COMPARATIVE CLINICAL EVALUATION OF EFFICACY AND SAFETY OF CLOTRIMAZOLE VAGINAL FILM VS CANESTEN V6 VAGINAL TABLET IN THE MANAGEMENT OF SYMPTOMATIC VULVOVAGINAL CANDIDIASIS IN NON PREGNANT WOMEN - OPEN LABEL, RANDOMIZED, COMPARATIVE, PARALLEL, PROSPECTIVE, MULTICENTRIC STUDY
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 10
- 主要终点
- - Proportion of patients with clinical cure - defined as complete resolution of signs and symptoms pertaining to VVC at the end of day 7 in each treatment group.
研究概览
简要总结
It is an Open Label, Randomized, Comparative, Parallel, Prospective, Multicentric study. The primary objective of this is to evaluate the clinical efficacy of Clotrimazole Vaginal film as compared to Canesten V6 vaginal tablet in the management of symptomatic vulvovaginal candidiasis in non pregnant women.
The Secondary objective of this trial is to assess the safety of Clotrimazole vaginal film as compared to Canesten V6 vaginal tablet in the management of symptomatic vulvovaginal candidiasis in non pregnant women. Duration of therapy is 7 days, safety follow up will be conducted up to day 14.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women aged 18 to 45 years with clinical diagnosis of symptomatic vulvovaginal candidiasis.
- •Subjects with positive baseline potassium hydroxide (KOH) wet mount from a vaginal smear revealing filamentous hyphae / pseudo hyphae or budding yeast cells.
- •Presence of > 1 vulvovaginal sign (erythema, edema, excoriation), presence of > 1 vulvovaginal symptom (itching / pruritus, irritation in and around vagina, burning); composite severity score of >
- •Patients with negative whiff test.
- •Patients with vaginal pH < 4.
- •Agree to abstain from intercourse during the study period.
- •Agree not to douche or use any intravaginal products during the study period.
- •Willing to report response to treatment as per protocol during the study period.
- •Willing to give written informed consent.
排除标准
- •Post-menopausal women
- •Menstruating at diagnosis
- •Pregnancy or nursing mothers
- •Use of intravaginal pessaries, immune suppressive therapy in the last 2 weeks.
- •Presence of another vaginal condition, cervical cancer.
- •H/O hypersensitivity to study medication, serious illness.
结局指标
主要结局
- Proportion of patients with clinical cure - defined as complete resolution of signs and symptoms pertaining to VVC at the end of day 7 in each treatment group.
时间窗: Day 3,7,14
- Proportion of patients with mycological cure – negative potassium hydroxide (KOH) wet mount from vaginal smear for filamentous hyphae / pseudo hyphae or budding yeast cells at the end of day 7 in each treatment group.
时间窗: Day 3,7,14
- Proportion of patients with Therapeutic cure – defined as clinical and mycological cure at end of day 7 in each treatment group.
时间窗: Day 3,7,14
次要结局
- Treatment Emergent Adverse Events(Day 3, 7, 14)