Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole

• Status: Completed
• Trial end date: 2020-11-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Dopamine; Dopamine Agonists; Ropinirole

Criteria

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