Skip to content

Verification of the equivalence of Nugent scores for vaginal swab samples and vaginal discharge sheet samples for vaginal secretions

Verification of the equivalence of Nugent scores for vaginal swab samples and vaginal discharge sheet samples for vaginal secretions - Verification of the equivalence of Nugent scores for vaginal swab samples and vaginal discharge sheet samples for vaginal secretions

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056153
Enrollment
50
Registered
2024-11-21
Start date
2024-11-22
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial vaginosis

Interventions

For 3 days during the test period, participants will wear a vaginal discharge sheet and collect vaginal secretions using a designated swab.

Sponsors

Kobayashi Pharmaceutical Co., Ltd.
Lead Sponsor
LUNA DOCTOR
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Nugent score results given by panty liner usage

Secondary

MeasureTime frame
Nugent score from physician-collected swabs

Countries

Japan

Contacts

Public Contactmakoto shirato

Kobayashi Pharmaceutical Co., Ltd. Wellness care RD Group Wellness care Products Department Household Products Headquarters

m.shirato@kobayashi.co.jp08041982183

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026