Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment
Recruiting
Phase 4Interventional Study
Prolactinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
University Hospital, Basel, Switzerland · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
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 (treat…
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 stomach, gastric band)
* Patient incapable of giving informed consent due to cognitive impairment or other reasons (e.g., legal incapacity)
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