BridgeMD
Tests treatment safety and results for Prolactinoma
Official title Safety and Potency of a High Cabergoline Dosage in Microprolactinomas
ClinicalTrials.gov ID: NCT07463235
What this study is testing
What is Cabergoline?
Cabergoline is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for prolactinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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
You likely can't join 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)
See the full eligibility 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...
- 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)
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Belo Horizonte, Brazil
- Botucatu, Brazil
- Brasília, Brazil
- Campinas, Brazil
- Curitiba, Brazil
- Goiânia, Brazil
- Ponta Grossa, Brazil
- Porto Alegre, Brazil
- Recife, Brazil
- Ribeirão Preto, Brazil
- Rio de Janeiro, Brazil
- São Paulo, Brazil
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Belo Horizonte, Brazil; Botucatu, Brazil; Brasília, Brazil; Campinas, Brazil; Curitiba, Brazil; Goiânia, Brazil and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.