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Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole

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ClinicalTrials.gov Identifier: NCT03038308
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : September 2, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Gabrielle Page-Wilson, Columbia University

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.

Condition or disease Intervention/treatment Phase
Hyperprolactinemia Prolactinoma Drug: Ropinirole Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Intervention Model: Single Group Assignment
Intervention 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
Primary Purpose: Treatment
Official Title: Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole: A Dose Escalation Study of Efficacy and Tolerability
Actual Study Start Date : September 16, 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020


Arm Intervention/treatment
Experimental: Drug Drug: Ropinirole



Primary Outcome Measures :
  1. Prolactin concentrations [ Time Frame: 6-12 months ]
    Serum prolactin concentrations


Secondary Outcome Measures :
  1. Tumor size [ Time Frame: 6-12 months ]
    Radiologic assessment of tumor size before and after treatment will be made by MRI.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03038308


Contacts
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Contact: Gabrielle Page-Wilson, M.D. 212-305-3725 gp2287@cumc.columbia.edu

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Gabrielle Page-Wilson, M.D.    212-305-3725    gp2287@cumc.columbia.edu   
Sponsors and Collaborators
Columbia University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Gabrielle Page-Wilson, M.D. Columbia University

Publications:
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Responsible Party: Gabrielle Page-Wilson, Assistant Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT03038308     History of Changes
Other Study ID Numbers: AAAI8604
1R21DK112093-01 ( U.S. NIH Grant/Contract )
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Gabrielle Page-Wilson, Columbia University:
ropinirole
hyperprolactinemia
prolactin
Additional relevant MeSH terms:
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Prolactinoma
Hyperprolactinemia
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Dopamine
Ropinirole
Dopamine Agonists
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antiparkinson Agents
Anti-Dyskinesia Agents