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 range18 Years
SexFEMALE
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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…