NCT03839875已完成4 期
A National, Multi-central, Open-label, Single-arm, Phase IV Study to Evaluate Efficacy and Safety of Gynomax® XL Ovule in the Treatment of Trichomonal Vaginitis, Bacterial Vaginosis, Candidal Vulvovaginitis and Mixed Vaginal Infections
Exeltis Turkey1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2019年4月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Percentage of patients with complete response to treatment
研究概览
简要总结
Efficacy and safety of Gynomax® XL ovule in the treatment of trichomonal vaginitis, bacterial vaginosis, candidal vulvovaginitis and mixed vaginal infections will be evaluated in this open label, single-arm, multicentral study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Female patients with age ≥ 18 and ≤ 45 years
- •Patients requiring treatment for bacterial vaginosis, candidal vulvovaginitis or mixed infections according to the investigator's decision
- •Signed informed consent
排除标准
- •Known hypersensitivity to active ingredients of the study medications
- •Vaginismus, endometriosis, dyspareunia
- •Detection of urinary tract infection in urinalysis
- •Acute or chronic infections such as pancreatitis, hypertriglyceridemia, liver diseases, benign or malign tumors
- •Usage of herbal medicines that interfere with microsomal enzymes, especially cytochrome P450 (phenytoin, phenobarbital, primidone, carbamazepine, rifampicin, topiramate, felbamate, griseofulvin, HIV protease inhibitors such as ritonavir, nucleoside reverse transcriptase inhibitors such as efavirenz)
- •History of cardiovascular event
- •Advanced hypertension and diabetes
- •Presence or known risk or of venous or arterial thromboembolism
- •Undiagnosed abnormal vaginal bleeding, bleeding disorders, genital tumors
- •Use of drugs containing ombitasvir / paritaprevir / ritonavir or dasabuvir during or two weeks before initiation of the study
- •Pregnancy and/or breastfeeding
- •Participation in any other trial 30 days before initiation of the study
- •Postmenopausal women
- •Abuse of alcohol
- •Usage of medications containing acenocoumarol, anisindione, dicoumarol, phenindione, phenprocoumon, warfarin, cholestyramine, cimetidine, cyclosporine, disulfiram, fluorouracil, fosphenitoin, ketoconazole, lithium, rifampin, tacrolimus or propranolol
- •Presence of a sexually transmitted disease such as syphilis, gonorrhea, etc. according to the investigators decision
研究组 & 干预措施
Active Treatment
Experimental
干预措施: Gynomax® XL Vaginal Ovule (Drug)
结局指标
主要结局
Percentage of patients with complete response to treatment
时间窗: 10 Days after completion of treatment
次要结局
- Percentage of patients with no response to treatment(10 Days after completion of treatment)
- Percentage of patients with partial response to treatment(10 Days after completion of treatment)
研究者
研究点 (1)
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