A Phase 3 interventional study of Cabergoline and Cabergoline in Prolactinoma and Prolactin Excess, sponsored by University of Sao Paulo General Hospital. Recruiting at 16 sites in Brazil. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-13.
Sponsored by University of Sao Paulo General Hospital · Phase 3, Interventional, and Treatment
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.
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.
28 studies on the registry are indexed under Prolactinoma; 5 are open to participants now.
This study's planned enrollment of 70 is above the median of 55 across 14 interventional studies indexed under Prolactinoma.
Browse Prolactinoma studies →University of Sao Paulo General Hospital is the lead sponsor of 611 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Cabergoline
Drug: Cabergoline
Patients eligible for the study and randomized to the HIGH CAB arm will start oral CAB, 1 pill of 0.5mg, once a week. The dose will be increased by 0.5mg every week until the target dose of 3.5 mg/w. This initial low-dose-escalating regimen of 7 weeks will be used to prevent symptoms of intolerance. When 3.5 mg/w (1 pill every day) is reached, the patient must maintain this dose for 6 months. After this period, a 1-month de-escalation regime is implemented, reducing the dose by 1 mg/w (2 pills per week) until discontinuation.
The standard dosage group will receive conventional treatment as recommended by current guidelines: a low dose of CAB enough to achieve normoPRL for 2 years. All patients will start CAB with 1 pill (0.5mg) once a week. The CAB dose can be adjusted during visits if hyperPRL is not resolved (maximum dose 2mg/w to prevent inclusion of resistant cases). The expected dose used for this arm during follow-up is between 0.5 and 1 mg/w. After completion of 2 years of treatment, all patients will have CAB withdrawn, irrespective of tumor reduction, PRL levels or last CAB dose used.
Remission
Compare laboratory and clinical recurrence of hyperPRL at 3, 6 and 12 months after CAB treatment in the high dosage group vs the standard dosage group (conventional treatment). Laboratory recurrence will be characterized after withdrawal from CAB treatment by the presence of PRL levels above 2x the normal upper limit of reference, after a previous period where PRL levels were within the normal range. At least two separate serum samples are needed to confirm recurrence. The time between samples will be more than a week to ensure sustained elevation. Clinical recurrence will be defined as the recrudescence of symptomatic hyperPRL.
Time frame: 3, 6 and 12 months after treatment
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Aug 2027, 17 months after the start.
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Studies of the drug tested here: Cabergoline
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