UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062351 |
|---|---|
| Receipt number | R000071360 |
| Scientific Title | Exploratory study of multi-omics factors associated with core body temperature in menstrual-related symptoms |
| Date of disclosure of the study information | 2026/07/27 |
| Last modified on | 2026/07/27 15:04:15 |
* 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
A study of changes in body temperature, physical and mental condition, and blood components during the menstrual cycle
Acronym
Menstrual Cycle and Core Body Temperature Study
Scientific Title
Exploratory study of multi-omics factors associated with core body temperature in menstrual-related symptoms
Scientific Title:Acronym
Menstrual Symptoms Core Temperature Multi-omics Study
Region
| Japan |
Condition
Condition
Menstrual-related symptoms
Classification by specialty
| Medicine in general | Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To longitudinally collect core body temperature, physiological measurements, symptom assessments, and blood multi-omics data from women with menstrual-related symptoms and healthy women, and to identify molecular factors associated with physiological changes during the menstrual cycle.
Basic objectives2
Others
Basic objectives -Others
Exploratory observational study to investigate the associations among core body temperature, physiological measurements, symptoms, and blood multi-omics data during the menstrual cycle.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between longitudinal core body temperature and blood multi-omics profiles during the menstrual cycle
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
| 18 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
Participants must meet all of the following criteria:
Premenopausal women aged 18 to 49 years
Japanese nationals of Asian ethnicity
Body weight of 40 kg or more
Provision of written informed consent after receiving a sufficient explanation of the study
No irregular menstrual cycles, defined as cycles of 24 days or shorter or 39 days or longer, with cycle-to-cycle variation of no more than 6 days
Either of the following:
Women diagnosed with menstrual-related symptoms
Healthy women without a diagnosis of menstrual-related symptoms
Key exclusion criteria
Participants meeting any of the following criteria will be excluded:
Clinically significant systemic diseases (e.g., hematologic, renal, pulmonary, or cardiovascular diseases)
History of major trauma, surgery, or major bleeding within the past 3 months
Pregnant, breastfeeding, or postmenopausal women
Use of a pacemaker or implantable electrical medical device
Scheduled MRI examination or air travel during the core body temperature monitoring period
Judged unsuitable for participation by the principal investigator (e.g., severe sleep disorders, excessive stress, menopausal symptoms)
Students or staff belonging to the investigators' laboratory, or students whose academic evaluation is conducted by the investigators
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shinpei |
| Middle name | |
| Last name | Kawaoka |
Organization
Tohoku University
Division name
Institute of Development, Aging and Cancer
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8568
shinpei.kawaoka.c1@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shinpei |
| Middle name | |
| Last name | Kawaoka |
Organization
Tohoku University
Division name
Institute of Development, Aging and Cancer
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8568
Homepage URL
shinpei.kawaoka.c1@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
Ethics Committee, Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
Tel
022-717-8568
shinpei.kawaoka.c1@tohoku.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
| 2026 | Year | 07 | Month | 27 | 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 | 07 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Before initiation
Management information
Registered date
| 2026 | Year | 07 | Month | 27 | Day |
Last modified on
| 2026 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071360
