EUCTR2012-001338-32-NO
Active, not recruiting
Phase 1
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
St. Olavs Hospital Trondheim University Hospital0 sites80 target enrollmentMay 10, 2012
Conditionsnon-functioning pituitary adenomasMedDRA 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]
DrugsDostinex and Cabaser
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- non-functioning pituitary adenomas
- Sponsor
- St. Olavs Hospital Trondheim University Hospital
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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