[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596474":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":35,"responsibleParty":51,"collaborators":24,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":24,"enrollmentInfo":63,"targetDuration":24,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":37,"whyStopped":24,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University Hospital, Basel, Switzerland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental intervention arm (Cabergoline)","ACTIVE_COMPARATOR","The experimental intervention arm aims to treat patients (with hyperprolactinemia) with Cabergoline (Dopamine Agonist) by targeting the suppression of prolactin levels (below the normal plasma prolactin range).",[13],"Drug: Cabergoline (Dopamine Agonist)",{"label":15,"type":10,"description":16,"interventionNames":17},"Control intervention arm (Cabergoline)","The control intervention arm aims to treat patients (with hyperprolactinemia ) with Cabergoline (Dopamine Agonist) by targeting the normalisation of prolactin levels (within the normal plasma prolactin range).",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Cabergoline (Dopamine Agonist)","Cabergoline is available in tablet form, with doses of 0.5 mg per tablet. The standard dosing for hyperprolactinemia typically starts at 0.25 mg to 0.5 mg per week, which can be gradually increased based on the patient's response, with a usual range of 0.25 mg to 2 mg per week. The dose required to achieve the target prolactin levels (pre- defined for each intervention arm) may vary between patients, so a fixed dose is not specified. This allows for individualized treatment based on each patient's response.",[15,9],null,[26],{"name":27,"affiliation":28,"role":29},"Cihan Atila, Dr.","University Hospital Basel, Dept. of Endocrinology, Metabolism & Diabetes","PRINCIPAL_INVESTIGATOR",[31],{"name":27,"role":32,"phone":33,"phoneExt":24,"email":34},"CONTACT","+41 61 328 4579","cihan.atila@usb.ch",[36],{"facility":28,"status":37,"city":38,"state":24,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Basel","4031","Switzerland","CH",{"type":43,"coordinates":44},"Point",[45,46],7.57327,47.55839,{"lat":46,"lon":45},[49,50],{"name":27,"role":32,"phone":24,"phoneExt":24,"email":34},{"name":27,"role":29,"phone":24,"phoneExt":24,"email":24},{"type":52,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100596474","phase-4-metabolic-outcomes-in-patients-with-prolactinomas-under-dopamine-agonist-treatment-100596474",false,"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)","ALL","18 Years",{"count":64,"type":65},60,"ESTIMATED","INTERVENTIONAL",[68],"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.",[71],"Prolactinoma",[73,74,75,76,77,78,79],"hyperprolactinemia","cabergoline","prolactin level","Dopamine agonist","glucose level","Oral Glucose Tolerance Test","hypoprolactinemia","2025-09-22",{"date":82,"type":83},"2025-09-23","ACTUAL",{"date":85,"type":83},"2025-09-16",{"date":87,"type":65},"2029-12-31",{"name":5,"class":6},1]