Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Vulvovaginal Candidiasis

Outcome Measures

Primary Outcomes (1)

The proportion of subjects with therapeutic cure
defined as absence of signs and symptoms of VVC plus negative culture of vaginal swabs for growth of Candida species
Day 28

Secondary Outcomes (5)

The proportion of subjects therapeutic cure
Day 14
The proportion of subjects with clinical cure
Day 14 and Day 28
The proportion of subjects with mycological cure
Day 14 and Day 28
Changes from baseline in VVC signs and symptoms score
Day 14 and Day 28
The proportion of subjects receiving rescue therapy during the study
28 days

Study Arms (2)

Treatment group A

EXPERIMENTAL

SHR8008 capsule

Drug: SHR8008 capsule

Treatment group B

ACTIVE COMPARATOR

Fluconazole capsule

Drug: Fluconazole capsule

Interventions

SHR8008 capsuleDrug

once daily for 2 days(Day 1 and Day 2),oral

Treatment group A

Fluconazole capsuleDrug

once daily for 2 days(Every 72 hours) ,oral

Treatment group B

Eligibility Criteria

Age18 Years - 75 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Females ≥18 and ≤75 years old;
Clinical diagnosis with VVC episodes at screening, signs and symptoms score of ≥ 7, with a documented positive potassium hydroxide (KOH) or Gram staining;

Sponsors & Collaborators

Jiangsu HengRui Medicine Co., Ltd.
Industrylead

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102200, China

MeSH Terms

Interventions

Fluconazole

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Enrollment

322 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 7, 2021

First Posted

July 9, 2021

Study Start

April 24, 2021

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Treatment group A

Treatment group B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Treatment group A

Treatment group B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations