Comparison of Treatment Outcome of Cabergoline According to Target Prolactin Levels in Patients With Prolactinoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	19 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03457389
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Seoul National University Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jung Hee Kim, M.D
Principal Investigator Affiliation	Seoul National University Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Korea, Republic of
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pituitary Adenoma, Prolactinoma, Pituitary Tumor, Recurrence Tumor

Additional Details

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.

Arms & Interventions

Arms

Experimental: Experimental group

Serum prolactin level is adjusted to less than 5 ng/mL during cabergoline administration.

Active Comparator: Control group

Serum prolactin level is adjusted to normal range during cabergoline administration.

Interventions

Drug: - Cabergoline

Cabergoline tablet

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital

Seoul, , 03080

Site Contact

Jung Hee Kim, M.D

[email protected]

82-2-2072-4073

Clinical Trial Finder