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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)

Efficacy of Bromocriptine For Fever Reduction in Acute Neurologic Injury

Phase 1
Completed
Conditions
Subarachnoid Hemorrhage
Ischemic Stroke
Subdural Hematoma
Traumatic Brain Injury
Intracerebral Hemorrhage
Fever
Interventions
First Posted Date
2018-04-12
Last Posted Date
2021-06-24
Lead Sponsor
University of California, San Francisco
Target Recruit Count
47
Registration Number
NCT03496545
Locations
🇺🇸

Zuckerberg San Francisco General Hospital and Trauma Center, San Francisco, California, United States

🇺🇸

University of California, San Francisco Medical Center - Parnassus, San Francisco, California, United States

Evaluation of Bromocriptine, Metoprolol and Tamsulosin in Eyes With Non-Central DME

Phase 1
Withdrawn
Conditions
Diabetic Macular Edema
Interventions
First Posted Date
2017-12-27
Last Posted Date
2019-04-01
Lead Sponsor
Andrew Moshfeghi, MD, MBA
Registration Number
NCT03384524

Dopaminergic Modulation of Frontostriatal Function With a Dopamine Agonist and COMT Inhibitor

Phase 4
Withdrawn
Conditions
Addiction
Interventions
First Posted Date
2016-10-11
Last Posted Date
2021-11-16
Lead Sponsor
University of California, Berkeley
Registration Number
NCT02929485
Locations
🇺🇸

University of California, San Francisco, San Francisco, California, United States

🇺🇸

University of California, Berkeley, Berkeley, California, United States

Efficacy and Safety of Dexamethasone Prevention for Patients of Ovarian Hyperstimulation Syndrome

Phase 2
Conditions
Ovarian Hyperstimulation Syndrome
Interventions
First Posted Date
2016-07-27
Last Posted Date
2016-07-27
Lead Sponsor
Sun Yat-sen University
Target Recruit Count
200
Registration Number
NCT02846493
Locations
🇨🇳

The Sixth Affiliated Hospital,Sun Yat-Sen University, Guangzhou, Guangdong, China

Bromocriptine-QR Therapy on Sympathetic Tone and Vascular Biology in Type 2 Diabetes Subjects

Phase 4
Completed
Conditions
Diabetic Autonomic Neuropathy
Interventions
Drug: Placebo
First Posted Date
2016-02-17
Last Posted Date
2021-12-10
Lead Sponsor
Eastern Virginia Medical School
Target Recruit Count
84
Registration Number
NCT02682901
Locations
🇺🇸

Eastern Virgnia Medical School, Strelitz Diabetes Center, Norfolk, Virginia, United States

Bromocriptine in the Treatment of Peripartum Cardiomyopathy

Phase 3
Withdrawn
Conditions
Peripartum Cardiomyopathy
Interventions
Other: Guideline-driven medical therapy (GDMT)
First Posted Date
2015-10-29
Last Posted Date
2023-04-04
Lead Sponsor
Montreal Heart Institute
Registration Number
NCT02590601
Locations
🇨🇦

Montreal Heart Institute, Monteal, Quebec, Canada

Bromocriptine Quick Release (BCQR) as Adjunct Therapy in Type 1 Diabetes

Phase 2
Completed
Conditions
Type 1 Diabetes
Interventions
Other: Placebo
First Posted Date
2015-09-09
Last Posted Date
2021-09-13
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
108
Registration Number
NCT02544321
Locations
🇺🇸

University of Colorado-Denver, Anshutz Medical Campus, Aurora, Colorado, United States

Bromocriptine and Insulin Sensitivity

Not Applicable
Completed
Conditions
Insulin Sensitivity
Interventions
First Posted Date
2015-04-29
Last Posted Date
2016-05-24
Lead Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Target Recruit Count
15
Registration Number
NCT02428946
Locations
🇳🇱

Academic Medical Center, Amsterdam, Netherlands

Dopaminergic Effects on Brown Adipose Tissue

Not Applicable
Completed
Conditions
Obesity
Interventions
First Posted Date
2015-04-29
Last Posted Date
2015-04-29
Lead Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Target Recruit Count
8
Registration Number
NCT02428933
Locations
🇳🇱

Academic Medical Center, Amsterdam, Netherlands

Effect of Cycloset on Glycemic Control When Added to Glucagon-like Peptide 1 (GLP-1) Analogue Therapy

Phase 4
Completed
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2014-11-24
Last Posted Date
2019-06-21
Lead Sponsor
The University of Texas Health Science Center at San Antonio
Target Recruit Count
23
Registration Number
NCT02299050
Locations
🇺🇸

University of Texas Health Science Center, San Antonio, Texas, United States

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