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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT07045935
Eligibility Criteria:
Inclusion Criteria (treatment-naïve patients):
* 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.
Inclusion Criteria (treatment-naïve patients):
* 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07045935
Study Brief:
Protocol Section:
NCT07045935