Phase 1 study
Not yet recruiting Phase 1
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Emeritus Research Sydney | Sydney | NSW | Status not stated |
| University of the Sunshine Coast Clinical Trials Maroochydore | Maroochydore | QLD | Status not stated |
| University of the Sunshine Coast Clinical Trials Morayfield | Morayfield | QLD | Status not stated |
| Emeritus Research Camberwell | Camberwell | VIC | Status not stated |
voxsanity.com.au · trial sites from public registries · registry record synced 15 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Inclusion Criteria:
* Diagnosed with bacterial vaginosis, defined by Nugent score ≥ 7, at Screening.
* Clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the site PI or designee.
* Negative testing for sexually transmitted infections (STIs) that would require antibiotic treatment (STIs: syphilis, trichomonas, gonorrhea, chlamydia) at Screening.
* Not pregnant at Screening and Enrollment.
* Regular menstrual cycles or on stable hormonal contraception.
Exclusion Criteria:
* Positive for Candida spp. by microscopy, culture, or nucleic acid-based testing at screening and not willing to receive concurrent oral antifungal treatment.
* Participants who have undergone hysterectomy (total or supracervical) or trachelectomy.
* History of
1. Cancer of the female reproductive tract
2. Uncontrolled recurrent genital herpes simplex infection, defined by at least 1 active episode in the past 6 months.
3. Significant coronary artery disease, myocardial infarction, chronic obstructive pulmonary disease, chronic renal failure, decompensated cirrhosis, or any other condition that in the opinion of the site PI or designee will compromise ability to participate in the study.
4. Any disease that may require genital corticosteroid administration during the study period. Inhaled, intranasal, and topical corticosteroids for other parts of the body are allowed.
5. Regular heavy menstrual bleeding to an extent that may interfere with study product use or protocol specified assessments, in the judgement of the investigator
* History of autoimmune disease including, but not limited to, Hashimoto's thyroiditis, pernicious anemia, Addison's disease, rheumatoid arthritis, lupus, multiple sclerosis, myasthenia gravis, Grave's disease, celiac disease, sprue, psoriasis, sarcoidosis, scleroderma, diabetes mellitus, etc. Evidence of autoimmune disease or receiving immunosuppressive therapy at the discretion of site PI or designee.
* Vaginal cleansing practices within 7 days prior to dosing.
* Patients with human immunodeficiency virus (HIV) infection, regardless of treatment status.
* History of severe allergic or anaphylactic reactions, or sensitivity to the IP, its constituents, or metronidazole.
* Use of a hormonal vaginal ring device.
* Vital signs with systolic blood pressure \> 180 mm/Hg or diastolic blood pressure \> 110 mm/Hg at Screening.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 15 October 2026.
- This page last checked by Voxsanity: 15 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.