Safety and Potency of a High Cabergoline Dosage in Microprolactinomas
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.
• 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 include:
• 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)