Bacterial Vaginosis TreatmentPhase 1NCT07514416
To Test a New Drug (LCFA-01) for Safety and PK in Healthy Adults for Bacterial Vaginosis Infection.
A Phase 1 study testing LCFA-01 in people with Bacterial Vaginosis Treatment, run by Massachusetts General Hospital at 1 site in Australia.
Trial summary
This study is being done to check how safe and comfortable LCFA-01 is when used inside the vagina. LCFA-01 is a natural product that contains oleic acid, and it comes as a soft gel capsule that participants will place in the vagina using their fingers. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginosis Treatment
- What is being tested?
- LCFA-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 28 Apr 2026to 22 Oct 2026
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females aged 18 to 40 years (inclusive) who are pre-menopausal at the time of providing informed consent
- You should be generally healthy, with no major past illnesses, and your doctor should not see anything concerning during your check-up before starting the study.
- Your BMI (a measure of weight and height) must be between 18.0 and 34.9.
- You must be a non-smoker or only an occasional smoker. If you smoke 2 cigarettes or less per week (or similar, like vaping or cigars), you may still join, depending on the study doctor's decision.
- Your blood and urine test results should be normal, unless the study doctor decides that a slightly abnormal result is not a problem.
- You must test negative for common sexually transmitted infections (STIs) at the screening visit.
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- You must not be pregnant at Screening or when you join the study.
- You should have regular periods, unless you are using hormonal birth control that stops your periods. If you do have regular periods, you will join the study within 5 days after your period ends.
- You must agree not to use any vaginal products (like creams, gels, or suppositories) during the study.
- You must agree not to have sexual intercourse during the study and also avoid:
- receptive oral sex anal sex vaginal sex toys
- If you can become pregnant, you must use a reliable form of birth control starting from Screening until 90 days after your last dose of the study product.(Using only condoms is not enough.)
- You must be willing and able to come to all required study visits.
- You must be willing to sign a consent form after the study has been explained to you, including how your samples may be stored for future research.
Who cannot join
- Women who currently have moderate or severe vaginal symptoms (such as pain, itching, burning, or unusual discharge) at the Screening visit cannot join the study.
- Women with physical or mental health conditions that, in the opinion of the study doctor, would make it difficult for them to follow the study rules or finish the study will not be able to participate.
- Women who have had certain surgeries, such as:
- removal of the uterus (full or partial hysterectomy) major surgeries on the cervix, vagina, or uterus (for example: cervical cone biopsy,removal of the cervix, or major uterine surgery)
- cannot participate because these procedures may change the vaginal or reproductive anatomy, which could affect study results.
- Women with certain medical conditions, including:
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- Serious diseases of the vagina, cervix, or uterus, such as:
- cancers of the female reproductive system
- endometriosis
- chronic or recurrent vaginal infections
- Uncontrolled genital herpes, meaning they had at least one active outbreak in the past 6 months.
- Serious health problems such as: heart disease or a past heart attack chronic lung disease (like COPD) chronic kidney failure severe liver disease (cirrhosis) or any other serious condition that the study doctor believes would make it unsafe to join the study.
- Any condition that would require using steroid medicines inside the genital area during the study. (Steroid creams used on the skin, inhalers, or nose sprays are allowed.) e. A yeast infection (vulvovaginal candidiasis) found during Screening. f. Repeated episodes of bacterial vaginosis (BV), meaning two or more episodes in the past year.
- Women who have ever had an autoimmune disease cannot join the study.
- Autoimmune diseases happen when the body's immune system attacks its own tissues. Examples include:
- Hashimoto's thyroid disease Pernicious anemia Addison's disease Rheumatoid arthritis Lupus Multiple sclerosis Myasthenia gravis Grave's disease Celiac disease Psoriasis Sarcoidosis Scleroderma Diabetes (Type 1)
- Also, anyone who shows signs of an autoimmune disease now, or is taking medicines that weaken the immune system, may be excluded based on the study doctor's judgment.
- Women who were diagnosed with a cervicovaginal infection (such as gonorrhea, chlamydia, trichomonas, or Mycoplasma genitalium) within 30 days before Screening cannot join.
- Women who had an infection requiring antibiotics or antifungal medicines within 14 days before Screening cannot join.
- Women who used any vaginal cleaning practices in the past 14 days cannot participate.
- This includes:
- vaginal douching using products to clean, wash, dry, or "freshen" the vagina
- Women who test positive for syphilis at Screening cannot join.
- Women who have HIV cannot participate, whether the infection is treated, untreated, or well controlled.
- Women who have chronic hepatitis B infection cannot join the study.
- Women who are currently taking medicine to treat hepatitis C cannot participate.
- Women who have used long-acting investigational medicines, such as injectable HIV prevention products (PrEP), within the past year cannot join.
- Women who are using a non-hormonal IUD, like the copper T IUD, or a hormonal vaginal ring, cannot take part in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of LCFA-01, an Intravaginal Product, in Healthy Participants for Bacterial Vaginosis Treatment
This study is being done to check how safe and comfortable LCFA-01 is when used inside the vagina. LCFA-01 is a natural product that contains oleic acid, and it comes as a soft gel capsule that participants will place in the vagina using their fingers.
The main purpose of the study is to make sure the product is safe and does not cause any problems or discomfort. The study will also measure how much of the product stays in the vagina and whether any of it enters the bloodstream. This helps researchers understand how the body absorbs and handles the product.
Read more
Finally, the study will also look at early signs of how the product might affect the natural bacteria in the vagina.
In the future, LCFA-01 may be used to treat bacterial vaginosis (BV).
Read the detailed description
This study is testing a new vaginal product called LCFA-01 for the first time in humans. The goal is to see:
- if it is safe,
- if women can tolerate it well, and
- what happens to the product inside the body after it's used.
Up to 30 healthy adult women who are 18 years to 40 years of age and who are not pregnant \& not in menopause.
Women first go through a "Screening period" lasting up to 35 days. Doctors make sure they are healthy and can join the study.
The whole study period lasts 2 weeks:
Week 1: Using the product
Women use the vaginal product once a day for 7 days. Day 1 and Day 2: They use it at the clinic, so doctors can watch closely for safety.
Day 3 to Day 7: They use it at home.
Women also take their own vaginal swab samples every day at home. During the first week, they take the swab before using the product.
Week 2: No product
Women stop using the product but continue to self-swab at home. They come back for a check-up at the end of this week.
There will be 2 groups (cohorts), each trying a different amount of LCFA-01:
In each group, 2 out of 3 women get LCFA-01
1 out of 3 gets a placebo (a harmless, inactive product)
This helps researchers compare effects.
Only 2 women (one gets LCFA-01, one gets placebo) are treated first in each group.
Doctors watch them for 24 hours. If everything looks safe, the rest of the women in that group can begin the study.
Are there any side effects? Is the product safe and comfortable to use? Does any of the product get into the bloodstream? How long does the product stay in the vagina? How does it affect the vaginal environment?
- Conditions
- Bacterial Vaginosis Treatment
- Being tested
- LCFA-01, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCFA-01Drug
LCFA-01 Drug Product is a soft gelatin capsule, containing oleic acid at 2 dosage strengths (200 mg and 400 mg).
PlaceboDrug
LCFA-01 Placebo is a soft gelatin capsule, of which the composition is similar to that of LCFA-01 Drug Product, but without the active pharmaceutical ingredient.
| Study group | Role | What they receive |
|---|---|---|
| LCFA-01 | Experimental | Dose 1 (200 mg) Dose 2 (400 mg) Dose Formulation- The soft gelatin capsule is light-to-medium yellow in color and oblong in shape Route of Administration- Vaginal Receives: Drug: LCFA-01 |
| Placebo | Placebo comparator | Route of Administration- Vaginal Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events (TEAEs)
Measured: Day 1 to Day 14
Clinically significant changes in Physical examinations
Measured: Baseline, Day 2, Day 8, Day 10, Day 14
Clinically significant changes in Vital Signs as per protocol
Measured: Baseline, Day2, Day 8, Day 10, Day 14
Clinically significant changes in Safety Laboratory Parameters as per protocol
Measured: Baseline, Day 1, Day 2, Day 8, Day 10
Self-Reported Symptoms-abnormal vaginal odor
Measured: Baseline to Day 14
Self-Reported Symptoms-pain, tenderness
Measured: Baseline to Day 14
Self-Reported Symptoms- dyspareunia
Measured: Baseline to Day 14
Self-Reported Symptoms- dysmenorrhea/cramping with menses
Measured: Baseline to Day 14
Self-Reported Symptoms- vaginal vulvar itching
Measured: Baseline to Day 14
Self-Reported Symptoms-vulvar edema
Measured: Baseline to Day 14
Self-Reported Symptoms- vulvar erythema
Measured: Baseline to Day 14
Self-Reported Symptoms-vulvar lesions
Measured: Baseline to Day 14
Self-Reported Symptoms-Bartholin or Skene's gland lesions
Measured: Baseline to Day 14
Secondary outcomes (4)
PK parameters derived from plasma concentration for Maximum concentration (Cmax)
Measured: On Day 1, 2, 8, 10
Observed concentrations of LCFA-01 in vaginal samples post-dosing
Measured: Day 1, 2, 8, 10, 14
PK parameters derived from plasma concentration for Area Under the Curve (AUC)
Measured: On Day 1, 2, 8, 10
PK parameters derived from plasma concentration for Time to maximum concentration( Tmax)
Measured: On Day 1, 2, 8, 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start28 Apr 2026
- Primary completion2 Sep 2026
- Study completion22 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial Vaginosis TreatmentStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Caroline Mitchell, MD, MPH, Massachusetts General Hospital, Meilin Zhu, PhD, Massachusetts General Hospital
- Responsible party
- Principal investigator, Douglas Kwon, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514416
- Sponsor's protocol ID
- FLOURISH-1
- Status last verified
- Sep 2026
- First submitted
- 4 Mar 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of LCFA-01, an Intravaginal Product, in Healthy Participants for Bacterial Vaginosis Treatment
- ClinicalTrials.gov ID
- NCT07514416
- Acronym / sponsor ID
- FLOURISH-1
- Conditions
- Bacterial Vaginosis Treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Caroline Mitchell, MD, MPH, Massachusetts General Hospital, Meilin Zhu, PhD, Massachusetts General Hospital
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 2 Sep 2026 (actual)
- Study completion
- 22 Oct 2026 (estimated)
- First posted
- 7 Apr 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 study is being done to check how safe and comfortable LCFA-01 is when used inside the vagina. LCFA-01 is a natural product that contains oleic acid, and it comes as a soft gel capsule that participants will place in the vagina using their fingers.
The main purpose of the study is to make sure the product is safe and does not cause any problems or discomfort. The study will also measure how much of the product stays in the vagina and whether any of it enters the bloodstream. This helps researchers understand how the body absorbs and handles the product.
Finally, the study will also look at early signs of how the product might affect the natural bacteria in the vagina.
In the future, LCFA-01 may be used to treat bacterial vaginosis (BV).
Detailed description
This study is testing a new vaginal product called LCFA-01 for the first time in humans. The goal is to see:
- if it is safe,
- if women can tolerate it well, and
- what happens to the product inside the body after it's used.
Up to 30 healthy adult women who are 18 years to 40 years of age and who are not pregnant \& not in menopause.
Women first go through a "Screening period" lasting up to 35 days. Doctors make sure they are healthy and can join the study.
The whole study period lasts 2 weeks:
Week 1: Using the product
Women use the vaginal product once a day for 7 days. Day 1 and Day 2: They use it at the clinic, so doctors can watch closely for safety.
Day 3 to Day 7: They use it at home.
Women also take their own vaginal swab samples every day at home. During the first week, they take the swab before using the product.
Week 2: No product
Women stop using the product but continue to self-swab at home. They come back for a check-up at the end of this week.
There will be 2 groups (cohorts), each trying a different amount of LCFA-01:
In each group, 2 out of 3 women get LCFA-01
1 out of 3 gets a placebo (a harmless, inactive product)
This helps researchers compare effects.
Only 2 women (one gets LCFA-01, one gets placebo) are treated first in each group.
Doctors watch them for 24 hours. If everything looks safe, the rest of the women in that group can begin the study.
Are there any side effects? Is the product safe and comfortable to use? Does any of the product get into the bloodstream? How long does the product stay in the vagina? How does it affect the vaginal environment?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LCFA-01 | Experimental | Drug: LCFA-01Dose 1 (200 mg) Dose 2 (400 mg) Dose Formulation- The soft gelatin capsule is light-to-medium yellow in color and oblong in shape Route of Administration- Vaginal |
| Placebo | Placebo comparator | Drug: PlaceboRoute of Administration- Vaginal |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Females aged 18 to 40 years (inclusive) who are pre-menopausal at the time of providing informed consent
- You should be generally healthy, with no major past illnesses, and your doctor should not see anything concerning during your check-up before starting the study.
- Your BMI (a measure of weight and height) must be between 18.0 and 34.9.
- You must be a non-smoker or only an occasional smoker. If you smoke 2 cigarettes or less per week (or similar, like vaping or cigars), you may still join, depending on the study doctor's decision.
- Your blood and urine test results should be normal, unless the study doctor decides that a slightly abnormal result is not a problem.
Key exclusion criteria (28 listed)
- Women who currently have moderate or severe vaginal symptoms (such as pain, itching, burning, or unusual discharge) at the Screening visit cannot join the study.
- Women with physical or mental health conditions that, in the opinion of the study doctor, would make it difficult for them to follow the study rules or finish the study will not be able to participate.
- Women who have had certain surgeries, such as:
- removal of the uterus (full or partial hysterectomy) major surgeries on the cervix, vagina, or uterus (for example: cervical cone biopsy,removal of the cervix, or major uterine surgery)
- cannot participate because these procedures may change the vaginal or reproductive anatomy, which could affect study results.
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 |
|---|---|---|
| LCFA-01LCFA-01 Drug Product is a soft gelatin capsule, containing oleic acid at 2 dosage strengths (200 mg and 400 mg). | Drug | LCFA-01 |
| PlaceboLCFA-01 Placebo is a soft gelatin capsule, of which the composition is similar to that of LCFA-01 Drug Product, but without the active pharmaceutical ingredient. | Drug | Placebo |
Primary outcome
Treatment-emergent adverse events (TEAEs)
Time frame: Day 1 to Day 14
Clinically significant changes in Physical examinations
Time frame: Baseline, Day 2, Day 8, Day 10, Day 14
Clinically significant changes in Vital Signs as per protocol
Time frame: Baseline, Day2, Day 8, Day 10, Day 14
Clinically significant changes in Safety Laboratory Parameters as per protocol
Time frame: Baseline, Day 1, Day 2, Day 8, Day 10
Self-Reported Symptoms-abnormal vaginal odor
Time frame: Baseline to Day 14
Self-Reported Symptoms-pain, tenderness
Time frame: Baseline to Day 14
Self-Reported Symptoms- dyspareunia
Time frame: Baseline to Day 14
Self-Reported Symptoms- dysmenorrhea/cramping with menses
Time frame: Baseline to Day 14
Self-Reported Symptoms- vaginal vulvar itching
Time frame: Baseline to Day 14
Self-Reported Symptoms-vulvar edema
Time frame: Baseline to Day 14
Self-Reported Symptoms- vulvar erythema
Time frame: Baseline to Day 14
Self-Reported Symptoms-vulvar lesions
Time frame: Baseline to Day 14
Self-Reported Symptoms-Bartholin or Skene's gland lesions
Time frame: Baseline to Day 14
4 secondary outcomes
PK parameters derived from plasma concentration for Maximum concentration (Cmax)
Time frame: On Day 1, 2, 8, 10
Observed concentrations of LCFA-01 in vaginal samples post-dosing
Time frame: Day 1, 2, 8, 10, 14
PK parameters derived from plasma concentration for Area Under the Curve (AUC)
Time frame: On Day 1, 2, 8, 10
PK parameters derived from plasma concentration for Time to maximum concentration( Tmax)
Time frame: On Day 1, 2, 8, 10
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 11 Sep 2026.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LCFA-01 in people with Bacterial Vaginosis Treatment, run by Massachusetts General Hospital at 1 site in Australia.
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 14 inclusion and 28 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: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse events (TEAEs) (time frame: Day 1 to Day 14). The study lists 13 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 11 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.