NCT05552378已完成不适用
A Single Arm Stuidy to Confirm Safety and Efficacy of Multi-Gyn FloraFem Study for Treatment of Vulvo Vaginal Candidiasis Symptoms
Karo Pharma AB1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年2月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To determine the efficacy of Multi-Gyn FloraFem in relieving itch during vaginal candidiasis (based on 0-10 point scale score improvement > 1 related to vulvovaginal candidiasis at Visit 2.
研究概览
简要总结
Women diagnosed with Vulvovaginal Candidiasis by the health care professional will be enrolled in the study. All participants should fulfil inclusion and exclusion criteria.
The study product will be used for 5 days, once a day. The doctor will evaluate the patients before and at the end of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women diagnosed with Vulvovaginal Candidiasis confirmed by:itching, and/or burning, irritation, edema, redness, crumbly white discharge
- •Aged >18 years
- •Signed written informed consent form
- •Willing to comply to the follow-up schedule
- •Subject affiliated to a health social security system.
- •Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit, during all the study and at least 1 month after the study end.
排除标准
- •Current clinically manifest of sexually transmitted gynecologically infection, genital tract infection, bacterial vaginosis or aerobic vaginitis (incl. clinical obvious gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with cervicitis, urethritis, salpingitis)
- •Current genital malignancies
- •Chemotherapy for any reason in last 6 months
- •Radiotherapy in the genitourinary system in the last 12 months
- •Pregnancy or currently attempting to conceive
- •Lactation
- •Use of other treatment for vaginal conditions during the course of the clinical investigation
- •Known allergies to ingredients of the product
- •Concomitant medication for treatment of vaginal infections, or other use of intravaginal medication during the course of the clinical investigation
结局指标
主要结局
To determine the efficacy of Multi-Gyn FloraFem in relieving itch during vaginal candidiasis (based on 0-10 point scale score improvement > 1 related to vulvovaginal candidiasis at Visit 2.
时间窗: 1 week
Women should have at least itch related to vaginal candidiasis.
次要结局
未报告次要终点
研究者
研究点 (1)
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