Clinical trial · Interventional
Comparison of Treatment Outcome of Cabergoline According to Target Prolactin Levels in Patients With Prolactinoma
Comparison of Treatment Outcome of Cabergoline According to Target Prolactin Levels in Patients With Prolactinoma: A Prospective, Randomized, Open Label, Active-controlled, Clinical Trial
NCT03457389CI-TRIAL-00044080unknownN/AClinicalTrials.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 aim of this study is to investigate whether inhibition of serum prolactin levels below normal range during cabergoline administration may reduce the recurrence rate after drug withdrawal in patients with prolactinomas.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pituitary Adenoma | Pituitary Neuroendocrine Tumor | ALIAS | 0.90 |
| Pituitary Tumor | Pituitary Gland Neoplasm | ALIAS | 0.90 |
| Prolactinoma | Lactotroph Pituitary Neuroendocrine Tumor | ALIAS | 0.90 |
| Recurrence Tumor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cabergoline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Serum prolactin level is adjusted to less than 5 ng/mL during cabergoline administration.
- interventionNames
- Drug: Cabergoline
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Serum prolactin level is adjusted to normal range during cabergoline administration.
- interventionNames
- Drug: Cabergoline
Primary outcomes (1)
- measure
- Recurrence rate within 1 year after cabergoline withdrawal
- timeFrame
- From 4 year to 5 years after cabergoline administration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Adults, male or female aged 19 years or older * diagnosed with prolactinoma * No previous history of surgery, medication, or radiation therapy Exclusion Criteria: * Invasive prolactinomas except invading cavernous sinus * Taking dopaminergic medications * Taking medications that can affect serum prolactin level (including estrogenic hormone, oral contraceptive drugs, intrauterine devices) * Hyperprolactinemia due to secondary causes * History of pituitary apoplexy within the last 3 months * Patients with mental illness that should avoid dopamine agonists * Patients with history of cardiac valve diseases * Patients with history of pulmonary fibrosis, retroperitoneal fibrosis, and cystic fibrosis * Moderate degree of hepatic or renal insufficiency (IDMS Modification of Diet in Renal Disease glomerular filtration rate (MDRD GFR) \<45 ml/min/1.73m2) * Patients with cabergoline hypersensitivity reaction * Pregnant or breast feeding patients
References
Publications (0)
Data not yet available
No reference posted for this study.