UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019306 |
|---|---|
| Receipt number | R000022327 |
| Scientific Title | Measurement of plasma kisspeptin concentrations for subjects with sexual dysfunction, amenorrhea or chorionic disease |
| Date of disclosure of the study information | 2015/10/13 |
| Last modified on | 2018/04/11 10:21:03 |
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Basic information
Public title
Measurement of plasma kisspeptin concentrations for subjects with sexual dysfunction, amenorrhea or chorionic disease
Acronym
Measurement of plasma kisspeptin concentrations in humans
Scientific Title
Measurement of plasma kisspeptin concentrations for subjects with sexual dysfunction, amenorrhea or chorionic disease
Scientific Title:Acronym
Measurement of plasma kisspeptin concentrations in humans
Region
| Japan |
Condition
Condition
sexual dysfunction, amenorrhea, chorionic disease
Classification by specialty
| Endocrinology and Metabolism | Obstetrics and Gynecology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Elucidation for physiological roles of plasma kisspeptin concentrations in subjects with sexual dysfunction, amenorrhea or chorionic disease
Basic objectives2
Others
Basic objectives -Others
Elucidation for physiological roles of plasma kisspeptin concentrations in subjects with sexual dysfunction, amenorrhea or chorionic disease
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
plasma kisspeptin concentrations
Key secondary outcomes
physiological or pathological condition of subjects
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
| 1 | weeks-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
subjects with sexual dysfunction, amenorrhea or chorionic disease who are agreed to join this study
Key exclusion criteria
Subjects 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
Department of medicine
Zip code
Address
Nyufune314-5, Okabecho, Fujieda 421-1115, Shizuoka, Japan
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
Department of medicine
Zip code
Address
Nyufune314-5, Okabecho, Fujieda 421-1115, Shizuoka, Japan
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
Other related organizations
Co-sponsor
Fujieda Municipal General Hospital
Laboratory of Clinical Biochemistry, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences
Name of secondary funder(s)
Japan society for promoting science
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
朝比奈診療所（静岡県）、藤枝市立総合病院（静岡県）、東京薬科大学病態生化学教室（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 13 | 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
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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Blood samplings will be performed before and after treatment.
Management information
Registered date
| 2015 | Year | 10 | Month | 09 | Day |
Last modified on
| 2018 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022327
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/04/11 | 研究計画.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2018/04/11 | データ仕様書.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2018/04/11 | Results.docx |
