NCT05074602Unknown3 期
A Randomized, Double-Blind, Double-Dummy, Parallel Fluconazole Controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Recurrent Vulvovaginal Candidiasis (RVVC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- The proportion of subjects with one or more culture-verified VVC episodes during the study.
研究概览
简要总结
The purpose of this study is to evaluate the Efficacy and Safety of SHR8008 capsule In Subjects With Recurrent 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.
- •Have a history of RVVC at screening.
- •Suitable for oral therapy and able to swallow capsules intact.
- •Subjects of childbearing potential must use highly effective contraceptive measures throughout the study.
- •Willing to sign the informed consent form to participate in this study.
排除标准
- •Presence of concomitant vulvovaginitis caused by other pathogens.
- •Have a 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 (not applicable to subjects with a history of total hysterectomy).
- •Any condition that, in the opinion of the investigator, could impact drug absorption, distribution, or elimination.
- •Moderate to severe hepatic and/or renal disorders.
- •Significant laboratory abnormality at screening.
- •QTc interval greater than 470 ms or other clinically significant ECG abnormality at screening.
- •Have received systemic or vulvovaginal antifungal drugs, antibacterials, antitrichomonal, CYP3A4 substrates or inducers or inhibitors, and vulvovaginal corticosteroids within 7 days prior to randomization.
- •Have received any estrogen replacement therapy or vaginal topical products.
- •Have received systemic corticosteroid therapy within 30 days or systemic immunosuppressant therapy within 90 days prior to randomization;
- •Have planned surgery or other medical procedures that may impact compliance with the protocol;
- •Known history of hypersensitivity or intolerance to azole antifungal drugs.
- •History of narcotic or drug abuse or alcoholism, or any other medical, psychiatric or social condition that in the investigator's opinion could preclude compliance with the protocol.
- •Women who are pregnant or lactating, or planning to become pregnant during the study period.
- •Have received VT-1161 study medication in a previous study or received any investigational medicinal product (IMP) in a clinical study within 5 half-lives of that IMP prior to screening (if the half-life is unknown, 60 days prior to screening);
- •other conditions unsuitable for participation in the study.
研究组 & 干预措施
SHR8008
Experimental
干预措施: SHR8008 (Drug)
Fluconazole
Active Comparator
干预措施: Fluconazole (Drug)
结局指标
主要结局
The proportion of subjects with one or more culture-verified VVC episodes during the study.
时间窗: 50 weeks
次要结局
- The proportion of subjects with one or more culture-verified VVC episodes during the follow-up phase.(Week 27 through Week 50)
- The proportion of subjects with resolved VVC episode (clinical signs and symptoms score of < 3) during induction phase(Day 14)
- Time to first recurrence of a culture-verified VVC episode during the maintenance phase and follow-up phase.(Week 3 through Week 50)
- The proportion of subjects with therapeutic cure, clinical cure, and mycological cure during the maintenance phase.(Day 14)
- The proportion of subjects with therapeutic cure (clinical cure plus mycological cure) at the end of induction phase.(Day 14)
- The proportion of subjects with 2 culture-verified VVC episodes during the study.(week 50)
- The proportion of subjects with at least one positive culture for Candida species during the maintenance phase and follow-up phase(Week 3 through Week 50)
- The proportion of subjects with clinical cure (defined as the absence of all signs and symptoms of VVC) at the end of induction phase .(Day 14)
- The proportion of subjects with one or more culture-verified VVC episode during the maintenance phase(Week 3 through Week 26)
- The proportion of subjects with ≥ 3 culture-verified VVC episodes during the study.(week 50)
- The proportion of subjects with one or more culture-verified VVC episodes during the maintenance phase and follow-up phase.(Week 3 through Week 50)
- The proportion of subjects receiving rescue treatment during the maintenance phase and follow-up phase.(Week 3 through Week 50)
- The proportion of subjects with mycological cure (defined as vaginal swab culture negative for growth of Candida species) at the end of induction phase.(Day 14)
- The proportion of subjects with at least one positive culture for Candida species during the maintenance phase(Week 3 through Week 26)
- The proportion of subjects with at least one positive culture for Candida species during the follow-up phase(Week 27 through Week 50)
研究者
研究点 (1)
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