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

UMIN ID: UMIN000056153

Registered date:21/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Bacterial vaginosis
• Date of first enrollment: 2024/11/22
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): For 3 days during the test period, participants will wear a vaginal discharge sheet and collect vaginal secretions using a designated swab.

Outcome(s)

• Primary Outcome: Nugent score results given by panty liner usage
• Secondary Outcome: Nugent score from physician-collected swabs

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 60years-old
• Gender: Female
• Exclude 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

Related Information

• Primary Sponsor: Kobayashi Pharmaceutical Co., Ltd.
• Secondary Sponsor: LUNA DOCTOR
• Source(s) of Monetary Support: Kobayashi Pharmaceutical Co., Ltd.