CompletedPhase 1/2

Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole

United States16 participantsStarted 2016-09-16

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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.

Timeframe: 6-12 months

Trial details

NCT IDNCT03038308

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-11-05

Results submitted2021-07-09

View on ClinicalTrials.gov More Hyperprolactinemia trials