UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052505 |
|---|---|
| Receipt number | R000059920 |
| Scientific Title | Survey on vascular function in premenopausal women |
| Date of disclosure of the study information | 2025/02/28 |
| Last modified on | 2024/08/26 13:51:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Survey on vascular function in premenopausal women
Acronym
Survey on vascular function in premenopausal women
Scientific Title
Survey on vascular function in premenopausal women
Scientific Title:Acronym
Survey on vascular function in premenopausal women
Region
| Japan |
Condition
Condition
healthy women
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between vascular function and physical/mental symptoms in premenopausal women.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vascular function, physical/mental symptoms
Key secondary outcomes
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
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Individuals who have provided written consent for participation in the study.
2) Japanese premenopausal women between 20 and under 40 years of age at the time of consent
3) Individuals with a BMI less than 25
4) Individuals who can come to the clinic on the designated examination date and undergo the examination.
Key exclusion criteria
1) Individuals with soy allergy symptoms
2) Individuals with metal allergy symptoms
3) Individuals who wearing a pacemaker or other medical electrical device
4) Individuals who are pregnant, lactating, or wish to become pregnant during the study period
5) Individuals who have diastolic blood pressure lower than 40 mmHg or systolic blood pressure of higher than 180 mmHg
6) Individuals with any chronic disease and receiving drug treatment.
7) Individuals who have had uterus or bilateral ovaries removed
8) Individuals participating in other clinical trials
9) Individuals whoes test results are positive for syphilis serology, HIV antigen antibody, HVC antibody, or HBs antigen.
10) Individuals who are judged by the principal investigator/ study director to be inappropriate to participate in the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakajima |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5, Higashiueno, Taito-ku, Tokyo
TEL
03-6240-1162
info@ueno-asagao.clinic
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings CO., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5, Higashiueno, Taito-ku, Tokyo
TEL
03-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings CO., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5, Higashiueno, Taito-ku, Tokyo
Tel
03-6240-1162
jimukyoku@tes-h.co.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
うえのあさがおクリニック （東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 28 | 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
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
| 2023 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 10 | Month | 16 | Day |
Last modified on
| 2024 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059920
