ProlactinomaPhase 3SPARAGMOSNCT07463235
Safety and Potency of a High Cabergoline Dosage in Microprolactinomas
A Phase 3 study testing Cabergoline in people with Prolactinoma and Prolactin Excess, run by University of Sao Paulo General Hospital at 16 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prolactinoma, Prolactin Excess
- What is being tested?
- Cabergoline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 16 sitesBrazil
- Study dates
- 4 Mar 2026to 20 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Willing and able to provide written informed consent prior to any study-related procedures
- 2. Adults >18 years old
- 3. Pre-menopausal women
- 4. Presence of signs and symptoms matching prolactinoma
- 5. Hyperprolactinemia, defined as a prolactin (PRL) level ≥2 times the local laboratory maximum level of normality, present at the time of enrolment
- 6. Presence of an identifiable pituitary mass on MRI with a maximum diameter of less than 1cm, independently of Knosp/invasiveness of the cavernous sinus
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- 7. Treatment naïve
- 8. Females who engage in heterosexual intercourse must agree to use either a highly effective or a clinically acceptable method of contraception from the beginning of screening to the last study visit, which will include:
- Hysterectomy or bilateral salpingectomy
- Bilateral tubal occlusion or ligation
- Vasectomized partner
- Intrauterine device (copper or hormonal)
- Progestogen-only contraception (oral, injectable or implantable)
- Male or female condom with or without spermicide
- Sexual abstinence (only when it is the usual and preferred lifestyle of the subject)
Who cannot join
- 1. History of primary hyperparathyroidism
- 2. Use of combined hormonal contraceptive within the past 4 weeks
- 3. Pregnancy or current pregnancy desire
- 4. Prolactinoma associated with a known genetic syndrome
- 5. Familial history of pituitary adenoma
- 6. Renal failure (estimated glomerular filtration rate <30 mL/min /1.73m2)
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- 7. IGF-1 level above the age-adjusted normal range of the local laboratory (IGF 1 >1x ULNR)
- 8. Idiopathic hyperprolactinemia (normal MRI) or presence of macroprolactinemia
- 9. Concomitant mental condition rendering her unable to understand the nature, scope, and possible consequences of the study, and/or decompensated psychiatric disease (i.e. gambling or severe obsessive-compulsive disorder), as judged by the Investigator
- 10. Chronic use of drugs related to hyperprolactinemia (such as metoclopramide, methyldopa, ranitidine, and opioid-related analgesics)
- 11. Resistant prolactinoma, defined as non-normalization of PRL levels with 2mg/w of CAB
- 12. Patients in the high dosage group who did not use 3.5mg/w of CAB for an entire 6 months (due to intolerance or non-compliance) or failed to achieve the target dose for any other reason
- 13. Active malignant disease within the last 5 years, except basal and squamous cell carcinoma of the skin with complete local excision
- 14. Any decompensated chronic condition (i.e. heart failure NYHA 3-4, diabetes with HbA1c >8.5%, hypothyroidism with TSH >10 mIU/L) that, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes
- 15. Male sex
- 16. Cushing stigmas (moon face, muscle weakness, red striation) or suspicious
- 17. Prior radiotherapy of the pituitary gland area for any reason
- 18. Additional pituitary tumor-directed therapy, including temozolomide, everolimus, lapatinib, or cytotoxic chemotherapy
- 19. Hepatopathy with AST/TGO or ALT/TGP >3x the upper limit of normality
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
Brazil16 sites, 15 recruiting
- Recruiting
UFMG
Belo Horizonte
BSSR, 42 999849091, beatrizssrocha@gmail.com
- Recruiting
Unesp
Botucatu
VSNN, 42 999849091, vania.nunes-nogueira@unesp.br
- Recruiting
UNB
Brasília
LAN, 42 999849091, draluciananaves@gmail.com
- Recruiting
Unicamp
Campinas
HMG, 42 999849091, heraldmg@uol.com.br
- Recruiting
UFPR
Curitiba
CLB, 42 999849091, clbogus@uol.com.br
- Recruiting
UFG
Goiânia
MLDR, 42 999849091, mnkedias@ufg.br
- Recruiting
CPC
Ponta Grossa
MAMS, 42 999849091, matheoaugusto@hotmail.com
- Completed
HCPA
Porto Alegre
- Recruiting
Hospital Moinhos de Vento
Porto Alegre
GAFSR, 42 999849091, guilherme.rollin@gmail.com
- Recruiting
Sta Casa-RS
Porto Alegre
MCO, 42 999849091, miriamoliveira1697@gmail.com
- Recruiting
UFPE
Recife
LV, lvilarf@gmail.com
- Recruiting
USP-RP
Ribeirão Preto
MC, 42 999849091, castrom@fmrp.usp.br
- Recruiting
UFRJ
Rio de Janeiro
MRG, 42 999849091, mgadelha@hucff.ufrj.br
- Recruiting
HCFMUSP
São Paulo
MAMS, 42 999849091, matheoaugusto@hotmail.com
- Recruiting
Sta Casa-SP
São Paulo
CBFB, 42 999849091, cbformiga@gmail.com
- Recruiting
Unifesp
São Paulo
JA, 42 999849091, julioabucham@uol.com.br
About this study
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.
Read the 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.
- Conditions
- Prolactinoma, Prolactin Excess
- Being tested
- Cabergoline
- Keywords
- cabergoline, prolactinoma, remission
- Medical subject headings
- Prolactinoma, Hyperprolactinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabergolineDrug
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.
CabergolineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| HIGH CAB dose | Experimental | Not described Receives: Drug: Cabergoline |
| Conventional therapy | Active comparator | Not described Receives: Drug: Cabergoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3, 6 and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start4 Mar 2026
- Primary completion20 Aug 2027 (estimated)
- Study completion20 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProlactinomaStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Glezer, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463235
- Sponsor's protocol ID
- 94925726.0.1001.0068
- Other IDs
- 94925726.0.1001.0068
- Acronym
- SPARAGMOS
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Potency of a High Cabergoline Dosage in Microprolactinomas
- ClinicalTrials.gov ID
- NCT07463235
- Acronym / sponsor ID
- SPARAGMOS / 94925726.0.1001.0068
- Conditions
- Prolactinoma, Prolactin Excess
- Keywords
- cabergoline, prolactinoma, remission
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 20 Aug 2027 (estimated)
- Study completion
- 20 Dec 2029 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIGH CAB dose | Experimental | Drug: Cabergoline |
| Conventional therapy | Active comparator | Drug: Cabergoline |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 1. Willing and able to provide written informed consent prior to any study-related procedures
- 2. Adults >18 years old
- 3. Pre-menopausal women
- 4. Presence of signs and symptoms matching prolactinoma
- 5. Hyperprolactinemia, defined as a prolactin (PRL) level ≥2 times the local laboratory maximum level of normality, present at the time of enrolment
Key exclusion criteria (19 listed)
- 1. History of primary hyperparathyroidism
- 2. Use of combined hormonal contraceptive within the past 4 weeks
- 3. Pregnancy or current pregnancy desire
- 4. Prolactinoma associated with a known genetic syndrome
- 5. Familial history of pituitary adenoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CabergolinePatients 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. | Drug | HIGH CAB dose |
| CabergolineThe 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. | Drug | Conventional therapy |
Primary outcome
Remission
Time frame: 3, 6 and 12 months after treatment
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cabergoline in people with Prolactinoma and Prolactin Excess, run by University of Sao Paulo General Hospital at 16 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Glezer, MD, PhD (55 11 995791108, andrea.glezer@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission (time frame: 3, 6 and 12 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.