Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

Safety and Potency of a High Cabergoline Dosage in Microprolactinomas

Safety and Potency of a High Cabergoline Dosage in Microprolactinomas (NCT07463235) is a Phase 3 interventional studying Prolactinoma and Prolactin Excess, sponsored by University of Sao Paulo General Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Prolactinoma, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 70 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Prolactinoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 1\. Willing and able to provide written willing to sign a consent form 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 - 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 Should NOT Join This Trial: - 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) - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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 * 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) Exclusion Criteria: * 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) * 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

Treatments Being Tested

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.

DRUG

Cabergoline

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.

Locations (16)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

UFMG

Belo Horizonte, Brazil

Unesp

Botucatu, Brazil

UNB

Brasília, Brazil

Unicamp

Campinas, Brazil

UFPR

Curitiba, Brazil

UFG

Goiânia, Brazil

CPC

Ponta Grossa, Brazil

HCPA

Porto Alegre, Brazil

Hospital Moinhos de Vento

Porto Alegre, Brazil

Sta Casa-RS

Porto Alegre, Brazil

UFPE

Recife, Brazil

USP-RP

Ribeirão Preto, Brazil

UFRJ

Rio de Janeiro, Brazil

HCFMUSP

São Paulo, Brazil

Sta Casa-SP

São Paulo, Brazil

Unifesp

São Paulo, Brazil

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07463235), the sponsor (University of Sao Paulo General Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07463235 clinical trial studying?

Who can participate in NCT07463235?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07463235?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07463235. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07463235. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.