Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hyperprolactinemia, Prolactinoma

Intervention / Treatment
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* Drug: Ropinirole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 1) Forced titration dose response PKPD study and 2) A prospective open-label outpatient dose escalation trial of ropinirole for treatment of prolactinomas and hyperprolactinemia.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ROP Intervention<br>Patients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study | Drug: Ropinirole<br>* 0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole<br>* Other names: ROP therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects That Achieved Stable PRL Normalization | Serum prolactin concentrations (PRL levels) were measured in patients at baseline and at follow-up. | 6-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Unchanged Tumor Size | Radiologic assessment of tumor size before and after treatment will be made by MRI. | 6-12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ropinirole, hyperprolactinemia, prolactin