Cabergoline

Generic Name: Cabergoline

Brand Names: Dostinex

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₃₇N_₅O_₂

CAS Number: 81409-90-7

Unique Ingredient Identifier: LL60K9J05T

Background: Cabergoline, an ergot derivative, is a long-acting dopamine agonist and prolactin inhibitor. It is used to treat hyperprolactinemic disorders and Parkinsonian Syndrome. Cabergoline possesses potent agonist activity on dopamine D2 receptors.

Indication: For the treatment of hyperprolactinemic disorders, either idiopathic or due to prolactinoma (prolactin-secreting adenomas). May also be used to manage symptoms of Parkinsonian Syndrome as monotherapy during initial symptomatic management or as an adjunct to levodopa therapy during advanced stages of disease.

Associated Conditions: Hyperprolactinemia, Idiopathic hyperprolactinemic disorder

Associated Therapies: Inhibition of physiological lactation

Clinical Trials

Compare the Efficacy of Human Albumin With Cabergoline to Prevent Ovarian Hyper Stimulation in Assisted Reproductive Technology (ART) Program

Phase 1

Completed

Conditions: Ovarian Hyperstimulation Syndrome

Interventions: Drug: Control
Drug: Cabergoline

First Posted Date: 2009-11-06

Last Posted Date: 2015-05-06

Lead Sponsor: Royan Institute

Target Recruit Count: 10

Registration Number: NCT01009567

Locations: 🇮🇷
Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR, Tehran, Iran, Islamic Republic of

Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor

Phase 3

Completed

Conditions: Cushing's Disease
Corticotroph Adenoma

Interventions: Drug: Cabergoline

First Posted Date: 2009-04-29

Last Posted Date: 2009-04-29

Lead Sponsor: Seth Gordhandas Sunderdas Medical College

Registration Number: NCT00889525

Locations: 🇮🇳
Seth GSMC & KEM hospital, Mumbai, Maharashtra, India

Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fed Conditions

Phase 1

Completed

Conditions: To Determine Bioequivalence Under Fed Conditions

Interventions: Drug: Dostinex
Drug: Cabergoline

First Posted Date: 2008-04-04

Last Posted Date: 2017-09-26

Lead Sponsor: Par Pharmaceutical, Inc.

Target Recruit Count: 24

Registration Number: NCT00652873

Locations: 🇨🇦
Anapharm, Inc., Sainte-Foy, Quebec, Canada

Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fasting Conditions

Phase 1

Completed

Conditions: To Determine Bioequivalence Under Fasting Conditions

Interventions: Drug: Cabergoline
Drug: Dostinex

First Posted Date: 2008-04-04

Last Posted Date: 2008-04-04

Lead Sponsor: Par Pharmaceutical, Inc.

Target Recruit Count: 40

Registration Number: NCT00653055

Locations: 🇨🇦
Anapharm, Inc., Sainte-Foy, Quebec, Canada

A Study to Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS

Phase 3

Completed

Conditions: Restless Legs Syndrome

Interventions: Drug: Cabergoline
Other: Placebo

First Posted Date: 2008-02-29

Last Posted Date: 2011-04-25

Lead Sponsor: Pfizer

Target Recruit Count: 43

Registration Number: NCT00627003

A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS

Phase 3

Completed

Conditions: Restless Legs Syndrome

Interventions: Drug: cabergoline
Drug: levodopa

First Posted Date: 2008-02-28

Last Posted Date: 2008-10-29

Lead Sponsor: Pfizer

Target Recruit Count: 361

Registration Number: NCT00625547

Locations: 🇨🇭
Pfizer Investigational Site, Zürich, Switzerland

Cardiac Valve Complications in Prolactinomas Treated With Cabergoline

Completed

Conditions: Prolactinomas

Interventions: Drug: Cabergoline

First Posted Date: 2007-04-16

Last Posted Date: 2008-04-16

Lead Sponsor: Federico II University

Target Recruit Count: 50

Registration Number: NCT00460616

Locations: 🇮🇹
Department of Molecular and Clinical Endocrinology and Oncology, University Federico II of Naples, via S. Pansini 5 Naples, Italy

Cabergoline Reduces OHSS

Phase 3

Completed

Conditions: Ovarian Hyperstimulation Syndrome

First Posted Date: 2007-02-26

Last Posted Date: 2007-02-27

Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

Target Recruit Count: 60

Registration Number: NCT00440258

Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease.

Phase 4

Terminated

Conditions: Parkinson Disease

First Posted Date: 2005-09-15

Last Posted Date: 2007-05-25

Lead Sponsor: Pfizer

Target Recruit Count: 220

Registration Number: NCT00174239

Locations: 🇪🇸
Pfizer Investigational Site, Sevilla, Spain

Dopamine Turnover Rate as Surrogate Parameter for Diagnosis of Early Parkinson's Disease

Phase 4

Completed

Conditions: Parkinson's Disease

Interventions: Drug: Cabergoline
Drug: Levodopa

First Posted Date: 2005-09-12

Last Posted Date: 2012-12-18

Lead Sponsor: Technische Universität Dresden

Target Recruit Count: 39

Registration Number: NCT00153972

Locations: 🇩🇪
Department of Nuclear Medicine at the Technical University of Dresden, Dresden, Saxony, Germany
🇩🇪
Department of Neurology at the Technical University of Dresden, Dresden, Saxony, Germany

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