Comparison of Treatment Outcome of Cabergoline According to Target Prolactin Levels in Patients With Prolactinoma

STATUS

Recruiting
End date

Dec 31, 2024
participants needed

68
sponsor

Seoul National University Hospital

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Updated on 27 February 2022

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cabergoline

prolactin

drug withdrawal

prolactinoma

Summary

The aim of this study is to investigate whether inhibition of serum prolactin levels below normal range during cabergoline administration may reduce the recurrence rate after drug withdrawal in patients with prolactinomas.

Description

Prolactinoma patients will be assigned to a experimental group that maintains serum prolactin levels below 5 ng/mL and a control group that maintains normal serum prolactin levels. After that, cabergoline will be maintained at a therapeutic dose for 130 weeks. After cabergoline is discontinued, patients will be followed up with serum prolactin measurement for 52 weeks.

Details

Condition	Pituitary Adenoma, Prolactinoma, Pituitary Tumor, Recurrence Tumor
Treatment	Cabergoline
Clinical Study Identifier	NCT03457389
Sponsor	Seoul National University Hospital
Last Modified on	27 February 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Adults, male or female aged 19 years or older
	diagnosed with prolactinoma
	No previous history of surgery, medication, or radiation therapy
Exclusion Criteria
	Invasive prolactinomas except invading cavernous sinus
	Taking dopaminergic medications
	Taking medications that can affect serum prolactin level (including estrogenic hormone, oral contraceptive drugs, intrauterine devices)
	Hyperprolactinemia due to secondary causes
	History of pituitary apoplexy within the last 3 months
	Patients with mental illness that should avoid dopamine agonists
	Patients with history of cardiac valve diseases
	Patients with history of pulmonary fibrosis, retroperitoneal fibrosis, and cystic fibrosis
	Moderate degree of hepatic or renal insufficiency (IDMS Modification of Diet in Renal Disease glomerular filtration rate (MDRD GFR) <45 ml/min/1.73m2)
	Patients with cabergoline hypersensitivity reaction
	Pregnant or breast feeding patients

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Comparison of Treatment Outcome of Cabergoline According to Target Prolactin Levels in Patients With Prolactinoma