COMPARATIVE CLINICAL EVALUATION OF EFFICACY AND SAFETY OF TIOCONAZOLE VAGINAL FILM VS CANESTEN V6 VAGINAL TABLET IN THE MANAGEMENT OF SYMPTOMATIC VULVOVAGINAL CANDIDIASIS IN NON-PREGNANT WOMEN - OPEN LABEL, RANDOMIZED, PARALLEL, PROSPECTIVE, MULTICENTRIC STUDY.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 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 resolution or improvement of clinical signs and symptoms pertaining to VVC at the end of day 7 in each treatment group.
研究概览
简要总结
| Design: Open-label, randomized, |
| parallel-group, prospective, multicentric clinical trial. |
Objectives: To evaluate the clinical efficacy and safety of Tioconazole Vaginal Film 300 mg compared to Canesten V6 Vaginal Tablet in treating symptomatic vulvovaginal candidiasis (VVC) in non-pregnant women.
Treatment Regimen
Tioconazole Vaginal Film 300 mg: Single-dose administration.
Canesten V6 Vaginal Tablet: Daily administration for 7 consecutive days.
Safety Follow-up: Conducted up to Day 14 post-treatment.
Primary Outcomes
Clinical Cure: Proportion of patients with resolution or improvement of clinical signs and symptoms of VVC at Day 7.
Mycological Cure: Proportion of patients with negative potassium hydroxide (KOH) wet mount from vaginal smear for filamentous hyphae, pseudo hyphae, or budding yeast cells at Day 7.
Therapeutic Cure: Proportion of patients achieving both clinical and mycological cure at Day 7.
Secondary Outcome
Treatment-Emergent Adverse Events (TEAEs): Incidence of adverse events occurring during the treatment period, assessed at Days 7 and 14.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Women aged 18 to 45 years with clinical diagnosis of symptomatic vulvovaginal candidiasis 2.Subjects with positive baseline potassium hydroxide (KOH) wet mount from a vaginal smear revealing filamentous hyphae or pseudo hyphae or budding yeast cells 3.Presence of more than 1 vulvovaginal sign (erythema, Edema, excoriation), presence of more than 1 vulvovaginal symptom (itching or pruritus, irritation in and around vagina, burning; composite severity score of greater than 7 4.Patients with negative whiff test 5.Patients with vaginal pH less than 4.5 6.Agree to abstain from intercourse during the study period 7.Agree not to douche or use any intravaginal products during the study period 8.Willing to report response to treatment as per protocol during the study period 9.Willing to give written informed consent.
排除标准
- •Post menopausal women
- •Menstruating at diagnosis
- •Pregnancy or nursing mothers
- •Use of intravaginal pessaries, corticosteroids, immune suppressive, immunostimulant therapy in the last 2 weeks Presence of another vaginal condition, cervical cancer
- •History of hypersensitivity to study medication, serious illness
- •Patients with uncontrolled Diabetes mellitus.
结局指标
主要结局
-Proportion of patients with clinical cure - defined as resolution or improvement of clinical signs and symptoms pertaining to VVC at the end of day 7 in each treatment group.
时间窗: Day 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 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 7,14
次要结局
- Treatment emergent adverse events (TEAEs)(Day 7,14.)
研究者
Dr U Shobha Jagdish Chandra
Hetero Healthcare Limited