UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055863 |
|---|---|
| Receipt number | R000063845 |
| Scientific Title | Assessment of the impact of menstruation-related symptoms on daily life through wearable terminals and questionnaires. |
| Date of disclosure of the study information | 2024/10/21 |
| Last modified on | 2025/04/02 10:07:23 |
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Basic information
Public title
Assessment of the impact of menstruation-related symptoms on daily life through wearable terminals and questionnaires.
Acronym
Assessment of the impact of menstruation-related symptoms on daily life through wearable terminals and questionnaires.
Scientific Title
Assessment of the impact of menstruation-related symptoms on daily life through wearable terminals and questionnaires.
Scientific Title:Acronym
Assessment of the impact of menstruation-related symptoms on daily life through wearable terminals and questionnaires.
Region
| Japan |
Condition
Condition
Adult woman
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the possibility of quantifying the impact of menstruation-related symptoms on daily life using biometric data acquired from wearable devices.
Basic objectives2
Others
Basic objectives -Others
Quantifying the impact of menstruation-related symptoms on daily life using biometric data
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Explore wearable device data in relation to MDQ scores
Key secondary outcomes
(1)Explore wearable device data associated with QOL questionnaire scores
(2)Relationship between physical condition records and MDQ scores in apps
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
| 18 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
(1)Premenopausal women between the ages of 18 and 49 at the time consent is obtained
(2)Those whose menstrual cycles can be confirmed
(3)Those who regularly record menstrual information in a health care application
(4)Own a smartphone device on which the wearable device application can be installed, and agree to the terms of use for the wearable device and application used in the study.
(5)Those who have given appropriate written consent to participate in this study.
Key exclusion criteria
(1)Who have an infectious disease or a disease under treatment that makes it difficult for them to manage their health
(2)Patients who have been taking estrogen/progestin, progestin, or GnRH analogs within 2 months of the start of the study
(3)Who have not had a menstrual period for more than 3 months, are pregnant, or are lactating
(4)Who are using devices or medications that can affect the heartbeat, such as pacemakers or drugs
(5)Those with eczema, allergies, asthma, sensitive skin, or other conditions that could easily cause dermatitis due to wearable devices
(6)Any other person who is deemed by the principal investigator to be inappropriate to participate in this study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kazumichi |
| Middle name | |
| Last name | Minato |
Organization
TechDoctor, Inc.
Division name
Board Member
Zip code
104-0031
Address
2-2-1 Kyobashi, Chuo-ku, Tokyo
TEL
03-5476-8889
minato@technology-doctor.com
Public contact
Name of contact person
| 1st name | Kosaku |
| Middle name | |
| Last name | Kawada |
Organization
TechDoctor, Inc.
Division name
Business Development
Zip code
104-0031
Address
2-2-1 Kyobashi, Chuo-ku, Tokyo
TEL
03-5476-8889
Homepage URL
kawada@technology-doctor.com
Sponsor or person
Institute
TechDoctor, Inc.
Institute
Department
Personal name
Funding Source
Organization
ASKA Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
ASKA Pharmaceutical Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yoyogi Mental Clinic Research Ethics Committee
Address
4-26-11 Sendagaya, Shibuya-ku, Tokyo
Tel
03-6804-2227
cns_jimu(a)triad-j.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 21 | 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
| 2024 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2025 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2025 | Year | 09 | Month | 30 | Day |
Other
Other related information
Quantifying the impact of menstruation-related symptoms on daily life using biometric data
Management information
Registered date
| 2024 | Year | 10 | Month | 17 | Day |
Last modified on
| 2025 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063845
