   For participants enrolled as external participants or under the Linkage study (where research activities include no more than blood draws), any female who could possibly become pregnant will be screened using clinical criteria (history, with pregnancy testing only if indicated) for exclusion and this information will be documented in the consent process note in EMR. If a participant has initially been registered as external location and then presents on-site, then pregnancy test will be performed if within the reproductive age group.\n2. Patients with any medical, physical, psychiatric, or social condition, which, in the opinion of the investigators, would make participation in this protocol not in their best interest, will be excluded from the study.\n3. Patients who are critically ill, unstable, or with severe organ failure that may affect\u002Flimit the endocrine evaluation and place unsustainable demands on CC or NICHD resources may be excluded.",true,"ALL","2 Years","70 Years",{"count":21,"type":22},2000,"ESTIMATED","OBSERVATIONAL","There is a variety of tumors affecting the pituitary gland in childhood; some of these tumors (eg craniopharyngioma) are included among the most common central nervous system tumors in childhood. The gene(s) involved in the pathogenesis of these tumors are largely not known; their possible association with other developmental defects or inheritance pattern(s) has not been investigated. The present study serves as a (i) screening\u002Ftraining, and, (ii) a research protocol.\n\nAs a screening and training study, this protocol allows our Institute to admit children with tumors of the hypothalamic-pituitary unit to the pediatric endocrine clinics and wards of the NIH Clinical Center for the purposes of\n\n(i) training our fellows and students in the identification of genetic defects associated with pituitary tumor formation, and\n\n(ii) teaching our fellows and students the recognition, management and complications of pituitary tumors\n\nAs a research study, this protocol aims at\n\n(i) developing new clinical studies for the recognition and therapy of pituitary tumors; as an example, two new studies have emerged within the context of this protocol: (a) investigation of a new research magnetic resonance imaging (MRI) tool and its usefulness in the identification of pituitary tumors, and (b) investigation of the psychological effects of cortisol secretion in pediatric patients with Cushing disease. Continuation of this protocol will eventually lead to new, separate protocols that will address all aspects of diagnosis of pituitary tumors and their therapy in childhood.\n\n(ii) Identifying the genetic components of pituitary oncogenesis; those will be investigated by (a) studying the inheritance pattern of pituitary tumors in childhood and their possible association with other conditions in the families of the patients, and (ii) collecting tumor tissues and examining their molecular genetics. As with the clinical studies, the present protocol may help generate ideas for future studies on the treatment and clinical follow up of pediatric patients with tumors of the pituitary gland and, thus, lead to the development of better therapeutic regimens for these neoplasms.",[26,27,28,29],"Panhypopituitarism","Gigantism\u002FAcromegaly","Prolactinoma","Cushing Disease",[31,32,33,34,29,35],"Developmental Defect","Oncogenesis","Evaluation and Management","Psychological","Natural History","RECRUITING","2026-06-23",{"date":39,"type":40},"2026-06-24","ACTUAL",{"date":42,"type":40},"1997-04-21",{"name":44,"class":45},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100628561","phase-3-safety-and-potency-of-a-high-cabergoline-dosage-in-microprolactinomas-100628561","NCT07463235","Safety and Potency of a High Cabergoline Dosage in Microprolactinomas","SPARAGMOS","Inclusion Criteria:\n\n* 1\\. Willing and able to provide written informed consent prior to any study-related procedures\n* 2\\. Adults \\>18 years old\n* 3\\. Pre-menopausal women\n* 4\\. Presence of signs and symptoms matching prolactinoma\n* 5\\. Hyperprolactinemia, defined as a prolactin (PRL) level ≥2 times the local laboratory maximum level of normality, present at the time of enrolment\n* 6\\. Presence of an identifiable pituitary mass on MRI with a maximum diameter of less than 1cm, independently of Knosp\u002Finvasiveness of the cavernous sinus\n* 7\\. Treatment naïve\n* 8\\. Females who engage in heterosexual intercourse must agree to use either a highly effective or a clinically acceptable method of contraception from the beginning of screening to the last study visit, which will include:\n* Hysterectomy or bilateral salpingectomy\n* Bilateral tubal occlusion or ligation\n* Vasectomized partner\n* Intrauterine device (copper or hormonal)\n* Progestogen-only contraception (oral, injectable or implantable)\n* Male or female condom with or without spermicide\n* Sexual abstinence (only when it is the usual and preferred lifestyle of the subject)\n\nExclusion Criteria:\n\n* 1\\. History of primary hyperparathyroidism\n* 2\\. Use of combined hormonal contraceptive within the past 4 weeks\n* 3\\. Pregnancy or current pregnancy desire\n* 4\\. Prolactinoma associated with a known genetic syndrome\n* 5\\. Familial history of pituitary adenoma\n* 6\\. Renal failure (estimated glomerular filtration rate \\\u003C30 mL\u002Fmin \u002F1.73m2)\n* 7\\. IGF-1 level above the age-adjusted normal range of the local laboratory (IGF 1 \\>1x ULNR)\n* 8\\. Idiopathic hyperprolactinemia (normal MRI) or presence of macroprolactinemia\n* 9\\. Concomitant mental condition rendering her unable to understand the nature, scope, and possible consequences of the study, and\u002For decompensated psychiatric disease (i.e. gambling or severe obsessive-compulsive disorder), as judged by the Investigator\n* 10\\. Chronic use of drugs related to hyperprolactinemia (such as metoclopramide, methyldopa, ranitidine, and opioid-related analgesics)\n* 11\\. Resistant prolactinoma, defined as non-normalization of PRL levels with 2mg\u002Fw of CAB\n* 12\\. Patients in the high dosage group who did not use 3.5mg\u002Fw of CAB for an entire 6 months (due to intolerance or non-compliance) or failed to achieve the target dose for any other reason\n* 13\\. Active malignant disease within the last 5 years, except basal and squamous cell carcinoma of the skin with complete local excision\n* 14\\. Any decompensated chronic condition (i.e. heart failure NYHA 3-4, diabetes with HbA1c \\>8.5%, hypothyroidism with TSH \\>10 mIU\u002FL) that, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes\n* 15\\. Male sex\n* 16\\. Cushing stigmas (moon face, muscle weakness, red striation) or suspicious\n* 17\\. Prior radiotherapy of the pituitary gland area for any reason\n* 18\\. Additional pituitary tumor-directed therapy, including temozolomide, everolimus, lapatinib, or cytotoxic chemotherapy\n* 19\\. Hepatopathy with AST\u002FTGO or ALT\u002FTGP \\>3x the upper limit of normality","FEMALE","18 Years",{"count":57,"type":22},70,"INTERVENTIONAL",[60],"PHASE3","This will be a multicenter, prospective, randomized, open-label trial with women harboring microprolactinomas and treatment naïve. The sample will be added consecutively and randomized into 2 unblinded groups: the high dosage group will receive a high cabergoline (CAB) dose for a period of \\~6 months vs the standard dosage group, which will use the lowest needed dose of CAB to achieve normoprolactinemia for 2 years. The primary outcome will be remission rate.",[28,63],"Prolactin Excess",[65,66,67],"cabergoline","prolactinoma","remission","2026-03-10",{"date":70,"type":40},"2026-03-13",{"date":72,"type":40},"2026-03-04",{"date":74,"type":22},"2029-12-20",{"name":76,"class":77},"University of Sao Paulo General Hospital","OTHER",16,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":46},"100613560","how-estrogen-fluctuations-before-diagnosis-affect-the-size-prolactin-secreting-tumors-100613560","NCT07268183","How Estrogen Fluctuations Before Diagnosis Affect the Size Prolactin-secreting Tumors","Influence of Pre-diagnostic Estrogen Fluctuations on the Development of Prolactin-Secreting Macroadenomas or Microadenomas: A Comparative Study Conducted at Hôpital Louis Pradel","OEMacroPrL","Inclusion Criteria of cases :\n\n* Female patients aged ≥ 18 years at recruitment (diagnosis may have occurred before age 18).\n* Diagnosis of a prolactin-secreting macroadenoma established between January 2013 and December 2023. The diagnosis may have been made either in the Endocrinology Department of Hôpital Louis Pradel or by another medical team, whether within or outside the hospital setting. However, follow-up or part of the follow-up must have been performed in the Endocrinology Department of Hospices Civils de Lyon (HCL)\n* Diagnosis established by : A hypothalamic-pituitary MRI centered on the sella turcica, performed with gadolinium injection, including fine T1-weighted coronal and sagittal slices (1.5-3 mm), showing an adenoma with at least one axis measuring \\> 10 mm, AND Serum prolactin \\> 100 µg\u002FL, or 24-100 µg\u002FL with either a favorable response to medical therapy or histopathological confirmation after surgery.\n* Ability to understand the study and provide informed non-opposition.\n\nInclusion Criteria of controls :\n\n* Female patients aged ≥ 18 years at the time of recruitment (diagnosis may have occurred before age 18).\n* Diagnosis of a prolactin-secreting microadenoma established between January 2013 and December 2023. The diagnosis may have been made in any medical center, but follow-up or part of the follow-up must have been carried out in the Endocrinology Department of Hôpital Louis Pradel.\n* Diagnosis must be based on: A hypothalamic-pituitary MRI centered on the sella turcica, performed with gadolinium injection, including fine T1-weighted coronal and sagittal slices (1.5-3 mm), showing a prolactin-secreting adenoma with all axes measuring \\\u003C 10 mm, AND A biological assessment performed outside any condition likely to bias results (significant stress, physical exertion, pregnancy, or intake of hyperprolactinemia-inducing drugs unrelated to prolactinoma treatment), showing serum prolactin \\> 24 µg\u002FL.\n* Ability to understand the nature and implications of the study and to provide informed non-opposition to participation.\n\nExclusion Criteria of cases :\n\n* Presence of a non-secreting macroadenoma.\n* History of isolated hyperprolactinemia or an isolated pituitary lesion documented prior to 2013, without subsequent direct diagnosis of prolactinoma.\n* Presence of a known genetic abnormality or a genetic syndrome predisposing to the development of a prolactin-secreting adenoma.\n\nExclusion Criteria of controls :\n\n* Presence of a non-secreting microadenoma.\n* Uncertain diagnosis of adenoma with an ongoing therapeutic trial.\n* Isolated hyperprolactinemia without evidence of adenoma.\n* Hyperprolactinemia or pituitary lesion without hyperprolactinemia documented prior to 2013, without subsequent direct diagnosis of prolactinoma.\n* Presence of a known genetic abnormality or a genetic syndrome predisposing to the development of a prolactin-secreting adenoma",{"count":88,"type":22},180,"Prolactinomas are the most common pituitary adenomas, representing about two-thirds of clinically relevant cases. Their prevalence is around 50 per 100,000 individuals, with an incidence of 3-5 new cases per 100,000 per year and has been rising in recent decades.\n\nThey may increase morbidity and mortality due to several factors:\n\n* Hormone hypersecretion: excess prolactin causes galactorrhea, amenorrhea, and infertility.\n* Mass effect: macroadenomas can compress adjacent structures, leading to headaches, visual loss, or neurological symptoms.\n* Treatment complications: medical or surgical treatments may carry risks.\n\nA marked sex difference exists, with a male-to-female ratio of 1:5-1:10, and peak diagnosis in women aged 25-44. This disparity disappears after menopause, supporting a potential role of estrogens in tumor development. Lactotrope cells, from which prolactinomas arise, are estrogen-sensitive, unlike other pituitary tumor cells (e.g., somatotrophs, gonadotrophs).\n\nA large 2022 prospective cohort (nurses) suggested a possible association between pituitary adenomas and both combined oral contraceptives (COCs) and hormone therapy (HT). However, limitations included self-reported diagnoses, lack of adenoma characterization, and contradictory findings (association with HT but not consistently with COCs). A 2009 case-control study including all adenomas found no link with hormonal contraception, while older studies from the 1980s assessed high-dose contraceptives no longer in use.\n\nMicroprolactinomas are 4-5 times more frequent than macroprolactinomas (≥10 mm). Distinguishing between the two is essential, as they differ in clinical presentation, prognosis, and sex distribution. Macroadenomas are more common in men, possibly due to delayed diagnosis, as symptoms such as decreased libido are less specific, whereas women often present with amenorrhea or galactorrhea. However, studies suggest tumor size is not directly linked to symptom duration, indicating other factors may explain macroadenoma development.\n\nWhy some patients develop macro- rather than microadenomas remains unclear. Estrogen exposure is a possible explanation. It is therefore relevant to investigate whether women with macroprolactinomas had greater exposure to endogenous estrogens (early menarche, late menopause, pregnancies, breastfeeding) or exogenous estrogens (contraception, menopausal HT) compared to women with microprolactinomas.\n\nThe hypothesis is that women with macroprolactinomas were exposed to higher cumulative levels of estrogens before diagnosis than women with microprolactinomas.",[28,91],"Macroprolactinoma",[28,91,93,94,95,96,97,98,99],"pituitary adenomas","lactotroph adenoma","risk factor","microprolactinoma","Combined hormonal contraception","combined oral contraception","estrogen impact","2026-01-21",{"date":102,"type":40},"2026-01-22",{"date":104,"type":40},"2026-01-06",{"date":106,"type":22},"2027-01-06",{"name":108,"class":77},"Hospices Civils de Lyon",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":58,"phases":119,"briefSummary":121,"conditions":122,"keywords":123,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":46},"100596474","phase-4-metabolic-outcomes-in-patients-with-prolactinomas-under-dopamine-agonist-treatment-100596474","NCT07045935","Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment","Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment - A Randomized, Single-Blind Active- Controlled Trial","ProBOLIC","Inclusion Criteria (treatment-naïve patients):\n\n* Diagnosed adult patients (at least 18 years of age) with prolactinoma-induced hyperprolactinemia, defined as a prolactin level ≥ two times the local laboratory maximum and radiographic criteria, based on current guidelines.\n\nInclusion Criteria (treatment-naïve patients):\n\n* Diagnosed adult patients (at least 18 years of age) with prolactinoma-induced hyperprolactinaemia based on current guidelines.\n* Patients treated with cabergoline as DA therapy and prolactin levels within the normal range\n\nExclusion Criteria:\n\n* alternative explanation for hyperprolactinaemia\n* Active substance use disorder within the last six months\n* Current or previous psychotic disorder\n* Pregnancy or breastfeeding within the last 8 weeks\n* Severe hepatic insufficiency or cholestasis\n\n  * Child Pugh C or\n  * AST\u002F ALT \\> 3 x the upper limit of normal ULN or\n  * Cholestasis (total bilirubin \\> 2x ULN)\n* Severe renal impairment (eGFR \\\u003C 30 ml\u002Fmin)\n* History of pulmonary, pericardial, and\u002For retroperitoneal fibrotic disorders\n* Concomitant treatment with strong or moderate CYP3A4 inhibitors\n* Local complications on morphological imaging, related to signs or clinical symptoms which make surgical intervention necessary or a clear patient's preference for surgical treatment\n* Gastrointestinal disease or previous surgery: chronic active inflammatory bowel disease, active gastrointestinal ulcer disease, or surgery on the gastrointestinal tract (e.g. sleeve stomach, gastric band)\n* Patient incapable of giving informed consent due to cognitive impairment or other reasons (e.g., legal incapacity)",{"count":118,"type":22},60,[120],"PHASE4","This randomized, active-controlled, parallel-arm, single-blind trial is to compare the effects of Dopamine agonists (DA) therapy targeting different established treatment strategies on glucose metabolism assessed by an oral glucose tolerance test.",[28],[124,65,125,126,127,128,129],"hyperprolactinemia","prolactin level","Dopamine agonist","glucose level","Oral Glucose Tolerance Test","hypoprolactinemia","2025-09-22",{"date":132,"type":40},"2025-09-23",{"date":134,"type":40},"2025-09-16",{"date":136,"type":22},"2029-12-31",{"name":138,"class":77},"University Hospital, Basel, Switzerland"]