Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole

Hyperprolactinemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03038308
• Other study ID #: AAAI8604
• Secondary ID: 1R21DK112093-01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 16, 2016
• Est. completion date: November 5, 2020

Study information

• Verified date: May 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 5, 2020
• Est. primary completion date: November 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

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

Related Conditions & MeSH terms

• Hyperprolactinemia
• Prolactinoma

Intervention

Drug:
• Ropinirole
0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Liu S, Hu C, Peters J, Tsang A, Cremers S, Bies R, Page-Wilson G. Pharmacokinetics and pharmacodynamics of ropinirole in patients with prolactinomas. Br J Clin Pharmacol. 2019 Feb;85(2):366-376. doi: 10.1111/bcp.13802. Epub 2018 Nov 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	6-12 months
Secondary	Number of Subjects With Stable or Decreased Tumor Size	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.	6 months