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
Qualifiers
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
Treatments tested in this trial
- Cabergoline
- Cabergoline
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov