At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 16 enrolled
Drug / intervention
Ropiniroledrug
Likely dose
Ropinirole 0.25 mg/day to 6.0 mg/day orally (dose escalation)AI-extracted
Key inclusion· 4
- ✓Age 18–70 years
- ✓Prolactin level at least 2 times the upper limit of normal
- ✓Pituitary adenoma on MRI ≤1.5 cm in greatest diameter and ≥5 mm from optic chiasm
- ✓Normal renal and liver function
Key exclusion· 7
- ✕Use of medications known to interfere with prolactin secretion, prolactin metabolism, or ropinirole metabolism
- ✕Use of another dopamine agonist within 4 weeks prior to enrollment
- ✕Pituitary stalk compression on MRI
- ✕History of visual field abnormalities or previous pituitary radiation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole: A Dose Escalation Study of Efficacy and Tolerability
In Brief
A Phase 2 clinical trial evaluating Ropinirole for Hyperprolactinemia and Prolactinoma. Completed, enrolled 16 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperprolactinemia, Prolactinoma
CountriesUnited States
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartSep 2016
First PostedJan 2017
Primary CompletionNov 2020
TodayJul 2026
First PostedJan 31, 2017
Enrollment StartSep 16, 2016
Primary CompletionNov 5, 2020
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 9.4 years ago
Interventions
Ropiniroledrug
0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole