Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole

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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

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.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Percentage of Subjects That Achieved Stable PRL Normalization

Secondary Outcome

 Number of Subjects With Unchanged Tumor Size

Condition

Hyperprolactinemia

Intervention

Ropinirole

Study Arms / Comparison Groups

 ROP Intervention
Description:  Patients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

16

Start Date

September 16, 2016

Completion Date

November 5, 2020

Primary Completion Date

November 5, 2020

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
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Gabrielle Page-Wilson, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03038308

Organization ID

AAAI8604

Secondary IDs

1R21DK112093-01

Responsible Party

Sponsor

Study Sponsor

Columbia University

Collaborators

 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Sponsor

Gabrielle Page-Wilson, M.D., Principal Investigator, Columbia University


Verification Date

July 2021