NCT07483671

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

A Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of BPR-101 Capsules in Combination With Metronidazole for the Prevention of Recurrence of Bacterial Vaginosis (BV).

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Chengdu Syncor Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2026-04-15
• Primary completion: 2027-01-24
• Completion: 2027-01-24
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

1 site across 1 country: China