To Test a New Drug (LCFA-01) for Safety and PK in Healthy Adults for Bacterial Vaginosis Infection.

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Bacterial Vaginosis Treatment

In brief

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).

Key facts

Study ID: NCT07514416
Run by: Massachusetts General Hospital
People needed: 30
Starts: 2026-04-28
Expected to finish: 2026-08-12
Last updated by the study team: 2026-07-14

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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.
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.

You may not qualify if…

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:
a. Serious diseases of the vagina, cervix, or uterus, such as:
cancers of the female reproductive system
endometriosis
chronic or recurrent vaginal infections
b. Uncontrolled genital herpes, meaning they had at least one active outbreak in the past 6 months.
c. 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.
d. 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.

Where it is running

Allied Health Hub Morayfield — Brisbane, Queensland, Australia (enrolling)

Full record on ClinicalTrials.gov

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