Back to resultsTreatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole
Primary Purpose
Hyperprolactinemia, Prolactinoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ropinirole
Sponsored by
About this trial
This is an interventional treatment trial for Hyperprolactinemia focused on measuring ropinirole, hyperprolactinemia, prolactin
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
Sites / Locations
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ROP Intervention
Arm Description
Patients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study
Outcomes
Primary Outcome Measures
Percentage of Subjects That Achieved Stable PRL Normalization
Serum prolactin concentrations (PRL levels) were measured in patients at baseline and at follow-up.
Secondary Outcome Measures
Number of Subjects With Unchanged Tumor Size
Radiologic assessment of tumor size before and after treatment will be made by MRI.
Full Information
NCT ID
NCT03038308
First Posted
January 30, 2017
Last Updated
July 9, 2021
Sponsor
Columbia University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT03038308
Brief Title
Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole
Official Title
Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole: A Dose Escalation Study of Efficacy and Tolerability
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 16, 2016 (Actual)
Primary Completion Date
November 5, 2020 (Actual)
Study Completion Date
November 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperprolactinemia, Prolactinoma
Keywords
ropinirole, hyperprolactinemia, prolactin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
Open-label studies
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ROP Intervention
Arm Type
Experimental
Arm Description
Patients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study
Intervention Type
Drug
Intervention Name(s)
Ropinirole
Other Intervention Name(s)
ROP therapy
Intervention Description
0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole
Primary Outcome Measure Information:
Title
Percentage of Subjects That Achieved Stable PRL Normalization
Description
Serum prolactin concentrations (PRL levels) were measured in patients at baseline and at follow-up.
Time Frame
6-12 months
Secondary Outcome Measure Information:
Title
Number of Subjects With Unchanged Tumor Size
Description
Radiologic assessment of tumor size before and after treatment will be made by MRI.
Time Frame
6-12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabrielle Page-Wilson, M.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30362146
Citation
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.
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Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole
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