Status:
ACTIVE_NOT_RECRUITING
Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas
Lead Sponsor:
St. Olavs Hospital
Collaborating Sponsors:
Norwegian University of Science and Technology
Conditions:
Pituitary Neoplasms
Adenoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Due to lack of hormone overproduction in non-functioning pituitary adenomas (NFPAs), only the symptomatic adenomas or large adenomas with proven growth and risk for symptoms in near future will underg...
Eligibility Criteria
Inclusion
- A previously untreated non-functioning pituitary macroadenoma (largest diameter ≥ 10 mm) with either demonstrated growth on repeated MRI scans or ≤ 2 mm distance to chiasma opticum, or:
- a residual non-functioning pituitary adenoma after surgery (largest diameter ≥ 5 mm) that is either extrasellar and/or with documented growth after surgical treatment of a non-functioning pituitary macroadenoma
Exclusion
- Clear indication for surgery at the time of inclusion
- Previous radiation therapy
- Pituitary surgery the last 6 months
- Previous apoplexy/bleeding in the adenoma
- Pregnancy or lactation
- 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
- unfit to participate due to any other reason
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02288962
Start Date
November 1 2014
End Date
December 1 2028
Last Update
June 8 2025
Active Locations (3)
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1
Department of Endocrinology, Akershus University hospital
Oslo, Norway
2
Department of Endocrinology, St. Olavs Hospital
Trondheim, Norway, 7006
3
Sahlgrenska University Hospital
Gothenburg, Sweden