Clinical trial · Interventional
Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment
Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment - A Randomized, Single-Blind Active- Controlled Trial
NCT07045935CI-TRIAL-00095621ProBOLICrecruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prolactinoma | Lactotroph Pituitary Neuroendocrine Tumor | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cabergoline (Dopamine Agonist) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Experimental intervention arm (Cabergoline)
- description
- The experimental intervention arm aims to treat patients (with hyperprolactinemia) with Cabergoline (Dopamine Agonist) by targeting the suppression of prolactin levels (below the normal plasma prolactin range).
- interventionNames
- Drug: Cabergoline (Dopamine Agonist)
- type
- ACTIVE_COMPARATOR
- label
- Control intervention arm (Cabergoline)
- description
- The control intervention arm aims to treat patients (with hyperprolactinemia ) with Cabergoline (Dopamine Agonist) by targeting the normalisation of prolactin levels (within the normal plasma prolactin range).
- interventionNames
- Drug: Cabergoline (Dopamine Agonist)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.