UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048514 |
|---|---|
| Receipt number | R000055284 |
| Scientific Title | Verification of correlation and temperature stability of female hormones in blood and urine |
| Date of disclosure of the study information | 2022/07/29 |
| Last modified on | 2022/11/14 09:08:22 |
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Basic information
Public title
Verification of correlation and temperature stability of female hormones in blood and urine
Acronym
Verification of correlation and temperature stability of female hormones in blood and urine
Scientific Title
Verification of correlation and temperature stability of female hormones in blood and urine
Scientific Title:Acronym
Verification of correlation and temperature stability of female hormones in blood and urine
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validate the correlation and temperature stability of AMH and E2 in blood and urine in women aged between 20 and 49 years.
Basic objectives2
Others
Basic objectives -Others
Correlation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Correlation between the measurement values in dried blood spot by finger prick and urine of AMH and E2
2.Temperature stability of AMH and E2 in urine (rate of change at 0, 4 and 7 days at 25 and 37 degrees)
Key secondary outcomes
1. Association between subjects' backgrounds and measurement values of AMH and E2 in biological samples (dried blood spot and urine)
2.Verification of measurement for female hormones other than AMH or E2 (LH, FSH, prolactin and testosterone) in urine
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
Female
Key inclusion criteria
1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Healthy Japanese women who are 20 years old or more and under 50 years old
Key exclusion criteria
1.Persons who have chronic illness, receiving medication, have a serious disease history
2.Persons who regularly use medicines such as the pill or foods with health claims (foods for specified health use, foods with functional claims and foods with nutritional claims) etc., that may affect results
3.Persons who are menopausal
4.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
5.Persons who were judged as inappropriate for study participants by the general doctor or the principal investigator
6.Persons who take antithrombotic or antiplatelet agents
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Kimura |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development Department
Zip code
466-0058
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, Japan
TEL
052-734-8885
kimura.naoko@hc-sys.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Kimura |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development Department
Zip code
466-0058
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, Japan
TEL
052-734-8885
Homepage URL
kimura.naoko@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ROHTO Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel
052-734-8885
soumu@hc-sys.jp
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
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
| 2022 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Validate the correlation and temperature stability of AMH and E2 in blood and urine
Management information
Registered date
| 2022 | Year | 07 | Month | 29 | Day |
Last modified on
| 2022 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055284
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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