UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063122 |
|---|---|
| Receipt number | R000072256 |
| Scientific Title | Verification of the effects of wearing pantyliners with different specifications on subjective usability and physiological indices in healthy adult females |
| Date of disclosure of the study information | 2026/10/08 |
| Last modified on | 2026/09/30 17:29:17 |
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Basic information
Public title
Verification of the effects of wearing pantyliners with different specifications on subjective usability and physiological indices in healthy adult females
Acronym
Verification of the effects of wearing pantyliners with different specifications on subjective usability and physiological indices in healthy adult females
Scientific Title
Verification of the effects of wearing pantyliners with different specifications on subjective usability and physiological indices in healthy adult females
Scientific Title:Acronym
Verification of the effects of wearing pantyliners with different specifications on subjective usability and physiological indices in healthy adult females
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether differences occur in subjective comfort and physiological indices during wearing and exercising with panty liners of different specifications in healthy adult females.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective questionnaire on usability
Key secondary outcomes
Changes in cerebral blood flow due to use of test products
Changes in heart rate due to use of test products
Changes in salivary stress markers due to use of test products
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Put on a pantyliner (A) and perform a walking test.
Interventions/Control_2
Put on a pantyliner (B) and perform a walking test.
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
| Not applicable |
Gender
Female
Key inclusion criteria
1)Healthy female university students aged 18 and older
2)Non-smokers
3)Individuals who are not receiving outpatient treatment or medical care for hypertension, diabetes, psychiatric disorders, sleep disorders, or serious diseases
4)Individuals who gave written informed consent voluntarily after receiving explanation and fully understanding the study upon participation
Key exclusion criteria
1)Heavy alcohol drinkers (average pure alcohol intake of 60 g or more per day)
2)Individuals who have received hormone replacement therapy within the past year or are taking oral contraceptives
3)Individuals with extremely irregular eating habits, shift workers, night-shift workers, or those with irregular life rhythms
4)Individuals who routinely consume medicines or health foods aimed at stress reduction or blood flow improvement (guideline: 3 times or more per week) and cannot stop after consenting
5)Individuals with skin troubles in the delicate zone
6)Individuals who may show an allergic reaction to the test product
7)Individuals with a history or current medical condition causing abnormal vaginal discharge
8)Individuals who are pregnant, planning to become pregnant, or lactating
9)Individuals with irregular menstruation (guideline: average menstrual cycle of 24 days or less, or 39 days or more)
10)Individuals who plan to significantly alter their lifestyle habits during the study period, such as long-term travel
11)Individuals expected to undergo major changes or stressful situations in home or school environments
12)Individuals currently participating in other clinical trials, within 4 weeks after trial completion, or planning to participate in other clinical trials after consenting to this study
13)Other individuals deemed inappropriate as study subjects by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Iwahana |
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Division name
Life Science Research Department R&D Headquarters
Zip code
562-0029
Address
4-1-66, Saito aokita. Minoh, Osaka, Japan
TEL
(06)-6231-1144
y.iwahana@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Yamashita |
| Middle name | |
| Last name | Yurina |
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Division name
Life Science Research Department R&D Headquarters
Zip code
562-0029
Address
4-1-66, Saito aokita. Minoh, Osaka, Japan
TEL
(06)-6231-1144
Homepage URL
yu.yamashita@kobayashi.co.jp
Sponsor or person
Institute
KOBAYASHI Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Otemon Gakuin Educational Foundation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo
Tel
03-5408-1599
shiba_palace@s-palace-clinic.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
追手門学院大学 安威キャンパス(大阪府)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 08 | 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 | 09 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 30 | Day |
Last modified on
| 2026 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072256
