Safety and Potency of a High Cabergoline Dosage in Microprolactinomas

Exclusion Criteria

• •1\. History of primary hyperparathyroidism
• •2\. Use of combined hormonal contraceptive within the past 4 weeks
• •3\. Pregnancy or current pregnancy desire
• •4\. Prolactinoma associated with a known genetic syndrome
• •5\. Familial history of pituitary adenoma
• •6\. Renal failure (estimated glomerular filtration rate \<30 mL/min /1.73m2)
• •7\. IGF-1 level above the age-adjusted normal range of the local laboratory (IGF 1 \>1x ULNR)
• •8\. Idiopathic hyperprolactinemia (normal MRI) or presence of macroprolactinemia
• •9\. Concomitant mental condition rendering her unable to understand the nature, scope, and possible consequences of the study, and/or decompensated psychiatric disease (i.e. gambling or severe obsessive-compulsive disorder), as judged by the Investigator
• •10\. Chronic use of drugs related to hyperprolactinemia (such as metoclopramide, methyldopa, ranitidine, and opioid-related analgesics)
• •11\. Resistant prolactinoma, defined as non-normalization of PRL levels with 2mg/w of CAB
• •12\. Patients in the high dosage group who did not use 3.5mg/w of CAB for an entire 6 months (due to intolerance or non-compliance) or failed to achieve the target dose for any other reason
• •13\. Active malignant disease within the last 5 years, except basal and squamous cell carcinoma of the skin with complete local excision
• •14\. Any decompensated chronic condition (i.e. heart failure NYHA 3-4, diabetes with HbA1c \>8.5%, hypothyroidism with TSH \>10 mIU/L) 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
• •15\. Male sex
• •16\. Cushing stigmas (moon face, muscle weakness, red striation) or suspicious
• •17\. Prior radiotherapy of the pituitary gland area for any reason
• •18\. Additional pituitary tumor-directed therapy, including temozolomide, everolimus, lapatinib, or cytotoxic chemotherapy
• •19\. Hepatopathy with AST/TGO or ALT/TGP \>3x the upper limit of normality