Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole

Columbia University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Prolactinoma; Hyperprolactinemia

Treatments: Drug: Ropinirole

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03038308

1R21DK112093-01 (U.S. NIH Grant/Contract)

AAAI8604

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages 18-70 years
• Prolactin level (PRL) ≥2 times upper limit of normal
• Pituitary adenomas on MRI ≤ 1.5cm in greatest diameter and ≥ 5mm from the optic chiasm
• Normal renal and liver function
• Agrees to barrier contraception if pre-menopausal

Exclusion criteria

• Use of medications known to interfere with PRL secretion and PRL and Ropinirole (ROP) metabolism
• Use of another dopamine agonist during the 4 weeks prior
• Pituitary stalk compression on MRI
• History of visual field abnormalities or previous radiation
• Untreated hypothyroidism
• Consumption of > 2 alcoholic drinks per day
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

ROP Intervention

Experimental group

Description:

Patients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study

Treatment:

Drug: Ropinirole