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Efficacy and Safety Study of BPR-101 Capsules in Combination With Metronidazole in BV Patients

NCT07483671 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-03-19

No results posted yet for this study

Summary

This trial employed a multicenter, randomized, double-blind, parallel, placebo-controlled design to evaluate the preventive effect of BPR-101 capsules combined with metronidazole on the recurrence of BV, as well as the cure rate and safety.

Conditions

  • Bacterial Vaginosis

Interventions

DRUG

BPR-101 capsules:Investigational product for the treatment of BV

administered vaginally and orally as per study protocol.

OTHER

Placebo：matching the investigational product in appearance, dosage form, and route of administration

administered vaginally and orally as per study protocol.

Sponsors & Collaborators

  • Chengdu Syncor Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • FengXia Xue, Doctor of Medicine(M.D.) · 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
2026-04-15
Primary Completion
2027-01-24
Completion
2027-01-24

Countries

  • China

Study Locations

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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 NCT07483671 on ClinicalTrials.gov