NCT07045935 Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment
| NCT ID | NCT07045935 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | Prolactinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-09-16 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2025-09-16 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 (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)
Contact & Investigator
Cihan Atila, Dr.
PRINCIPAL INVESTIGATOR
University Hospital Basel, Dept. of Endocrinology, Metabolism & Diabetes
Frequently Asked Questions
Who can join the NCT07045935 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Prolactinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07045935 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07045935 currently recruiting?
Yes, NCT07045935 is actively recruiting participants. Contact the research team at cihan.atila@usb.ch for enrollment information.
Where is the NCT07045935 trial being conducted?
This trial is being conducted at Basel, Switzerland.
Who is sponsoring the NCT07045935 clinical trial?
NCT07045935 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Cihan Atila, Dr. at University Hospital Basel, Dept. of Endocrinology, Metabolism & Diabetes. The trial plans to enroll 60 participants.