HyperprolactinemiaNCT00436111
Characterization of Macroprolactinemia
An observational study of Hyperprolactinemia, run by Kansai Medical University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyperprolactinemia
- How many people
- Not given
- Where
- 1 siteJapan
- Study dates
- Jan 2005to Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of hyperprolactinemia
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hyperprolactinemia
- Keywords
- hyperprolactinemia, autoantibody
- Medical subject headings
- Hyperprolactinemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2007 (estimated)
- Study startJan 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HyperprolactinemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Kansai Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Naoki Hattori, M.D., Ph.D., Study chair, Department of Pharmacology, Kansai Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436111
- Sponsor's protocol ID
- KK-2007-1
- Status last verified
- Feb 2007
- First submitted
- 15 Feb 2007
- Last updated
- 16 Feb 2007
- Results posted
- No
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.
PubMed 16899562Hattori 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.
PubMed 15687336Hattori 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.
PubMed 9284753Hattori 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.
PubMed 1430082
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Macroprolactinemia
- ClinicalTrials.gov ID
- NCT00436111
- Acronym / sponsor ID
- KK-2007-1
- Conditions
- Hyperprolactinemia
- Keywords
- hyperprolactinemia, autoantibody
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Kansai Medical UniversityUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Dec 2006
- First posted
- 16 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of hyperprolactinemia
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2007.
- Results publication: PubMed 16899562Hattori 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.
- Results publication: PubMed 15687336Hattori 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.
- Results publication: PubMed 9284753Hattori 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.
- Results publication: PubMed 1430082Hattori 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naoki Hattori, M.D., Ph.D. study chair
Department of Pharmacology, Kansai Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperprolactinemia, run by Kansai Medical University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00436111, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2007.