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Bromocriptine

Generic Name
Bromocriptine
Brand Names
Cycloset, Parlodel
Drug Type
Small Molecule
Chemical Formula
C32H40BrN5O5
CAS Number
25614-03-3
Unique Ingredient Identifier
3A64E3G5ZO
Background

Bromocriptine mesylate is a semisynthetic ergot alkaloid derivative with potent dopaminergic activity. It inhibits prolactin secretion and may be used to treat dysfunctions associated with hyperprolactinemia. Bromocriptine is also indicated for the management of signs and symptoms of Parkinsonian Syndrome, as well as the treatment of acromegaly. Bromocriptine has been associated with pulmonary fibrosis, and can also cause sustained suppression of somatotropin (growth hormone) secretion in some patients with acromegaly.

In 1995, the FDA withdrew the approval of bromocriptine mesylate for the prevention of physiological lactation after finding that bromocriptine was not shown to be safe for use. It continues to be used for the indications mentioned above.

Indication

For the treatment of galactorrhea due to hyperprolactinemia, prolactin-dependent menstrual disorders and infertility, prolactin-secreting adenomas, prolactin-dependent male hypogonadism, as adjunct therapy to surgery or radiotherapy for acromegaly or as monotherapy is special cases, as monotherapy in early Parksinsonian Syndrome or as an adjunct with levodopa in advanced cases with motor complications. Bromocriptine has also been used off-label to treat restless legs syndrome and neuroleptic malignant syndrome.

Associated Conditions
Acromegaly, Hyperprolactinemia, Parkinson's Disease (PD), Type 2 Diabetes Mellitus, Neuroleptic malignant syndrome (NMS)

Ophthalmologic Safety of Long Term Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's Disease

Phase 4
Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2014-09-08
Last Posted Date
2014-09-08
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
705
Registration Number
NCT02233023

Safety and Efficacy of Pramipexole and Bromocriptine Combined With L-dopa in Parkinson's Disease

Phase 3
Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2014-06-24
Last Posted Date
2014-06-24
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
315
Registration Number
NCT02172573

Effect of Bromocriptine on Insulin Resistance in Polycystic Ovarian Syndrome - A Pilot Study

Phase 3
Conditions
Insulin Resistance
PCOS
Interventions
First Posted Date
2014-05-08
Last Posted Date
2014-05-08
Lead Sponsor
IWK Health Centre
Target Recruit Count
60
Registration Number
NCT02133755
Locations
🇨🇦

IWK Health Centre, Halifax, Nova Scotia, Canada

Pharmacokinetic Study of CYCLOSET ® 0.8 mg Tablets in Children and Adolescent Type 2 Diabetes Mellitus Subjects

Phase 1
Completed
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2014-03-05
Last Posted Date
2016-08-29
Lead Sponsor
VeroScience
Target Recruit Count
18
Registration Number
NCT02078440
Locations
🇺🇸

Hope Research Institute, Llc, Phoenix, Arizona, United States

🇺🇸

Yale Center for Clinical Investigation, New Haven, Connecticut, United States

🇺🇸

The Children's Mercy Hospital, Kansas City, Missouri, United States

and more 2 locations

Bromocriptine and Pentoxifylline in Ophthalmopathy Autoimmune Treatment

Not Applicable
Terminated
Conditions
Graves Ophthalmopathy
Interventions
First Posted Date
2013-07-09
Last Posted Date
2013-07-09
Lead Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Target Recruit Count
31
Registration Number
NCT01893450
Locations
🇲🇽

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Distrito Federal, Mexico

Vaginal Bromocriptine for Treatment of Adenomyosis

Phase 1
Completed
Conditions
Adenomyosis
Interventions
First Posted Date
2013-03-29
Last Posted Date
2018-01-12
Lead Sponsor
Mayo Clinic
Target Recruit Count
1
Registration Number
NCT01821001
Locations
🇺🇸

Mayo Clinic in Rochester, Rochester, Minnesota, United States

Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease

Phase 4
Completed
Conditions
Parkinson's Disease
Interventions
First Posted Date
2012-08-28
Last Posted Date
2017-09-15
Lead Sponsor
Sandoz
Target Recruit Count
121
Registration Number
NCT01673724
Locations
🇰🇷

Korea University Anam Hospital, Seoul, Korea, Republic of

🇰🇷

Korea University Ansan Hospital, Ansan, Korea, Republic of

🇰🇷

Inje University Busan Paik Hospital, Busan, Korea, Republic of

and more 4 locations

Effect of Bromocriptine on Left Ventricular Function in Women With Peripartum Cardiomyopathy

Phase 2
Completed
Conditions
Peripartum Cardiomyopathy
Interventions
First Posted Date
2009-10-20
Last Posted Date
2020-09-07
Lead Sponsor
Hannover Medical School
Target Recruit Count
64
Registration Number
NCT00998556
Locations
🇩🇪

Hannover Medical School (MHH), Hannover, Niedersachsen, Germany

Fed Study of (Parlodel®) Bromocriptine Mesylate Capsules 5 mg

First Posted Date
2008-04-01
Last Posted Date
2024-04-24
Lead Sponsor
Mylan Pharmaceuticals Inc
Target Recruit Count
120
Registration Number
NCT00649168
Locations
🇨🇦

MDS Pharma Services, Montreal, Quebec, Canada

Fed Study of (Parlodel®) 2.5 mg Bromocriptine Mesylate Tablets

First Posted Date
2008-04-01
Last Posted Date
2024-04-24
Lead Sponsor
Mylan Pharmaceuticals Inc
Target Recruit Count
119
Registration Number
NCT00650520
Locations
🇨🇦

MDS Pharma Services, Montreal, Quebec, Canada

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