Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole

Phase 1

Completed

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 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.

Recruitment & Eligibility

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

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects That Achieved PRL Normalization as Defined by a Serum Prolactin Level Less Than 25ng/mL at Any Time Point During the Study Treatment Period.	6-12 months	Serum prolactin concentrations (PRL levels) were measured in patients at baseline, 2 and 4 weeks after starting therapy and then once monthly thereafter for 24 weeks. Serum prolactin was measured in duplicate by two-site chemiluminescent enzyme immunometric assay using the Immulite 1000 Analyzer (Siemens Healthcare Diagnostics, Deerfield, IL). The reference range for serum prolactin is 1.9-25 ng/ml for adult females.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Stable or Decreased Tumor Size	6 months	Number of subjects with stable or decreased tumor size from baseline assessment to assessment after 6 months of treatment. Radiologic assessment of tumor size before and after treatment will be made by MRI.