Comparative Study of the Efficacy and Safety of LactiSal 1% Vaginal Gel and LactSal 50 mg Vaginal Tablet Versus Clotrimazole 100 mg Vaginal Tablet in the Treatment of Vulvovaginal Candidiasis (VVC)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Medinova AG
- 主要终点
- Clinical cure rate
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of LactiSal 1%vaginal gel and LactiSal 50 mg vaginal tablet with the standart treatment of clotrimazole 100 mg vaginal tablet in woman with vulvovaginal candidiasis (VVC)
详细描述
National multicenter,randomized, open-label, active-controlled with three parallel groups.Eligible patients are randomized to receive LactiSal 1% vaginal gel, LactiSal 50 mg vaginal tablet or clotrimazole 100 mg vaginal tablet for 6 days. Control examaminations are performed 10 after entry and 4 weeks after control visit 1.
The study investigates the clinical efficacy and safety of Lactisal 1% vaginal gel and LactiSal 50mg vaginal tablets in the intended use, i.e. vaginal application, and the following intended claims:
- Treatment of vaginal yeast vaginitis
- Relieves vaginal itching, burning, redness and discharge in case of yeast vaginitis
- Inhibition of yeast colonization in the vagina in case of yeast vaginitis. The study is designed to compare the clinical efficacy and safety of Lactisal 1% vaginal gel and LactiSal 50 mg vaginal tablets to a current standard drug therapy, i.e. clotrimazole 100 mg vaginal tablets.
While LactiSal is classified as medical device class IIa, the comparator is a medicinal (pharmaceutical) product. The study represents a "mixed" study, comparing the efficacy of a medical device with a pharmaceutical product.
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
- 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
- 否
入选标准
- •Clinical signs & symptoms of VVC as Total Severity Score, TSC 4 (range 0-15):
- •vaginal itching (range 0-3) ,
- •vaginal burning or soreness (range 0-3),
- •abnormal vaginal discharge (range 0-3),
- •vulvo/vaginal erythema or oedema (range 0-3),
- •vulvar excoriation or fissure formation (range 0-3).
- •Direct microscopy (Wet smear) positive for yeast forms (hyphae, pseudohyphae) or budding yeasts
- •Normal vaginal pH (≤4.5)
- •Age: 18 years and older
- •Signed Written Informed Consent to participate in this study.
排除标准
- •Recurrent VVC (4 episodes of VVC in the past 12 months).
- •Women with other vaginal infections, e.g. bacterial vaginosis, aerobic vaginitis, trichomoniasis, and mixed infections.
- •Women using oral or vaginal antifungals within 2 weeks prior to enrolment.
- •Women using any intra-vaginal products, also vaginal douches containing soaps and other anionic, surface-active substances, within 2 weeks prior to enrolment.
- •Women using any antibiotic or anti-infective within 2 weeks prior to enrolment.
- •Women having menstruation bleeding at enrolment
- •Cervicitis, cervical erosions, and malignant tumours in the genital tract
- •Pregnancy or lactation.
- •Women not consenting to be sexually abstinent during the treatment, not taking oral contraceptive or not having an IUD for contraception
- •Woman using intravaginal pessaries, rings, sponges or diaphragms
- •Severe systemic diseases (diabetes mellitus, cancer, tuberculosis, autoimmune diseases, severe psychiatric conditions, etc.).
- •Women with confirmed or suspected STD (HIV infection, gonorrhoea, syphilis, chlamydiasis, etc.).
- •Known or suspected hypersensitivity to one of the study medications, inclusive their excipients.
- •Participation of patient in another clinical study concomitantly or within 30 days prior to enrolment
- •Patient is relative of, or staff directly reporting to, the investigator.
研究组 & 干预措施
LactiSal vaginal gel 1%
5g of 1%LactiSal Gel vaginal gel once daily for 6 days
干预措施: LactiSal vaginal gel 1% (Device)
LactiSal vaginal tablet 50 mg
50 mg of LactiSal vaginal tablet daily for 6 days
干预措施: LactiSal vaginal tablet 50mg (Device)
Clotrimazole vaginal tablet 100mg
100 mg Clotrimazole vaginal tablet daily for 6 days
干预措施: Clotrimazole vaginal tablet 100mg (Drug)
结局指标
主要结局
Clinical cure rate
时间窗: 10 days after entry (C1)
Clinical cure is defined as patient having a Total Severity Score of less than 3. The Total Severity Score (TSC) is assessed by the Investigator, examining and interviewing the patient. The TSC is the sum score of the 5 individual signs symptoms - vaginal itching, vaginal burning or soreness, abnormal vaginal discharge, vulvovaginal erythema or oedema and vulval excoriation or fissure formation. Each sign and symptom is assessed with a score from 0 to 3, resulting in total score for TSC of 0 to 15.
次要结局
- Patient's satisfaction(10 days after entry visit and 4 weeks after control visit 1)
- The Total Severity Score (TSC) Individual clinical signs and symptoms(10 days after entry visit and 4 weeks after control visit 1)
- Direct microscopy (Wet smear)(10 days after entry visit and 4 weeks after control visit 1)
- pH(10 days after entry visit and 4 weeks after control visit 1)
- Candida culture(10 days after entry visit and 4 weeks after control visit 1)
- Microbiological cure rate(10 days after entry visit and 4 weeks after control visit 1)
- Clinical cure rate(4 weeks after control visit 1)
- Therapeutic cure rate(10 days after entry visit and 4 weeks after control visit 1)
- Dyspareunia and external dysuria(10 days after entry visit and 4 weeks after control visit 1)
- Efficacy assessment(10 days after entry visit and 4 weeks after control visit 1)
- Patients diary(10 days after entry visit and 4 weeks after control visit 1)