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Not yet recruitingNCT07875673Updated Oct 15, 2026

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

A Phase 1 interventional study of metronidazole (MTZ)+ LCFA-01 placebo + LC103 placebo and metronidazole (MTZ)+ LCFA-01 + LC103 placebo in Bacterial Vaginosis, sponsored by Massachusetts General Hospital. Not yet recruiting at 6 sites in 2 countries. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Massachusetts General Hospital · Phase 1, Interventional, and Treatment

Updated Oct 15, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
280
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

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

02

Conditions studied

  • Bacterial Vaginosis

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03

In context

Vaginosis, Bacterial

228 studies on the registry are indexed under Vaginosis, Bacterial; 39 are open to participants now.

This study's planned enrollment of 280 is above the median of 100 across 194 interventional studies indexed under Vaginosis, Bacterial.

Browse Vaginosis, Bacterial studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.

Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
280 participants (estimated)

Study arms

  • Experimental
    Arm 1

    Drug: metronidazole (MTZ)+ LCFA-01 placebo + LC103 placebo

  • Experimental
    Arm 2

    Drug: metronidazole (MTZ)+ LCFA-01 + LC103 placebo

  • Experimental
    Arm 3

    Drug: metronidazole (MTZ)+ LC103 + LCFA-01 placebo

  • Experimental
    Arm 4

    Drug: metronidazole (MTZ)+ LC103+ LCFA-01

  • Experimental
    Arm 5

    Drug: LCFA-01 + LC103

Interventions

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

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

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

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

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

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

  • Drugmetronidazole (MTZ)+ LC103+ LCFA-01

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

  • DrugLCFA-01 + LC103

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

06

What researchers measure

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

  5. Clinically significant changes in Physical examinations

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

  6. Self-Reported Symptoms- abnormal vaginal odor

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

  7. Self-Reported Symptoms- pain, tenderness

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

  8. Self-Reported Symptoms- dyspareunia

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

  9. Self-Reported Symptoms- dysmenorrhea/cramping with menses

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

  10. Self-Reported Symptoms- vaginal vulvar itching

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

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

07

Study locations

6 sites
  • Emeritus Research Sydney
    Sydney, New South Wales 2019, Australia
  • University of the Sunshine Coast Clinical Trials Maroochydore
    Maroochydore, Queensland 4558, Australia
    • Christopher Moller, Dr · Contact · cmoller@usc.edu.au · +61 5456 5265
    • Christopher Moller, Dr · Principal investigator
  • University of the Sunshine Coast Clinical Trials Morayfield
    Morayfield, Queensland 4506, Australia
    • Christopher Moller, Dr · Contact · cmoller@usc.edu.au · +61 5456 5265
    • Christopher Moller, Dr · Principal investigator
  • Emeritus Research Camberwell
    Camberwell, Victoria 3124, Australia
  • CAPRISA Centre for the AIDS Programme of Research
    Durban, KwaZulu-Natal 4001, South Africa
  • FRESH (Females Rising through Education, Support and Health)
    Umlazi, KwaZulu-Natal 4066, South Africa
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07875673
Lead sponsor
Massachusetts General Hospital
Responsible party
Douglas Kwon (Principle Investigator, Massachusetts General Hospital) — Principal investigator
First posted
Oct 15, 2026
Start date
Feb 3, 2027 (estimated)
Primary completion
Feb 3, 2028 (estimated)
Completion
May 20, 2028 (estimated)
Last update
Oct 15, 2026

Study contacts

Douglas Kwon, Dr.
Contact
dkwon@mgh.harvard.edu
+1 (857) 268-7160
Dr. Caroline Mitchell, MD, PHD
Contact
caroline.mitchell@mgh.harvard.edu
+16177242182
Christopher Moller, Dr.
principal investigator · University of the Sunshine Coast Clinical Trials Maroochydore, QLD

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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