A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Condition(s) studied
Investigational drug(s) / intervention(s)
metronidazole (MTZ)+ LCFA-01 placebo + LC103 placebo: Route of Administration: MTZ- Oral LCFA-01 placebo- Vaginal LC103 placebo- Vaginal
metronidazole (MTZ)+ LCFA-01 + LC103 placebo: Route of Administration: MTZ- Oral LCFA-01- Vaginal LC103 placebo- Vaginal
metronidazole (MTZ)+ LC103 + LCFA-01 placebo: Route of Administration: MTZ- Oral LCFA-01 placebo- Vaginal LC103- Vaginal
metronidazole (MTZ)+ LC103+ LCFA-01: Route of Administration: MTZ- Oral LCFA-01- Vaginal LC103- Vaginal
LCFA-01 + LC103: Route of Administration: LCFA-01- Vaginal LC103- Vaginal
Study summary
This Phase 1b study will evaluate different combinations of LCFA-01, LC103, and the antibiotic metronidazole in women with bacterial vaginosis (BV). Participants will be randomly assigned to one of five treatment groups and followed for approximately 13 weeks to assess the safety of the treatments, how well they work to treat BV, and their effects on the vaginal microbiome.
Up to 280 participants will be enrolled in this study
Eligibility
Primary outcome measure(s)
- Incidence of TEAEs. — From Day 1 to Day 93 (EOS visit)
- Incidence of SAEs — From Day 1 to Day 93 (EOS visit)
- Clinically significant changes in Safety Laboratory Parameters as per protocol — From Day 1 to Day 93 (EOS visit)
- Assess Lactobacillus crispatus dominance in vaginal microbiota — 3 weeks after product use cessation
Proportion of participants with Lactobacillus crispatus dominance, defined as \>50% relative abundance based on metagenomic sequencing of vaginal microbiota samples. - Clinically significant changes in Physical examinations — From Day 1 to Day 93 (EOS visit)
- Self-Reported Symptoms- abnormal vaginal odor — From Day 1 to Day 93 (EOS visit)
- Self-Reported Symptoms- pain, tenderness — From Day 1 to Day 93 (EOS visit)
- Self-Reported Symptoms- dyspareunia — From Day 1 to Day 93 (EOS visit)
- Self-Reported Symptoms- dysmenorrhea/cramping with menses — From Day 1 to Day 93 (EOS visit)
- Self-Reported Symptoms- vaginal vulvar itching — From Day 1 to Day 93 (EOS visit)
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| Emeritus Research Sydney | Sydney | New South Wales | |
| University of the Sunshine Coast Clinical Trials Maroochydore | Maroochydore | Queensland | |
| University of the Sunshine Coast Clinical Trials Morayfield | Morayfield | Queensland | |
| Emeritus Research Camberwell | Camberwell | Victoria | |
| CAPRISA Centre for the AIDS Programme of Research | Durban | KwaZulu-Natal | |
| FRESH (Females Rising through Education, Support and Health) | Umlazi | KwaZulu-Natal |
More Massachusetts General Hospital trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07875673 on ClinicalTrials.gov ↗ ← All trials in Australia