UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056153 |
|---|---|
| Receipt number | R000063741 |
| Scientific Title | Verification of the equivalence of Nugent scores for vaginal swab samples and vaginal discharge sheet samples for vaginal secretions |
| Date of disclosure of the study information | 2024/11/21 |
| Last modified on | 2024/11/19 10:52:53 |
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Basic information
Public title
Verification of the equivalence of Nugent scores for vaginal swab samples and vaginal discharge sheet samples for vaginal secretions
Acronym
Verification of the equivalence of Nugent scores for vaginal swab samples and vaginal discharge sheet samples for vaginal secretions
Scientific Title
Verification of the equivalence of Nugent scores for vaginal swab samples and vaginal discharge sheet samples for vaginal secretions
Scientific Title:Acronym
Verification of the equivalence of Nugent scores for vaginal swab samples and vaginal discharge sheet samples for vaginal secretions
Region
| Japan |
Condition
Condition
Bacterial vaginosis
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Understanding the discrepancy between Nugent score results given by panty liner usage, clinical results by physicians, and Nugent score from physician-collected swabs to identify the challenges in establishing mail-in testing technology using panty liners.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Nugent score results given by panty liner usage
Key secondary outcomes
Nugent score from physician-collected swabs
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
For 3 days during the test period, participants will wear a vaginal discharge sheet and collect vaginal secretions using a designated swab.
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
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
- Biological females
- Individuals aged between 20 to 60 at the time of consent acquisition
- Individuals able to comply with all regulations on the day of the test
- Individuals able to post used sanitary pads on the day of use during the test period
- Individuals able to post used swabs on the day of use during the test period
- Individuals who can submit the microbial collection adhesive seal from the skin surface during the test period
- Individuals who can visit the designated medical institution at the specified time during the test period
- Individuals who, after having received an explanation concerning this test, have given their written consent, fully understanding the contents thereof.
Key exclusion criteria
Those who cannot cooperate with the test during the test period
Those who have their menstrual period during the test period (2nd screening to the day of treatment)
Those who are pregnant, breastfeeding, intending to get pregnant during the test period, or who may possibly be pregnant
Those who have reached menopause
Those with symptoms of urinary incontinence
Those with bleeding from the vagina or vulva
Those who can't stop using vulva products, cosmetics, lubricants, bidets, washlets, vaginal washers, etc. during the test period
Those who are expected to take time to get mail or see a designated medical institution, such as those living on remote islands
Those who can't put on and take off the product on their own (e.g., people with dementia)
Those who have used the test samples and felt any abnormalities
Those who have weak skin on the vulva (e.g., easily chafed or irritated)
Any other individuals that the investigator deems as inappropriate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | ryuichi |
| Middle name | |
| Last name | kiyoe |
Organization
Kobayashi Pharmaceutical Co., Ltd.
Division name
Wellness care RD Group Wellness care Products Department Household Products Headquarters
Zip code
567-0057
Address
1-30-3,Toyokawa,Ibaraki-city,Osaka
TEL
08041982183
r.kiyoe@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | makoto |
| Middle name | |
| Last name | shirato |
Organization
Kobayashi Pharmaceutical Co., Ltd.
Division name
Wellness care RD Group Wellness care Products Department Household Products Headquarters
Zip code
567-0057
Address
1-30-3,Toyokawa,Ibaraki-city,Osaka
TEL
08041982183
Homepage URL
m.shirato@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
LUNA DOCTOR
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1590
jimukyoku@mail.souken-r.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
帝国衛生検査所（神奈川県）、小林製薬株式会社中央研究所（大阪府）、昭和メディカルサイエンス（東京都）、福山臨床検査センター（広島県）、大阪がん循環器病予防センター（大阪府）、愛知医科大学病院（愛知県）、Myskin株式会社（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 21 | 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
| 2024 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 14 | Day |
Last modified on
| 2024 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063741
