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NCT03038308 · REGISTRY CONDITION SEARCH

Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2024-06-04

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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.

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outcome · POSTED

Number of Subjects With Stable or Decreased Tumor Size

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
maximum Age
70 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study
    intervention Names
    1. Drug: Ropinirole
    label
    ROP Intervention
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. ROP Intervention
    description
    0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole
    name
    Ropinirole
    other Names
    1. ROP therapy
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
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 Info
masking
NONE
masking Description
Open-label studies
primary Purpose
TREATMENT
Enrollment
count
16
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    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.
    time Frame
    6-12 months
secondary Outcomes
  1. description
    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.
    measure
    Number of Subjects With Stable or Decreased Tumor Size
    time Frame
    6 months
Full 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.
Source references
references
  1. 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.
    pmid
    30362146
    type
    BACKGROUND
  2. citation
    Heneghan LJ, Tsang A, Dimino C, Khandji AG, Panigrahi SK, Page-Wilson G. Ropinirole for the Treatment of Hyperprolactinemia: A Dose-Escalation Study of Efficacy and Tolerability. J Clin Endocrinol Metab. 2024 Jan 18;109(2):e667-e674. doi: 10.1210/clinem/dgad545.
    pmid
    37715962
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        exact text
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        start
        0
      offset unit
      unicode_code_points
      query cond
      Pituitary Tumors
      query disease state id
      ds-pituitary-tumors
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-pituitary-tumors-000.json
      source file sha256
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      source string sha256
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    Preserved source evidence · Not medical advice