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Clinical Trials/EUCTR2012-001338-32-NO
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

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.

Registry
who.int
Start Date
May 10, 2012
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
St. Olavs Hospital Trondheim University Hospital

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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