Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
NCT ID:
NCT07034859
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07034859
Study Brief:
Protocol Section:
NCT07034859