Ireland
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Starting soon Phase 1

A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment

NCT07875673 · tracked via the Priya Life Science Australia tracker
Phase
Phase 1
Started
2027-02-03
Last updated
2026-10-15

Condition(s) studied

Bacterial Vaginosis

Investigational drug(s) / intervention(s)

metronidazole (MTZ)+ LCFA-01 placebo + LC103 placebometronidazole (MTZ)+ LCFA-01 + LC103 placebometronidazole (MTZ)+ LC103 + LCFA-01 placebometronidazole (MTZ)+ LC103+ LCFA-01All Metronidazole trials (18) →All LCFA-01 trials (2) →LCFA-01 + LC103 →

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

Sex
FEMALE
Min age
18 Years
Max age
40 Years
Healthy volunteers
No
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.

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)

FacilityCityRegionStatus
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
Official registry record

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