Cabergoline in the Management of Nonfunctioning Pituitary Adenoma

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Jun 15, 2025

Keywords

ClinConnect Summary

1. BACKGROUND and study rationale The overall prevalence of pituitary adenoma in the general population ranges from 1 in 865 to 1 in 2688 adults. Of these tumors, between 15% and 54% are nonfunctioning pituitary adenomas (NFPAs). Most NFPAs are macroadenomas with diameter greater than 10 mm. Generally, surgery is recommended as first-line treatment of symptomatic NFPAs. However, medical therapies or radiation therapy or active surveillance may be indicated for some patients.

Cabergoline (Dostinex), a dopamine agonist which has been widely used to treat hyperprolactinemia, prolactinoma f...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female ≥ 18 years of age at Visit 1.
• • Documentation of NFPA as evidenced by diagnostic criteria and size ≥ 0.5 cm in diameter.
• • Absence of previous hormonal pituitary hypersecretion, except prolactin level ≤ 30 ng/ml
• • Absence of previous radiotherapy or radiosurgery
• • Written informed consent
• Exclusion Criteria:
• • Allergic to cabergoline or ergotamine
• • Currently receiving cabergoline
• • With moderate to severe symptoms of mass effect, such as visual defect, headache, cranial nerve palsy.
• • AST, ALT over 2.5 times of the upper limit.
• • Chronic kidney disease, stage 4 and 5.
• • Hypotension
• • History of congestive heart failure, NYHA Fc III, IV
• • History of moderate or severe valvular heart disease.
• • History of Parkinson's disease.
• • History of pulmonary fibrosis
• • Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
• • History of previous pituitary surgery or radiotherapy
• • Psychotic psychiatric disease
• • Active gastrointestinal tract bleeding
• • History of Raynaud's phenomenon
• • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.