Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment

NCT ID: NCT07045935

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-16
• Study Completion Date: 2029-12-31

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.

Detailed Description

Prolactinomas are the most common pituitary tumors, leading to hyperprolactinemia, which causes hypogonadism, infertility, and is associated with adverse metabolic effects such as insulin resistance, dyslipidemia, and obesity. Dopamine agonists (DAs), especially cabergoline, are the first-line treatment. They reduce prolactin levels and tumor size effectively. Despite their widespread use, there are no evidence-based guidelines regarding target prolactin levels during DA therapy. Limited evidence suggests that different prolactin levels may have different effects on metabolic health. This trial aims to assess glucose tolerance, insulin sensitivity, and beta-cell function-using OGTT with insulin levels-after 12 months of DA treatment, to target treatment options.

In Switzerland, cabergoline is the preferred DAs for treating hyperprolactinemia.

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.

Conditions

Prolactinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental intervention arm (Cabergoline)

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).

Group Type: ACTIVE_COMPARATOR

Cabergoline (Dopamine Agonist)

Intervention Type: 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)

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).

Group Type: ACTIVE_COMPARATOR

Cabergoline (Dopamine Agonist)

Intervention Type: 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.

Interventions

Cabergoline (Dopamine Agonist)

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cihan Atila, Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Basel, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Cihan Atila, Dr.

Role: CONTACT

cihan.atila@usb.ch

+41 61 328 4579

Facility Contacts

Cihan Atila, Dr.

Role: primary

cihan.atila@usb.ch

Other Identifiers

2025-00829; kt25Atila

Identifier Type: -

Identifier Source: org_study_id