Cabergoline in the Management of Nonfunctioning Pituitary Adenoma (NCT07034859) | Clinical Trial Compass
By InvitationPhase 4
Cabergoline in the Management of Nonfunctioning Pituitary Adenoma
Taiwan30 participantsStarted 2024-05-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportions of tumor shrinkage after 48 week-treatment