This study is a clinical trial evaluating a new formulation in healthy women. The purpose of the study is to assess the product's safety and tolerability and to evaluate how the body processes it across different dose levels.

The study treatment is a small capsule that you insert into the vagina once a day, usually before going to bed, except for the first two days when you insert whilst atending the clinic visit. It's placed by hand, and no special applicator is needed. While using the study treatment, participants are asked not to use other vaginal products or have sex.

Vaginal health issues, including imbalances in bacteria, affect a huge number of women at some point in their lives and can lead to discomfort, infections, and frequent symptoms that interfere with everyday life. The findings will help researchers determine how to use and further study this formulation.

Current treatments often rely on antibiotics, which don't always work long-term and can sometimes lead to symptoms coming back.

You may be able to participate if:

• You're aged 18-40
• You've a healthy female non-menopausal
• You're not pregnant
• You have regular menstrual cycles or suppressed menses
• You're on a highly effective contraception

This trial will be conducted at our Morayfield clinic in Moreton Bay.

Eligible participants will be paid up to $2,500 for their time in the trial.

This trial has been reviewed and approved by an independent Human Research Ethics Committee.

What's involved?

This study runs for about 2 weeks, including a screening visit, 7 days of study product use, and 7 days of follow-up. Participants will attend up to 6 in-person clinic visits, all conducted at the study site, and will complete some study activities at home.

If you’re eligible, you’ll be randomly assigned to receive either the investigational product or a placebo. A placebo is a medication with no active ingredients or a procedure without any medical benefit. It looks like the real thing, but it is not.

Throughout the study, your health will be closely monitored by the research team.

Procedures:

• Health checks (including physical exams, vital signs, and medical history updates)
• Blood samples for safety and study measurements
• Urine samples, including pregnancy testing
• Vaginal samples (such as swabs and pH checks)
• Pelvic exams at all visits – includes speculum examination
• Self-administration of the study capsule once daily for 7 days
• Completion of questionnaires and a daily diary about symptoms and study experience.

Where can I find more information?

You can request more information by contacting the recruitment team on 07 5409 8640 or trialparticipant@usc.edu.au. Do not send personal medical details to this email address. Alternatively, the team will be happy to answer any questions you may have when they call.