Bacterial VaginosisPhase 1NCT07875673
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
A Phase 1 study testing metronidazole (MTZ)+ LC103+ LCFA-01 and LCFA-01 + LC103 in people with Bacterial Vaginosis, run by Massachusetts General Hospital at 6 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- metronidazole (MTZ)+ LC103+ LCFA-01 and LCFA-01 + LC103
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 3 Feb 2027to 20 May 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
- Uncontrolled recurrent genital herpes simplex infection, defined by at least 1 active episode in the past 6 months.
- 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.
Show all 14Show fewer
- 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.
- 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.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
Australia4 sites
Emeritus Research Camberwell
Camberwell, Victoria, 3124
Sewa Rijal, Dr, 03 9509 6166, sewarijal@emeritusresearch.com
Sewa Rijal, Dr
University of the Sunshine Coast Clinical Trials Maroochydore
Maroochydore, Queensland, 4558
Christopher Moller, Dr, +61 5456 5265, cmoller@usc.edu.au
Christopher Moller, Dr
University of the Sunshine Coast Clinical Trials Morayfield
Morayfield, Queensland, 4506
Christopher Moller, Dr, +61 5456 5265, cmoller@usc.edu.au
Christopher Moller, Dr
Emeritus Research Sydney
Sydney, New South Wales, 2019
Danielle Corish, Dr, 02 8964 8186, daniellecorish@emeritusresearch.com
Danielle Corish, Dr
South Africa2 sites
CAPRISA Centre for the AIDS Programme of Research
Durban, KwaZulu-Natal, 4001
Disebo Potloane, Dr., +27 (0)31 655 0687, disebo.makhaza@caprisa.org
Disebo Potloane, Dr.
FRESH (Females Rising through Education, Support and Health)
Umlazi, KwaZulu-Natal, 4066
Rosie Mgqibisa, Dr, +2782 726 4430, mngqibisa@ecarefoundation.com
Rosie Mgqibisa, Dr
About this study
Official title: A Phase 1b Study of Intravaginal Products, LCFA-01 and LC103, for Bacterial Vaginosis Treatment
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
- Conditions
- Bacterial Vaginosis
- Being tested
- metronidazole (MTZ)+ LCFA-01 placebo + LC103 placebo, metronidazole (MTZ)+ LCFA-01 + LC103 placebo, metronidazole (MTZ)+ LC103 + LCFA-01 placebo, metronidazole (MTZ)+ LC103+ LCFA-01, LCFA-01 + LC103
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metronidazole (MTZ)+ LCFA-01 placebo + LC103 placeboDrug
Route of Administration:
MTZ- Oral LCFA-01 placebo- Vaginal LC103 placebo- Vaginal
metronidazole (MTZ)+ LCFA-01 + LC103 placeboDrug
Route of Administration:
MTZ- Oral LCFA-01- Vaginal LC103 placebo- Vaginal
metronidazole (MTZ)+ LC103 + LCFA-01 placeboDrug
Route of Administration:
MTZ- Oral LCFA-01 placebo- Vaginal LC103- Vaginal
metronidazole (MTZ)+ LC103+ LCFA-01Drug
Route of Administration:
MTZ- Oral LCFA-01- Vaginal LC103- Vaginal
LCFA-01 + LC103Drug
Route of Administration:
LCFA-01- Vaginal LC103- Vaginal
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: metronidazole (MTZ)+ LCFA-01 placebo + LC103 placebo |
| Arm 2 | Experimental | Not described Receives: Drug: metronidazole (MTZ)+ LCFA-01 + LC103 placebo |
| Arm 3 | Experimental | Not described Receives: Drug: metronidazole (MTZ)+ LC103 + LCFA-01 placebo |
| Arm 4 | Experimental | Not described Receives: Drug: metronidazole (MTZ)+ LC103+ LCFA-01 |
| Arm 5 | Experimental | Not described Receives: Drug: LCFA-01 + LC103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of TEAEs.
Measured: From Day 1 to Day 93 (EOS visit)
Incidence of SAEs
Measured: From Day 1 to Day 93 (EOS visit)
Clinically significant changes in Safety Laboratory Parameters as per protocol
Measured: From Day 1 to Day 93 (EOS visit)
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.
Measured: 3 weeks after product use cessation
Clinically significant changes in Physical examinations
Measured: From Day 1 to Day 93 (EOS visit)
Self-Reported Symptoms- abnormal vaginal odor
Measured: From Day 1 to Day 93 (EOS visit)
Self-Reported Symptoms- pain, tenderness
Measured: From Day 1 to Day 93 (EOS visit)
Self-Reported Symptoms- dyspareunia
Measured: From Day 1 to Day 93 (EOS visit)
Self-Reported Symptoms- dysmenorrhea/cramping with menses
Measured: From Day 1 to Day 93 (EOS visit)
Self-Reported Symptoms- vaginal vulvar itching
Measured: From Day 1 to Day 93 (EOS visit)
Secondary outcomes (2)
Recurrence of bacterial vaginosis (BV)
Proportion of participants with recurrent bacterial vaginosis, defined as Nugent score ≥7.
Measured: 3 weeks after product use cessation
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.
Measured: 8 weeks and 12 weeks after product use cessation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start3 Feb 2027 (estimated)
- Primary completion3 Feb 2028 (estimated)
- Study completion20 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas Kwon, Massachusetts General Hospital
- Investigators
- Christopher Moller, Dr., Principal investigator, University of the Sunshine Coast Clinical Trials Maroochydore, QLD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875673
- Sponsor's protocol ID
- FLOURISH-2
- Status last verified
- Sep 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of Intravaginal Products, LCFA-01 and LC103, for Bacterial Vaginosis Treatment
- ClinicalTrials.gov ID
- NCT07875673
- Acronym / sponsor ID
- FLOURISH-2
- Conditions
- Bacterial Vaginosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 3 Feb 2027 (estimated)
- Primary completion
- 3 Feb 2028 (estimated)
- Study completion
- 20 May 2028 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: metronidazole (MTZ)+ LCFA-01 placebo + LC103 placebo |
| Arm 2 | Experimental | Drug: metronidazole (MTZ)+ LCFA-01 + LC103 placebo |
| Arm 3 | Experimental | Drug: metronidazole (MTZ)+ LC103 + LCFA-01 placebo |
| Arm 4 | Experimental | Drug: metronidazole (MTZ)+ LC103+ LCFA-01 |
| Arm 5 | Experimental | Drug: LCFA-01 + LC103 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metronidazole (MTZ)+ LCFA-01 placebo + LC103 placeboRoute of Administration: MTZ- Oral LCFA-01 placebo- Vaginal LC103 placebo- Vaginal | Drug | Arm 1 |
| metronidazole (MTZ)+ LCFA-01 + LC103 placeboRoute of Administration: MTZ- Oral LCFA-01- Vaginal LC103 placebo- Vaginal | Drug | Arm 2 |
| metronidazole (MTZ)+ LC103 + LCFA-01 placeboRoute of Administration: MTZ- Oral LCFA-01 placebo- Vaginal LC103- Vaginal | Drug | Arm 3 |
| metronidazole (MTZ)+ LC103+ LCFA-01Route of Administration: MTZ- Oral LCFA-01- Vaginal LC103- Vaginal | Drug | Arm 4 |
| LCFA-01 + LC103Route of Administration: LCFA-01- Vaginal LC103- Vaginal | Drug | Arm 5 |
Primary outcome
Incidence of TEAEs.
Time frame: From Day 1 to Day 93 (EOS visit)
Incidence of SAEs
Time frame: From Day 1 to Day 93 (EOS visit)
Clinically significant changes in Safety Laboratory Parameters as per protocol
Time frame: From Day 1 to Day 93 (EOS visit)
Assess Lactobacillus crispatus dominance in vaginal microbiota
Time frame: 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
Time frame: From Day 1 to Day 93 (EOS visit)
Self-Reported Symptoms- abnormal vaginal odor
Time frame: From Day 1 to Day 93 (EOS visit)
Self-Reported Symptoms- pain, tenderness
Time frame: From Day 1 to Day 93 (EOS visit)
Self-Reported Symptoms- dyspareunia
Time frame: From Day 1 to Day 93 (EOS visit)
Self-Reported Symptoms- dysmenorrhea/cramping with menses
Time frame: From Day 1 to Day 93 (EOS visit)
Self-Reported Symptoms- vaginal vulvar itching
Time frame: From Day 1 to Day 93 (EOS visit)
2 secondary outcomes
Recurrence of bacterial vaginosis (BV)
Time frame: 3 weeks after product use cessation
Lactobacillus crispatus dominance in the vaginal microbiota
Time frame: 8 weeks and 12 weeks after product use cessation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Bacterial Vaginosis
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
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Multi-Gyn FemiTotal for the Treatment and Prevention of Vulvovaginal Candidiasis Symptoms and Bacterial Vaginosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Moller, Dr. principal investigator
University of the Sunshine Coast Clinical Trials Maroochydore, QLD
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing metronidazole (MTZ)+ LC103+ LCFA-01 and LCFA-01 + LC103 in people with Bacterial Vaginosis, run by Massachusetts General Hospital at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Douglas Kwon, Dr. (+1 (857) 268-7160, dkwon@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of TEAEs. (time frame: From Day 1 to Day 93 (EOS visit)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.