UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060995 |
|---|---|
| Receipt number | R000069796 |
| Scientific Title | A feasibility study on the development of digital biomarkers for the quantitative evaluation of menstrual pain using wearable devices |
| Date of disclosure of the study information | 2026/03/20 |
| Last modified on | 2026/03/19 17:20:48 |
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Basic information
Public title
A study to find a method to objectively measure the severity of menstrual pain using a smartwatch
Acronym
A study to find a method to objectively measure the severity of menstrual pain using a smartwatch
Scientific Title
A feasibility study on the development of digital biomarkers for the quantitative evaluation of menstrual pain using wearable devices
Scientific Title:Acronym
A feasibility study on the development of digital biomarkers for the quantitative evaluation of menstrual pain using wearable devices
Region
| Japan |
Condition
Condition
Adult women
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the possibility of developing a digital biomarker for estimating the intensity of menstrual pain in Japanese women
Basic objectives2
Others
Basic objectives -Others
Algorithm Development and Verification
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Estimation accuracy of dysmenorrhea score based on biometric data
Key secondary outcomes
Exploratory investigations using biometric data, including the following items, will be conducted:
(1) Estimation accuracy of pain VAS
(2) Estimation accuracy of MDQ score
(3) Estimation accuracy of EQ-5D-5L score
(4) Prediction accuracy of dysmenorrhea score from the next menstrual cycle onwards
(5) Relationship between physical condition records in the app and each questionnaire score
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Premenopausal women aged 18 to 45 years at the time of informed consent
(2) Those who can confirm regular menstrual cycles (24-38 day cycle)
(3) Those who routinely record menstrual information in a healthcare application
(4) Those who own a smartphone capable of installing the wearable device application and can agree to the terms of use regarding the wearable device and application used in the study
(5) Those who have provided appropriate written informed consent to participate in this study
Key exclusion criteria
(1) Those who have taken oral contraceptives, low-dose estrogen-progestin combinations, progestin preparations, or GnRH analog preparations within 2 months prior to the start of the study
(2) Those who have had no menstruation for the past 3 months or more, are pregnant, breastfeeding, or actively desiring to become pregnant during the study period
(3) Those using devices or medications that may affect heart rate, such as pacemakers or certain drugs
(4) Those with highly irregular sleep rhythms, such as shift workers
(5) Those with chronic pain disorders (e.g., chronic migraine or fibromyalgia), poorly controlled severe psychiatric disorders, infectious diseases, or diseases under treatment, making health management difficult
(6) Those with symptoms such as eczema, allergies, asthma, or sensitive skin that are prone to dermatitis caused by wearable devices
(7) Others judged inappropriate to participate in this study by the principal investigator
Target sample size
360
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
| 2026 | Year | 03 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 08 | Month | 30 | Day |
Other
Other related information
To investigate the possibility of developing a digital biomarker for estimating the intensity of menstrual pain in Japanese women
Management information
Registered date
| 2026 | Year | 03 | Month | 19 | Day |
Last modified on
| 2026 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069796
