Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 as well as non-interventional protocols evaluate cabergoline across various endocrine, neurological, and substance use disorders, including hyperprolactinemia, Parkinson's disease, and cocaine dependence. Ranging from active and completed to terminated studies, this research is supported by a mix of academic medical centers, hospital networks, government agencies, and pharmaceutical sponsors.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07045935 RECRUITING
Prolactinoma
University Hospital, Basel, Switzerland
 2025-09-16 PHASE4
NCT07034859 ENROLLING_BY_INVITATION
Pituitary Adenoma; MRI; RCT
National Taiwan University Hospital
 2024-05-20 PHASE4
NCT07603466 ENROLLING_BY_INVITATION
Cushing Disease Due to Increased ACTH Secretion
University of Basrah
 2026-05-11 PHASE4
NCT07568574 ENROLLING_BY_INVITATION
Safety and Impact of Medically Supervised Performance Enhancing Substance Usage in Healthy Elite Athletes
Enhanced Emirates Limited
 2026-03-12
NCT07386080 NOT_YET_RECRUITING
Scizophrenia
Zealand University Hospital
 2026-05-01 PHASE4
NCT07072910 RECRUITING
Migraine
Aarhus University Hospital
 2025-11-12 PHASE2
NCT07492160 RECRUITING
Pregnancy; Abortion
Maimonides Medical Center
 2026-03-16 PHASE2
NCT07463235 RECRUITING
Prolactinoma; Prolactin Excess
University of Sao Paulo General Hospital
 2026-03-04 PHASE3
NCT06909123 WITHDRAWN
Lactation Suppressed
Stanford University
 2026-07 PHASE2
NCT02288962 ACTIVE_NOT_RECRUITING
Pituitary Neoplasms; Adenoma
St. Olavs Hospital
 2014-11 PHASE3
NCT07124221 RECRUITING
Hyperprolactinemia
Changchun GeneScience Pharmaceutical Co., Ltd.
 2025-09-12 PHASE3
NCT07043322 RECRUITING
Gynecologic Disease
Tanta University
 2025-06-30 PHASE2
NCT07732387 NOT_YET_RECRUITING
Erectile Dysfunctions; Healthy Volunteer
Yanping Kong
 2026-08-01 PHASE1
NCT07008417 ACTIVE_NOT_RECRUITING
Hyperprolactinemia
Changchun GeneScience Pharmaceutical Co., Ltd.
 2025-06-30 PHASE1
NCT03928288 COMPLETED
Endometriosis
Boston Children's Hospital
 2019-12-02 PHASE2
NCT07255911 RECRUITING
PCOS
Mst.Sumyara Khatun
 2025-02-07
NCT06029673 COMPLETED
Lactation Suppressed
Stanford University
 2024-02-07 PHASE2
NCT03457389 UNKNOWN
Pituitary Adenoma; Prolactinoma; Pituitary Tumor; Recurrence Tumor
Seoul National University Hospital
 2018-02-22
NCT06123026 RECRUITING
Lactation Suppressed; Second Trimester Abortion
Northwestern University
 2023-12-18 PHASE4
NCT07168837 COMPLETED
PCOS (Polycystic Ovary Syndrome)
Al-Azhar University
 2023-01-10
NCT06333691 COMPLETED
Ovarian Hyperstimulation Syndrome
Minia University
 2022-10-01
NCT01794793 COMPLETED
Cushing's Disease; Acromegaly; Neuroendocrine Tumors; Pituitary Tumors; Ectopic ACTH Secreting (EAS) Tumors; Dumping Syndrome; Prostate Cancer; Melanoma Negative for bRAF; Melanoma Negative for nRAS
RECORDATI GROUP
 2013-06-10 PHASE4
NCT05525611 COMPLETED
Migraine
University of Aarhus
 2022-09-05
NCT05981742 COMPLETED
Polycystic Ovary Syndrome
Al-Rasheed University College
 2022-09-21 PHASE2
NCT04262024 COMPLETED
Health Education
Woman's Health University Hospital, Egypt
 2020-02-01 PHASE1
NCT05024422 COMPLETED
Lactation Suppressed
HaEmek Medical Center, Israel
 2021-12-31
NCT04038749 UNKNOWN
Lactation Suppressed
Żelazna Medical Centre, LLC
 2019-06-16
NCT04701333 COMPLETED
Lactation Suppressed
Stanford University
 2021-04-01 PHASE2
NCT06560814 COMPLETED
Endometriosis; Infertility, Female
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
 2020-07-01 PHASE2
NCT04096027 COMPLETED
Infertility, Female
Fertility Center of Las Vegas
 2019-09-23 PHASE4
NCT03400865 UNKNOWN
Resistance, Disease; Prolactinoma
Zhebao Wu
 2018-10-25
NCT03313661 UNKNOWN
Diabetes
Sherief Abd-Elsalam
 2017-10-14 PHASE3
NCT03965572 Unknown status
Lactation Suppressed|Cabergoline Adverse Reaction|Postpartum DVT|Postpartum Depression
Laniado Hospital
 2019-06-07 --
NCT03549741 UNKNOWN
Infertility
Assiut University
 2018-07 PHASE2; PHASE3
NCT02620605 UNKNOWN
Ovarian Hyperstimulation Syndrome
Mona M Shaban
 2017-12-20 PHASE3
NCT02542410 COMPLETED
Endometriosis
Boston Children's Hospital
 2016-05 PHASE2
NCT03263299 UNKNOWN
Invitro Fertilization
Cairo University
 2017-08 PHASE4
NCT02875587 COMPLETED
OHSS
Aljazeera Hospital
 2016-10 PHASE2
NCT03457389 Recruiting
Pituitary Adenoma|Prolactinoma|Pituitary Tumor|Recurrence Tumor
Seoul National University Hospital
 2018-02-22 Not Applicable
NCT02306564 UNKNOWN
Infertility
Kasr El Aini Hospital
 2014-12 PHASE2; PHASE3
NCT03473613 COMPLETED
Ovarian Hyperstimulation
Benha University
 2014-10-01 PHASE3
NCT03271918 COMPLETED
Pituitary Adenoma; Nonfunctioning Pituitary Adenoma
University of Sao Paulo General Hospital
 2015-02-01 PHASE3
NCT02644304 UNKNOWN
Female Reproductive Problem
Woman's Health University Hospital, Egypt
 2015-05 PHASE2
NCT01915303 TERMINATED
Cushings Disease
Novartis Pharmaceuticals
 2014-03-06 PHASE2
NCT01730729 COMPLETED
Recurrent Breast Cancer; Stage IV Breast Cancer
Northwestern University
 2013-02-11 EARLY_PHASE1
NCT02271360 COMPLETED
Infertility
Benha University
 2014-04 PHASE2; PHASE3
NCT02461875 UNKNOWN
OHSS
Aljazeera Hospital
 2013-05 PHASE2
NCT02134249 COMPLETED
Infertility
Benha University
 2014-04 PHASE2; PHASE3
NCT01984320 COMPLETED
OHSS
Cairo University
 2013-10
NCT01535859 COMPLETED
Ovarian Hyperstimulation Syndrome
KK Women's and Children's Hospital
 2012-04 PHASE3
NCT01009567 COMPLETED
Ovarian Hyperstimulation Syndrome
Royan Institute
 2009-06 PHASE1; PHASE2
NCT01620138 COMPLETED
Non-functioning Pituitary Adenomas; Prolactinomas
Universidade Federal do Rio de Janeiro
 2010-03 PHASE2; PHASE3
NCT01459601 UNKNOWN
Diabetes Type 2
Mashhad University of Medical Sciences
 2012-01
NCT01143584 UNKNOWN
Macroprolactinoma
Post Graduate Institute of Medical Education and Research, Chandigarh
 2010-05
NCT01651364 COMPLETED
Cocaine Dependence; Cocaine Abuse; Cocaine Addiction; Substance Abuse
Baylor College of Medicine
 2011-07 PHASE1
NCT01957839 COMPLETED
Adverse Reaction to Other Drugs and Medicines
Istanbul Bakirkoy Maternity and Children Diseases Hospital
 2010-03 PHASE4
NCT01651364 Completed
Cocaine Dependence|Cocaine Abuse|Cocaine Addiction|Substance Abuse
Baylor College of Medicine|National Institute on Drug Abuse (NIDA)
 2011-07 Phase 1
NCT01065376 COMPLETED
In Vitro Fertilization
Shin Kong Wu Ho-Su Memorial Hospital
 2010-01 PHASE4
NCT01270711 Completed
Parkinson''s Disease|Hyperprolactinemia
Pfizer
 2010-11 --
NCT00376064 COMPLETED
Acromegaly
Novartis Pharmaceuticals
 2006-03 PHASE4
NCT01278342 COMPLETED
Acromegaly
Novartis Pharmaceuticals
 2006-09 PHASE4
NCT01009567 Completed
Ovarian Hyperstimulation Syndrome
Royan Institute
 2009-06 Phase 1|Phase 2
NCT01569256 COMPLETED
Polycystic Ovarian Syndrome; Ovarian Hyperstimulation Syndrome
Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
 2008-03
NCT00153972 COMPLETED
Parkinson's Disease
Technische Universität Dresden
 2005-02 PHASE4
NCT01530490 COMPLETED
Complications Associated With Artificial Fertilization; Disorder of Endocrine Ovary
Hospital de Cruces
 2007-08 EARLY_PHASE1
NCT00595140 COMPLETED
Acromegaly
Ludwig-Maximilians - University of Munich
 2008-01 PHASE4
NCT00129181 COMPLETED
Parkinson Disease; Parkinsonian Syndrome
Institute for Neurodegenerative Disorders
 2005-01
NCT00242008 COMPLETED
Parkinson's Disease
UCB Pharma
 2004-12 PHASE3
NCT00153972 Completed
Parkinson''s Disease
Technische Universität Dresden|Pfizer
 2005-02 Phase 4
NCT01395602 COMPLETED
Body Weight; Impaired Glucose Tolerance in Obese
Columbia University
 2002-04 PHASE1; PHASE2
NCT00652873 COMPLETED
To Determine Bioequivalence Under Fed Conditions
Par Pharmaceutical, Inc.
 2001-07 PHASE1
NCT00653055 COMPLETED
To Determine Bioequivalence Under Fasting Conditions
Par Pharmaceutical, Inc.
 2001-08 PHASE1
NCT00440258 COMPLETED
Ovarian Hyperstimulation Syndrome
Instituto Valenciano de Infertilidad, IVI VALENCIA
 2004-04 PHASE3
NCT00033111 COMPLETED
Cocaine-Related Disorders; Substance-Related Disorders
National Institute on Drug Abuse (NIDA)
 2001-06 PHASE2
NCT00889525 COMPLETED
Cushing's Disease; Corticotroph Adenoma
Seth Gordhandas Sunderdas Medical College
 2007-11 PHASE3
NCT00174239 TERMINATED
Parkinson Disease
Pfizer
 2004-07 PHASE4
NCT00625547 COMPLETED
Restless Legs Syndrome
Pfizer
 2003-01 PHASE3
NCT00627003 COMPLETED
Restless Legs Syndrome
Pfizer
 2002-11 PHASE3

(data from https://clinicaltrials.gov, updated on 2025-09-23)

Check the Cabergoline product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cabergoline selectively binds as a potent agonist to dopamine D2 receptors on pituitary lactotroph cells, triggering receptor activation that inhibits adenylate cyclase activity and reduces intracellular cyclic AMP levels. This suppression of second-messenger signaling leads to a marked inhibition of prolactin synthesis and secretion, providing therapeutic efficacy in clinical trial conditions such as prolactinomas, hyperprolactinemia, and Parkinson's disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.