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
Updated on 27 February 2022
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 IdentifierNCT03457389
SponsorSeoul National University Hospital
Last Modified on27 February 2022

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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