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 @ 12:46 PM
Ignite Modification Date:
2025-12-24 @ 12:46 PM
NCT ID:
NCT06163261
Eligibility Criteria:
Inclusion Criteria:
* Patients with clinically significant non-functioning pituitary adenoma treated with surgery during the last ten years
* Stable hormone replacement therapy ≥ 6 months
* Ability to communicate in Swedish.
Exclusion Criteria:
* Patients with any other pituitary tumors than non-functioning pituitary adenoma
* Patients who possibly need tumor intervention, either with surgery or radiotherapy, within one year
* Other diseases or co-morbidities that may have significant impact on the outcome variables, including:
* Ongoing substance abuse and/or untreated psychiatric disorder, including psychoses and bipolar disease (except treatment with SSRI (Selective Serotonin Reuptake Inhibitor) and or SNRI (Serotonin-Norepinephrine Reuptake Inhibitor) for mild/moderate depression and/or anxiety which is allowed).
* Medical therapy with opioids, sedatives or hypnotics (besides treatment with zopiclone and zolpidem which are allowed).
* Current or previous history of neurological diseases with impaired mobility.
* High alcohol consumption (more than 14 alcohol units per week)
* Ongoing treatment for cancer.
* Uncontrolled hypertension or presence of clinically significant cardiac disease
* Severe respiratory insufficiency.
* Severely impaired hepatic function (ALT (Alanine Aminotransferase) and/or AST (Aspartate Aminotransferase) concentrations two times above the upper limit of normal).
* Severely impaired renal function (Glomerular filtration rate \<45 ml/min).
* Untreated hypo- or hyperthyroidism
* Pregnancy or breast feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06163261
Study Brief:
Protocol Section:
NCT06163261