Clinical trial

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

Name

AAAI8604

Description

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.

Trial arms

Trial start

2016-09-16

Estimated PCD

2020-11-05

Trial end

2020-11-05

Status

Completed

Phase

Early phase I

Treatment

Ropinirole

0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole

Arms:

ROP Intervention

Other names:

ROP therapy

Size

Primary endpoint

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

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open-label studies'}}, 'enrollmentInfo': {'count': 16, 'type': 'ACTUAL'}}

Updated at

2024-06-04

1 organization

1 product

2 indications

Organization

Product

Indication

Indication