Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment

NCT07045935 | Recruiting Phase 4

• 1 other identifier: 2025-00829; kt25Atila
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prolactinoma

Keywords

hyperprolactinemia; cabergoline; prolactin level; Dopamine agonist; glucose level; Oral Glucose Tolerance Test; hypoprolactinemia

Outcome Measures

Primary Outcomes (1)

• 2-hour post-oral glucose tolerance test (OGTT) plasma glucose levels

  The OGTT is a test used to assess the ability to process glucose. It involves fasting overnight and then drinking a solution containing a measured amount of glucose (75g). Blood Samples are taken at 120 min after glucose intake.

  assessed at 12 months after randomisation

Secondary Outcomes (9)

• Change in Insulin sensitivity by MATSUDA Index

  measured at time points (0, 30, 60, 90, and 120 minutes) during the OGTT

• Change in Insulin Sensitivity Index (ISI)

  measured at time points (0, 30, 60, 90, and 120 minutes) during the OGTT

• Change in Quantitative Insulin Sensitivity Check Index (QUICKI)

  measured at time points Screening, Month 6, Month 12, Month 24

• Change in Glycated Haemoglobin (HbA1c)

  measured at time points Screening, Month 3, Month 6, Month 12

• Change in Fasting glucose (mmol/L)

  measured at time points Screening, Month 3, Month 6, Month 12

Study Arms (2)

Experimental intervention arm (Cabergoline)

ACTIVE COMPARATOR

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).

Drug: Cabergoline (Dopamine Agonist)

Control intervention arm (Cabergoline)

ACTIVE COMPARATOR

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).

Drug: Cabergoline (Dopamine Agonist)

Interventions

Cabergoline (Dopamine Agonist) DRUG

Cabergoline is available in tablet form, with doses of 0.5 mg per tablet. The standard dosing for hyperprolactinemia typically starts at 0.25 mg to 0.5 mg per week, which can be gradually increased based on the patient's response, with a usual range of 0.25 mg to 2 mg per week. The dose required to achieve the target prolactin levels (pre- defined for each intervention arm) may vary between patients, so a fixed dose is not specified. This allows for individualized treatment based on each patient's response.

Control intervention arm (Cabergoline); Experimental intervention arm (Cabergoline)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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 may not qualify 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
• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

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

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Prolactinoma; Hyperprolactinemia; Prolactin Deficiency, Isolated

Interventions

Cabergoline; Dopamine Agonists

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pituitary Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Hyperpituitarism

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Cihan Atila, Dr.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cihan Atila, Dr.

CONTACT

+41 61 328 4579; cihan.atila@usb.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors (e.g., study nurses and study physicians) will all remain blinded to the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, Single-Blind Active-Controlled Trial

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: July 1, 2025
• Study Start: September 16, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

CH (1)