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
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 older than 18 years
- Pre-menopausal women
- Presence of signs and symptoms matching prolactinoma
- Hyperprolactinemia defined as prolactin level at least 2 times the local lab maximum normal level at enrollment
- Identifiable pituitary mass on MRI with maximum diameter less than 1 cm
- Treatment naïve (no prior treatment for prolactinoma)
- Females engaging in heterosexual intercourse must agree to use effective or clinically acceptable contraception throughout the study
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 less than 30 mL/min/1.73m2
- IGF-1 level above the age-adjusted normal range
- Idiopathic hyperprolactinemia (normal MRI) or macroprolactinemia
- Mental condition impairing understanding of the study or decompensated psychiatric disease
- Chronic use of drugs causing hyperprolactinemia (e.g., metoclopramide, methyldopa, ranitidine, opioids)
- Resistant prolactinoma defined as failure to normalize prolactin with 2 mg/week of cabergoline
- Patients in high dose group who did not use 3.5 mg/week cabergoline for full 6 months or failed to achieve target dose
- Active malignancy within last 5 years except certain skin cancers
- Decompensated chronic conditions impeding study compliance or safety
- Male sex
- Signs suspicious for Cushing syndrome
- Prior radiotherapy to pituitary area
- Additional pituitary tumor therapies including specific chemotherapy agents
- Liver disease with elevated liver enzymes above 3 times normal
AI-Screening
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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
CONTACT
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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