Efficacy and Safety of Vaginal Lactobacillus Dual Probiotic Capsules in Bacterial Vaginosis (NCT07418957) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Vaginal Lactobacillus Dual Probiotic Capsules in Bacterial Vaginosis
China402 participantsStarted 2024-06-12
Plain-language summary
Primary Objective: To confirm that the clinical cure rate of Vaginal Lactobacillus Dual Probiotic Capsules for bacterial vaginosis (BV) is superior to placebo at the 21-30 day post-treatment visit (Day 21 to Day 30).
Key Secondary Objective: To compare the clinical cure rate of Vaginal Lactobacillus Dual Probiotic Capsules versus placebo for BV at the 15-18 day post-treatment visit (Day 15 to Day 18).
Other Secondary Objectives: 1) To comprehensively assess the therapeutic efficacy of the study drug versus placebo for BV at Day 15 to 18 and Day 21 to 30; 2) To evaluate the safety profile of the study drug for BV treatment compared with placebo, including adverse events and clinical laboratory findings.
Study Design \& Randomization: This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial. An independent biostatistician generated the subject and drug randomization lists via SAS software, which were imported into an Interactive Web Response System (IWRS). Investigators at each site obtain randomization and drug numbers through the IWRS for subject allocation.
Blinding \& Allocation Concealment: Double-blinding is implemented for both investigators and subjects. The study drug and placebo are identical in appearance, shape, specification, and dosage form. Blinding procedures are performed by personnel unrelated to the trial, with a complete and detailed record of the entire blinding process maintained throughout the study.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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Inclusion criteria
✓. The subjects fully understand the purpose, nature, methods, and potential adverse reactions of the trial, voluntarily participate in the study, and sign an informed consent form before the trial begins;
✓. Females aged ≥18 years and ≤50 years, with normal and regular menstrual cycles;
✓. Have a history of sexual activity, are willing to undergo vaginal medication, and agree to avoid using other intravaginal products (such as contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) and sexual activity throughout the entire trial period;
✓. Clinically diagnosed with Bacterial Vaginosis (BV), requiring the simultaneous satisfaction of all four Amsel criteria:
✓. 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 tract infections;
✕. Presence of vulvovaginitis caused by other infectious etiologies, such as vulvovaginal candidiasis (VVC), trichomonal vaginitis (TV), aerobic vaginitis (AV score ≥3), gonorrhea, Chlamydia trachomatisinfection, etc.;
✕. History of significant diseases involving the cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, urogenital, endocrine, or psychiatric systems, which in the investigator's judgment may affect participant safety;