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Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv16
  2. Primary completion date: Dec 2025 to Dec 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 2027 to Dec 2028
    • Site details revised at 3 of 3 sites
    v15
  3. Re-verified, no change to tracked fieldsv14
  4. Primary completion date: May 2022 to Dec 2025
    • Study completion date: May 2026 to Dec 2027
    v13
  5. Primary completion date: May 2021 to May 2022
    • Study completion date: May 2025 to May 2026
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. 5 versions Re-verified since Dec 19, 2016, no change to tracked fieldsv7-v11
  2. Study sites: 2 to 3
    • Study title shortened, about 6 words
    v6
  3. 3 versions Re-verified since May 12, 2015, no change to tracked fieldsv3-v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Secondary endpoints revised (5)
    • Site details revised at 2 of 2 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02288962
Lead Sponsor St. Olavs Hospital
Collaborators: Norwegian University of Science and Technology
Conditions
(from sponsor)		 Pituitary Neoplasms, Adenoma
Related terms Adenoma, Pituitary Neoplasms
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov