NCT05031481撤回2 期
National, Multicenter, Randomized, Double-blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Different Doses of Venus Association in Patients With Vulvovaginal Candidiasis
EMS0 个研究点开始时间: 2022年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Time to first relief of symptoms
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of different doses of Venus association in the treatment of 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
- •Age greater than or equal to 18 years;
- •Female participants, post-menarche;
- •Clinical diagnosis of vulvovaginal candidiasis, defined as white, fluid or creamy vaginal discharge, in addition to the following findings:
- •Itching and one or more of the following signs and symptoms characterized as moderate or severe: vulvar/vaginal erythema, edema, burning, irritation, and excoriation;
- •Normal vaginal pH;
- •Preparation of KOH or saline from a sample taken from inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or growing yeast.
排除标准
- •Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
- •Participation in a clinical trial in the year prior to this study;
- •Pregnancy or risk of pregnancy and lactating patients;
- •Known hypersensitivity to any of the formula compounds;
- •Virgin participants;
- •Postmenopausal participants or with vaginal atrophy;
- •Participants with other vaginal infections;
- •Participants with recurrent vulvovaginal candidiasis;
- •Participants using immunosuppressive drugs;
- •Participants diagnosed with serious systemic diseases.
研究组 & 干预措施
VENUS 20 + 0,064
Experimental
Venus association vaginal cream, single dose.
干预措施: Venus 20 + 0,064 (Drug)
VENUS 20 + 1
Experimental
Venus association vaginal cream, single dose.
干预措施: Venus 20 + 1 (Drug)
VENUS 20 + 4
Experimental
Venus association vaginal cream, single dose.
干预措施: Venus 20 + 4 (Drug)
Butoconazole nitrate 100 mg
Active Comparator
Butoconazole nitrate vaginal cream, single-dose containing 100 mg.
干预措施: Butoconazole nitrate (Drug)
结局指标
主要结局
Time to first relief of symptoms
时间窗: 0-24 hours
Time to obtain moderate relief of at least one of the evaluated symptoms (itching, irritation or burning) after the application of the medication.
次要结局
- Adverse events(28 days)
研究者
相似试验
已完成
不适用
Multi-polar RF and PEMF for Treatment of Symptoms Associated With Vulvovaginal AtrophyVulvovaginal AtrophyNCT03725410Venus Concept81
尚未招募
不适用
A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic ValveAortic Valve DiseaseCardiovascular DiseasesNCT05941455Jilin Venus Haoyue Medtech Limited155
已完成
2 期
APSV in Vaccinia Naive AdultsSmallpoxNCT00050518National Institute of Allergy and Infectious Diseases (NIAID)444
终止
2 期
Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyUlcerative ColitisNCT00279435Facet Biotech25
已完成
2 期
A Combination Therapy In Patients With Social Anxiety DisorderSocial PhobiaNCT00403962GlaxoSmithKline204