- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00436111
Characterization of Macroprolactinemia
The purpose of this study is to clarify the nature of macroprolactin which has recently been highlighted because of the high prevalence and a diagnostic pitfall of hyperprolactinemia. The results of this study are beneficial for the patients to whom unnecessary medications and unnecessary radiological examinations have been performed.
We used the remained serum samples taken for routine prolactin determination during the past several years. Since the blood was basically taken to examine the causes of hyperprolactinemia and only remained serum samples were used for this study, the Ethics Committee of Kobe City General Hospital judged that it was not required to obtain approval number.
Study Overview
Status
Conditions
Study Type
Contacts and Locations
Study Locations
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Osaka, Japan, 570-8506
- Kansai Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of hyperprolactinemia
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Naoki Hattori, M.D., Ph.D., Department of Pharmacology, Kansai Medical University
Publications and helpful links
General Publications
- Hattori N, Nakayama Y, Kitagawa K, Ishihara T, Saiki Y, Inagaki C. Anti-prolactin (PRL) autoantibody-binding sites (epitopes) on PRL molecule in macroprolactinemia. J Endocrinol. 2006 Aug;190(2):287-93. doi: 10.1677/joe.1.06871.
- Hattori N, Ikekubo K, Nakaya Y, Kitagawa K, Inagaki C. Immunoglobulin G subclasses and prolactin (PRL) isoforms in macroprolactinemia due to anti-PRL autoantibodies. J Clin Endocrinol Metab. 2005 May;90(5):3036-44. doi: 10.1210/jc.2004-1600. Epub 2005 Feb 1.
- Hattori N, Inagaki C. Anti-prolactin (PRL) autoantibodies cause asymptomatic hyperprolactinemia: bioassay and clearance studies of PRL-immunoglobulin G complex. J Clin Endocrinol Metab. 1997 Sep;82(9):3107-10. doi: 10.1210/jcem.82.9.4250.
- Hattori N, Ishihara T, Ikekubo K, Moridera K, Hino M, Kurahachi H. Autoantibody to human prolactin in patients with idiopathic hyperprolactinemia. J Clin Endocrinol Metab. 1992 Nov;75(5):1226-9. doi: 10.1210/jcem.75.5.1430082.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KK-2007-1
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