Safety and Potency of a High Cabergoline Dosage in Microprolactinomas
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Sao Paulo General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cabergoline
DrugPatients eligible for the study and randomized to the HIGH CAB arm will start oral CAB, 1 pill of 0.5mg, once a week. The dose will be increased by 0.5mg every week until the target dose of 3.5 mg/w. This initial low-dose-escalating regimen of 7 weeks will be used to prevent symptoms of intolerance. When 3.5 mg/w (1 pill every day) is reached, the patient must maintain this dose for 6 months. After this period, a 1-month de-escalation regime is implemented, reducing the dose by 1 mg/w (2 pills per week) until discontinuation.
Cabergoline
DrugThe standard dosage group will receive conventional treatment as recommended by current guidelines: a low dose of CAB enough to achieve normoPRL for 2 years. All patients will start CAB with 1 pill (0.5mg) once a week. The CAB dose can be adjusted during visits if hyperPRL is not resolved (maximum dose 2mg/w to prevent inclusion of resistant cases). The expected dose used for this arm during follow-up is between 0.5 and 1 mg/w. After completion of 2 years of treatment, all patients will have CAB withdrawn, irrespective of tumor reduction, PRL levels or last CAB dose used.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: HIGH CAB doseExperimental treatment 1 intervention
Group B: Conventional therapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Remission
Compare laboratory and clinical recurrence of hyperPRL at 3, 6 and 12 months after CAB treatment in the high dosage group vs the standard dosage group (conventional treatment). Laboratory recurrence will be characterized after withdrawal from CAB treatment by the presence of PRL levels above 2x the normal upper limit of reference, after a previous period where PRL levels were within the normal range. At least two separate serum samples are needed to confirm recurrence. The time between samples will be more than a week to ensure sustained elevation. Clinical recurrence will be defined as the recrudescence of symptomatic hyperPRL.
Time frame
3, 6 and 12 months after treatmentSponsors and contacts
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Source ClinicalTrials.gov