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

MON580.130.3

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.

2020-07-20

2021-05-06

2021-08-26

Completed

Early phase I

577

Inclusion Criteria: 1. Female patients with age of ≥ 18 and ≤ 55 years who have a regular menstrual cycle (at least 10 times a year) 2. Female patients who previously experienced vaginal intercourse 3. Patients requiring treatment for bacterial vaginosis, candidal vulvovaginitis, trichomonal vaginitis or mixed infections according to the investigator's decision 4. Signed informed consent Exclusion Criteria: 1. Known hypersensitivity to active ingredients (including their derivatives) of the study medications 2. Vaginismus, endometriosis, dyspareunia 3. Detection of urinary tract infection in urinalysis 4. Pancreatitis, hypertriglyceridemia, liver diseases, benign or malign tumors and ongoing organ failure 5. 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) 6. History of cardiovascular event 7. Uncontrolled diabetes and hypertension 8. Presence or known risk or of venous or arterial thromboembolism 9. Undiagnosed abnormal vaginal bleeding, bleeding disorders, bleeding due to intrauterine device implantation during study period, presence of genital tumors 10. Use of drugs containing ombitasvir / paritaprevir / ritonavir or dasabuvir during or two weeks before initiation of the study 11. Pregnancy and/or breastfeeding 12. Participation in any other trial 30 days before initiation of the study 13. Postmenopausal women 14. Chronic alcoholism 15. Patients with organic neurological disorders 16. Patients with blood dyscrasia or with a history of blood dyscrasia 17. Usage of medications containing acenocoumarol, anisindione, dicoumarol, phenindione, phenprocoumon, warfarin, cholestyramine, cimetidine, cyclosporine, disulfiram, fluorouracil, fosphenitoin, ketoconazole, lithium, rifampin, tacrolimus or propranolol 18. Presence of a sexually transmitted disease such as syphilis, gonorrhea, chlamydia etc. according to the investigator's decision 19. Patients who cannot perform sexual abstinence during the study 20. Patients whose treatment may be affected due to sagging of uterus or any other anatomical disorder

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 577, 'type': 'ACTUAL'}}

2023-09-28