Comparison of Treatment Outcome of Cabergoline According to Target Prolactin Levels in Patients W… (NCT03457389) | Clinical Trial Compass
UnknownNot Applicable
Comparison of Treatment Outcome of Cabergoline According to Target Prolactin Levels in Patients With Prolactinoma
South Korea68 participantsStarted 2018-02-22
Plain-language summary
The aim of this study is to investigate whether inhibition of serum prolactin levels below normal range during cabergoline administration may reduce the recurrence rate after drug withdrawal in patients with prolactinomas.
Who can participate
Age range
19 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:
* Adults, male or female aged 19 years or older
* diagnosed with prolactinoma
* No previous history of surgery, medication, or radiation therapy
Exclusion Criteria:
* Invasive prolactinomas except invading cavernous sinus
* Taking dopaminergic medications
* Taking medications that can affect serum prolactin level (including estrogenic hormone, oral contraceptive drugs, intrauterine devices)
* Hyperprolactinemia due to secondary causes
* History of pituitary apoplexy within the last 3 months
* Patients with mental illness that should avoid dopamine agonists
* Patients with history of cardiac valve diseases
* Patients with history of pulmonary fibrosis, retroperitoneal fibrosis, and cystic fibrosis
* Moderate degree of hepatic or renal insufficiency (IDMS Modification of Diet in Renal Disease glomerular filtration rate (MDRD GFR) \<45 ml/min/1.73m2)
* Patients with cabergoline hypersensitivity reaction
* Pregnant or breast feeding patients
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
Recurrence rate within 1 year after cabergoline withdrawal
Timeframe: From 4 year to 5 years after cabergoline administration