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

NCT05074602 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2021-10-12

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-14
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05074602 on ClinicalTrials.gov