NCT07045935Recrutement en cours
Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment
Résumé
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.
Critères d'éligibilité
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)
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Phase 4
- Type d'étude
- Interventionnelle
- Pays
- Suisse
- Promoteur
- University Hospital, Basel, Switzerland(Autre)
- N° de protocole
- 2025-00829; kt25Atila
- Pathologies
- Prolactinoma
- Interventions
- Médicament
Traitements évalués
- Cabergoline (Dopamine Agonist)
Lieux · 1
- Basel, SuisseUniversity Hospital Basel, Dept. of Endocrinology, Metabolism & DiabetesRecrute dans ce centre
Au total, dans le monde, le seul centre listé au registre recrute.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 23 septembre 2025).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
Autres identifiants
- 2025 · financement NIH
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.