Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:40 AM
Study NCT ID:
NCT07463235
Status:
RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Potency of a High Cabergoline Dosage in Microprolactinomas
Sponsor:
University of Sao Paulo General Hospital
Organization:
Study Overview
Official Title:
Safety and Potency of a High Cabergoline Dosage in Microprolactinomas
Status:
RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPARAGMOS
Brief Summary:
This will be a multicenter, prospective, randomized, open-label trial with women harboring microprolactinomas and treatment naïve. The sample will be added consecutively and randomized into 2 unblinded groups: the high dosage group will receive a high cabergoline (CAB) dose for a period of \~6 months vs the standard dosage group, which will use the lowest needed dose of CAB to achieve normoprolactinemia for 2 years. The primary outcome will be remission rate.
Detailed Description:
Prolactinoma is the most common subtype of pituitary adenoma, and dopamine agonists are the gold standard for treatment, primarily CAB. The SPARAGMOS trial will be an interventional, randomized, open-label, multicenter study utilizing a high dose of CAB for \~6 months to suppress prolactin levels, with the hypothetical goal of achieving greater tumor apoptosis and remission rates. The control group will receive CAB for two years at the lowest dose necessary to achieve normoprolactinemia, as per current guidelines. Of note, for both groups, the final cumulative dose will be similar. The findings from this trial have the potential to inform and redefine future therapeutic strategies for microprolactinoma.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 94925726.0.1001.0068 | OTHER | CAPPesq | View |