Safety and Potency of a High Cabergoline Dosage in Microprolactinomas

Recruiting now · Phase 3

Conditions studied: Prolactinoma, Prolactin Excess

In brief

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.

Key facts

Study ID

NCT07463235

Run by

University of Sao Paulo General Hospital

People needed

70

Starts

2026-03-04

Expected to finish

2029-12-20

Last updated by the study team

2026-03-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Unifesp — São Paulo, Brazil (enrolling)
• Unesp — Botucatu, Brazil (enrolling)
• UNB — Brasília, Brazil (enrolling)
• Unicamp — Campinas, Brazil (enrolling)
• UFPR — Curitiba, Brazil (enrolling)
• UFG — Goiânia, Brazil (enrolling)
• CPC — Ponta Grossa, Brazil (enrolling)
• UFMG — Belo Horizonte, Brazil (enrolling)
• Hospital Moinhos de Vento — Porto Alegre, Brazil (enrolling)
• Sta Casa-RS — Porto Alegre, Brazil (enrolling)
• UFPE — Recife, Brazil (enrolling)
• USP-RP — Ribeirão Preto, Brazil (enrolling)
• UFRJ — Rio de Janeiro, Brazil (enrolling)
• HCFMUSP — São Paulo, Brazil (enrolling)
• Sta Casa-SP — São Paulo, Brazil (enrolling)
• HCPA — Porto Alegre, Brazil

Full record on ClinicalTrials.gov

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