NCT02186145Unknown3 期
Single Blind Randomized Study of Efficacy and Safety of Vaginal Cream With Association of Metronidazole, Nystatin and Dexamethasone in the Treatment of Bacterial and Fungal Vaginal Infections
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Therapeutic cure
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of association of metronidazole, nystatin and dexamethasone in the treatment of bacterial and fungal vaginal infections.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menarche women and premenopausal women, between 18 and 50 years old;
- •Diagnosis of bacterial vaginosis (Amsel criteria), fungal (positive KOH test)or mixed vaginal infection;
- •Patients who have regular menstrual cycles (patients with regular menstrual cycles with intervals between 21 to 35 days, duration of 1 to 7 days)
排除标准
- •Patients who have a known hypersensitivity to components of the formula ;
- •Pregnant and lactating women ;
- •Patients with other vaginal infections, such as infection by Trichomonas vaginalis , C. trachomatis, Neisseria gonorrhoeae , herpes or HPV.
- •Knowledge of positive test result for human immunodeficiency virus ;
- •Patients in treatment of cervical intraepithelial neoplasia or carcinoma of the cervix ;
- •Patients who have undergone gynecological procedures in the month prior to inclusion (such as cauterization of the cervix , cervical biopsy, high-frequency surgery) ;
- •Patients with other vaginal or vulvar conditions that may confound interpretation of clinical response;
- •Patients who received intravaginal or systemic antimicrobial or antifungal therapy 14 days before randomization ;
- •Patients on immunosuppressive medications (such as corticosteroids , cyclosporine , etc. ) ;
- •Known or suspected cancer ;
- •Participation in any experimental study or ingestion of any experimental drug 12 months before the start of this study.
研究组 & 干预措施
Association of metronidazole; nystatin and dexamethasone
Experimental
Intravaginal cream containing metronidazole (500 mg), nystatin ( 100.000 UI) and dexamethasone (0,32 mg) once a day. Period: 10 days.
干预措施: Association of metronidazole; nystatin and dexamethasone (Drug)
Flagyl
Active Comparator
Vaginal cream of metronidazole 500 mg, nystatin 100.000 UI - once a day. Period: 10 days
干预措施: Flagyl (Drug)
结局指标
主要结局
Therapeutic cure
时间窗: Day 21-35
Therapeutic cure which is based on a combination of clinical outcome and Gram's stain results (Nugentscore)/mycological eradication.
次要结局
- Evaluation on vulvovaginal inflammation(21 - 35 days)
研究者
研究点 (1)
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