Status:

UNKNOWN

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

Lead Sponsor:

Seoul National University Hospital

Conditions:

Pituitary Adenoma

Prolactinoma

Eligibility:

All Genders

19+ years

Phase:

NA

Brief 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 patien...

Detailed 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, cabergo...

Eligibility Criteria

Inclusion

  • Adults, male or female aged 19 years or older
  • diagnosed with prolactinoma
  • No previous history of surgery, medication, or radiation therapy

Exclusion

  • 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

Key Trial Info

Start Date :

February 22 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2024

Estimated Enrollment :

68 Patients enrolled

Trial Details

Trial ID

NCT03457389

Start Date

February 22 2018

End Date

December 31 2024

Last Update

March 18 2020

Active Locations (1)

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1

Seoul National University Hospital

Seoul, South Korea, 03080