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Last Updated: May 19, 2022

CLINICAL TRIALS PROFILE FOR DOSTINEX


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All Clinical Trials for Dostinex

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00033111 ↗ A Study of Cabergoline for the Treatment of Cocaine Dependence - 1 Completed University of California, Los Angeles Phase 2 2001-06-01 The purpose of this study is to assess cabergoline for the Treatment of Cocaine Dependence
NCT00033111 ↗ A Study of Cabergoline for the Treatment of Cocaine Dependence - 1 Completed National Institute on Drug Abuse (NIDA) Phase 2 2001-06-01 The purpose of this study is to assess cabergoline for the Treatment of Cocaine Dependence
NCT00460616 ↗ Cardiac Valve Complications in Prolactinomas Treated With Cabergoline Completed Federico II University 2007-01-01 Dopamine agonists are first-line agents for the treatment of prolactinomas (1) and Parkinson's disease (2). There is evidence supporting a causal relationship between the occurrence of drug-induced "restrictive" valvular heart disease and treatment with pergolide (3): in several cases, the valvulopathy improved when pergolide was discontinued (4). Valvular heart damage has also been reported with the ergot-derived dopamine agonists bromocriptine and cabergoline (5,6). Two recent studies (7,8) have further demonstrated that both pergolide and cabergoline are associated with an increased risk of new cardiac valve regurgitation in patients treated for Parkinson's disease. The valvular abnormalities seen with ergot-derived dopamine agonists are similar to those observed in patients receiving ergot alkaloid agents (such as ergotamine and methysergide) in the treatment of migraine, or fenfluramine and dexfenfluramine in the treatment of obesity. These abnormalities also closely resemble carcinoid-related valvulopathies (9). Cardiac valve disease has never been reported in patients with prolactinomas who require treatment with dopamine-agonists even life-long (1). At variance with patients with Parkinson's disease, patients with prolactinomas are younger and are treated with an average dose of dopamine-agonists that is significantly lower (median bromocriptine dose 5 mg/day and median cabergoline dose 1 mg/week). Because of the young age of treatment beginning (most patients with microprolactinomas start dopamine-agonist treatment in early adulthood), treatment might be continued for over 3 decades: the cumulative risk of low doses of dopamine agonists for such a long period of treatment is currently unknown. To assess the prevalence of cardiac valve disease in patients treated with cabergoline, we wish to perform an echocardiography screening in a large representative sample of patients with prolactinoma who were treated with cabergoline for at least 12 months and in a group of control subjects recruited prospectively. We wish to evaluate the severity of regurgitation for the mitral, aortic, and tricuspid valves. Changes in cardiac valve apparatus was compared with treatment duration and cumulative cabergoline dose.
NCT00652873 ↗ Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fed Conditions Completed Anapharm Phase 1 2001-07-01 To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus Dostinex (reference)
NCT00652873 ↗ Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fed Conditions Completed Par Pharmaceutical, Inc. Phase 1 2001-07-01 To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus Dostinex (reference)
NCT00653055 ↗ Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fasting Conditions Completed Anapharm Phase 1 2001-08-01 To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus Dostinex (reference)
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dostinex

Condition Name

Condition Name for Dostinex
Intervention Trials
Infertility 3
Ovarian Hyperstimulation Syndrome 2
Acromegaly 2
Endometriosis 2
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Condition MeSH

Condition MeSH for Dostinex
Intervention Trials
Ovarian Hyperstimulation Syndrome 5
Pituitary Diseases 4
Pituitary Neoplasms 4
Infertility 3
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Clinical Trial Locations for Dostinex

Trials by Country

Trials by Country for Dostinex
Location Trials
United States 12
Brazil 8
Italy 7
Japan 6
Canada 5
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Trials by US State

Trials by US State for Dostinex
Location Trials
California 3
Massachusetts 2
Washington 1
Virginia 1
New York 1
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Clinical Trial Progress for Dostinex

Clinical Trial Phase

Clinical Trial Phase for Dostinex
Clinical Trial Phase Trials
Phase 4 2
Phase 3 3
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Dostinex
Clinical Trial Phase Trials
Completed 15
Recruiting 4
Active, not recruiting 1
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Clinical Trial Sponsors for Dostinex

Sponsor Name

Sponsor Name for Dostinex
Sponsor Trials
Anapharm 2
Par Pharmaceutical, Inc. 2
Benha University 2
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Sponsor Type

Sponsor Type for Dostinex
Sponsor Trials
Other 23
Industry 7
NIH 2
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