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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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30 January 2023 |
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Main ID: |
NCT02288962 |
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Date of registration:
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05/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas
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Scientific title:
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Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas (NFPAs) - a Randomized Controlled Trial |
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Date of first enrolment:
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November 2014 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02288962 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Norway
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Sweden
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Contacts
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Name:
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Stine L Fougner, MD PhD |
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Address:
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Telephone:
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Email:
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stine.fougner@ntnu.no |
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Affiliation:
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Name:
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Stine L Fougner, md phd |
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Address:
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Telephone:
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Email:
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stine.fougner@ntnu.no |
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Affiliation:
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Name:
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Sven M Carlsen, prof md |
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Address:
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Telephone:
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Email:
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Affiliation:
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Norwegian University of Science and Technology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pituitary Neoplasms
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Adenoma
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Intervention(s)
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Drug: cabergoline
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Primary Outcome(s)
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change in tumour volume during the main study of two years
[Time Frame: 2 years]
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Secondary Outcome(s)
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need for surgical and/or radiation treatment
[Time Frame: up till 2 years]
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impulse control disorder
[Time Frame: up till 2 years]
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change in tumour's distance to chiasma opticum in mm
[Time Frame: up till 2 years]
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development of cardiac valvulopathy
[Time Frame: up till 2 years]
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changed pituitary function
[Time Frame: up till 2 years]
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Secondary ID(s)
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2012/677
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2012-001338-32
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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