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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03038308 |
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Date of registration:
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30/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole
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Scientific title:
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Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole: A Dose Escalation Study of Efficacy and Tolerability |
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Date of first enrolment:
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September 16, 2016 |
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Target sample size:
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23 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03038308 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Gabrielle Page-Wilson, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Columbia University |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hyperprolactinemia
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Prolactinoma
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Intervention(s)
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Drug: Ropinirole
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Primary Outcome(s)
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Prolactin concentrations
[Time Frame: 6-12 months]
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Secondary Outcome(s)
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Tumor size
[Time Frame: 6-12 months]
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Secondary ID(s)
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1R21DK112093-01
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AAAI8604
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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