Cabergoline 0.5 MG: Cabergoline (Dostinex ®) 0.5 mg/tablet. Cabergoline will be given orally 1mg/week (Day1-14), 2mg/week (Day15-end of the study).
Study summary
The goal of this clinical trial is to learn if Cabergoline (Dostinex), a dopamine agonist which has been widely used to treat hyperprolactinemia, prolactinoma for many years, works to treat nonfunctioning pituitary adenoma (NFPA) in adults. The main questions it aims to answer are:
Does cabergoline reduce the size of NFPA effectively when used as primary therapy?
Participants will:
Be 1:1 randomized into two groups. Either to take cabergoline or none for 48 weeks, Visit the clinic every 12 weeks for checkups and tests, Undergo scheduled imaging studies, Magnetic Resonance Imaging (MRI) to measure the change of tumor size.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Male or female ≥ 18 years of age at Visit 1.
* Documentation of NFPA as evidenced by diagnostic criteria and size ≥ 0.5 cm in diameter.
* Absence of previous hormonal pituitary hypersecretion, except prolactin level ≤ 30 ng/ml
* Absence of previous radiotherapy or radiosurgery
* Written informed consent
Exclusion Criteria:
* Allergic to cabergoline or ergotamine
* Currently receiving cabergoline
* With moderate to severe symptoms of mass effect, such as visual defect, headache, cranial nerve palsy.
* AST, ALT over 2.5 times of the upper limit.
* Chronic kidney disease, stage 4 and 5.
* Hypotension
* History of congestive heart failure, NYHA Fc III, IV
* History of moderate or severe valvular heart disease.
* History of Parkinson's disease.
* History of pulmonary fibrosis
* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
* History of previous pituitary surgery or radiotherapy
* Psychotic psychiatric disease
* Active gastrointestinal tract bleeding
* History of Raynaud's phenomenon
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Primary outcome measure(s)
Proportions of tumor shrinkage after 48 week-treatment — Baseline (Visit 1), 12th Week (Visit 4), 24th Week (Visit 5), 48th Week (Visit 7) The tumor volume will be calculated via ITK-SNAP version 3.6.0 at visit 1, 4, 5, 7. The largest diameter of tumor will also be measured at visit 1, 4, 5, 7. The within-group differences were examined by Wilcoxon signed-rank test. The between-group differences were examined by Wilcoxon rank-sum test.
The proportion of tumor shrinkage will be examined at visit 7. The between-group differences were examined by McNemar test
Trial sites (1)
Facility
City
Region
Status
National Taiwan University Hospital
Taipei
Taiwan
More National Taiwan University Hospital trials in Taiwan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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