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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.
Prolactinoma patients will be assigned to a experimental group that maintains serum prolactin levels below 5 ng/mL and a control group that maintains normal serum prolactin levels. After that, cabergoline will be maintained at a therapeutic dose for 130 weeks. After cabergoline is discontinued, patients will be followed up with serum prolactin measurement for 52 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Serum prolactin level is adjusted to less than 5 ng/mL during cabergoline administration. |
|
| Control group | Active Comparator | Serum prolactin level is adjusted to normal range during cabergoline administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabergoline | Drug | Cabergoline tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate within 1 year after cabergoline withdrawal | Record of PRL levels on every 3 month follow-up visit | From 4 year to 5 years after cabergoline administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time to normalization of serum prolactin level | Record of PRL levels on follow-up visit | Up to 1 year |
| Change from baseline on tumor volume measured by pituitary MRI | Record of he tumor volume from pituitary MRI on every 12-month follow-up visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jung Hyun Lee | Contact | 82-2-2072-4073 | leejh001515@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Jung Hee Kim, M.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| D010911 | Pituitary Neoplasms |
| D015175 | Prolactinoma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007029 | Hypothalamic Neoplasms |
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| ID | Term |
|---|---|
| D000077465 | Cabergoline |
| ID | Term |
|---|---|
| D004873 | Ergolines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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One experimental group and one control group
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| Up to 3 years |
| Change from baseline of visual field defect | Record the Visual field scale on every 6 month follow-up visit, | Up to 3 years |
| D015173 |
| Supratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007027 | Hypothalamic Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006576 |
| Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |