Treatment of hyperprolactinemia with the non-ergoline dopamine agonist ropinirole: A dose escalation study of efficacy and tolerability
Ropinirole for the treatment of hyperprolactinemia
Sponsor: Columbia University and NIDDK
Enrolling: Male and Female Patients
Study Length: 6 Months
Clinic Visits: 8
IRB Number: AAAI8604
U.S. Govt. ID: NCT03038308
Contact: Cara Dimino: 212-305-3725 / cd2922@cumc.columbia.edu
Additional Study Information: The purpose of this study is evaluate the use of the non-ergoline dopamine agonist ropinirole for the treatment of high prolactin levels in patients with hyperprolactinemia and prolactinomas (pituitary tumors that make prolactin). Treatment of high prolactin levels with traditional ergot dopamine agonist drugs can be limited by medication side effects, pharmacologic resistance, and by concerns regarding the potential risk of cardiac valve disease. Ropinirole is a non-ergot dopamine agonist that work directly at D2 receptors, which are found on tumors that make prolactin. Ropinirole has an established safety profile as it is FDA approved for the treatment of Parkinson's disease and Restless Leg Syndrome. Studies show it lowers prolactin levels in patients with Parkinson's disease and in normal healthy volunteers without major side effects. These characteristics make it a potentially useful drug for the treatment of high prolactin levels from tumors or other causes. The overall goal of this clinical trial is therefore to evaluate the efficacy and tolerability of ropinirole for the treatment of high prolactin levels and prolactinomas. This is a 24-week clinical trial. It involves: A medical history review and physical exams by Dr. Page-Wilson Ongoing treatment with ropinirole Adjustment of the ropinirole dose tailored to your body's response Regular blood tests for hormone levels Periodic visits to the research center for check-ups Completion of a short questionnaire during each visit Weekly calls from the research team and personalized medical follow-up.
This study is closed
Investigator
Gabrielle Page Wilson, MD
Do You Qualify?
Are you over 18 years old? Yes No
Has a doctor ever told you that you have high prolactin levels? Yes No
Do you have a pituitary tumor that is making prolactin (prolactinoma)? Yes No
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For more information, please contact:
Cara Dimino
cd2922@cumc.columbia.edu
212-305-3725