Safety and Potency of a High Cabergoline Dosage in Microprolactinomas (NCT07463235) | Clinical Trial Compass
RecruitingPhase 3
Safety and Potency of a High Cabergoline Dosage in Microprolactinomas
Brazil70 participantsStarted 2026-03-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 /1.73…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.