Safety and Potency of a High Cabergoline Dosage in Microprolactinomas

NCT07463235 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 94925726.0.1001.0068
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 16

Brief Summary

This will be a multicenter, prospective, randomized, open-label trial with women harboring microprolactinomas and treatment naïve. The sample will be added consecutively and randomized into 2 unblinded groups: the high dosage group will receive a high cabergoline (CAB) dose for a period of \~6 months vs the standard dosage group, which will use the lowest needed dose of CAB to achieve normoprolactinemia for 2 years. The primary outcome will be remission rate.

Conditions

Prolactinoma; Prolactin Excess

Keywords

cabergoline; prolactinoma; remission

Outcome Measures

Primary Outcomes (1)

• Remission

  Compare laboratory and clinical recurrence of hyperPRL at 3, 6 and 12 months after CAB treatment in the high dosage group vs the standard dosage group (conventional treatment). Laboratory recurrence will be characterized after withdrawal from CAB treatment by the presence of PRL levels above 2x the normal upper limit of reference, after a previous period where PRL levels were within the normal range. At least two separate serum samples are needed to confirm recurrence. The time between samples will be more than a week to ensure sustained elevation. Clinical recurrence will be defined as the recrudescence of symptomatic hyperPRL.

  3, 6 and 12 months after treatment

Study Arms (2)

HIGH CAB dose

EXPERIMENTAL

Drug: Cabergoline

Conventional therapy

ACTIVE COMPARATOR

Drug: Cabergoline

Interventions

Cabergoline DRUG

Patients eligible for the study and randomized to the HIGH CAB arm will start oral CAB, 1 pill of 0.5mg, once a week. The dose will be increased by 0.5mg every week until the target dose of 3.5 mg/w. This initial low-dose-escalating regimen of 7 weeks will be used to prevent symptoms of intolerance. When 3.5 mg/w (1 pill every day) is reached, the patient must maintain this dose for 6 months. After this period, a 1-month de-escalation regime is implemented, reducing the dose by 1 mg/w (2 pills per week) until discontinuation.

HIGH CAB dose

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Willing and able to provide written informed consent prior to any study-related procedures
• \. Adults \>18 years old
• \. Pre-menopausal women
• \. Presence of signs and symptoms matching prolactinoma
• \. Hyperprolactinemia, defined as a prolactin (PRL) level ≥2 times the local laboratory maximum level of normality, present at the time of enrolment
• \. Presence of an identifiable pituitary mass on MRI with a maximum diameter of less than 1cm, independently of Knosp/invasiveness of the cavernous sinus
• \. Treatment naïve
• \. Females who engage in heterosexual intercourse must agree to use either a highly effective or a clinically acceptable method of contraception from the beginning of screening to the last study visit, which will include:
• Hysterectomy or bilateral salpingectomy
• Bilateral tubal occlusion or ligation
• Vasectomized partner
• Intrauterine device (copper or hormonal)
• Progestogen-only contraception (oral, injectable or implantable)
• Male or female condom with or without spermicide
• Sexual abstinence (only when it is the usual and preferred lifestyle of the subject)

You may not qualify if:

• \. History of primary hyperparathyroidism
• \. Use of combined hormonal contraceptive within the past 4 weeks
• \. Pregnancy or current pregnancy desire
• \. Prolactinoma associated with a known genetic syndrome
• \. Familial history of pituitary adenoma
• \. Renal failure (estimated glomerular filtration rate \<30 mL/min /1.73m2)
• \. IGF-1 level above the age-adjusted normal range of the local laboratory (IGF 1 \>1x ULNR)
• \. Idiopathic hyperprolactinemia (normal MRI) or presence of macroprolactinemia
• \. Concomitant mental condition rendering her unable to understand the nature, scope, and possible consequences of the study, and/or decompensated psychiatric disease (i.e. gambling or severe obsessive-compulsive disorder), as judged by the Investigator
• \. Chronic use of drugs related to hyperprolactinemia (such as metoclopramide, methyldopa, ranitidine, and opioid-related analgesics)
• \. Resistant prolactinoma, defined as non-normalization of PRL levels with 2mg/w of CAB
• \. Patients in the high dosage group who did not use 3.5mg/w of CAB for an entire 6 months (due to intolerance or non-compliance) or failed to achieve the target dose for any other reason
• \. Active malignant disease within the last 5 years, except basal and squamous cell carcinoma of the skin with complete local excision
• \. Any decompensated chronic condition (i.e. heart failure NYHA 3-4, diabetes with HbA1c \>8.5%, hypothyroidism with TSH \>10 mIU/L) that, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes
• \. Male sex

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (16)

UFMG

Belo Horizonte, Brazil

RECRUITING

Unesp

Botucatu, Brazil

RECRUITING

UNB

Brasília, Brazil

RECRUITING

Unicamp

Campinas, Brazil

RECRUITING

UFPR

Curitiba, Brazil

RECRUITING

UFG

Goiânia, Brazil

RECRUITING

CPC

Ponta Grossa, Brazil

RECRUITING

HCPA

Porto Alegre, Brazil

COMPLETED

Hospital Moinhos de Vento

Porto Alegre, Brazil

RECRUITING

Sta Casa-RS

Porto Alegre, Brazil

RECRUITING

UFPE

Recife, Brazil

RECRUITING

USP-RP

Ribeirão Preto, Brazil

RECRUITING

UFRJ

Rio de Janeiro, Brazil

RECRUITING

HCFMUSP

São Paulo, Brazil

RECRUITING

Sta Casa-SP

São Paulo, Brazil

RECRUITING

Unifesp

São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Prolactinoma; Hyperprolactinemia

Interventions

Cabergoline

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

Central Study Contacts

Andrea Glezer, MD, PhD

CONTACT

55 11 995791108; andrea.glezer@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 11, 2026
• Study Start: March 4, 2026
• Primary Completion (Estimated): August 20, 2027
• Study Completion (Estimated): December 20, 2029
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

BR (16)