Efficacy of Rapid Escalation of Cabergoline in Comparison to Conventional Dosing in Prolactin Secreting Macroadenomas.
Macroprolactinoma
About this trial
This is an interventional treatment trial for Macroprolactinoma focused on measuring Prolactin, Cabergoline, Macroadenomas, escalation
Eligibility Criteria
Inclusion Criteria:
Males or females presenting with
- Prolactin secreting macroadenomas (≥10 mm maximum diameter)
- With/without visual complaints
- With /without parasellar or suprasellar extension
- Treatment Naïve
Exclusion Criteria:
- On treatment with dopamine agonists.
- Taking other drugs influencing prolactin Levels.
- Systemic disease like Chronic Kidney Disease, Chronic Lung Disease
- Other secondary causes of hyperprolactinemia.
- Prolactin secreting microadenomas
- Pregnancy during follow up
- Prolactinoma as part of MEN-1 Syndrome
- History suggestive of recent apoplexy (3 months)
- Contraindication to cabergoline therapy like pre existing psychosis.
Sites / Locations
- Postgraduate Institute of Medical Education and ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Rapid escalation
Conventional escalation
Weekly escalation of cabergoline dose in macroprolactinomas Start with 1 mg/week. increase by 1mg/wk every week till 4 weeks. after 4 weeks Cabergoline dose would be increased @1mg/wk every 4 weekly till normalization of prolactin and >50% decrease in tumor volume from baseline.
Conventional escalation of cabergoline In the Conventional escalation group schedule of cabergoline dosing will be 0.5 mg once a week for 4 weeks. Cabergoline will be incrementally dose adjusted on the basis of individual Prolactin values till amelioration of hyper prolactinemia @ 0.5 mg/wk every 4 weeks, till 24 weeks or till primary endpoint.