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Could a short, High-Dose drug course cure small pituitary tumors?

NCT ID NCT07463235

Disease control Sponsor: University of Sao Paulo General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a higher dose of the drug cabergoline, taken for about 6 months, can achieve lasting remission in women with small prolactinomas (non-cancerous pituitary tumors that cause excess prolactin). 70 premenopausal women will be randomly assigned to either the high-dose short course or standard long-term low-dose treatment. The goal is to see if the high-dose approach leads to normal prolactin levels for at least a year after stopping the drug, potentially avoiding years of daily medication.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cabergoline (a drug that lowers prolactin levels)
What this could lead to
If successful, this could offer a shorter, more effective treatment course for small prolactinomas, potentially allowing women to stop medication sooner without the tumor returning.
What could go wrong
This is a relatively small, early-phase trial (70 participants) and the high dose may cause more side effects. Remission may not be permanent, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

hyperprolactinemia prolactin-producing pituitary gland adenoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prolactin excess Prolactinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CPC

    RECRUITING

    Ponta Grossa, Brazil

  • HCFMUSP

    RECRUITING

    São Paulo, Brazil

  • HCPA

    COMPLETED

    Porto Alegre, Brazil

  • Hospital Moinhos de Vento

    RECRUITING

    Porto Alegre, Brazil

  • Sta Casa-RS

    RECRUITING

    Porto Alegre, Brazil

  • Sta Casa-SP

    RECRUITING

    São Paulo, Brazil

  • UFG

    RECRUITING

    Goiânia, Brazil

  • UFMG

    RECRUITING

    Belo Horizonte, Brazil

  • UFPE

    RECRUITING

    Recife, Brazil

  • UFPR

    RECRUITING

    Curitiba, Brazil

  • UFRJ

    RECRUITING

    Rio de Janeiro, Brazil

  • UNB

    RECRUITING

    Brasília, Brazil

  • USP-RP

    RECRUITING

    Ribeirão Preto, Brazil

  • Unesp

    RECRUITING

    Botucatu, Brazil

  • Unicamp

    RECRUITING

    Campinas, Brazil

  • Unifesp

    RECRUITING

    São Paulo, Brazil

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