NCT04956419Unknown3 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 322
- 试验地点
- 1
- 主要终点
- The proportion of subjects with therapeutic cure
研究概览
简要总结
The purpose of this study is to evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole In Subjects with Acute vulvovaginal Candidiasis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment group A
Experimental
SHR8008 capsule
干预措施: SHR8008 capsule (Drug)
Treatment group B
Active Comparator
Fluconazole capsule
干预措施: Fluconazole capsule (Drug)
结局指标
主要结局
The proportion of subjects with therapeutic cure
时间窗: Day 28
defined as absence of signs and symptoms of VVC plus negative culture of vaginal swabs for growth of Candida species
次要结局
- 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)
研究者
研究点 (1)
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