Evaluation of Efficacy and Safety of Two New Formulations Compared to Gynomax® XL Ovule (One-Shot)
Trichomonal Vaginitis, Bacterial Vaginosis, Candidal Vulvovaginitis
About this trial
This is an interventional treatment trial for Trichomonal Vaginitis
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Ege University Family Planning and Infertility Application and Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN A)
fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN B)
Gynomax® XL Vaginal Ovule
EVEGYN A is a fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule.
EVEGYN B is a fixed-dose combination of 600 mg fenticonazole nitrate + 2000 mg tinidazole + 100 mg lidocaine vaginal ovule.
Gynomax® XL is a fixed-dose combination of 300 mg tinidazole + 200 mg tioconazole nitrate + 100 mg lidocaine