UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012579 |
|---|---|
| Receipt number | R000014714 |
| Scientific Title | Plasma kisspeptin levels in patients with hypogonadism or trophoblastic diseases |
| Date of disclosure of the study information | 2013/12/14 |
| Last modified on | 2015/03/25 22:39:45 |
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Basic information
Public title
Plasma kisspeptin levels in patients with hypogonadism or trophoblastic diseases
Acronym
Plasma kisspeptin levels in patients with hypogonadism or trophoblastic diseases
Scientific Title
Plasma kisspeptin levels in patients with hypogonadism or trophoblastic diseases
Scientific Title:Acronym
Plasma kisspeptin levels in patients with hypogonadism or trophoblastic diseases
Region
| Japan |
Condition
Condition
hypogonadism, trophoblastic diseases
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand the clinical roles of kisspeptin, we measure plasma kisspeptin levels in patients with hypogonadism or trophoblastic diseases
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
values of plasma kisspeptin concentrations
Key secondary outcomes
clinical implications in diseases
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with hypogonadism or trophoblastic diseases.
males or females with secondary sexual characters as normal controls.
Key exclusion criteria
patients who denied to join this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato KOTANI |
Organization
Asahina Shinryoujo
Division name
division of medicine
Zip code
Address
Nyufuen314-5, Okabecho, Fujieda, Shizuoka 421-1115
TEL
054-668-0272
masatokotani@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato KOTANI |
Organization
Asahina Shinryoujo
Division name
division of medicine
Zip code
Address
Nyufuen314-5, Okabecho, Fujieda, Shizuoka 421-1115
TEL
054-668-0272
Homepage URL
masatokotani@yahoo.co.jp
Sponsor or person
Institute
Asahina Shinryoujo
Institute
Department
Personal name
Funding Source
Organization
Asahina Shinryoujo
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Fujieda Municipal General Hospital
Department of Clinical Biochemistry, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
823
Org. issuing International ID_1
Fujieda Municipal General Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
藤枝市立総合病院(Fujieda Municipal general Hospital)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The relationship between circulating kisspeptin and sexual hormones levels in healthy females.
Katagiri F, Kotani M, Hirai T, Kagawa J.
Biochem Biophys Res Commun. 2015 Mar 13;458(3):663-6.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2013 | Year | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
We try to find and observe if there is a patient in the hospital.
Management information
Registered date
| 2013 | Year | 12 | Month | 14 | Day |
Last modified on
| 2015 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014714
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
