Evaluation of Efficacy and Safety of Two New Formulations Compared to Gynomax® XL Ovule

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.

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