NCT00436111

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2007

Completed
Last Updated

February 16, 2007

Status Verified

February 1, 2007

First QC Date

February 15, 2007

Last Update Submit

February 15, 2007

Conditions

Hyperprolactinemia

Keywords

hyperprolactinemiaautoantibody

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of hyperprolactinemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kansai Medical University

Osaka, Osaka, 570-8506, Japan

Location

Related Publications (4)

  • 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.

    PMID: 16899562RESULT

  • 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.

    PMID: 15687336RESULT

  • 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.

    PMID: 9284753RESULT

  • 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.

    PMID: 1430082RESULT

MeSH Terms

Conditions

Hyperprolactinemia

Condition Hierarchy (Ancestors)

HyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Naoki Hattori, M.D., Ph.D.

    Department of Pharmacology, Kansai Medical University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2007

First Posted

February 16, 2007

Study Start

January 1, 2005

Study Completion

December 1, 2006

Last Updated

February 16, 2007

Record last verified: 2007-02

Locations

JP(1)