Non-functioning pituitary adenoma
Conditions
Brief summary
• The change in tumour volume during the main study of two years. This includes the percentage and absolute change in tumour volume, but also the number of patients with significant tumour shrinkage or tumour growth (defined by ≥ 10 % or ≥ 2 mm shrinkage/growth in at least one dimension).
Detailed description
• The need for surgical and/or radiation treatment during the study period • The development of new pituitary failure or changed pituitary function during the study, or new or changed visual field defects or other cranial nerve affections • The change in tumour’s distance to chiasma opticum (mm) • The response on gonadotropins (FSH, LH) and/or their subunits, particularly the α-subunit. A possible correlation between the tumour size response and the hormone levels and change during treatment
Interventions
DRUGDostinex 0
DRUG5 mg tabletter
Sponsors
St. Olavs Hospital HF
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • The change in tumour volume during the main study of two years. This includes the percentage and absolute change in tumour volume, but also the number of patients with significant tumour shrinkage or tumour growth (defined by ≥ 10 % or ≥ 2 mm shrinkage/growth in at least one dimension). | — |
Secondary
| Measure | Time frame |
|---|---|
| • The need for surgical and/or radiation treatment during the study period • The development of new pituitary failure or changed pituitary function during the study, or new or changed visual field defects or other cranial nerve affections • The change in tumour’s distance to chiasma opticum (mm) • The response on gonadotropins (FSH, LH) and/or their subunits, particularly the α-subunit. A possible correlation between the tumour size response and the hormone levels and change during treatment | — |
Countries
Norway
Outcome results
None listed