NCT03038308

Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Hyperprolactinemia
• Prolactinoma

Interventions

Type	Name	Description
DRUG	Ropinirole	0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole

Timeline

• Start date: 2016-09-16
• Primary completion: 2020-11-05
• Completion: 2020-11-05
• First posted: 2017-01-31
• Last updated: 2024-06-04
• Results posted: 2021-07-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study