Dopamine agonist treatment of non-functioning pituitary adenomas - a randomized controlled trial.

Dopamine agonist treatment of non-functioning pituitary adenomas (NFPAs) - a randomized controlled trial. The efficacy of cabergoline on tumour volume in previously untreated macroadenomas or residual adenomas after pituitary surgery or irradiation. - Dopamine agonist treatment of non-functioning pituitary adenomas

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001338-32-NO

Enrollment

Registered

2012-05-10

Start date

2012-09-24

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-functioning pituitary adenomas MedDRA version: 14.1 Level: LLT Classification code 10035079 Term: Pituitary adenoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Dostinex and Cabaser Product Name: cabergoline Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. A previously untreated non-functioning pituitary macroadenoma (largest diameter = 10 mm) OR a residual tumour after surgical treatment of a non-functioning pituitary macroadenoma 2. Age 18-75 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35

Exclusion criteria

Exclusion criteria: 1. Clear indication for surgery at the time of inclusion 2. Radiation therapy the last 2 years prior to inclusion, or radiation therapy >2 years earlier if significant tumour shrinkage after treatment 3. Pituitary surgery the last 6 months 4. Apoplexy/bleeding in the adenoma 5. Pregnancy or lactation 6. Contraindications for cabergoline treatment: Known cardiac valvular disease Known pulmonal, pericardial or retroperitoneal fibrosis Clinical significant liver insufficiency Use of medications that interact with cabergoline 7. Unfit to participate due to any other reason

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the effect of medical treatment with cabergoline on tumour volume in non-functioning pituitary adenomas.;Secondary Objective: To evaluate the effect of medical treatment with cabergoline in non-functioning pituitary adenomas on pituitary function, and on the need for non-medical treatment. To evaluate possible complications to dopamine agonist treatment in non-functioning pituitary adenomas.;Primary end point(s): The change in tumour volume during the study. This includes the percentage and absolute change in tumour volume, but also the number of patients with significant tumour shrinkage or tumour growth.;Timepoint(s) of evaluation of this end point: At 2 years (at cross-over) and 4 years (end of study). Interim analyses will be performed after one year to ensure and document safety.	—

Measure

Time frame

Main Objective: To study the effect of medical treatment with cabergoline on tumour volume in non-functioning pituitary adenomas.;Secondary Objective: To evaluate the effect of medical treatment with cabergoline in non-functioning pituitary adenomas on pituitary function, and on the need for non-medical treatment. To evaluate possible complications to dopamine agonist treatment in non-functioning pituitary adenomas.;Primary end point(s): The change in tumour volume during the study. This includes the percentage and absolute change in tumour volume, but also the number of patients with significant tumour shrinkage or tumour growth.;Timepoint(s) of evaluation of this end point: At 2 years (at cross-over) and 4 years (end of study). Interim analyses will be performed after one year to ensure and document safety.

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Secondary

Measure	Time frame
Secondary end point(s): • The need for surgical and/or radiation treatment during the study period. • The development of new or changed pituitary failure during the study, or new or changed visual field defects or other cranial nerve affections. • The change in tumour’s distance to chiasma opticum (mm). • The response on gonadotropins (FSH, LH) and/or their subunits, particularly the a-subunit. We will also examine a possible correlation between the tumour size response and the hormone levels and hormone response during treatment. • The development of cardiac valvulopathy • The development of impulse control disorder. ;Timepoint(s) of evaluation of this end point: At 2 years (at cross-over) and 4 years (end of study).	—

Measure

Time frame

Secondary end point(s): • The need for surgical and/or radiation treatment during the study period. • The development of new or changed pituitary failure during the study, or new or changed visual field defects or other cranial nerve affections. • The change in tumour’s distance to chiasma opticum (mm). • The response on gonadotropins (FSH, LH) and/or their subunits, particularly the a-subunit. We will also examine a possible correlation between the tumour size response and the hormone levels and hormone response during treatment. • The development of cardiac valvulopathy • The development of impulse control disorder. ;Timepoint(s) of evaluation of this end point: At 2 years (at cross-over) and 4 years (end of study).

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Countries

Norway

Contacts

Public ContactDepartment of Endocrinology

St. Olavs Hospital Trondheim University Hospital

stine.fougner@ntnu.no4772825120

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026