BridgeMD
Tests treatment safety and results for Bacterial Vaginosis Treatment
Official title To Test a New Drug (LCFA-01) for Safety and PK in Healthy Adults for Bacterial Vaginosis Infection.
ClinicalTrials.gov ID: NCT07514416
What this study is testing
What is LCFA-01?
LCFA-01 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for bacterial vaginosis treatment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only. Healthy volunteers may be eligible.
You may be able to join 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...
- 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...
- Your blood and urine test results should be normal, unless the study doctor decides that a slightly abnormal result is not a problem.
You likely can't join if
- Women who currently have moderate or severe vaginal symptoms (such as pain, itching, burning, or unusual discharge) at the Screening visit cannot...
- 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...
- 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...
- 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:
See the full eligibility criteria
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Brisbane, Queensland, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brisbane, Queensland, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.