UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054413 |
|---|---|
| Receipt number | R000062132 |
| Scientific Title | An Observational Study on the Effect of Menstruation on Women's Quality of Life |
| Date of disclosure of the study information | 2024/05/16 |
| Last modified on | 2025/11/06 11:10:09 |
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Basic information
Public title
An Observational Study on the Effect of Menstruation on Women's Quality of Life
Acronym
An Observational Study on the Effect of Menstruation on Women's Quality of Life
Scientific Title
An Observational Study on the Effect of Menstruation on Women's Quality of Life
Scientific Title:Acronym
An Observational Study on the Effect of Menstruation on Women's Quality of Life
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to create an evaluation index that can encourage women to seek medical attention and cope with menstrual pain according to its severity.
Basic objectives2
Others
Basic objectives -Others
This study aims to create an evaluation index that can encourage women to seek medical attention and cope with menstrual pain according to its severity.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-administered questionnaire
Key secondary outcomes
Transvaginal ultrasound
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
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Subjects who are able to give their free and voluntary consent to participate in this study.
2.Subjects with menstrual pain
Key exclusion criteria
1.Subject who is pregnant, may be pregnant, or are breastfeeding at the time of transvaginal ultrasound
2.Subjects who do not have regular menstrual periods
3.Subjects who have been taking the pill for more than 1 year
4.Subjects who always feel lower abdominal pain for reasons other than menstruation, even outside of menstrual periods.
5.Subjects who always feel back pain for reasons other than menstruation, even outside of menstrual periods
6.Subjects judged as unsuitable for the study by the investigational doctor for other reasons.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | HONMA |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
hisc-acad.res@s.do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | HONMA |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
Homepage URL
hisc-acad.res@s.do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
ROHTO Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
ROHTO Pharmaceutical Co., Ltd.
Ritsuo Honda
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Hokkaido Information University
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel
011-385-4411
soumu@do-johodai.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
ライズ円山クリニック
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 16 | 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
| 2023 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to create an evaluation index that can encourage women to seek medical attention and cope with menstrual pain according to its severity.
Management information
Registered date
| 2024 | Year | 05 | Month | 16 | Day |
Last modified on
| 2025 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062132
