UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058883 |
|---|---|
| Receipt number | R000067280 |
| Scientific Title | Verifying Femtech's Effectiveness Focusing on Online Consultations for Menopausal Symptoms in Working Women |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/08/25 10:34:49 |
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Basic information
Public title
Evaluation Study on the Effectiveness of Online Consultation Tools for Menopausal Symptoms in Working Women
Acronym
Effectiveness of Online Consultation Tools for Menopausal Symptoms in Working Women
Scientific Title
Verifying Femtech's Effectiveness Focusing on Online Consultations for Menopausal Symptoms in Working Women
Scientific Title:Acronym
Effectiveness of Online Consultation Tools for Menopausal Symptoms in Working Women
Region
| Japan |
Condition
Condition
menopausal disorder
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify whether an online consultation tool, primarily based on LINE chat consultations, is effective in alleviating menopausal symptoms and improving work productivity for working women who suspect they have menopausal symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
*Mental and Physical State Related to Menopausal Symptoms: Simplified Menopausal Index (SMI)
The assessment will be conducted at three timepoints: before the start of the intervention, three months after the start, and six months after the start.
Key secondary outcomes
*Current medical treatment status including the information on existing conditions related to menopausal symptoms, gynecological diseases, and mental health disorders.
*Self-assessment of knowledge on menopausal symptoms.
*Lifestyle habits: physical activity levels, sedentary time, exercise preference, sleep duration, smoking and drinking habits, dietary intake (meals and snacks), height, and weight.
*Work Performance: WHO-HPQ (WHO Health and Productivity Questionnaire) and SPQ (Single-Item Productivity Question)
*Occupational stress and social support: Brief Job Stress Questionnaire
* Well-being: the relevant four items from CES-D (Center for Epidemiologic Studies Depression Scale)
*Depressive symptoms: PHQ-8 (Patient Health Questionnaire-8)
Each assessment will be conducted at three timepoints: before the start of the intervention, three months after the start, and six months after the start.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: Receive free access to an online learning tool and a chat consultation service provided via LINE by TRULY Inc.. This service is operated under the supervision of medical professionals. Through the LINE platform, participants can directly access educational content and chat consultations on women's health issues, primarily menopausal symptoms. Responses to these consultations will be provided by doctors, nurses, and public health nurses who have contracts with TRULY Inc., ensuring that all advice is based on reliable medical knowledge.
Interventions/Control_2
Control group: no intervention will be provided during the study period. After the study ends, participants in the control group will be given free access to the same online learning tool and chat consultation service via LINE, provided by TRULY Inc. for six months, as offered to the intervention group.
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
| 45 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Must possess a LINE account and use it regularly.
2) Female, aged between 45 and 55 years old (inclusive).
3) Must be currently employed (regardless of employment type).
4) Must have experienced irregular menstruation or amenorrhea (absence of menstruation) for at least 12 consecutive months within the past 12 months.
5) Must be aware of at least mild menopausal symptoms (a score of 26 or higher on the Simplified Menopausal Index [SMI]).
6) Must be able to use the internet via a smartphone, tablet, or computer.
7) Must be able to understand explanations provided in Japanese and be judged capable of giving informed consent online voluntarily.
Key exclusion criteria
1) Currently be receiving treatment for menopausal symptoms (e.g., hormone replacement therapy, herbal medicine).
2) Currently be receiving treatment for gynecological diseases.
3) Currently be receiving treatment for mental health disorders.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Mayumi |
| Middle name | |
| Last name | Mizumura |
Organization
Ochanomizu University
Division name
Faculty of Core Research, Humanities Division
Zip code
112-8610
Address
2-1-1 Otsuka, Bunkyo, Tokyo, Japan
TEL
03-5978-5264
mizumura.mayumi@ocha.ac.jp
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Mizumura |
Organization
Ochanomizu University
Division name
Faculty of Core Research, Humanities Division
Zip code
112-8610
Address
2-1-1 Otsuka, Bunkyo, Tokyo, Japan
TEL
03-5978-5264
Homepage URL
mizumura.mayumi@ocha.ac.jp
Sponsor or person
Institute
Ochanomizu University
Institute
Department
Personal name
Funding Source
Organization
Research Institute of Economy, Trade and Industry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ochanomizu University
Address
2-1-1 Otsuka, Bunkyo, Tokyo, Japan
Tel
03-5978-5264
mizumura.mayumi@ocha.ac.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
| 2025 | Year | 09 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 25 | Day |
Last modified on
| 2025 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067280
