Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment (NCT07045935) | Clinical Trial Compass
RecruitingPhase 4
Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment
Switzerland60 participantsStarted 2025-09-16
Plain-language summary
This randomized, active-controlled, parallel-arm, single-blind trial is to compare the effects of Dopamine agonists (DA) therapy targeting different established treatment strategies on glucose metabolism assessed by an oral glucose tolerance test.
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 (treatment-naïve patients):
* Diagnosed adult patients (at least 18 years of age) with prolactinoma-induced hyperprolactinemia, defined as a prolactin level ≥ two times the local laboratory maximum and radiographic criteria, based on current guidelines.
Inclusion Criteria (treatment-naïve patients):
* Diagnosed adult patients (at least 18 years of age) with prolactinoma-induced hyperprolactinaemia based on current guidelines.
* Patients treated with cabergoline as DA therapy and prolactin levels within the normal range
Exclusion Criteria:
* alternative explanation for hyperprolactinaemia
* Active substance use disorder within the last six months
* Current or previous psychotic disorder
* Pregnancy or breastfeeding within the last 8 weeks
* Severe hepatic insufficiency or cholestasis
* Child Pugh C or
* AST/ ALT \> 3 x the upper limit of normal ULN or
* Cholestasis (total bilirubin \> 2x ULN)
* Severe renal impairment (eGFR \< 30 ml/min)
* History of pulmonary, pericardial, and/or retroperitoneal fibrotic disorders
* Concomitant treatment with strong or moderate CYP3A4 inhibitors
* Local complications on morphological imaging, related to signs or clinical symptoms which make surgical intervention necessary or a clear patient's preference for surgical treatment
* Gastrointestinal disease or previous surgery: chronic active inflammatory bowel disease, active gastrointestinal ulcer disease, or surgery on the gastrointestinal tract (e.g. sleeve stoma…
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
2-hour post-oral glucose tolerance test (OGTT) plasma glucose levels
Timeframe: assessed at 12 months after randomisation