Clinical trial · Interventional
Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole
Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole: A Dose Escalation Study of Efficacy and Tolerability
NCT03038308CI-TRIAL-00077682completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hyperprolactinemia | — | UNRESOLVED | — |
| Prolactinoma | Lactotroph Pituitary Neuroendocrine Tumor | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ropinirole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ROP Intervention
- description
- Patients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study
- interventionNames
- Drug: Ropinirole
Primary outcomes (1)
- 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.
- timeFrame
- 6-12 months
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDLiu 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
- DERIVEDHeneghan 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