Clinical trial NCT04956419: A Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Vulvovaginal Candidiasis
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-09
Enrollment: 322
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Fluconazole Controlled, Multicenter Phase III Clinical Study
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: The proportion of subjects with therapeutic cure
timeFrame: Day 28
Secondary outcomes:
measure: The proportion of subjects therapeutic cure
timeFrame: Day 14
measure: The proportion of subjects with clinical cure
timeFrame: Day 14 and Day 28
measure: The proportion of subjects with mycological cure
timeFrame: Day 14 and Day 28
measure: Changes from baseline in VVC signs and symptoms score
timeFrame: Day 14 and Day 28
measure: The proportion of subjects receiving rescue therapy during the study
timeFrame: 28 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
state: Beijing
Study officials:
References: