Who is sponsoring NCT04107480?

NCT04107480 is sponsored by Leiden University Medical Center.

What drugs are being tested in NCT04107480?

Interventions in NCT04107480: Endoscopic trans-sphenoidal adenoma resection, Dopamine Agonists.

What condition does NCT04107480 study?

NCT04107480 studies Prolactinoma, Prolactin-Producing Pituitary Tumor.

Is NCT04107480 still recruiting?

NCT04107480 is currently status unknown. Last updated 20 July 2020.

Last reviewed 2020-07-20 · How we verify

NCT04107480

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

PRolaCT - Three Prolactinoma RCTs

Status unknown Phase 4 Last updated 20 July 2020

What this trial tests

Phase 4 trial testing Endoscopic trans-sphenoidal adenoma resection in Prolactinoma in 880 participants. Status unknown.

Timeline

21 June 2019

Primary endpoint
31 March 2024

31 March 2026

Quick facts

Lead sponsor	Leiden University Medical Center
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	880
Start date	21 June 2019
Primary completion	31 March 2024
Estimated completion	31 March 2026
Sites	3 locations across Netherlands

Drugs / interventions tested

Endoscopic trans-sphenoidal adenoma resection
Dopamine Agonists — full drug profile →

Conditions studied

Prolactinoma — all drugs for Prolactinoma →
Prolactin-Producing Pituitary Tumor — all drugs for Prolactin-Producing Pituitary Tumor →

Sponsor

Leiden University Medical Center

Who can join

18 and older, any sex, with Prolactinoma or Prolactin-Producing Pituitary Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to investigate if endoscopic trans-sphenoidal prolactinoma resection as a first line treatment, or as an equally valid second line treatment after a short (4-6 months) or long (\>2 years) period of pretreatment with a dopamine agonist is superior to standard care for several outcome parameters. The main objectives are to investigate this for quality of life and remission rate. The secondary objectives are to investigate this for biochemical disease control, recurrence rates, clinical symptom control, tumor shrinkage on MRI, pituitary functioning, the occurrence of adverse reactions to treatment, disease burden, and cost-effectiveness.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

The PRolaCT studies - a study protocol for a combined randomised clinical trial and observational cohort study design in prolactinoma.
Zandbergen IM, Zamanipoor Najafabadi AH, Pelsma ICM, van den Akker-van Marle ME, et al · · 2021 · cited 15× · PMID 34563236 · DOI 10.1186/s13063-021-05604-y
Outcome Squares Integrating Efficacy and Safety, as Applied to Functioning Pituitary Adenoma Surgery.
de Vries F, Lobatto DJ, Verstegen MJT, Schutte PJ, et al · · 2021 · cited 13× · PMID 33693739 · DOI 10.1210/clinem/dgab138
Antiangiogenic Effect of Dopamine and Dopaminergic Agonists as an Adjuvant Therapeutic Option in the Treatment of Cancer, Endometriosis, and Osteoarthritis.
Mendoza-Torreblanca JG, Cárdenas-Rodríguez N, Carro-Rodríguez J, Contreras-García IJ, et al · · 2023 · cited 6× · PMID 37373348 · DOI 10.3390/ijms241210199

Verify or expand the search:

Other recruiting trials for Prolactinoma

Currently open trials in the same condition.

NCT07463235 — Safety and Potency of a High Cabergoline Dosage in Microprolactinomas · Phase 3 · recruiting
NCT07268183 — How Estrogen Fluctuations Before Diagnosis Affect the Size Prolactin-secreting Tumors · recruiting
NCT07045935 — Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment · Phase 4 · recruiting
NCT06936813 — The PROMISE Survey · active not recruiting
NCT00001595 — An Investigation of Pituitary Tumors and Related Hypothalmic Disorders · recruiting

Other Leiden University Medical Center trials

Trials by the same sponsor.

NCT07312565 — Occurrence of Abdominal Aortic Aneurysms in Patients With Aneurysmal Subarachnoid Hemorrhage · not yet recruiting
NCT07090343 — Semaglutide in Patients Undergoing Transcatether Aortic Valve Replacement · Phase 3 · not yet recruiting
NCT07498738 — Making Diabetes Care Fit for Young Adults Living With Type 1 Diabetes: Observations, Reflections and Expert Opinions · NA · not yet recruiting
NCT06545292 — Microsampling for Therapeutic Drug Monitoring of Oral Oncolytics in Oncology Patients · NA · recruiting
NCT07021495 — SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY) · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04107480 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Leiden University Medical Center
Last refreshed: 20 July 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04107480.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing