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

ConditionBacterial Vaginosis
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorMassachusetts General Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Cancer of the female reproductive tract

Trial design

Design model

Parallel

Treatments tested in this trial

  • metronidazole (MTZ)+ LCFA-01 placebo + LC103 placebo

    Drug

    Route of Administration: MTZ- Oral LCFA-01 placebo- Vaginal LC103 placebo- Vaginal

  • metronidazole (MTZ)+ LCFA-01 + LC103 placebo

    Drug

    Route of Administration: MTZ- Oral LCFA-01- Vaginal LC103 placebo- Vaginal

  • metronidazole (MTZ)+ LC103 + LCFA-01 placebo

    Drug

    Route of Administration: MTZ- Oral LCFA-01 placebo- Vaginal LC103- Vaginal

  • metronidazole (MTZ)+ LC103+ LCFA-01

    Drug

    Route of Administration: MTZ- Oral LCFA-01- Vaginal LC103- Vaginal

  • LCFA-01 + LC103

    Drug

    Route of Administration: LCFA-01- Vaginal LC103- Vaginal

Treatment groups

280 Participants
are divided into 5 treatment groups
Group A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Experimental treatment 1 intervention
Group C: Arm 3Experimental treatment 1 intervention
Group D: Arm 4Experimental treatment 1 intervention
Group E: Arm 5Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of TEAEs.

Time frame
From Day 1 to Day 93 (EOS visit)
2

Incidence of SAEs

Time frame
From Day 1 to Day 93 (EOS visit)
3

Clinically significant changes in Safety Laboratory Parameters as per protocol

Time frame
From Day 1 to Day 93 (EOS visit)
4

Assess Lactobacillus crispatus dominance in vaginal microbiota

Proportion of participants with Lactobacillus crispatus dominance, defined as \>50% relative abundance based on metagenomic sequencing of vaginal microbiota samples.

Time frame
3 weeks after product use cessation

Secondary outcomes

1

Recurrence of bacterial vaginosis (BV)

Proportion of participants with recurrent bacterial vaginosis, defined as Nugent score ≥7.

Time frame
3 weeks after product use cessation
2

Lactobacillus crispatus dominance in the vaginal microbiota

Proportion of participants with Lactobacillus crispatus dominance, defined as \>50% relative abundance based on metagenomic sequencing of vaginal microbiota samples.

Time frame
8 weeks and 12 weeks after product use cessation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: