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

NCT ID: NCT04956419

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 322 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-24
• Study Completion Date: 2021-09-30

Brief Summary

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

Conditions

Acute Vulvovaginal Candidiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment group A

SHR8008 capsule

Group Type: EXPERIMENTAL

SHR8008 capsule

Intervention Type: DRUG

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

Treatment group B

Fluconazole capsule

Group Type: ACTIVE_COMPARATOR

Fluconazole capsule

Intervention Type: DRUG

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

Interventions

SHR8008 capsule

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

Intervention Type: DRUG

Fluconazole capsule

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

SHR8008-302

Identifier Type: -

Identifier Source: org_study_id