MedTrace Logo

Efficacy and Safety of Vaginal Lactobacillus Dual Probiotic Capsules in Bacterial Vaginosis

NCT07418957 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2026-02-18

No results posted yet for this study

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.

Conditions

  • Bacterial Vaginosis (BV)

Interventions

DRUG

Vaginal Lactobacillus Dual Probiotic Capsules

Investigational product for the treatment of BV, administered vaginally as per study protocol.

OTHER

Placebo

Placebo, matching the investigational product in appearance, dosage form, and route of administration, used as the control intervention in this double-blind, randomized trial.

Sponsors & Collaborators

  • Guangdong Longchuangji Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Fengxia F Xue, Study leader · Tianjin Medical University General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-12
Primary Completion
2025-05-17
Completion
2025-07-03

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07418957 on ClinicalTrials.gov