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NOT YET RECRUITING
NCT07888699
PHASE2

WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis

Sponsor: SPH Sine Pharmaceutical Laboratories Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial enrolling approximately 150 pre-menopausal women with bacterial vaginosis (BV). Participants will be randomized 1:1:1 to three groups. All participants will receive oral metronidazole 0.4 g twice daily for 7 days. In addition, participants will take vaginal capsules (high-dose WST03, low-dose WST03, or matched placebo) once daily for 14 days. The primary endpoint is cumulative BV recurrence rate at Week 12. This trial evaluates the efficacy and safety of WST03 plus metronidazole for lowering BV recurrence and explores its impact on vaginal microecology.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled PhaseⅡ Study to Evaluate the Efficacy and Safety of WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis

Key Details

Gender

FEMALE

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-10-20

Completion Date

2027-12-25

Last Updated

2026-10-22

Healthy Volunteers

No

Interventions

DRUG

High-dose WST03 Vaginal Capsule Metronidazole

High-dose vaginal capsule containing multi-strain live lactobacilli; vaginal administration, once daily for 14 consecutive days (Day 1-14). Metronidazole 0.4 g twice daily for 7 days (Day1-7).

DRUG

Low-dose WST03 Vaginal Capsule Metronidazole

Low-dose vaginal capsule containing multi-strain live lactobacilli; vaginal administration, once daily for 14 consecutive days (Day 1-14). Metronidazole 0.4 g twice daily for 7 days (Day1-7).

DRUG

Placebo Vaginal Capsule Metronidazole

Placebo vaginal capsule, visually identical to WST03 capsule, vaginal administration, once daily for 14 consecutive days (Day1-14). Metronidazole 0.4 g twice daily for 7 days (Day1-7).

Locations (14)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijing, Beijing Municipality, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Shenzhen University of Technology General Hospital

Shenzhen, Guangdong, China

Liuzhou Maternal and Child Health Hospital

Liuzhou, Guangxi, China

The First Affiliated Hospital of Henan Medical University

Xinxiang, Henan, China

Taihe Hospital, Shiyan City

Shiyan, Hubei, China

Zhuzhou Maternal and Child Health Hospital

Zhuzhou, Hunan, China

The Second Hospital of Jilin University

Changchun, Jilin, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, China

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Chengdu Women's and Children's Central Hospital

Chengdu, Sichuan, China

Women's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China