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

Phase 1

• Conditions: non-functioning pituitary adenomas; MedDRA version: 14.1Level: LLTClassification code 10035079Term: Pituitary adenomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2012-001338-32-NO
• Lead Sponsor: St. Olavs Hospital Trondheim University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-10
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified