Actively Recruiting
Safety and Potency of a High Cabergoline Dosage in Microprolactinomas
Led by University of Sao Paulo General Hospital · Updated on 2026-03-13
70
Participants Needed
16
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter, randomized, open-label trial to study women with microprolactinomas who have not previously been treated. The study compares two dosing regimens of cabergoline (CAB), a dopamine agonist used to treat prolactinomas. The goal is to evaluate remission rates and potentially improve future treatments for this condition by testing a higher dose against the current standard dose over different time periods. Participants will be randomly assigned to one of two groups. The high-dose group will receive escalating doses of oral CAB over 7 weeks to reach 3.5 mg per week, maintain this dose for about 6 months, and then gradually reduce the dose over 1 month. The standard-dose group will take a lower dose of CAB sufficient to normalize prolactin levels, adjusted as needed, for 2 years. After treatment, CAB will be withdrawn for all patients regardless of tumor size or hormone levels. During the study, participants will be closely monitored with clinical evaluations and laboratory tests to assess remission at 3, 6, and 12 months after treatment starts. Researchers will track hormone levels, tumor size, and any side effects. The total duration of involvement varies by treatment group, ranging from about 6 months to 2 years, followed by dose discontinuation. This approach aims to provide detailed information on the safety and effectiveness of the different dosing strategies.
CONDITIONS
Brief Title
Safety and Potency of a High Cabergoline Dosage in Microprolactinomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent prior to any study-related procedures
- Adults over 18 years old
- Pre-menopausal women
- Presence of signs and symptoms matching prolactinoma
- Hyperprolactinemia defined as prolactin level at least 2 times above the local normal maximum
- Identifiable pituitary mass on MRI less than 1 cm in diameter
- Treatment naive (no prior treatment)
- Females engaging in heterosexual intercourse must agree to use an effective or acceptable contraception method from screening to last study visit
You will not qualify if you...
- History of primary hyperparathyroidism
- Use of combined hormonal contraceptive within the past 4 weeks
- Pregnancy or current desire to become pregnant
- Prolactinoma associated with a known genetic syndrome
- Familial history of pituitary adenoma
- Renal failure with estimated glomerular filtration rate below 30 mL/min/1.73m2
- IGF-1 level above age-adjusted normal range
- Idiopathic hyperprolactinemia (normal MRI) or macroprolactinemia
- Mental conditions impairing understanding of the study or decompensated psychiatric disease
- Chronic use of drugs associated with hyperprolactinemia
- Resistant prolactinoma defined as non-normalization of prolactin with 2 mg/week cabergoline
- High dosage group patients who did not maintain 3.5 mg/week cabergoline for 6 months
- Active malignant disease within last 5 years except certain skin cancers
- Decompensated chronic conditions that may impede study compliance
- Male sex
- Signs suspicious for Cushing syndrome
- Prior radiotherapy to pituitary area
- Additional pituitary tumor-directed therapies
- Hepatopathy with liver enzymes above 3 times normal limit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 weeks dose escalation plus 6 months high dose and 1 month de-escalation OR 2 years conventional low-dose treatment
Participants receive cabergoline treatment either by escalating to a high dose over 7 weeks followed by 6 months at 3.5 mg/week with a 1-month dose de-escalation, or by conventional low-dose treatment aiming for normoprolactinemia for 2 years.
Regular visits for dose adjustment and monitoring during treatment
Trial Site Locations
Total: 16 locations
1
UFMG
Belo Horizonte, Brazil
Actively Recruiting
2
Unesp
Botucatu, Brazil
Actively Recruiting
3
UNB
Brasília, Brazil
Actively Recruiting
4
Unicamp
Campinas, Brazil
Actively Recruiting
5
UFPR
Curitiba, Brazil
Actively Recruiting
6
UFG
Goiânia, Brazil
Actively Recruiting
7
CPC
Ponta Grossa, Brazil
Actively Recruiting
8
HCPA
Porto Alegre, Brazil
Completed
9
Hospital Moinhos de Vento
Porto Alegre, Brazil
Actively Recruiting
10
Sta Casa-RS
Porto Alegre, Brazil
Actively Recruiting
11
UFPE
Recife, Brazil
Actively Recruiting
12
USP-RP
Ribeirão Preto, Brazil
Actively Recruiting
13
UFRJ
Rio de Janeiro, Brazil
Actively Recruiting
14
HCFMUSP
São Paulo, Brazil
Actively Recruiting
15
Sta Casa-SP
São Paulo, Brazil
Actively Recruiting
16
Unifesp
São Paulo, Brazil
Actively Recruiting
Research Team
A
Andrea Glezer, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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