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
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