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WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Sponsor: SPH Sine Pharmaceutical Laboratories Co., Ltd.
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
Conditions
Interventions
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).
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).
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