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

NCT ID: NCT03457389

Last Updated: 2020-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-22

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pituitary Adenoma Prolactinoma Pituitary Tumor Recurrence Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One experimental group and one control group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental group

Serum prolactin level is adjusted to less than 5 ng/mL during cabergoline administration.

Group Type EXPERIMENTAL

Cabergoline

Intervention Type DRUG

Cabergoline tablet

Control group

Serum prolactin level is adjusted to normal range during cabergoline administration.

Group Type ACTIVE_COMPARATOR

Cabergoline

Intervention Type DRUG

Cabergoline tablet

Interventions

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Cabergoline

Cabergoline tablet

Intervention Type DRUG

Other Intervention Names

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Caverlactin

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jung Hee Kim

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jung Hee Kim, M.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jung Hyun Lee

Role: CONTACT

82-2-2072-4073

Facility Contacts

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Jung Hee Kim, M.D

Role: primary

Other Identifiers

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1711-119-901

Identifier Type: -

Identifier Source: org_study_id

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