Tokyo, Oct. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063122) titled 'Verification of the effects of wearing pantyliners with different specifications on subjective usability and physiological indices in healthy adult females' on Oct. 8.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - KOBAYASHI Pharmaceutical Co., Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
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 Size - 20
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072256
Disclaimer: Curated by HT Syndication.