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

Last updated: March 17, 2020
Sponsor: Seoul National University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pituitary Disorders

Brain Tumor

Treatment

N/A

Clinical Study ID

NCT03457389
1711-119-901
  • Ages > 19
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults, male or female aged 19 years or older

  • diagnosed with prolactinoma

  • No previous history of surgery, medication, or radiation therapy

Exclusion

Exclusion Criteria:

  • Invasive prolactinomas except invading cavernous sinus

  • Taking dopaminergic medications

  • Taking medications that can affect serum prolactin level (including estrogenichormone, 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 cysticfibrosis

  • Moderate degree of hepatic or renal insufficiency (IDMS Modification of Diet in RenalDisease glomerular filtration rate (MDRD GFR) <45 ml/min/1.73m2)

  • Patients with cabergoline hypersensitivity reaction

  • Pregnant or breast feeding patients

Study Design

Total Participants: 68
Study Start date:
February 22, 2018
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

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