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Clinical Trials/NCT04956419
NCT04956419UnknownPhase 3

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

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country322 target enrollmentStarted: April 24, 2021Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Enrollment
322
Locations
1
Primary Endpoint
The proportion of subjects with therapeutic cure
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole In Subjects with Acute vulvovaginal Candidiasis

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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;
  • •Subjects of childbearing potential must have a negative pregnancy test result at screening and agree to use highly effective contraceptive measures throughout the study;
  • •Willing to sign the informed consent form to participate in this study.

Exclusion Criteria

  • •Have recurrent vulvovaginal candidiasis (RVVC) as defined by 4 or more confirmed VVC episodes in the past 12 months or history of RVVC;
  • •Presence of concomitant vulvovaginitis caused by other pathogens;
  • •History of cervical cancer, or "cervical intraepithelial neoplasia or malignancy" or "atypical squamous cells of undetermined significance (ASCUS)" as indicated by Pap test or other tests reported within 1 year before screening;
  • •Moderate to severe hepatic and/or renal disorders;
  • •Have received systemic or vulvovaginal antifungal drugs, antibacterials, antitrichomonal, CYP3A4 substrates or inducers or inhibitors, or vulvovaginal corticosteroids within 7 days prior to randomization;
  • •Have received any estrogen replacement therapy or vaginal topical products within 7 days prior to randomization;
  • •Have received systemic corticosteroid therapy within 30 days or systemic immunosuppressant therapy within 90 days prior to randomization;
  • •Presence of significant laboratory abnormalities at screening;
  • •QTc interval greater than 470 ms or other clinically significant ECG abnormalities at screening;
  • •Have planned surgeries or other medical procedures that may impact compliance with the protocol;
  • •Known history of hypersensitivity or intolerance to azole antifungal drugs;
  • •Being in the menstrual period, pregnant, or lactating at screening, or planning to become pregnant during the study period;
  • •History of narcotic or drug abuse or alcoholism within 6 months prior to screening;
  • •Have participated in another clinical study and received the investigational drug containing active ingredient within 30 days prior to screening;
  • •Other conditions unsuitable for participation in the study per investigator's judgment.

Arms & Interventions

Treatment group A

Experimental

SHR8008 capsule

Intervention: SHR8008 capsule (Drug)

Treatment group B

Active Comparator

Fluconazole capsule

Intervention: Fluconazole capsule (Drug)

Outcomes

Primary Outcomes

The proportion of subjects with therapeutic cure

Time Frame: Day 28

defined as absence of signs and symptoms of VVC plus negative culture of vaginal swabs for growth of Candida species

Secondary Outcomes

  • 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)
  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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