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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019306
Receipt No. 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

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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 Obsterics 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
Email 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
Email masatokotani@yahoo.co.jp

Sponsor
Institute Asahina Shinryoujo
Institute
Department

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
Email

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
URL(English) https://upload.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


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