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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Trichomonal Vaginitis, Bacterial Vaginosis, Candidal Vulvovaginitis, Mixed Vaginal Infections

Intervention / Treatment
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* Drug: EVEGYN A
* Drug: EVEGYN B
* Drug: Gynomax® XL Vaginal Ovule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN A)<br>EVEGYN A is a fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule. | Drug: EVEGYN A<br>* EVEGYN A: Fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1)<br>|
| Experimental: fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN B)<br>EVEGYN B is a fixed-dose combination of 600 mg fenticonazole nitrate + 2000 mg tinidazole + 100 mg lidocaine vaginal ovule. | Drug: EVEGYN B<br>* EVEGYN B: Fixed-dose combination of 600 mg fenticonazole nitrate + 2000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1)<br>|
| Active Comparator: Gynomax® XL Vaginal Ovule<br>Gynomax® XL is a fixed-dose combination of 300 mg tinidazole + 200 mg tioconazole nitrate + 100 mg lidocaine | Drug: Gynomax® XL Vaginal Ovule<br>* 200 mg tioconazole + 300 mg tinidazole + 100 mg lidocaine single dose / day, during three consecutive days (1x1 / 3 days)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who had complete response to treatment according to clinical findings | Efficacy | 13 days (+/- 5 days) after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who had partial response to treatment according to clinical findings | Efficacy | 13 days (+/- 5 days) after treatment | 
| Percentage of patients who recovered according to microbiological findings | Efficacy | 13 days (+/- 5 days) after treatment | 
| Frequency and percentage of patients with SAEs/AEs in each arm | Safety | 13 days (+/- 5 days) |