Phase III Study to Evaluate Efficacy and Safety of Different Formulations of Fenticonazole + Tinidazole + Lidocaine in the Treatment of Bacterial Vaginosis, Candidal Vulvovaginitis, Trichomonal Vaginitis and Mixed Infections
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 577
- 试验地点
- 1
- 主要终点
- Percentage of patients who had complete response to treatment according to clinical findings
研究概览
简要总结
Efficacy and safety of two new formulations compared to Gynomax® XL ovule in the treatment of trichomonal vaginitis, bacterial vaginosis, candidal vulvovaginitis and mixed vaginal infections was evaluated in this randomized, three-arms, multicentral study.
详细描述
This was a national, randomized, 3-arms, phase III study conducted in 16 centers in Türkiye.
It was aimed to evaluate the efficacy and safety of different fixed dose vaginal ovule formulations of fenticonazole + tinidazole + lidocaine (Formulation A and Formulation B) in the treatment of bacterial vaginosis, candidal vulvovaginitis, trichomonal vaginitis and mixed infections with comparison to Gynomax® XL vaginal ovule.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with age of ≥ 18 and ≤ 55 years who have a regular menstrual cycle (at least 10 times a year)
- •Female patients who previously experienced vaginal intercourse
- •Patients requiring treatment for bacterial vaginosis, candidal vulvovaginitis, trichomonal vaginitis or mixed infections according to the investigator's decision
- •Signed informed consent
排除标准
- •Known hypersensitivity to active ingredients (including their derivatives) of the study medications
- •Vaginismus, endometriosis, dyspareunia
- •Detection of urinary tract infection in urinalysis
- •Pancreatitis, hypertriglyceridemia, liver diseases, benign or malign tumors and ongoing organ failure
- •Usage of herbal medicines and drugs 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
- •Uncontrolled diabetes and hypertension
- •Presence or known risk or of venous or arterial thromboembolism
- •Undiagnosed abnormal vaginal bleeding, bleeding disorders, bleeding due to intrauterine device implantation during study period, presence of 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
- •Chronic alcoholism
- •Patients with organic neurological disorders
- •Patients with blood dyscrasia or with a history of blood dyscrasia
- •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, chlamydia etc. according to the investigator's decision
- •Patients who cannot perform sexual abstinence during the study
- •Patients whose treatment may be affected due to sagging of uterus or any other anatomical disorder
研究组 & 干预措施
fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN A)
EVEGYN A is a fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule.
干预措施: EVEGYN A (Drug)
fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN B)
EVEGYN B is a fixed-dose combination of 600 mg fenticonazole nitrate + 2000 mg tinidazole + 100 mg lidocaine vaginal ovule.
干预措施: EVEGYN B (Drug)
Gynomax® XL Vaginal Ovule
Gynomax® XL is a fixed-dose combination of 300 mg tinidazole + 200 mg tioconazole nitrate + 100 mg lidocaine
干预措施: Gynomax® XL Vaginal Ovule (Drug)
结局指标
主要结局
Percentage of patients who had complete response to treatment according to clinical findings
时间窗: 13 days (+/- 5 days) after treatment
Efficacy
次要结局
- Frequency and percentage of patients with SAEs/AEs in each arm(13 days (+/- 5 days))
- Percentage of patients who recovered according to microbiological findings(13 days (+/- 5 days) after treatment)
- Percentage of patients who had partial response to treatment according to clinical findings(13 days (+/- 5 days) after treatment)