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New treatment option for Prolactinoma
Official title Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment
ClinicalTrials.gov ID: NCT07045935
What this study is testing
What is Cabergoline (Dopamine Agonist)?
Cabergoline (Dopamine Agonist) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for prolactinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- (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...
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Basel, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basel, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.