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

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04956419
Collaborator
(none)
322
1
2
5.2
61.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: SHR8008 capsule
  • Drug: Fluconazole capsule
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
322 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Fluconazole Controlled, Multicenter Phase III Clinical StudyA Randomized, Double-Blind, Double-Dummy, Parallel-Group, Fluconazole Controlled, Multicenter Phase III Clinical Study
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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)
Actual Study Start Date :
Apr 24, 2021
Anticipated Primary Completion Date :
Sep 30, 2021
Anticipated Study Completion Date :
Sep 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group A

SHR8008 capsule

Drug: SHR8008 capsule
once daily for 2 days(Day 1 and Day 2),oral

Active Comparator: Treatment group B

Fluconazole capsule

Drug: Fluconazole capsule
once daily for 2 days(Every 72 hours) ,oral

Outcome Measures

Primary Outcome Measures

  1. The proportion of subjects with therapeutic cure [Day 28]

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

Secondary Outcome Measures

  1. The proportion of subjects therapeutic cure [Day 14]

  2. The proportion of subjects with clinical cure [Day 14 and Day 28]

    defined as absence of signs and symptoms of VVC

  3. The proportion of subjects with mycological cure [Day 14 and Day 28]

    defined as negative culture of vaginal swabs for growth of Candida species

  4. Changes from baseline in VVC signs and symptoms score [Day 14 and Day 28]

  5. The proportion of subjects receiving rescue therapy during the study [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Females ≥18 and ≤75 years old;

  2. Clinical diagnosis with VVC episodes at screening, signs and symptoms score of ≥ 7, with a documented positive potassium hydroxide (KOH) or Gram staining;

  3. Subjects of childbearing potential must have a negative pregnancy test result at screening and agree to use highly effective contraceptive measures throughout the study;

  4. Willing to sign the informed consent form to participate in this study.

Exclusion Criteria:
  1. Have recurrent vulvovaginal candidiasis (RVVC) as defined by 4 or more confirmed VVC episodes in the past 12 months or history of RVVC;

  2. Presence of concomitant vulvovaginitis caused by other pathogens;

  3. 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;

  4. Moderate to severe hepatic and/or renal disorders;

  5. Have received systemic or vulvovaginal antifungal drugs, antibacterials, antitrichomonal, CYP3A4 substrates or inducers or inhibitors, or vulvovaginal corticosteroids within 7 days prior to randomization;

  6. Have received any estrogen replacement therapy or vaginal topical products within 7 days prior to randomization;

  7. Have received systemic corticosteroid therapy within 30 days or systemic immunosuppressant therapy within 90 days prior to randomization;

  8. Presence of significant laboratory abnormalities at screening;

  9. QTc interval greater than 470 ms or other clinically significant ECG abnormalities at screening;

  10. Have planned surgeries or other medical procedures that may impact compliance with the protocol;

  11. Known history of hypersensitivity or intolerance to azole antifungal drugs;

  12. Being in the menstrual period, pregnant, or lactating at screening, or planning to become pregnant during the study period;

  13. History of narcotic or drug abuse or alcoholism within 6 months prior to screening;

  14. Have participated in another clinical study and received the investigational drug containing active ingredient within 30 days prior to screening;

  15. Other conditions unsuitable for participation in the study per investigator's judgment.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Tsinghua Changgung Hospital Beijing Beijing China 102200

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04956419
Other Study ID Numbers:
  • SHR8008-302
First Posted:
Jul 9, 2021
Last Update Posted:
Sep 16, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2021