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

Pituitary Adenoma Clinical Trial

Official title:

Comparison of Treatment Outcome of Cabergoline According to Target Prolactin Levels in Patients With Prolactinoma: A Prospective, Randomized, Open Label, Active-controlled, Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03457389
• Other study ID #: 1711-119-901
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2019
• Source: Seoul National University Hospital
• Contact: Jung Hyun Lee
• Phone: 82-2-2072-4073
• Email: leejh001515[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms
• Pituitary Tumor
• Prolactinoma
• Recurrence
• Recurrence Tumor

Intervention

Drug:
• Cabergoline
Cabergoline tablet

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to normalization of serum prolactin level	Record of PRL levels on follow-up visit	Up to 1 year
Secondary	Change from baseline on tumor volume measured by pituitary MRI	Record of he tumor volume from pituitary MRI on every 12-month follow-up visit	Up to 3 years
Secondary	Change from baseline of visual field defect	Record the Visual field scale on every 6 month follow-up visit,	Up to 3 years