Pituitary NeoplasmsPhase 3NCT02288962
Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas
A Phase 3 study testing cabergoline in people with Pituitary Neoplasms and Adenoma, run by St. Olavs Hospital at 3 sites in 2 countries.
Trial 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 undergo pituitary surgery. The remaining adenomas are monitored regularly. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pituitary Neoplasms, Adenoma
- What is being tested?
- cabergoline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2014to Dec 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Norway2 sites
Department of Endocrinology, Akershus University hospital
Oslo
Department of Endocrinology, St. Olavs Hospital
Trondheim, 7006
About this study
Official title: Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas (NFPAs) - a Randomized Controlled Trial
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 undergo pituitary surgery. The remaining adenomas are monitored regularly. Operation of these large adenomas will rarely remove all tumour tissue, and there is also a risk of worsening of pituitary function. Often, adenomas with the highest growth potential are operated several times and some also need radiation therapy, providing additional risk for pituitary failure. Unlike some of the hormone-producing adenomas, there is no established pharmacological treatment for NFPAs. However, there are a few non-randomized studies suggesting that treatment with dopamine agonists may slow growth, and also induce tumour shrinkage. At present, cabergoline is the dopamine agonist most widely used in the treatment of pituitary adenomas secreting prolactin.
Aim is to study the effect of medical treatment with cabergoline in non-functioning pituitary adenomas on the change in tumour volume.
- Conditions
- Pituitary Neoplasms, Adenoma
- Being tested
- cabergoline
- Keywords
- dopamine agonists, cabergoline
- Medical subject headings
- Pituitary Neoplasms, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cabergolineDrug
Also called galastop, FCE 21336, Cabaser, Dostinex
| Study group | Role | What they receive |
|---|---|---|
| cabergoline | Experimental | Target dose for cabergoline is 2 mg/week.The medication is administered in the evening to minimize side effects. If intolerable side effects occur despite this, it may be necessary to treat with a lower dose than 2 mg per week.
Treatment scheme: 0.5 mg x 1 per week the first 2 weeks, then 0.5 mg x 2 per week the next 2 weeks, then 1 + 0.5 mg per week the next 2 weeks, then 1 mg x 2 per week (target dose) for the rest of the study Receives: Drug: cabergoline |
| observation | No intervention | visits and controls as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in tumour volume during the main study of two years
This includes the percentage and absolute change in tumour volume, but also the number of patients with significant tumour shrinkage or tumour growth (defined by ≥ 10 % or ≥ 2 mm shrinkage/growth in at least one dimension)
Measured: 2 years
Secondary outcomes (5)
need for surgical and/or radiation treatment
Measured: up till 2 years
changed pituitary function
measured by analysis of blood tests, basal and stimulation tests
Measured: up till 2 years
change in tumour's distance to chiasma opticum in mm
as measured by analysis of MRI images
Measured: up till 2 years
development of cardiac valvulopathy
as measured by analysis of echo cardiography
Measured: up till 2 years
impulse control disorder
as measured by questionnaire visual files: clinical evaluation by ophthalmologist and perimetry
Measured: up till 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Sven M Carlsen, prof md, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288962
- Sponsor's protocol ID
- 2012/677
- Other IDs
- 2012-001338-32
- Status last verified
- Jul 2026
- First submitted
- 5 Nov 2014
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No