UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057436 |
|---|---|
| Receipt number | R000065623 |
| Scientific Title | A Comparative Study of Anterior and Posterior Scales in a Questionnaire for the Assessment of Premenstrual Syndrome (PMS) |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2025/10/03 14:51:23 |
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Basic information
Public title
A Comparative Study of Anterior and Posterior Scales in a Questionnaire for the Assessment of Premenstrual Syndrome (PMS)
Acronym
A Comparative Study of Anterior and Posterior Scales in a Questionnaire for the Assessment of Premenstrual Syndrome (PMS)
Scientific Title
A Comparative Study of Anterior and Posterior Scales in a Questionnaire for the Assessment of Premenstrual Syndrome (PMS)
Scientific Title:Acronym
A Comparative Study of Anterior and Posterior Scales in a Questionnaire for the Assessment of Premenstrual Syndrome (PMS)
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identify differences in the way symptoms are expressed when assessed using an anteroposterior or retrospective scale.
Basic objectives2
Others
Basic objectives -Others
Exploratory study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of anterior and posterior scale questionnaires
Key secondary outcomes
(1)PMTS-VAS
(2)PMTS-SR
(3)DRSP
(4)Modified MDQ
(5)POMS-2 shortened version for adults
(6)Comparison of Likert Scale and Visual Analog Scale (VAS)
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
(1)Women between 20 and 45 years of age at the time of obtaining consent to participate in the study
(2)Subjects with subjective symptoms of PMS
(3)Menstrual cycle of 25 to 38 days
(4)Those whose most recent menstrual period was between 13 and 20 days at the time of the first survey distribution.
(5)Those who have been fully informed of the purpose and content of this study, have the capacity to consent, and who volunteer of their own free will with full understanding, and whose consent can be obtained through electromagnetic informed consent.
Key exclusion criteria
(1)Menopausal women
(2)Currently using medications that affect ovulation (oral contraceptives (birth control pills), ovulation suppressants, hormonal agents)
(3)Who are currently receiving treatment or medication by a physician for a gynecological disorder (menopause, hormone replacement therapy, uterine, ovarian, or mammary gland disease, etc.)
(4)Who are currently receiving treatment or medication by a physician for a mental disorder (depression, anxiety, insomnia, panic disorder, etc.)
(5)Women who are currently pregnant.
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ohde |
Organization
Macromill, Inc.
Division name
Unit Manager, Clinical Research Business Unit, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower. 11F, 2-16-1 Konan, Minato-ku, Tokyo, JAPAN
TEL
070-3155-1692
ohde@macromill.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Mori |
Organization
Macromill, Inc.
Division name
Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower. 11F, 2-16-1 Konan, Minato-ku, Tokyo, JAPAN
TEL
080-5186-5400
Homepage URL
yuk_mori@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
Macromill, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
User Life Sciences Ethics Review Committee, Inc.
Address
372-3 Nibo, Iizuka-shi, Fukuoka
Tel
0948-82-3123
userlifescience.bm@gmail.com
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 | 03 | Month | 31 | 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
| 2025 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 17 | 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 | 03 | Month | 28 | Day |
Last modified on
| 2025 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065623
