Clinical Trial: Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole: A Dose Escalation Study of Efficacy and Tolerability

Brief Summary: The purpose of this study is to evaluate the use of the non-ergoline dopamine agonist ropinirole for the treatment of hyperprolactinemia in patients with idiopathic hyperprolactinemia and prolactinomas.

Detailed Summary: Treatment of prolactin secreting pituitary tumors 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. The overall goal of this project is therefore to evaluate, for the first time, the efficacy and tolerability of the selective D2/D3 receptor non-ergot dopamine agonist ropinirole for the treatment of prolactinomas. This proposal will establish the pharmacologic profile of this medication when used to treat hyperprolactinemia in patients with prolactinomas and will determine the impact of long-term ropinirole administration on critical clinical parameters including serum prolactin levels, gonadal function, and tumor regression, in order to establish ropinirole's utility as a new, clinically efficacious, safer and more tolerable therapeutic option for the treatment of prolactinomas that may prove particularly useful in patients with underlying cardiac valve disease and in those with resistance or intolerance to ergot dopamine agonists.
Sponsor: Columbia University

Current Primary Outcome: Prolactin concentrations [ Time Frame: 6-12 months ]

Serum prolactin concentrations


Original Primary Outcome: Same as current

Current Secondary Outcome: Tumor size [ Time Frame: 6-12 months ]

Radiologic assessment of tumor size before and after treatment will be made by MRI.


Original Secondary Outcome: Same as current

Information By: Columbia University

Dates:
Date Received: January 30, 2017
Date Started: September 16, 2016
Date Completion: July 1, 2019
Last Updated: January 30, 2017
Last Verified: January 2017