Bacterial Vaginosis, Candidal Vulvovaginitis, Mixed Vaginal Infections, Trichomonal Vaginitis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGEVEGYN A
EVEGYN A: Fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1)
DRUGEVEGYN B
EVEGYN B: Fixed-dose combination of 600 mg fenticonazole nitrate + 2000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1)
200 mg tioconazole + 300 mg tinidazole + 100 mg lidocaine single dose / day, during three consecutive days (1x1 / 3 days)
Sponsors
Monitor CRO
Exeltis Turkey
Ege University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients who had complete response to treatment according to clinical findings | 13 days (+/- 5 days) after treatment | Efficacy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients who had partial response to treatment according to clinical findings | 13 days (+/- 5 days) after treatment | Efficacy |
| Percentage of patients who recovered according to microbiological findings | 13 days (+/- 5 days) after treatment | Efficacy |
| Frequency and percentage of patients with SAEs/AEs in each arm | 13 days (+/- 5 days) | Safety |
Countries
Turkey (Türkiye)
Outcome results
None listed