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

NCT03457389 | Unknown DMC

• 1 other identifier: 1711-119-901
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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 patients with prolactinomas.

Conditions

Pituitary Adenoma; Prolactinoma; Pituitary Tumor; Recurrence Tumor

Keywords

Prolactinoma; Cabergoline; Recurrence

Outcome Measures

Primary Outcomes (1)

• Recurrence rate within 1 year after cabergoline withdrawal

  Record of PRL levels on every 3 month follow-up visit

  From 4 year to 5 years after cabergoline administration

Secondary Outcomes (3)

• Time to normalization of serum prolactin level

  Up to 1 year

• Change from baseline on tumor volume measured by pituitary MRI

  Up to 3 years

• Change from baseline of visual field defect

  Up to 3 years

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Drug: Cabergoline

Control group

ACTIVE COMPARATOR

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

Drug: Cabergoline

Interventions

Cabergoline DRUG

Cabergoline tablet

Also known as: Caverlactin

Control group; Experimental group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Pituitary Neoplasms; Prolactinoma; Recurrence

Interventions

Cabergoline

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jung Hee Kim, M.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung Hyun Lee

CONTACT

82-2-2072-4073; leejh001515@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: One experimental group and one control group

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: March 7, 2018
• Study Start: February 22, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 18, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)