UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048769 |
|---|---|
| Receipt number | R000055560 |
| Scientific Title | Core body temperature, menstrual cycle, and circadian rhythm |
| Date of disclosure of the study information | 2022/08/26 |
| Last modified on | 2023/02/27 12:19:42 |
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Basic information
Public title
Core body temperature, menstrual cycle, and circadian rhythm
Acronym
Core body temperature, menstrual cycle, and circadian rhythm
Scientific Title
Core body temperature, menstrual cycle, and circadian rhythm
Scientific Title:Acronym
Core body temperature, menstrual cycle, and circadian rhythm
Region
| Japan |
Condition
Condition
menstrual disorders and circadian rhythm disorders
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary aim is to test the feasibility of a study device to investigate core body temperature measured at the navel, menstrual periods, and circadian rhythm. The second aim is to examine whether the body temperature changes measured at the navel indicate circadian rhythm. The third aim is to identify factors that affect menstrual periods, sleep, or circadian rhythm.
Basic objectives2
Others
Basic objectives -Others
The feasibility study of a study device that can be used for investigating core body temperature measured at the navel, menstrual periods, and circadian rhythm.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The correlation between the body temperature changes measured at the navel and the melatonin curve projected by melatonin excretion.
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
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
1) Women who are in their 20s and 30s and have periods periodically. 2) Those who consent to join a study of their own will after receiving the right and thorough information about the study.
Key exclusion criteria
1) Those who have chronic diseases such as hypertension, diabetes, or cardiac diseases. 2) Those who have a mental illness such as anorexia. 3) Those who consume oral contraceptives. 4) Those who consume sleeping pills. 5) Those who have a gynecological disease and have medical treatment. 6) Those who have a navel piercing. 7) Those who are or can be pregnant, or hope to get pregnant within three months after the consent to join the study. 8) Those who a principal investigator of this study thinks is inappropriate as a subject.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Sayuri |
| Middle name | |
| Last name | Tanaka |
Organization
MEDITA inc.
Division name
CEO
Zip code
103-0024
Address
7-12 Nihon-bashi Kohikicho, Green Park Nihonbashi Mitsukoshimae 1101, Chuo-ku Tokyo, Japan
TEL
050-3184-0927
tanaka@medita.inc
Public contact
Name of contact person
| 1st name | Sayuri |
| Middle name | |
| Last name | Tanaka |
Organization
MEDITA inc.
Division name
N/A
Zip code
103-0024
Address
7-12 Nihon-bashi Kohikicho, Green Park Nihonbashi Mitsukoshimae 1101, Chuo-ku Tokyo, Japan
TEL
050-3184-0927
Homepage URL
clinical_trial@medita.inc
Sponsor or person
Institute
MEDITA inc.
Institute
Department
Personal name
Funding Source
Organization
New Energy and Industrial Technology Development Organization
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Public Health Research Center
Address
1-1-7, Nishiwaseda, Shinjuku, Tokyo, Japan
Tel
03-5287-5070
rinri@phrf.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
| 2022 | Year | 08 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This observational study asks subjects to stay at a hotel before and after their periods for measuring their body temperature at the navel, exercise and diet habits, sleep, and other vital data for approximately eight consecutive days.
Management information
Registered date
| 2022 | Year | 08 | Month | 26 | Day |
Last modified on
| 2023 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055560
