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

Hengrui Medicine

Status and phase: Unknown; Phase 3

Conditions: Acute Vulvovaginal Candidiasis

Treatments: Drug: Fluconazole capsule; Drug: SHR8008 capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT04956419

SHR8008-302

Details and patient eligibility

About

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

Enrollment: 322 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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322 participants in 2 patient groups

Treatment group A

Experimental group

Description:

SHR8008 capsule

Treatment:

Drug: SHR8008 capsule

Treatment group B

Active Comparator group

Description:

Fluconazole capsule

Treatment:

Drug: Fluconazole capsule