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).
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Treatment-emergent adverse events (TEAEs)
Timeframe: Day 1 to Day 14
Clinically significant changes in Physical examinations
Timeframe: Baseline, Day 2, Day 8, Day 10, Day 14
Clinically significant changes in Vital Signs as per protocol
Timeframe: Baseline, Day2, Day 8, Day 10, Day 14
Clinically significant changes in Safety Laboratory Parameters as per protocol
Timeframe: Baseline, Day 1, Day 2, Day 8, Day 10
Self-Reported Symptoms-abnormal vaginal odor
Timeframe: Baseline to Day 14
Self-Reported Symptoms-pain, tenderness
Timeframe: Baseline to Day 14
Self-Reported Symptoms- dyspareunia
Timeframe: Baseline to Day 14
Self-Reported Symptoms- dysmenorrhea/cramping with menses
Timeframe: Baseline to Day 14
Self-Reported Symptoms- vaginal vulvar itching
Timeframe: Baseline to Day 14
Self-Reported Symptoms-vulvar edema
Timeframe: Baseline to Day 14
Self-Reported Symptoms- vulvar erythema
Timeframe: Baseline to Day 14
Self-Reported Symptoms-vulvar lesions
Timeframe: Baseline to Day 14
Self-Reported Symptoms-Bartholin or Skene's gland lesions
Timeframe: Baseline to Day 14