[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prolactin-excess\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prolactin-excess":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":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"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},"100628561","phase-3-safety-and-potency-of-a-high-cabergoline-dosage-in-microprolactinomas-100628561",false,"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":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"Prolactinoma","Prolactin Excess",[29,30,31],"cabergoline","prolactinoma","remission","RECRUITING","2026-03-10",{"date":35,"type":36},"2026-03-13","ACTUAL",{"date":38,"type":36},"2026-03-04",{"date":40,"type":20},"2029-12-20",{"name":42,"class":43},"University of Sao Paulo General Hospital","OTHER",16]