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NOT YET RECRUITING
NCT07483671
PHASE2

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

Sponsor: Chengdu Syncor Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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).

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-04-15

Completion Date

2027-01-24

Last Updated

2026-03-19

Healthy Volunteers

No

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.

Locations (1)

Tianjin Medical University General Hospital

Tianjin, China