Itraconazole in acute vulvovaginal candidiasis (VVC): a dose finding study
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The primary effectiveness endpoint will be percentage of patients achieving clinical cure. (Clinical cure is defined as clear or almost clear symptoms [abnormal vaginal discharge, itching, redness, dysuria, dyspareunia]
研究概览
简要总结
This is an open label, prospective, randomized, dose finding, three arm, single-center clinical trial.Once the patient satisfies the inclusion criteria, she would be treated with itraconazole and fenticonazole as per the dosing schedule. Patients will be randomized to receive one of the treatments: Group I (n=35): Itraconazole 100 mg 2 capsules twice daily for 1 day + intravaginal fenticonazole 600 mg single dose on day 1., Group II (n=35): Itraconazole 100 mg 2 capsules twice daily for 2 days + intravaginal fenticonazole 600 mg single dose on day 1., Group III (n=35): Itraconazole 100 mg 1 capsules twice daily for 3 days + intravaginal fenticonazole 600 mg single dose on day 1. The patients would be called for regular follow up as per the schedule. Primary endpoint will be assessed for percentage of patients achieving clinical cure in each regime for all the groups and Improvement in each symptom and sign from baseline and each visit will be monitored as secondary parameter in all the groups. Even safety (incidences of treatment emergent adverse events (TEAEs)) will be checked throughout the study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients aged ≥ 18 years and ≤ 60 years.
- •Patients with acute vulvovaginal candidiasis (VVC) diagnosed clinically by presence of curdy white vaginal discharge.
- •Patients who are ready to give written informed consent, which includes a commitment to comply with all requirements, specified in the study protocol, among others a negative urine pregnancy test in the case of women of childbearing age.
- •Patients who the study staff deems reliable and mentally competent to carry out the study.
排除标准
- •Pregnant or nursing females.
- •Patients with chronic or recurrent VVC.
- •Patients who have received systemic or intravaginal antifungal treatment in the past 1 month.
- •Patients with concurrent bacterial, viral or trichomonal vaginal infection.
- •Patients with known hypersensitivity to the study drugs.
- •Patients with immunosuppressive disease or on immunosuppressive drugs.
- •Patients with liver dysfunction.
- •Patients with a history of seizures.
- •Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subject’s safety or interfere with the study assessments.
- •Any history of or concomitant medical condition that in the opinion of the Investigator(s) would compromise the subject’s ability to safely complete the study.
- •History of drug or alcohol dependency or abuse within approximately the last 2 years.
- •Currently enrolled in another clinical study or used any investigational drug or device within 30 days preceding informed consent or were scheduled to participate in another clinical study that involved an investigational product or investigational drug during the course of this study.
- •Any patient whom the investigator judged to be inappropriate for this study.
结局指标
主要结局
The primary effectiveness endpoint will be percentage of patients achieving clinical cure. (Clinical cure is defined as clear or almost clear symptoms [abnormal vaginal discharge, itching, redness, dysuria, dyspareunia]
时间窗: Day 1 and Day 7
次要结局
- Improvement in each symptom and sign from baseline in each visit, which will include physician as well as patient’s assessment of these signs and symptoms.(Day 1 and Day 7)