Pituitary AdenomaNCT03457389
Comparison of Treatment Outcome of Cabergoline According to Target Prolactin Levels in Patients With Prolactinoma
A study testing Cabergoline in people with Pituitary Adenoma and Prolactinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pituitary Adenoma, Prolactinoma, Pituitary Tumor
- What is being tested?
- Cabergoline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Feb 2018to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, male or female aged 19 years or older
- diagnosed with prolactinoma
- No previous history of surgery, medication, or radiation therapy
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Jung Hee Kim, M.D, jhkxingfu@gmail.com
About this study
Official title: Comparison of Treatment Outcome of Cabergoline According to Target Prolactin Levels in Patients With Prolactinoma: A Prospective, Randomized, Open Label, Active-controlled, Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Pituitary Adenoma, Prolactinoma, Pituitary Tumor, Recurrence Tumor
- Being tested
- Cabergoline
- Keywords
- Prolactinoma, Cabergoline, Recurrence
- Medical subject headings
- Pituitary Neoplasms, Prolactinoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabergolineDrug
Also called Caverlactin
Cabergoline tablet
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Serum prolactin level is adjusted to less than 5 ng/mL during cabergoline administration. Receives: Drug: Cabergoline |
| Control group | Active comparator | Serum prolactin level is adjusted to normal range during cabergoline administration. Receives: Drug: Cabergoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate within 1 year after cabergoline withdrawal
Record of PRL levels on every 3 month follow-up visit
Measured: From 4 year to 5 years after cabergoline administration
Secondary outcomes (3)
Time to normalization of serum prolactin level
Record of PRL levels on follow-up visit
Measured: 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
Measured: Up to 3 years
Change from baseline of visual field defect
Record the Visual field scale on every 6 month follow-up visit,
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start22 Feb 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary AdenomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One experimental group and one control group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung Hee Kim, Seoul National University Hospital
- Investigators
- Jung Hee Kim, M.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457389
- Sponsor's protocol ID
- 1711-119-901
- Status last verified
- Sep 2019
- First submitted
- 23 Jan 2018
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatment Outcome of Cabergoline According to Target Prolactin Levels in Patients With Prolactinoma: A Prospective, Randomized, Open Label, Active-controlled, Clinical Trial
- ClinicalTrials.gov ID
- NCT03457389
- Acronym / sponsor ID
- 1711-119-901
- Conditions
- Pituitary Adenoma, Prolactinoma, Pituitary Tumor, Recurrence Tumor
- Keywords
- Prolactinoma, Cabergoline, Recurrence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One experimental group and one control group
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: CabergolineSerum prolactin level is adjusted to less than 5 ng/mL during cabergoline administration. |
| Control group | Active comparator | Drug: CabergolineSerum prolactin level is adjusted to normal range during cabergoline administration. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults, male or female aged 19 years or older
- diagnosed with prolactinoma
- No previous history of surgery, medication, or radiation therapy
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CabergolineAlso: CaverlactinCabergoline tablet | Drug | Control group, Experimental group |
Primary outcome
Recurrence rate within 1 year after cabergoline withdrawal
Time frame: From 4 year to 5 years after cabergoline administration
Record of PRL levels on every 3 month follow-up visit
3 secondary outcomes
Time to normalization of serum prolactin level
Time frame: Up to 1 year
Change from baseline on tumor volume measured by pituitary MRI
Time frame: Up to 3 years
Change from baseline of visual field defect
Time frame: Up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung Hee Kim, M.D principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cabergoline in people with Pituitary Adenoma and Prolactinoma, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung Hyun Lee (82-2-2072-4073, leejh001515@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate within 1 year after cabergoline withdrawal (time frame: From 4 year to 5 years after cabergoline administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.