Live Double Combined Lactobacillus Capsule for Vaginal Use（IIa） (NCT07418996) | Clinical Trial Compass
CompletedPhase 2
Live Double Combined Lactobacillus Capsule for Vaginal Use（IIa）
China57 participantsStarted 2021-05-18
Plain-language summary
This is a mutilcenter, randomized, double-blind, Metronidazole controlled phase lIa clinical study to evaluate the safety and tolerability of dual - live lactobacilli-containing vaginal capsules for the treatment of Bacterial Vaginosis.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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Inclusion criteria
✓. Female, aged 18-50 years (inclusive), with prior sexual experience, willing to undergo vaginal drug administration, and agreeing to refrain from using intravaginal products (such as contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) not specified in the study throughout the entire trial period.
✓. Having a regular menstrual cycle (21-35 days).
✓. Clinical diagnosis of bacterial vaginosis (BV), defined as meeting at least three of the Amsel criteria, with clue cells exceeding 20% of the total vaginal epithelial cells, and a Nugent score ≥ 7.
✓. Able to understand and voluntarily sign the informed consent form.
Exclusion criteria
✕. Individuals with a history of allergies or known hypersensitivity to any known component of the investigational product.
✕. Known current diagnosis of pelvic inflammatory disease, cervicitis, or acute urogenital infection.
✕. Diagnosis of vulvovaginal candidiasis (VVC), trichomonal vaginitis (TV), or aerobic vaginitis (AV, with a score ≥5).
✕. Use of vaginal douching or other intravaginal treatments within 14 days prior to screening, or anticipated use during the trial period.
✕. Known diagnosis of uterine fibroids, endometrial hyperplasia, or adenomyosis requiring intervention, as assessed by the investigator.
✕. Patients who have used topical or systemic antimicrobial or antimycotic agents within 14 days prior to screening, or are anticipated to require such treatment during the trial period.
What they're measuring
1
Incidence of Treatment-emergent adverse events (Safety Evaluation)
Timeframe: Through study completion, an average of 30 days
2
Incidence of treatment-related adverse events (Safety Evaluation)
Timeframe: Through study completion, an average of 30 days