SYFd41e5b5fe66a44bfaa4e1ad54bb6d9a7Registry ID: 2024-516383-28-01|Not Yet RecruitingPhase 3
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interventional
N/A
1 country
1
To determine the non-inferiority of EES with respect to CAB (standard care) for the rate of biochemical remission (defined as prolactin normalization in the absence of treatment) at 6- and 12-month follow-up, in newly diagnosed, treatment naïve patients with m-PRL.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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September 2, 2024
Actual (reported)Prolactin levels will be measured on single fasting venous sampling at 6- and 12-month follow up to determine the rate of biochemical remission in patients treated with EES or CAB
To determine m-PRL remnant at MRI with g.c.m. performed at 6 and 12 months after EES or starting CAB. MRI with g.c.m will be performed at study enrollment (baseline) and at 6- and 12- month follow-up to evaluate m-PRL diameters, so the ability of EES and CAB to reduce tumor mass.
To determine in patients treated with CAB the rate of drug resistance (defined as failure to achieve normal prolactin levels and a reduction of adenoma size <50% on maximally tolerated doses after at least 6 months of treatment) through the measurement of prolactin levels at baseline and at 6- and 12-month follow-up.
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Formulated product
DOSTINEX 0,5 mg compresse
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
DOSTINEX 0,5 mg compresse
Named ingredient: Cabergoline
View registry recordAzienda Unita Sanitaria Locale Di Bologna
Bologna, 40139, Italy
Principal Investigator
First Submitted
September 2, 2024
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