NCT05074602

A Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Recurrent Vulvovaginal Candidiasis

A Randomized, Double-Blind, Double-Dummy, Parallel Fluconazole Controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Recurrent Vulvovaginal Candidiasis (RVVC)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the Efficacy and Safety of SHR8008 capsule In Subjects With Recurrent Vulvovaginal Candidiasis

Conditions

• Recurrent Vulvovaginal Candidiasis

Interventions

Type	Name	Description
DRUG	SHR8008	Dosing frequency: During Part 1, administered orally once daily for 2 days. During Part 2, administered orally once weekly for 11 weeks starting from Week 3, Route of administration: oral
DRUG	Fluconazole	Dosing frequency: During Part 1, administered orally 3 sequential doses (every 72 hours), During Part 2, administered orally once weekly for 6 Months starting from Week 3. Route of administration: oral

Timeline

• Start date: 2021-09-14
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2021-10-12
• Last updated: 2021-10-12

Locations

1 site across 1 country: China