NCT02713139撤回3 期
Phase III, Multicenter, Randomized, Parallel, Open Label, Controlled and Comparative Study to Evaluate the Efficacy and Safety of the Association of Clotrimazole 200mg and Metronidazole 0,75% (Colpistatin 5DT®) Compared to Gynecological Flagyl®(Metronidazole 100mg/g) and the Vaginal Cream Gino-Canesten® 3 (Clotrimazole 20mg/g) in the Syndromic Treatment of the Vaginal Discharge From Different Etiologies.
Ache Laboratorios Farmaceuticos S.A.0 个研究点开始时间: 2013年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Ceasing of the symptoms of vaginal discharge after 3(three) days of the end of the treatment
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of the association clotrimazole 200mg and metronidazole 0,75%(Clopistatin 5DT®) and whether it is superior when compared with metronidazole 100mg/g (gynecologic Flagyl®) and clotrimazole 20mg/g (Gino-Canesten® 3) in the syndromic treatment of vaginal discharge from different etiologies.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects that have already started sexual activity;
- •Subjects with complaints of vaginal discharge and had not received treatment in the 30 days before the enrollment visit;
- •Subjects in the premenopausal period must be under usage of acceptable contraceptive methods(oral contraceptive, injectable contraceptives, IUD, hormonal implant, hormone transdermal adhesive, tubal ligation) or are surgically sterile (bilateral oophorectomy or hysterectomy); or accept to utilize a barrier contraceptive provided by the sponsor during the period of the study;
- •Subjects with the capacity to comprehend and understand her participation in this clinical trial, manifested through informed consent form, even if with the help of another person (Legal representative).
排除标准
- •Subjects with chronic diseases (diabetes mellitus, neoplasia, renal failure, tuberculosis) or any clinical and/or laboratory find (anamnesis, physical exam and/or laboratory tests) that is interpreted, in the investigator's opinion, as a risk to the subject's participation in the clinical trial;
- •Menopausal women;
- •Known hyper-sensibility to any of the products' components;
- •Pregnant or lactating women;
- •Subjects with active genital ulcer and/or with Genital herpes diagnosis;
- •Diagnosis or suspicion of Inflammatory pelvic disease;
- •Diagnosis of Vulvar condyloma acuminata;
- •Subjects under the usage of systemic corticosteroids for a period superior than 2 (two) months or under the usage of chemotherapeutics;
- •Transplanted subjects;
- •Subjects with history of active autoimmune diseases or with immune suppression;
- •Subjects under the usage of medication or therapy described on the protocol item "Prohibited Treatments";
- •Subjects that have participated on a clinical trial in the last 12 months (Conselho Nacional de Saúde - Resolução 251, de 7 de agosto de 1997, item III, sub-item J), unless the subject can have a direct benefit, in the investigator opinion;
- •Subject that have a kinship or bond with any employees of Sponsor or Research center;
研究组 & 干预措施
Colpistatin 5DT
Experimental
干预措施: Clotrimazole + Metronidazole (Drug)
Gynecological Flagyl
Active Comparator
干预措施: Metronidazole (Drug)
Gino-Canesten 3
Active Comparator
干预措施: Clotrimazole (Drug)
结局指标
主要结局
Ceasing of the symptoms of vaginal discharge after 3(three) days of the end of the treatment
时间窗: From baseline to 3 days after the end of the treatment
Examination of the breasts and internal and external examination of the female genital organ.
次要结局
- Registry of Adverse Effects occurrence throughout the study(From baseline to 30 days after the end of the treatment)
- Vaginal microflora reconstitution through microbiological evaluation of vaginal material(From baseline to 30 days after treatment's end)
- Symptomatology recurrence and/or vaginal microflora alteration 30 days after the treatment's end(From baseline to 30 days after treatment's end)
研究者
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