Live Double Combined Lactobacillus Capsule for Vaginal Use(IIb) (NCT07418918) | Clinical Trial Compass
CompletedPhase 2
Live Double Combined Lactobacillus Capsule for Vaginal Use(IIb)
China66 participantsStarted 2023-01-03
Plain-language summary
This is a multicenter, randomized, double-blind, placebo-controlled phase IIb clinical study, to evaluate the efficacy and safety of the dual - live Lactobacilli-containing vaginal capsule for the treatment of bacterial vaginosis.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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Inclusion criteria
✓. The subject fully understands the purpose, nature, methods, and potential adverse reactions of the trial, voluntarily participates in the study, and provides written informed consent prior to trial commencement;
✓. Female aged 18 to 50 years (inclusive of the boundary values);
✓. History of sexual activity, willing to undergo vaginal administration of medication, and agrees to refrain from using other intravaginal products (e.g., contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) and from engaging in sexual activity throughout the entire trial period;
✓. Has a normal and regular menstrual cycle;
✓. Clinically diagnosed with bacterial vaginosis (BV), defined as having at least three positive findings on Amsel's criteria, including the presence of clue cells (i.e., clue cells accounting for \>20% of the total vaginal epithelial cells); and a Nugent score ≥ 7 points.
Exclusion criteria
✕. Known allergy to any component of the investigational drug;
✕. Known current diagnosis of pelvic inflammatory disease, cervicitis, or acute urogenital infection;
✕. Vulvovaginitis due to other infectious etiologies, such as vulvovaginal candidiasis (VVC), trichomonal vaginitis (TV), aerobic vaginitis (AV score ≥5), gonorrhea, or Chlamydia trachomatisinfection,etc;
✕. Pelvic examination at screening reveals the presence of condyloma acuminata (genital warts);
✕. History of complicated or recurrent VVC within 1 year prior to screening;
✕. History of significant diseases affecting the cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, urogenital, endocrine, or psychiatric systems, which in the investigator's judgment may compromise subject safety;