Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07045935

Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment

Led by University Hospital, Basel, Switzerland · Updated on 2025-09-23

60

Participants Needed

1

Research Sites

223 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older diagnosed with prolactinoma-induced hyperprolactinemia, defined by prolactin levels at least twice the local laboratory maximum and radiographic criteria according to current guidelines
  • Patients treated with cabergoline as dopamine agonist therapy with prolactin levels within the normal range
Not Eligible

You will not qualify if you...

  • Alternative explanation for hyperprolactinemia
  • 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, including Child Pugh C stage, AST/ALT over three times the upper limit of normal, or total bilirubin over twice the upper limit of normal
  • Severe renal impairment with eGFR less than 30 ml/min
  • History of pulmonary, pericardial, or retroperitoneal fibrotic disorders
  • Concomitant treatment with strong or moderate CYP3A4 inhibitors
  • Local complications requiring surgical intervention or patient preference for surgery
  • Chronic active inflammatory bowel disease, active gastrointestinal ulcer disease, or previous gastrointestinal surgery such as sleeve stomach or gastric band
  • Inability to provide informed consent due to cognitive impairment or legal incapacity

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospital Basel, Dept. of Endocrinology, Metabolism & Diabetes

Basel, Switzerland, 4031

Actively Recruiting

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Research Team

C

Cihan Atila, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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