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