UMIN-CTR Clinical Trial

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
Email	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
Email	kimura.naoko@hc-sys.jp

Sponsor
Institute	Healthcare Systems Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055284