Actively Recruiting
Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment
Led by University Hospital, Basel, Switzerland · Updated on 2025-09-23
60
Participants Needed
1
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older diagnosed with prolactinoma-induced hyperprolactinemia, defined by prolactin levels at least twice the local laboratory maximum and radiographic criteria according to current guidelines
- Patients treated with cabergoline as dopamine agonist therapy with prolactin levels within the normal range
You will not qualify if you...
- Alternative explanation for hyperprolactinemia
- 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, including Child Pugh C stage, AST/ALT over three times the upper limit of normal, or total bilirubin over twice the upper limit of normal
- Severe renal impairment with eGFR less than 30 ml/min
- History of pulmonary, pericardial, or retroperitoneal fibrotic disorders
- Concomitant treatment with strong or moderate CYP3A4 inhibitors
- Local complications requiring surgical intervention or patient preference for surgery
- Chronic active inflammatory bowel disease, active gastrointestinal ulcer disease, or previous gastrointestinal surgery such as sleeve stomach or gastric band
- Inability to provide informed consent due to cognitive impairment or legal incapacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital Basel, Dept. of Endocrinology, Metabolism & Diabetes
Basel, Switzerland, 4031
Actively Recruiting
Research Team
C
Cihan Atila, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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